&EPA United States Environmental Protection Agency Office of Pesticides and Toxic Subrtanns Washington DC 20460 August 1981 Coumaphos 0,0-diethyl 0-(3-chloro-4-methyl -2-oxo-2H-1-benzopyran-7-yl) phosphorothioate Pesticide Registration Standard ------- Coumaphos 0,0-diethyl 0-(3-chloro-4-inethyl 2-oxo-2H-l-benzopryan-7-yl) phosphorothioate Pesticide Registration Standard Elizabeth LaPointe George Beusch Hudson Boyd Harry Craven Mark Dow Carolyn Gregorio Curtis Laird Lionel Richardson William Schutte Robert Storherr Robert Zendzian Owen Beeder Lynn Brown Tbnda Hicks Gary Otakie Joseph Panetta Richard Johnson Project Manager Chemist Environ, Chemist Wildlife Bioloist Entomologist Tbxicologist Wildlife Biologist Environ. Chemist Economist Chemist Pharmacolog ist Project Manager Project Manager Secretary Project Manager Project Manager Acting Section Head June 30, 1981 Office of Pesticides and Toxic Substances Environmental Protection Agency 401 M Street, SW Washington, D.C. 20460 (SPRD) (HED) (HED) (HED) (BFSD) (HED) (HED) (HED) (BFSD) (BFSD) (HED) (SPRD) (SPRD) (SPRD) (SPRD) (SPRD) (SPRD) ------- Coumaphos Registration Standard Table of Contents Chapter 1 bwtoRegisterUnderaReqistrationStandard ............. 1 Organization of the Standard 1 Purpose of the Standard . . . . . . . . . . . . . . . 1 Requirement to Reregister under the Standard 3 “PrcductSpecific”I) itaar3”Generic”E ta..... .......... 3 E ta Canpensation Requirements under FIFRA 3(c)(1)(D) 4 Cbtaining L ita to Fill “E ta Gaps”; FIFRA 3(c)(2)(B)..... 6 ! mendments to the Standard • , • , , , , • • • , • • , • , • • • , 6 Chapter II Regulatory nsition . 8 Intrt* uction[[[ 8 t scription of chemical . . . . . . . . . . . . . . 8 Regulatorylksition/CoumaphosasSoleActive.................... 9 I q ulatory Rationale . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Criteria For Registration Under the Standard...... . ..... . . . . .... 10 quired Labeling . . . . . . . . . . . . . . . . . . . . 14 ¶1t)lerance Reassessment. . . . . . . * . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Chapter III Su nnary of 1 ta Requirements and t ta Gaps. ... . . .. 17 Chapter Iv Pro1uct Chemistry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 ‘l’echnical.... . .............e. .......... 50 Physica landchemicalProperties............. ------- Chapter V E vironmenta1 Fate.. . 52 Use Profile...... .... ........... ... .... .. .. .. .......... ... .. . .. . 52 E ivironrnental Fate SuiuT ary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 Ex xsure Profile . . . . . . . . . . . . . . . . . . . . . 52 Suninary of Major Data Gaps . 53 Chapter VI ‘ibxicology. . . . . . . . . • . . . * . . . 54 ‘IbxicologySumnary- I chn icalODu1 aPhOS.............. 54 ute ‘I Dxicity 54 Subchronic ‘Itxicity . . . . . . . . . . . . . . . . 54 Chronic ‘I% xicity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 ‘itxioo logySunmary—CoumaphosFormulations.....................55 ‘Ibxicity hazard Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 SuITrnar of Major 1 ta Gaps . . . . . . . . . . . 55 Chapter VII — Residue Ci emistry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Residue Chemistry — ‘I chnical 56 Residue C emistry Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Sunrnaz , of Major Data Gaps......... .... .... . . 57 Chapter VIII Ecological Effects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Ecological Effects Suninary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Sunuiary of Major i t.a Gaps . . . . . . . . . . . . . . 58 Chapter IX Efficacy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Efficacy SI.1rriT ary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Suninary of Major Data Gaps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 ....... .... ......................•. . 61 ------- I now ‘10 REGISTER UNDER A REGISTRATION STANDARD Organization of the Standard Purpose of the Standard Requirement to Re—register Under the Standard “Product Specific” Data and “Generic” Data Data Canpensation Requirements under FIFRA 3(c) (1) (D) Obtaining Data to Fill “Data Gaps”; FIFRA 3(c) (1) (D) Amendments to the Standard Organization of the Standard This first chapter explains the purpose of a Registration Standard and suiTrnarizes the legal principles involved in registering or reregistering under a Standard. The second chapter sets forth the requirements that must be met to obtain or retain registration for products covered by this particular Registration Standard. In the remaining chapters the Agency reviews the available data by scientific discipline, discusses the Agency’s concerns with the identified potential hazards, and logically develops the conditions and requirements that w uld reduce those hazards to acceptable levels. Purpose of the Standard Section 3 of the Federal Insecticide, Fungicide, and I denticide Act (FIFRA) provides that “no person in any State may distribute, sell, offer for sale, hold for sale, ship, deliver for shipoent, or receive (and having so received) deliver or offer to deliver, to any person any pesticide which is not registered with the Pdministrator [ of EPA) .“ TO approve the registration of a pesticide, the Administrator must find, pursuant to Section 3(c)(5) that: “(A) its cx position is such as to warrant the proposed claims for it; (B) its labeling and other material required to be subaitted oanply with the requirements of this Act; (C) it will perform its intended function without unreasonable adverse effects on the environment; and (D) when used in accordance with widespread and caimonly recognized practice it will not generally cause unreasonable adverse effects on the environment.” In making these findings, the Agency reviews a wide range of data which registrants are required to subeit and assesses the risks and benefits associated with the use of the proposed pesticide. But the established approach to making these findings has been found to be defective on t counts: First, EPA and its predecessor agency, the United States Department of Agriculture (USDA), routinely reviewed registration applications on a “product by product” basis, evaluating each product—specific application sanewhat independently. In the review of products containing similar ocntponents, there was little cç ortunity for retrospective review of the fu.U range of pertinent data available in Agency files and in the public literature. Thus the “product by product” approach was often inefficient and sanetimes resulted in inconsistent or inocii lete regulatory judgnents. 1 ------- Second, over the years, as a result of inevitable and continuing advances in scientific knowledge, methodology, and policy, the data base for many pesticides came to be considered inadequate by current scientific and regulatory standards. Given the long history of pesticide regulation in several agencies, it is even likely that materials may have been lost fran the data files. When EPA issued new requirements for registration in 1975 (40 CFR 162) and proposed new guidelines for hazard testing in 1978 (43 FR 29686, July 10, 1978 and 43 FR 37336, August 22, 1978), many products that had already been registered for years were being sold and used without the same assurances of human and environmental safety as was being required for new products. Because of this inconsistency, Congress directed EPA to reregister all previously registered products, so as to bring their registrations and their data bases into canpliance with current requirements. (See FIEW Section 3(g)]. Facing the enormous job of re-reviewing and calling—in new data for the approximately 35,000 current registrations, and realizing the inefficiencies of the “product by product” approach, the Agency decided that a new, more effective method of review was needed. A new review procedure has been developed. Under it, EPA publishes documents called Registration Standards, each of which discusses a particular pesticide active ingredient. Each Registration Standard summarizes all the data available to the Agency ai a particular active ingredient and its current uses, and sets forth the Agency’s cC1T prehensive position on the conditions and requirements for registration of all existing and future products which contain that active ingredient. These conditions and requirements, all of which must be met to obtain or retain full registration or reregistration under Section 3(c)(5) of FIFRA, include the sut*nission of needed scientific data which the Agency does not now have, canpliance with standards of toxicity, cauposition, labeling, and packaging, and satisfaction of the data canpensation provisions of FIFRA Section 3(c)(l)(D). The Standard will also serve as a tool for product classification. As part of the registration of a pesticide product, EPA may classify each product for “general use” or “restricted use” (FIFRA Section 3(d)]. A pesticide is classified for “restricted use” when sane special regulatory restriction is needed to ensure against unreasonable adverse effects to man or the environment. Many such risks of unreasonable adverse effects can be lessened if expressly-designed label precautions are strictly followed. Thus the special regulatory restriction for a “restricted use” pesticide is usually a requirement that it be applied only by, or under the supervision of, an applicator who has been certified by the State or Federal government as being canpetent to use pesticides safely, responsibly, and in accordance with label directions. A restricted—use pesticide can have other regulatory restrictions (40 CER 162.11(c) (5)] instead of, or in addition to, the certified applicator requiremente These other regulatory restrictions may include such actions as seasonal or regional limitations on use, or a requirement for the monitoring of residue levels after use. A pesticide classified for “general use,” or not classified at all, is available for use by any individual who is in xxnpliance with State or local regulations. The Registration Standard review caupares information about potential adverse effects of specific uses of the pesticide with risk criteria listed in 40 CFR 162.11(c), and thereby determines whether a product needs to be classified for “restricted use.” If the Standard does classify a pesticide for “restricted use,” this determination is stated in the second chapter. 2 ------- Requirement to Reregister Under the Standard FIFRA Section 3(g), as amended in 1978, directs EPA to reregister all currently registered products as expeditiously as possible. Congress also agreed that reregistration should be acoanplished by the use of Registration Standards. Each registrant of a currently registered product to which this Standard applies, and who wishes to continue to sell or distribute his product in canuerce, must apply for reregistration. His application must contain proposed labeling that canplies with this Standard. EPA will issue a notice of intent to cancel the registration of any currently registered product to which this Standard applies if the registrant fails to canply with the procedures for reregistration set forth in the Guidance Package which accanpanies this Standard. “ Product Specific” Data and “Generic” Data In the course of developing this Standard, EPA has determined the types of data needed for evaluation of the properties and effects of products to which the Standard applies, in the disciplinary areas of Product Chemistry, Environmental Fate, ‘Ibxicology, Residue Chemistry, and Ecological Effects. These determinations are based primarily on the data Guidelines proposed in 1978 (43 FR 29696, July 10, 1978, and 43 FR 37336, ugust 22, 1978), as applied to the use patterns of the products to which this Standard applies. Where it appeared that data fran a normally applicable Guidelines requirement was actually unnecessary to evaluate these products, the Standard indicates that the requirement has been waived. Cn the other hand, in sane cases studies not required by the Guidelines may be needed because of the particular ccttiposition or use pattern of products the Standard covers; if so, the Standard explains the Agency’s reasoning. Data guidelines have not yet been proposed for the Residue Chemistry discipline, but the requirements for such data have been in effect for sane time and are, the Agency believes, relatively familiar to registrants. Data which we have found are needed to evaluate the registrability of saiie products covered by the Standard may not be needed for the evaluation of other products, depending upon the canposition, formulation type, and intended uses of the product in question. The Standard states which data requirements apply to which product categories. (See the third chapter.) The various kinds of data normally required for registration of a pesticide product can be divided into ts basic groups: (A) data that are “ product specific, ” i.e., data that relate only to the properties or effects of a product with a particular cc*nposition (or a group of products with closely similar canposition); and (B) “ generic ” data that pertain to the properties or effects of a particular ingredient, and thus is relevant to an evaluation of the risks and benefits of all products containing that ingredient (or all such products having a certain use pattern), regardless of any such product’ s unique ccnLposition. The Agency requires certain “product specific” data for each product to characterize the product’s particular ccmçosition and physical/chemical properties (Product Chemistry), and to characterize the product’s acute toxicity (which is a function of its total canposition). The applicant for registration or reregistration of any p od t, whether it is a manufacturing— ------- use or end—use product, arx I without regard to its intended use pattern, must sutinit or cite enough of this kind of data to allow EPA to evaluate the product. For such purposes, “product specific” data on any product other than the applicant’ s is irrelevant, unless the other product is closely similar in cx nposition to the applicant’s. (Where it has been found practicable to group similar products for purposes of evaluating, with a single set of tests, all products in the group, the Standard so indicates.) “Product specific” data on the efficacy of particular end—use products is also required where the exact formulation may affect efficacy and where failure of efficacy could cause public health problems. All other data needed to evaluate pesticide products concerns the properties or effects of a particular ingredient of products (normally a pesticidally active ingredient, but in sane cases a pesticidally inactive, or “inert”, ingredient). Sane data in this “generic” category are required to evaluate the properties and effects of all products containing that ingredient [ e.g., the acute LD-50 of the active ingredient in its technical or purer grade; see proposed 40 CFR 163.81—1(a), 43 FR 373551. Other “generic” data are required to evaluate all products which both contain a particular ingredient and are intended for certain uses (see, e.g., proposed 40 CFR l6382—l, 43 ER 37363, which requires subchronic oral testing of the active ingredient with respect to certain use patterns only). Where a particular data requirement is use—pattern dependent, it will apply to each end— use product which is to be labeled for that use pattern (except where such end— use product is formulated fran a registered manufacturing-use product permitting such formulations) and to each manufacturing-Use product with labeling that allows it to be used to make end-use products with that use pattern. Thus, for example, a subchronic oral dosing study is needed to evaluate the safety of any manufacturing—use product that legally could be used to make an end—use, food-crop pesticide. But if an end—use product’ s label specified it was for use only in ways that involved no food/feed exposure and no repeated human exposure, the subchronic oral dosing study would not be required to evaluate the product’s safety; and if a manufacturing—use product’s label states that the product is for use only in making end-use products not involving food/feed use or repeated human exposure, that subchronic oral study would not be relevant to the evaluation of the manufacturing—use product either. If a registrant of a currently registered manufacturing-use or end—use product wishes to avoid the costs of data ainpensation [ under FIFRA Section 3(c) (1) (D)] or data generation (under Section 3(c)(2)(B)] for “generic” data that is required only with respect to sane use patterns, he may elect to delete those use patterns fran his labeling at the time he reregisters his product. An applicant for registration of a new product under this Standard may similarly request approval for only certain use patterns. I ta Compensation Requirements under FIFRA 3(c)(1)(D ) Under FIFRA Section 3(c) (1) (D), an applicant for registration, reregistration, or amended registration must offer to pay cmpensation for certain existing data the agency has used in developing the Registration Standard • The data for which cxxnpensation must be offered are all data which are described by all of the following criteria: 4 ------- (1) the data were first sulxnitted to EPA (or to its predecessor agencies, USDA or F1Y ), on or after January 1, 1970; (2) the data were sut:xnitted to. EPA (or USDT’t or FDA) by sane other applicant or registrant in support of an application for an experimental use permit, an amendment adding a new use to a registration, or for reregistration, or to support or maintain an existing registration; (3) the data are relevant to the Agency’ s decision to register or reregister the applicant’s product under the Peg istrat ion Standard, taking into account the applicant’ s product ‘ s canposition and intended use pattern(s); (4) the data are determined by EPA to be valid and usable in reaching regulatory conclusions; and (5) the data are not those for which the applicant has been exempted by FIFRA Section 3(c)(2)(D) fran the duty to offer to pay canpensation. (This exemption applies to the “generic” data concerning the safety of an active ingredient of the applicant’s product, not to “product specific” data. The exemption is available only to applicants whose product is labeled for end-uses for which the active ingredient in question is present in the applicant’s product because of his use of another registered product containing that active ingredient which he purchases fran another producer.) An applicant for reregistration of an already registered product under this Standard, or for registration of a new product under this Standard, accordingly must determine which of the data used by EPA in developing the Standard must be the subject of an offer to pay caupensation, and must subeit with his application the appropriate statements evidencing his canpliance with FIFRA Section 3(c)(l)(D). An applicant would never be required to offer to pay for “product specific” data subnitted by another firm. In many, if not in n st cases, data which are specific to another firm’s product will not suffice to allow EPA to evaluate the applicant’s product; that is, will not be useful to the Agency in determining whether the applicant’s product is registrable. There may be cases, however, where because of close similarities between the ocxnpositiOn of two or nore products, another firm’s data may suffice to allow EPA to evaluate sane or all of the “product specific” aspects of the applicant’s product. In such a case, the applicant may choose to cite that data instead of sukinitting data fran tests on his own product, and if he chooses that option, he u1d have to xmply with the Section 3(c) (1) (D) requirements with respect to each item of “generic” data that relates to his product’s intended uses. Each applicant for registration or reregistration of a manufacturing—use product, and each applicant for registration or reregistration of an end—use product, who is rot exempted by FIFRA Section 3(c)(2)(D), must cxxnply with the Section 3(c) (1) (D) requirements with respect to each item of “generic” data that relates to his product’ s intended uses. A detailed description of the procedures an applicant must follow in applying for reregistration (or new registration) under this Standard is found in the Guidance Package for this Standard. 5 ------- Obtaining Data to Fill “Data Gaps”; FIFRA 3(c)(2)(B ) Sane of the kinds of data EPA needs for its evaluation of the properties and effects of products to which this Standard applies have never been sub nitted to the Agency (or, if st.±mitted, have been found to have deficiencies rendering them inadequate for making registration decisions) and have not been located in the published literature search that EPA conducted as part of preparing this Standard. Such instances of missing but required data are referred to in the Standard as “data gaps.” FIFRA Section 3(c) (2) (B), added to FIFRA by the Congress in 1978, authorizes EPA to require registrants to whan a data requirement applies to generate (or otherwise produce) data to fill such “gaps” and sutinit those data to EPA. EPA must allow a reasonably sufficient period for this to be accanplished. If a registrant fails to take appropriate and timely steps to fill the data gaps identified by a Section 3(c) (2) (B) order, his product’s registration may be suspended until the data are sutinitted. A mechanism is provided whereby t or more registrants may agree to share in the costs of producing data for which they are both responsible. The Standard lists, in the third chapter, the “generic” data gaps and notes the classes of products to which these data gaps pertain. The Standard also points out that to be registrable under the Standard, a product must be supported by certain required “product specific” data. In sane cases, the Agency may possess sufficient “product specific” data on one currently registered product, but may lack such data on another. Only those Standards which apply to a very small number of currently registered products will attempt to state definitively the “product specific” data gaps on a “product—by-product” basis. (Although the Standard will in sane cases note which data that EPA does possess u1d suffice to satisfy certain “product specific” data requirements for a category of products with closely similar canposition characteristics.) As part of the process of reregistering currently registered products, EPA will issue Section 3(c)(2)(B) directives requiring the registrants to take appropriate steps to fill all identified data gaps -— whether the. data in question are “product specific” or “generic” —- in accordance with a schedule. Persons who wish to obtain registrations for new products under this Standard will be required to sutiuiit (or cite) sufficient “product specific” data before their applications are approved. Upon registration, they will be required under Section 3(c) (2) (B) to take appropriate steps to suti it data needed to fill “generic” data gaps. (We expect they will respond to this requirement by entering into cost-sharing agreements with other registrants who previously have been told they must furnish the data.) The Guidance Package for this Standard details the steps that must be taken by registrants to ccinply with Section 3(c)(2)(B). Anendments to the Standard Applications for registration which propose uses or formulations that are not presently covered by the Standard, or which present product cciupositions, product chemistry data, hazard data, toxicity levels, or labeling that do not meet the requirements of the Standard, will autanatically be considered by the Agency to be requests for amendments to the Standard. In response to such applications, the Agency may request additional data to support the proposed 6 ------- amendment to the Standard, or may deny the application for registration on the grounds that the proposed product v uld cause unreasonable adverse effects to the environment. In the former case, when additional data have been satisfactorily supplied, and providing that the data do not indicate the potential for unreasonable adverse effects, the Agency will then amend the Standard to cover the new registration. Each Registration Standard is based upon all data and information available to the Agency’s reviewers on a particular date prior to the publication date. This “cut-off” date is stated at the beginning of the second chapter. ny subsequent data sulmissions and any approved amendments will be incorporated into the Registration Standard by means of addenda, which are available for inspection at EPA in Washington, D.C., or copies of which may be requested fran the Agency. When all the present “data gaps” have been filled and the sutmitted data have been reviewed, the Agency will revise the Registration Standard. Thereafter, when the Agency determines that the internally maintained addenda have significantly altered the conditions for registration under the Standard, the document will be updated and reissued for publication. While the Registration Standard discusses only the uses and hazards of products containing the designated active ingredient(s), the Agency is also concerned with the potential hazards of sane inert ingredients and impurities. Independent of the developnent of any one Standard, the Agency has initiated the evaluation of sane inert pesticide ingredients. Where the Agency has identified inert ingredients of concern in a specific product to which the Standard applies, these ingredients will be pointed out in the Guidance Package. 7 ------- II Regulatory Position 1. Introduction This chapter describes the Z gency’s regulatory position on products which contain coumaphos as the sole active ingredient. The ? 4 gency’s regulatory position incorporates a number of considerations. Foren st anong these considerations is an analysis of the registrability of products containing coumaphos based on the risk criteria found in Section 162.11(a) of Title 40 of the U.S. Code of Federal Regulations. The 1 gency’s determination is presented below, and the rationale for this decision follows the position. In addition to the basic regulatory decision and rationale, this chapter includes the following: criteria for the registration of coumaphos products under the Standard; acceptable ranges and limits for product canposition, acute toxicity, and use pattern/application method; required labeling, and a tolerance reassessment. The scientific basis for decisions presented in this chapter can be found by reading the various disciplinary chapters (Chapters IV-IX) which provide sumaries of available scientific data on coumaphos. The data requirements and data gaps are presented in Chapter III. Also, the rationale for requiring data can be found in the footnotes of the tables in Chapter III. References to ) ency guidelines for testing are provided when appropriate. In instances where the data requirements differ fra u the guideline requirements, the rationale is presented in the footnotes of the tables. 2. I scription of Chemical Coumaphos is an insecticide used to control flies, fly larvae, cattle grubs, ticks, lice, fleas, , screwworms and fleeceworms on animals. The chemical name for coumaphos is 0, O-d iethyl 0- ( 3-chloro-4-methyl--2-oxo-2H-1-benzopyran—7- yl) phosphorothioate. For convenience in writing this Standard the name “coumaphos” will be used instead of the chemical names • Use of the name coumaphos, however, implies no endorsement of any product containing the active ingredient. Coumaphos is the camon name accepted by the International Organization of Standardization (ISO). The American National Standard Institute has rot recognized coumaphos as the accepted camon name. Trade names for counaphos include: Bay 21/199, Asuntol, Muscatox, Resitox, Baymix®, Meldane, Unbethion, and Co-Ral®. (Co-Ral is the registered trademark of the Farbenfabriken Bayer A.G. (MacI uga1l (19??) MRID 00005526). The technical chemical names for coumaphos are: a • 0, 0-diethyl 0—( 3—chloro -4-methyl—2-oxo-2H—1—benzopyran-7—yl) phosphorothioate b. 0- ( 3-chloro-4-methyl-7-counarinyl) 0, 0-diethyl phosphorothioate c. 0,0-diethyl 0-(3—chloro-4--methyl-7-counarinyl) phosphorothioate The Chemical Abstracts Registry (CAS) number for coumaphos is 56-72-4. The opp (Shaughnessey) number is 036501. The nolecular formula is C 14 H 16 C10 5 PS. ------- 3. 1 gu1atory Iksition for Products Containing Coumaphos as the Sole Active Ingredient Coumaphos as described in this Standard may be registered for sale, distributicri, formulation, arid use in the United States • Based on the review of the limited data, the Agency, as of May 12, 1981, finds that none of the risk criteria found in Section 162.11(a) of Title 40 of the U.S. Code of Federal Regulations (CFR) were met or exceeded for cournaphos. The Agency has considered the limited scientific data obtained frcni the open literature as of May 12, 1981 and those data suheiitted by the registrants up through the time of publication of this Standard. The Agency does not have reason to believe that the use of this insecticide will cause unreasonable adverse effects when used in canpliance with proper label directions and precautions. Also, at this time, the Agency has no data with which to classify existing counaphos products. Products will be classified when sufficient data are available. Existing coumaphos products may be reregistered subject to the conditions imposed fot data requirements. New coumaphos products may be registered under this Standard, and are subject to the same requirements. 4. Regulatory Rationale Counaphos was first registered as a pesticide in 1958. Current annual production in the U.S. arrounts to approximately 500,000 lbs. It is used as an insecticide on cattle, livestock, livestock bedding, sheep, goats, horses, dogs, arid dog bedding, poultry, poultry housing and poultry litter. It is applied as a dust, spray, dip, pour-on, and backrubber oiler. The products act on the surface of arid systemically in the animal. Because the pesticide is used to control certain public health pests on dogs (fleas, lice, arid ticks), proof of the efficacy of counaphos for these uses is a registration requirement (44 FR 27932: May 11, 1979). Coumaphos is registered under §24(c) of FIFRA for use within the states of New Mexico and California to meet special local needs. Five percent counaphos dust bags are registered for control of scabies mite on desert bighorn sheep in NeW Mexico. fle twenty-five percent wettable powder is registered for control of scabies mite on cattle in California. There are limited scientific studies available with which to assess the registrability of all coumaphos products. Available acute toxicity data indicate that: 1) a 50% wettable powder formulation is a severe eye irritant and has a low acute dermal toxicity; and 2) that the oral toxicity of technical counaphos is high. The data further indicate that a 25% wettable powder formulation has an oral LD four times itore toxic than a 50% wettable powder formulation. The one acce able chronic effects study denonstrates that counaphos is not oncogenic in rats arid mice. Several studies suggest that cournaphos is a cholinesterase inhibitor in animals although these studies do not meet the Agency’s Guidelines for testing (see Chapter VI). Residues of coumaphos are alequately analyzed in the literature and, as discussed in section 7 of this chapter, do not exceed established U.S. tolerances when the pesticide is applied according to label instructions (see Chapter VIII). Sme data are ayailable on the physical/chemical properties of technical coumaphos, but there are ma:jor gaps, particularly for the manufacturing-use and end—use products (see Chapter IV). Qie study is 9 ------- available on ecological effects arid there are no data on the environmental fate of oumaphos (see chapters V and VIII). The efficacy of the cxinpound ‘then used on dcis is partially established in the literature; however, the gency accepts the cxinpound as being efficacious on dogs based on the well—established efficacy for livestock (see Chapter IX). Although the data base is inccinplete, the ?iency has concluded that it should continue the registration for this product for the following reasons: -— No adverse effects have been discovered in the review of the available studies on coumaphos which are not already adequately addressed by FIFRA labeling requirements. Therefore, the benefits denonstrated by the sale of this product outweigh the known risks. -— The nine reported incidents under the Pesticide Incident Monitoring System (PIMS) involving this chemical are poorly documented and do riot establish that coumaphos, properly handled and applied, was the cause of the adverse effects. -— When coumaphos is applied according to label directions coumaphos residues do not exceed the established U.S. tolerances. -— The Standard protects against over—exposure to the pesticide in the residential setting by requiring either child—resistant packaging or veterinary use only for residential use products that n et the child resistant packaging criteria. -— The chemical is judged I y EPA to be efficacious in controlling fleas, lice, arid ticks on dogs and dog bedding. —— In accordance with FIFRA, the ? ency’ s policy is not to cancel routinely the registration of products merely because of a lack of data, or to withhold registration n rely because of lack of data. (See Sections 3(c)(2)(B) and 3(c)(7) of FIFRA). Rather, publication of the Standard provides a nechanism for identifying data needs and the registration arid reregistration requirements. The Standard allows for upgrading of labels during the period in which the required data are being generated. When these data are received, they will be reviewed by the Pt ency and the registrability of the chemical will be reassessed. 5. Criteria for Registration Under the Standard ‘lb be subject to this Standard, oouiiaphos products must meet the following conditions: — contain coumaphos as the sole active ingredient; -— be within acceptable standards of product canposition; -— be within acceptable acute toxicity limits; -— be labeled for acceptable end-uses; -— bear required labeling. 10 ------- Technical and manufacturing—use coumaphos products must bear label directions for formulation into acceptable end—uses. The applicant for registration or reregistration of counaphos products subject to this Standard must cxinply with all terms and conditions described in this Standard, including cclTrnitment to fill data gaps on a time schedule specified by the P ency and, when applicable, offer to pay oaapensation to the extent required by Sections 3(c)(l)(D) and 3(c)(2)(D) of FIFBA, as amended, 7 U.S.C. 136(c) (1) (D) and 136 (c) (2) (D). As discussed in Chapter I, applicants for registration under this Standard must contact the Pa ency for specific instructions, including updated information on data requirements and ca panies whose data can be cited and, in the event that these data are cited, to whem canpensation must be offered. A. Technical Coumaphos 1) Product Qx osition Standards ‘lb be covered under this Standard, the technical product may contain no less than 90% coumaphos as the sole active ingredient. Any technical product sutznitted for registration containing less than 90% coumaphos as the sole active ingredient will be considered a new product and will not be req istrable under this Standard. 2) Acute ‘ I xicity Limits The P ency will consider registration of technical coumaphos products in the following toxicity categories: I II III IV Acute Oral Toxicity yes yes yes yes Acute Dermal Toxicity yes yes yes yes Acute Inhalation Toxicity yes yes yes yes Primary Eye Irritation yes yes yes yes Primary Dermal Irritation yes yes yes yes 3) Use Patterns To be covered under this Standard, technical coumaphos products must be labeled for formulation into manufacturing—use products or for formulation into end-use pesticides which are intended for insecticidal applications on animals, animal housing, litter, and bedding. B. Manufacturing-Use Counaphos 1) Product Caiposition Standards To be covered under this Standard, manufacturing-use coumaphos must contain coumaphos as the sole active ingredient. In addition, all manufacturing-use coumaphos products must not contain impurities other than those in currently 11 ------- registered manufacturing—use products and at no higher concentration than those in currently registered products. Any manufacturing—use product not meeting these requirements will be considered a new product and will not be registrable under this Standard. Manufacturing-use products meeting these requirements may contain any percentage active ingredient. 2) Acute ¶Lbxicity Limits The kjency will consider registration of manufacturing—use coumaphos products in the following categories: I II III IV Acute Oral xicity yes yes yes yes Acute Dermal Dxicity yes yes yes yes Acute Inhalation ‘Ibxicity yes yes yes yes Primary Eye Irritation yes yes yes yes Primary Dermal Irritation yes yes yes yes 3) Use Patterns ¶Ib be covered under this Standard, manufacturing-use cournaphos products must be labeled for formulation into end—use pesticides which are intended for insecticidal applications on animals, animal housing, litter, and bedding. C. End-Use Cournaphos -- Dust, Wettable k 3er, Pressurized Spray, ur-on Liquid, and E uulsifiable Concentrate 1) Product Canposition Standards The following table shows the canposition standards end-use coumaphos products must meet to be acceptable under this Standard. In addition, all end—use counaphos products must not contain inerts and impurities other than those in currently registered end—use products and at no higher concentration than those in currently registered end-use products. Any end-use product not meeting these requirements will be considered a new product and will not be registrable under this Standard. ForTrulation. Percent Active Ingredient Dust (other than dog dust) up to 5% Wettable Pow er up to 25% Pressurized Liquids up to 3.5% Ikur-on Liquid up to 4% Dnulsifiable Concentrate up to 11.9% 12 ------- The only exception to the above ranges a ç1ies to products intended for control of fleas, , and ticks on dogs and dog bedding. Such products must not fall below 0.5% of the active ingredient for a dust, 1.0% for a pressurized liquid, and 0.2% for a dip. ‘lb be registered for use on dogs, coumaphos products below these concentrations will require the performance or citation of supportive efficacy testing. Inert ingredients in food—use formulations must be exempted fran the requirement of a tolerance (or have tolerances established) under 40 CFR 180.1001. Currently, there are 17 inert ingredients used in coumaphos end—use products that are not exempted under 40 CFR 180.1001(e). These 17 ingredients are listed in the guidance package which acccxnpanies this Standard. The gency has identified Freon, a chiorofluorocarbon, as an inert ingredient in certain coumaphos products, fran review of current Confidential Statements of Formula • The I gency has banned the use of chlorofluorocarbons in all but critical pesticide products. The Pgency does not consider coumaphos a critical product. Therefore, all products containing Freon are not registrable under this Standard. 2) Acute Ibxicity Limits The 1 ency will consider registration of any end-use coumaphos products for danestic use in the following categories: I II III IV Acute Oral Tbxicity no no yes yes Acute Derinal ‘Ibxicity no no yes yes Acute Inhalation Thxicity no no yes yes Primary Eye Irritation no no yes yes Primary Dermal Irritation no yes yes All coumaphos end-use products intended for danestic use as defined in 40 CFR 162.l6(b)(2) in ‘lbx Category III or IV, which meet the child resistant packaging criteria (40 CFR 162.16), must either be packaged for child resistance or be limited to and labeled for veterinary use only. ------- The ? gency will consider registration of any end—use counaphos products for nondanestic use with the following categories: I II III IV Acute Oral ¶t’ xicity no yes yes yes Acute Derinal ‘Itxicity no yes yes yes Acute Inhalation ¶L xicity no yes yes yes Primary Eye Irritation no yes yes yes Primary Dermal Irritation no yes yes yes There are no currently registered end-use products in ‘I x Category I. Any products sutinitted in this Category uld require supporting data, and uld not be registrable under this Standard. 3) Use Patterns and Application Methods ¶Ib be registered under this Standard, end-use coumaphos products must be labeled as insecticides for one or i ore of the following uses: food use non-food uses cattle dogs goats dog bedding swine livestock bedding horses poultry housing poultry poultry litter sheep be registered under this Standard, application rates of coumaphos products must not exceed current levels. This interim restriction is necessary because the data required to evaluate the environmental hazards of all coumaphos products are inccrnplete. The Agency will reassess maximum application rates of all uses when all data required have been sutmitted (see thapter III). 6. 1 quired Labeling Al .]. coumaphos products must bear labeling as specified in 40 CER 162.10. The guidance package for this Standard contains specific information regarding label requirements. 14 ------- A. Technical and Manufacturing-Use Products 1) Use Pattern Statements All technical and manufacturing—use products must list on the label the intended end-use of formulated products produced fran the technical or manufacturing—use products. In accordance with data to be suthUtted or cited, all coumaphos technical and manufacturing-use product labels must bear the following statements: “For Formulation into an end-use product or an intermediate to be formulated into an end-use product intended for insecticidal use on animals, animal housing, litter, and bedding. t ’ 2) Precautionary Statements Because of the absence of data needed to assess the environmental and health hazards of counaphos, the I½gency cannot evaluate the adequacy of precautionary statements on technical and manufacturing use product labels. Therefore, no changes to current label statements are required at this time • The agency may, after review of data to be su)initted under this Standard, require revisions to current labels and may impose additional label requirements. B. fl d-Use Coumaphos Products Because of the absence of data needed to assess the environmental and health hazards of cournaphos, the k ency cannot evaluate the adequacy of precautionary statements on coumaphos end-use product labels. Therefore, no changes to current label statements are required at this time. Registrants may, at their option, label all &ettable pow3er formulations according to the requirements of ¶Lbxicity Category I for eye irritation and thereby be granted a waiver of the requirement for further eye irritation testing (see Chapter III, ‘I ble C—2). The Pt ency may, after review of all data to be subnitted under this Standard, require revisions to current labels and may also impose a3ditional label requirements. 7. Iblerance Reassessment U. S. tolerances are established for residues of the insecticide coumaphos, 0,0— diethyl 0- ( 3-chloro-4-nlethyl-2-oxo-2H-l-benzopyran-7-y1) phosphorothioate, and its ox ’gen analog, 0 ,0-diethyl 0-3-chloro—4-niethyl-2-oxo--2H—l—benzopyran-7-yl- phosphate, in or on raw agricultural products as follows: (40 CFR 180.189): 1 ppn in or on meat, fat, and meat by—products of cattle, goats, hogs, horses, poultry, and sheep 0.5 p *n in milk fat (reflecting negligible residues in milk) 0.1 n in eggs. 15 ------- The tolerance established by the Canadian government is 0.5 ppii in meat . meat by—products and fat of cattle, goats horsesr hogs, poultry, and sheep. This is lower than the U.S. tolerance due to different methods of setting tolerances. The Canadian tolerance reflects expected residues that are statistically determined percentages of the maximum residues, rather than the maximum residues used in setting U.S tolerances. ¶I mporary Codex Maximum Residue P vels 1 ppu in poultry and fat of meat of cattle, 0.5 ppn in fat of meat of sheep, pigs, goats, milk, and milk products, and 0.05 ppn in eggs are proposed to be revoked due to a lack of supporting data. The theoretical maximum residue contribution (ThRC) of total coumaphos in the average ?nterican adult diet of milk, meat, fat, milk by—products, and eggs containing the respective U.S. tolerance levels is calculated to be 0.22 mgjday/l.5 kg. CoLinaphos applied at the currently registered U.S. application rates will r t exceed the established tolerances. Ebwever, the 1 ency is unable to establish an acceptable daily intake (ADI) value for counaphos because of the absence of acceptable sl ,se th1e_effect level” (NOEL) data. The ? gency is, therefore, unable to assess the safety of current tolerances because of the lack of chronic effects data. When the required chronic effects data are sutinitted (see xicology data gaps in Chapter III) the Pgency will assess the counaphos tolerances and revise them as necessary. In the meantime, current U.S. tolerance levels will remain in effect. 16 ------- III. Sumary of Data Requirements and Data Gaps AEplicants for registration of coumaphos products must cite or subiiit the information identified as required in the tables in this chapter. The tables a p1icab1e to end—use products indicate whether the product to be tested is the technical grade or a formulation. The tables list the Proposed Guidelines which describe the type of data and when the data are required to be su}xnitted [ 43 FR, No. 132, 29696 of July 10, 1978; and 43 FR, . 163, 37336 of August 22, 1978]. Justification for why the test is required is pro iided in the Guidelines. A discussion of why data additional to that already su}initted are necessary, or why data normally required are not necessary for this chemical, are explained in footnotes to the tables. The data requirements specified are the minimum that will be required. Areas where additional data may be required as the result of tiered testing are indicated. ‘7 ------- Thble Pr-i Product thesistzy (See thapter IV) c nerlc Data I quire ents l4ust i Ei ai Data &tiuitted urder FIFRA ? re Data D es EPA Have 3(c)(2) (Bfl If , maths I quired Data to Partially a11 d for sutnission G ide1ines ne of F This cx totally Satisfy Bibliogra )ic frott published date of Citation Test Stardard? Q iipisition this I quirement? Citation — — Stardard . 163.61—3 Product Identity yes Technical grade partial 00005526 yes, 1 8 ma. - flisciosure of active ingre— of Ingredients dient (1 AI) 163.61—4 Dascription of yes IGAI 00005192, 00005526 manufacturing 05012747, 00005193 163.61—5 Discussion on IGAI yes 05003798, 00005838, formation of 00005207, 00005435, ziintentiona1 00005188, 00005189, Ingredients 163.61—6 Daclaration sad as (See 163.61—5) cartification of ingredients limits 163.61—7 Product analytical yes 00005433, 00005189 ro mathods sal data 05003798, 00005278 05004290, 00005188, 00005187 163.61—8(1) a lcr 00005193, 00005307. 00005417, 00021981, 00005190, 00005526 163.61—8(2) o or yes (See 163.61—8(1)) 163.61—8(3) Melting Point I yes (See 163.61—8(U) July, 1981 ------- le A—i (Ccxit’d) Product th nistry (See thapter IV) Generic Data I quirei ents — l4ist Pdditional Data be Sthnitted under FI A Are Data I es EPA Have 3(c)(2)(8)? If so, nonths I quired Data to Partially allowed for sthnission Qilde lines t ne of Fbr This or totally Satisfy Bib1iogra ic fran piilished date of Citation st Standard? Cai ’osjtion this 1 quiresent? Citation — Standard . 163.61—8(4) Soithility yes ‘ibchnical graie pertial (See 163.61—8(1)) yes,-V 8 sos. of active ingre- dient (1 A1) 163.61—8(5) Stability !IGAI yes (See 163.61—8(1)) 163.61—8(6) tasol/Water fl3A1 so (See 163.61—8(1)) yes, 8 sos. pertition cx,efficient 163.61—8(7) Physical State yes ! ICAI yes (See 163.61—8(1)) I0 163.61—8(8) Dansity or Specific yes 9XA1 so (See 163.61—8(1)) yes, 8 sos. (kavity 163.61—8(9) alling Point yes I G A l (See 163.61—8(1)) so 163.61—8(10) V por Pressure yes ‘ I GAI (See 163.61—8(1)) so 163.61—8(11) *I yes !I GAI (See 163.61—8(1)) yes, 8 sos. 163.61—8(12) Storage Stability so July, 1981 ------- Table A—i (Cait’d) Product thenistry (See thapter I V) Generic Data I quiren nts ______- Ibat Mditional Data be Sthnitted under FIFRA Are Data i ee A Have 3(c)(2)(B)? If so, iTOflthS Icquired Data to Partially allowed for sd inission Qaidelines t ne of br This ix totally Satisfy 8ibliograi ic fran piblished date of Citaticn st Standard? Ca ositian this I c ilrenent? Citation 3/ — Standard . 163.61—8(13) Fl inability ro 163.61—8(14) idizinj cc ucir Action 163.61—8(15) Dcplcsiveness 163.61—8(16) Miscibility no 163.61—8(17) Viscosity Qaefficient 163.61—8(18) Q jusia tharacteristics 163.61—9(19) DIelectric weak— no * 1tage 163.61—9 oitta1 of no sa p1es July, 1981 ------- Footnotes Table A—i Product Chemistry Generic Data Requirements Coumaphos 1/ Certification that the ingredient statement accurately reflects current production is required. 2/ A quantitative description of Solubility is required. 3/ The following studies were used in developing the Standard. Although they are not cited in support of a specific Guideline requirement, they were generally used: 05006145, 05010317, 05002073, 00005208, 00005528, 05002075, 00005336, 05002340, 05004089, 05005130, 05002360, 05004866, 00021997, 05014477, 05010318, 05003797, 00005298, 05003798. 21 ------- Table A—2 Environmental Fate (See thapter V) Generic Data Requirements Q tznaptcs Mist Additional Data be Sut*nitted under FIFRA Are Data Daes EPA Have 3(c) (2) (B)? If so, months Required Data to Partially allowed for suheission Guidelines Nane of For This or totally Satisfy Bibliographic fran published date of Citation Test Standard? Com sition this Requirement? Citation ___Standard. 163.62—7(b) Hydrolysis Radio—labeled no ” yes, 8 sos. analytic grade or technical grade of active ingredient LAGf AI) 163.62—7(c) Photodegradation RLAG/ l AI no yes, 8 sos. 163.62—8(b) Aerobic Soil yes PL?tGfIGAI no yes, 26 sos. Metabolime 163.62—8(c) Anaerobic Soil RLAG/1 3AI no yes, 26 sos. Metabolime 163.62—8(d) Anaerobic Aquatic no Metabolisn 163.62—8(e) Aerobic Aquatic no Metabolisn 163.62—8(f) Microbial Metabo— lime: 2 (1) Effects of reserved-’ Microbes on Pesticides 2 (2) Effects of reserved—’ Pesticides on Microbes July, 1981 ------- Table A—2 (Cont’d) thvirorinental Fate (See thapter Vi Generic Data Requirenents GeLinaphos Itist ?dditional . Data Are Data Daes EPA Have Sutznitted under FIFRA 3(c) If Requried Data to Partially (2) (B)? so, allowed for suhoission Guidelines Nene of br This or totally Satisfy Bibliographic fr an date of Citation Test Standard? Composition this Requirement? Citation Standard. 163.62-8(g) Activated Slixlge reserved ’ - reserved- ’ 163.62-9(b) Leaching yes ’ Technical grade of the active ingredient (TGAI) no yes, 14 sos. 163.62—9(c) Volatility yes 1 i Ai no yes, 14 sos. 163.62—9(d) so rpt ion! Deso rpt ion yes IGAI no yes, 14 sos. 163.62—9 Ce) ter Dispersal yes A representative formulation type no yes, 14 sos. 163.62—10(b) Terrestrial Field Dissipation: (1) Field & Vege— table Crops (2) Tree Fruit & kit Crops Uses (3) Pasture Land Uses (4) Damestic Out— door Parks, Ornanental & Terf Uses 6’ reserved-’ 6’ reserved—’ 6’ reserved-’ no no no no July, 1981 ------- Table A—2 (Cont’d) Environmental Fate (See thapter V) Generic Data Requirenents O3tJnaphos ttist Additional Data be Subnitted under FIFRA Are Data 1 es EPA Have 3(c) (2) (B)? If so, uonths Guidelines Citation Name of Test Required Fbr This Sthadard? Composition ! ta to Partially or totally Satisfy this Requiresent? Bibliographic Citation a11o ed for subsission frun ptblished date of Standard. 163.62—10(f) combInation & Tank Nix Field Dissipa- tion no 163.62—10(g) tong Term Field Dissipation Stndy no 163.62—11(b) Accunulation in tational Crops reserved ’ 163.62—11(c) Accunulation In Irrigated Crops no 163.62—11(d) Fish A.cctznulation yes Radio—labeled analytic grade or technical grade of the active ingredient no yes, 14 sos. 163.62—11(e) SpecIal Stndies ?ccunulation In Aquatic Noncrop no 163.62—13 Di sposal & Storage reserved ’ Special Qxnpssition and ncentratIon in feces yes 2 ’ A representative formulation — type no yes, 14 sos. 3uly, 1981 ------- Table A—2 (Cont’d) Environmental Fate (See thapter V) Generic Data Requirsnents bua aphos tist Additional Data be Are Data Daes EPA flave Subnitted tmder FIFRA Required Data to Partially 3(c) (2) (B)? If so, months Guidelines Nane of For This or totally Satisfy a11o d for subnission Citation Test (5) Rights of Way, elterbelts & Related Uses Standard? no Conposition this Requirenent? B1bliogra ic Citation fron p.tlished date of Standard. 163.62—10(c) Aquatic Field Dissipation: (1) Aquatic Food Crop Uses (2) Aquatic Non- crop Uses (3) Specialized Aquatic Uses no no no no . 163.62—10(d) lèrrestrial/ Aquatic (Forest) Field Dissipation no 163.62—10(e) Aquatic Impacts Uses: (1) Direct Dis— charge (2) Indirect Discharge (3) Waste ter Treathent no no no July, 1981 ------- Footnotes Table A-2 Environmental Fate Generic Data Requirements Coumaphos 1/ One hydrolysis study (MRID 05004309) was reviewed and !ound scientifically invalid because of the lack of detailed information concerning experimental conditions, including temperature, darkness, and sterility of the samples. In addition, discrepancies were found in the calculated data dealing with levels of degraded coumaphos. 2/ The requirement for submission of these data is currently ‘being reserved pending the review and modification of the testing protocols. 3/ The mobility of the test substance and its degradates in soil shall be assessed either by soil thin layer chroma— tography, soil column, or batch equilibrium (adsorptjon/de— sorption) procedures. The use of coumaphos in dip vaps and disposal of vat contents into the environment justifies this data requirement, as well the use of dust bags (particularly in feed lots). 4/ Laboratory volatility studies using nonradioisotopic inalytical techniques are required to support the registration of all formulated products intended for henhouse use, (to which the greenhouse use referred to in l 63 .62—9(c) is similar) and to evaluate reentry hazards from choljnesterase— inhibiting pesticides, such as the health studies indicate for coumaphos. 5/ This requirement will be met by data provided on leaching. 6/ Data may be required pending the outcome of special studies of composition and concentration in feces. 7/ Data are required to show the maximum concentration of Eoumaphos and its degradation products in chicken litter and livestock manure at the time such materials are applied as fertilizer. 26 ------- Table A—3 E o1ogical Effects (See thapter VI) Generic Data i quirei ents __________________ _____________ ________________________— Must 7 dditiona1 Data be Sthnitted under FIFRA Are Data i es EPA Have 3(c) (2) (B)? If so, mnths quired Data to Partially al1 ed for sthnission Qiidelines } T of Fbr This or totally Satisfy Bibliographic fran p&tlished date of Citation ¶1 st Standard? O osition this E quira ent? Citation — Standard . 163.71—1 Avian Sirqle qredmical grale yes, 8 nos. Dse a1 IC of the active iogredient (!L AI) 163.71—2 Avian Dietary yes yes, 8 sos. LCso 163 .71—3 ma1ian Acute ro bxicity 163.71—4 A nan ! production 163.71—5 S inu1. & Actual ro Field Tasting for Matnials/Birds July, 1981 ------- Teble A-3 (Contd) 1ogica1 Effects (See Chapter Vi) Generic Data I quir i nts ?tzst h ditior r ta be SthTtittel under FIFHA Are Data tX,es EPA Have 3(c)(2 (B)? if so, ennths i quired Data to partially allowed for sulittission Guidelines of F This cx totally Satisfy Bibliographic ftun published date of Citation ‘ jest Standard? Carqosition this i quirement? Citation Standard . — ____ — 163.72—1 Fish Acute LC Technical grnde ro yee, 8 n s. of the active ingredient 163.72—2 Acute ‘Ioxicity • 05009242 no to Aqj.iatic invertthrates 163.72-3 Acute xicity to to Estuarine Marine Dagani 163.72—4 B tryolarvae & no Life-Cycle 163.72—5 k uatic Ckgan. no lbX. & s1due Stedies 163.72 —6 Simul. Actual Field Testing for ?quatic Ct’ganlsns July, 1981 ------- Table A—4 R)xi logy (See thapter VI) Generic Data I quirements - T ronar t & &fnitted xder FIPPA Are Data Xies EPA Have 3(c)(2)(B)? If , uonths 1 quirad Data to Partially alixxied for subuission QJide linss t i of I This totally Satisfy Bibliographic tram p A ished date of Citation Tast Standard? (lqx,sition this i guirenent? Citation Standard . ___________ 163.81—1 .ite C a1 yes Ta nica1 grade yes 00005496 Ibxic ity of the active ( 0018-0O4 ir redient ( AI) 00J.8-O03 163.81—2 te Der al yes, 8 ecs. ‘mx lcity 163.81—3 ite Ithalation yes, 8 nos. !lbxicity 163.81-4 Primary E yes 1r1AI yes, 8 nos. irritation 163.81—5 Primary Deneal yes To yes, 8 ma. irritation 163.81-6 Dermal ro yes, 8 me. Sensitization July, 1981 ------- Teble Pr-4 (Cont’d) xicology (See thapter VI) Generic Data 1 quiresont.s Gu os Must i idition r ta be Sitinitted under FIFRA Are Data rx es EPA Have 3(c)(2)(B)? If so, nonths I quired Data to Partially allowed for aubnission Guidelines te of br This cx totally Satisfy Bibliographic fran published date of Citation Test Standard? Q iiçosition this 1 quir nent? Citation Standard. — 163.83-I thnnic Feeding yes Ted nical grede rio ’ yes, 50 sos. of the active th redient {1 AI) 163.83—2 Gucogenicity yes yes 05009938 163.83-3 Teratogenicity yes so yes, 26 sos. 163.83—4 ! pra3 x tion yes yes, 38 sos. 163.84—(2—4) Iltitagenicity yes yes, 26 rca. 163.85—1 Mutaboli n yes D thle-labeled partial 05004087 yes ”, 26 sos. 05012220 163.86—1 [ Xxnestlc Animal Safety Testing July, 1981 ------- le A-4 ( nt’d) ! lbxicxilogy (See thapter VI) Generic Data I quiresents — - ?k2st iditiC4 al Data be SLt2nitted ueder FIFRA ?tre Data IXes EPA Have 3(c)(2)(B)? If n nths E (1iired Data to Partially allowed for suheission Qaide lines iie of Fbr This ox totally Satisfy Bibliographic fra n published date of Citation st Staedard? Cc.eç sition this tequirenient? Citation Star ard. 163.81—7 mute Delayed yesW 2’ d nical graie no yes, 14 nris Neurotoxicity of the active (j ,J thgredient (1 AI) 163.82-1 9bchronlc ka1 yes, 14 n s. øxicity 163.82—2 Sti3thronic naY (21-day) Deu a1 163.82-3 &.*thx ic 90— yes / I thnical grade yes. 14 nan. day Deonal Toxicity of t1 active iogredient 163.82—4 Sitchronic Leserved ’ Inhalation Toxicity 163.82—5 Sththronic reserved 2 urotoxicity juIy, 1981 ------- Footnotes Table A-4 Toxicology Generic Data Requirements Coumaphos 1/ Data are required on the technical chemical to provide aThasis for comparison with the end—use product testing. 2/ Data are required because coumaphos is a cholinesterase inhibitor. 3/ Two studies (MRID 00005384 & MRID 00005504) were reviewed and found to be insufficient to meet the data requirements. MRID 00005384 lacked histopathology and MRID 00005504 should have been performed on weanling rats in order to determine coumaphos’ toxicity during physical and sexual development. 4/ The subchronic 90—Day Dermal Toxicity Study (163.82—3) is required instead. 5/ Data are required because coumaphos is used on dogs and dog bedding and thus presents the potential for direct application to human skin. 6/ Testing is required if results from acute inhalation tests are positive. 7/ Testing is required if results from acute delayed n urotoxicity tests are positive. 8/ One study (MRID 00005473) was reviewed and found i adequate. The histopathology was inadequate with only 5 animals per dose being studied. No clinical studies were performed. 9/ One study (MRID 00005148) was reviewed and found not to meet the data requirements due to inadequate histopathology, 10/ Two studies (MRID 00004087 & MRID 05012220) provided some information on the identity of major metabolites and routes of elimination but no data are available to assess the absorption of coumaphos as a function of dose and duration of exposure. No information was provided on the disposition of the leaving gr p. Te ing is required with the double—labeled compound C P and C) to determine the fate of the parent compound and leaving group. 32 ------- 1 ble A—5 I eidue theslatry (See Ciiapter VII) Generic Data juiresents — i t iiticmal Data Sitinitted urder FIFEA Are Data Does E A iave 3(c) (2) (8)? If so, sonths I quired Data to Partially a11 for aLtInission Oiidelines Nsee of f c This or totally Satisfy 8ib1iogra )Ic fr a u pllisbed date of Citation st Stardau ? fl-”çositicn this Paquirenent? Citatiau — Stardard . ______ ttho1i in so plants Metd)O11S in yea A representative See footnote / Animals fr ” ’ticn type (P r) a’ Analytical Methods yes See footiote— residue Data: so residue Data: so residue Data: Milk yes 1 T See fotnote V a d Meat ki D gs Storage arvi Stability yes 00005190 July, 1981 ------- Footnotes Table A-5 Residue Chemistry Generic Data Requirements Co umapho s 1/ 05004087, — 05004483, 05100522, 00005454, 00005401, 05008968, 00005323, 05003806, 00005450 05003806, 05012748, 00005332, 00005392, 2/ 05004066, — 00005438, 05006630, 00005308, 00005080, 00005437 00005328, 00005342, 00005289, 00005509, 05004211, 05017521, 3/ 00005293, — 00005338, 05004690, 00005333, 00005396, 00005479, 00005831, 00005834, 00005235, 00005040, 00005456, 00005451, 00005161, 00005329, 00005186, 00005509, 00005830, 00005395, 00005822, 00005483, 00005214, 00005082, 00005042, 00005453, 05010354, 00005400, 05006630, 00005056, 00005080, 00005510, 00005511, 00005047, 00005485, 05010096, 00005074, 00005492, 00005448, 00005480, 00005456, 00005295, 00005493, 00005336, 05005830, 00005339, 05005125, 00005832, 00005491, 00005490, 00005441, 05004066, 00005840, 00005458 00005331, 05012915, 00005081, 00005051, 00005399, 00005048, 00005833, 00005317, 00005486, 00005437, 00005440, 00005842, 4/ The following studies were used in developing the Standard. Although they are not cited in support of a specific Guideline requirement, they were generally used: 05002359, 05016099, 00005439, 0500???? Knapp, 05004087, 00005402, 05108561, 05003799, 05006806. 34 ------- Table B—i Product-Chemistry (See Chapter IV) Product—Specific Data Requirements for Manufacturing—Use Products CounaFE os Mist Mditional Data be Sukinitted i.nder ‘I A Are Data Des EPA Have 3(c) (2) (B)? If so, scnths Required Data to Partially allowed for suheission Guidelines Name of For This or totally Satisfy Bib1iogra tiic from published date of Citation Test Standard? Composition this Requirement? Citation Standard. 163.61—3 Product Identity and disclosure of Ingredients yes Each product no yes, 8 sonthe 163.61—4 DescrIption of inanufactur 1mg process yes Each product no yes, 26 mnths 163.61—5 Discussion on formation of w intentIonal ingredients yes Each product no yes, 26 sonths 163.61-6 Declaration and certification of ingredients limits yes Each product no yes, 8 nonths 163.61-7 Product alytica1 methods and data yes Each product no yes, 8 nonths 163.61—8(1) Color no 163.61—8(2) C)3or no 163.61—8(3) Melting Point no ( ,1 U, July, 1981 ------- Table B—i (Cont’d) Product- hemistr (See thapter IV) Product Specific Data Requirements for Manufacturing—Use Products CoLinaphos f tist Mditional Data be Subuitted under FIFRA Are Data D es EPA Have 3(c) (2) (B)? If so, months Required Data to Partially allowed for subnission Guidelines Name of Fbr This or totally Satisfy Bibliographic frau pttlished date of Citation Test Standard? Composition this Requirement? Citation Standard. 163.61—8(4) Sol ±ility no 163.61—8 (5) Stability no 163.61—8(6) tenol/Water no partition coefficient 163.61—8(7) Vhysical State yes Each product yes, 8 sos. 163.61—8(8) Demeity or Specific yes Each product yes, 8 ens. Gravity 163.61—8(9) Boiling Point no 163.61—8(10) vapor Pressure 163.61—8(11) Each product yes, 8 sos. 163.61—8(12) Storage Stability yes Each product no yes, 8 sos. July, 1981 ( J 0% ------- Table B—i (Cont’d) Product-O anistry (See thapter IV) Product-Specific Data Requirenents for Manufacturing—Use Products a— Guidelines Citation Nene of Are Data Required Pbr This Standard? Co s osition Daes EPA Have Data to Partially or totally Satisfy this Requiranent? . BibliograçMc Citation tist I’dditional Data be Subnitted uider FIFRA 3(c) (2) (B)? If on, nontha allowed for st ission fran pi iished date of Standard. 163.61-8 (13) Fl ir ability yesr ’ Each product no yes, 8 sos. 163.61—8(14) Cbcidizing or Reducing Action yes ’ Each product no yes, 8 sos. 163.61—8(15) Explosiveness yes ’ Each product no yes, 8 sos. 163.61—8(16) Miscibility yes ” Each product no yes, 8 sos. 163.61-8(17) Viscosity Coefficient yesW Each prod*x t no yes, 8 sos. 163.61—8(18) Q,rrosion tharacteristics yes Each product no yes, 8 sos. 163.61-9(19) Dielectric Break— down Voltage no 163.61—9 $.tznittal of s 1es no July, 1981 ( 4 ------- Footnotes Table B—i Product Chemistry Product—Specific Chemistry Data Requirements for Manufacturing—Use Products Coumaphos 1/ For each product containing a volatile, flammable ing red lent. 2/ For each product containing an oxidizing or reducing agent as an Ingredient. 3/ For each product containing a potentially explosive ingredient. 4/ For emulsifiable products which may be diluted with petroleum solvents. 5/ For liquid formulations. 38 ------- Table 8—2 lbxicoloqy (See Qiapter VI) Product-Specific Data Requiresents for Manufacturing—Use Products Counaphos I vst Additional Data be Suh*nitted under FIFRP Are Data Daes EPA Have 3(c) (2)(B)? If so, months Required Data to Partially allowed for subuission Guidelines Name of For This or totally Satisfy Bibliographic fran Published date of Citation - _ Fest Standard?— - Com sition this Requiresent? Citation Standard. 163.81-1 ?cute Oral no lbxicity 163.81—2 ?cute Dermal no Th3cicity 163.81—3 Acute Inhalation no Thzicity 163.81—4 Primary Eye Irritation 163.81—5 Primary Dermal no Irritation 163.81-6 Dermal no Sensitization July, 1981 / Data are required on tI m technical product for extrapolation to the manufacturing—use prcd t. ‘0 ------- Table 8—2 (Cont’d) Toxiooloqy (See thapter VI) Product—Specific Data Requiresents for Manufacturing-Use Products LIna i os Dees EPA Have Data to Partially or totally Satisfy this Requirenent? Z4ist Pdditional Data be Subnitted under FIFRA 3(c)(2)(B)? If so, months al1o d for subnission fran pitlished date of 163.81—7 Pcute Delayed Neurotoxicity 163.82—1 ibchronic Oral Thxicity 163.82—2 & bchronic (21-day) Dermal 163.82—3 Subchronic 90— day Derinal ‘rbxicity 163.82—4 Subcbronic Inhalation lbxicity 163.82—5 &ibthroriic Neurotoxicity Guidelines Citation Nsne of Test Are Data Required For This no no no no Bibliographic Citation / Data ar. required on the technical product for ectrapolation to the manufacturing—use product. cD July, 1981 ------- Table 5—2 (Cont’d) Toxico1c gy (See thapter VI) Product—Specific Data Requirenents for Manufacturing—Use Products O,unaphos Mist Mditiona]. Data be Sutinitted der FIFRA Are Data Daes EPA Have 3(c) (2) (B)? If so, nonths Required Data to Partially allo d for subeission Guidelinee N e of For This 1 or totally Satisfy Bibliogra Mc fron pLtlished date of Citation Test Standard ? 1 Coeçosition this Requirenent? _ _ citaticn Standard . _______ 163.83—1 thronic Feeding no 163.83-2 cogenicity no 163.83—3 ratogenicity no 163.83—4 Reproduction no 163.84— (2-4) Jeitagenicity no 163.85—1 Metabol lse 163.86—1 Disnestic no Animal Safety Thsting July, 1981 / Data are required on the ted nica1 themical for ectrapolation to the manufacturing—t e product. ------- Table C—i Product—chemistry (See thapter IV) Product-Specific Data Requirements for End—Use Products O Lznaphos r4.ist Additional Data be Sutinitted mder FIFRA Are Data Daes EPA Have 3(c) (2)(B)? If no, nonths Required Data to Partially allowed for subnission Guidelines Name of FOr This or totally Satisfy Bibliogra ic from published date of Citation Test Standard? Composition this RequiraTlent? — Citation Standard. — 163.61—3 Product Identity yes Each product no yes, 8 nontha and disclosure of Ingredients 163.61-4 DescrIption of Each product yes, 26 months manufacturing process 163.61—5 Discussion on yes Each product yes, 26 months formation of ucintentional ingredients 163.61-6 Declaration and yes Each product yes, 8 months certification of ingredients limits 163.61—7 Product analyttcal yes Each product no yes, 8 months moth,ds and data 163.61—8(1) O,lor yes Each product no yes, 8 months 163.61—8(2) Q3or yes Each product no yes, 8 months 163.61—8(3) Melting Point no July, 1981 ------- Table C—i (Cont’d) Product-Chemistry (See Chapter IV) Product—Specific Data Requirements for End—Use Products cotmiaphos Guidelines Citation N&ne of Test Are Data Required For This Standard? Composition Does EPA Have Data to Partially or totally Satisfy this Requirement? Bibliographic Citation &ist dditional Data be Subeitted under FIFRA 3(c) (2) (B)? If so, sonths allowed for subuission from published date of Standard. 163.61—8(4) Solubility no 163.61—8(5) Stability to 163.61—8 (6) Octano ljWater partition coefficient no 163.61—8(7) Thysical State yes Each product no yes, 8 sonths 163.61—8(8) Density or Specific Gravity yes Each product no yes, 8 nonths 163.61—8(9) BoilIng Point no 163.61—8(10) Vapor Pressure no 163.61—8(11) I yes Each product no yeS, 8 ixonths 163.61-8(12) Storage Stability yes Each product no yes, 8 nonths July, 1981 (‘4 ------- Table C—i (Cont’d) Product-Chemistry (See Chapter IV) Product-Specific Data Requirements for Fn&-Use Products cbtinaphos ist Mditional Data be Subnitted u der FIFRA 7 re Data Ibes EPA Have 3(c) (2) (B)? If so, nonths N ne of Test Required Data to Partially For This or totally Satisfy Standard? Canposition this Requirement? Bibliogra lc Citation allowed for s hnission fron p tlished date of Standard. Guidelines Citation 163.61—8 (13) 163.61—8(14) 163.61—8(15) 163.61—8(16) 163.61—8(17) 163.61—8(18) 163.61—9(19) 163.61—9 Fl ability yes 4 ’ Each product no yes, 8 sos. Cbcidizing or Reducing Action yes ” Each product yes, 8 sos. E cp1oáiveness yee ’ Each product no yes, B sos. Miscibility yes Each product no yes, 8 sos. Viscosity Chef ficient yesW Each product yes, 8 sos. corrosion Characteristics Each product yes, 8 sos. Dielectric Break— do m Voltage no ibnitta1 of s tip1es July, 1981 . ------- Footnotes Table C—i Product Chemistry Product—Specific Chemistry Data Requirements for End—Use Products Coumaphos 1/ For each product containing a volatile, flammable ingredient. 2/ For each product containing an oxidizing or reducing agent as an ingredient. 3/ For each product containing a potentially explosive ingredient. 4/ For emulsifiable products which may be diluted with petroleum solvents. 5/ For liquid formulations. 45 ------- Table C—2 Toxicology (See thapter VI) Product—Specific Data Requirements for End—Use Products Counaphos P ist ?dditiona]. Data be Subnitted under FIFRA Are Data Daes EPA Have 3(c) (2) (B)? If so, sonths Required Data to Partially allowed for sithuissiori Guidelines N ne of For this or totally Satisfy Bibliographic fran published date of Citation Test Standard? Composition this Requirement? Citation Standard. 163.81—1 ? ute Oral yes Each product yes 00005416 yes, 8 sos. Thxicity 163.81—2 Pcute Dermal yes Each prcduct 4 ’ no yes, 8 sos. Ibxicity 163.81—3 Acute Inhalation yes ’ Each product ’ yes, 8 sos. ¶bxicity 163.81—4 Primary Eye yes ’ Each product no yes, 8 sos. Irritation 163.81—5 Primary Dermal yes Each productL’ yes, 8 sos. Irritation 163.81—6 rma1 Sensitization yes Each productV yes, B sos. July, 1981 ------- Footnotes Table C-2 Toxicology Product—Specific Date Requirements for End—Use Products Coumaphos 1/ The Agency has the option of combining end-use products Tnto groups of “substantially similar” products and requiring testing on only one product in the groups. Groups are made up of end—use products of similar concentrations and for- mulation type. This reduces the testing burden imposed on the registrant. In the case of coumaphos, however, available toxicity data show that products may not necessarily be rationally grouped by conventional means. Acute oral toxicity studies with technical coumaphos have demonstrated that the toxicity of the compound varies with the physical form of the chemical and the vehicle in which the oral administration is made (Hecht 1958, GS0018003). Studies have also shown that a 25% wettable powder for- mulation is four times more toxic than a 50% wettable powder formulation (Lamb and Anderson, 1974, MRID 00005416, Hecht, 1958, GS0018003). The Agency would be willing to consider combining coumaphos end—use formulations into groups of substantially similar products if the above anomalies in the oral toxicity data can be explained. Otherwise, testing is required on each coumaphos end—use formulation. 2/ Testing is required if products are found to produce a respirable vapor, or if 20% more of the aerodynamic equivalent is composed of particles not larger than 10 microns. 3/ One study (MRID 00005414) has shown that a 50% wettable pOwder formulation causes eye irritation and corneal damage in rabbits at 21 days, placing the formulation in Toxicity Category I. The Agency will waive primary eye irritation testing for other coumaphos wettable powder formulations if registrants agree to place Toxicity Category I precautionery statements on the end—use product labels. 47 ------- 1 ble C—3 Efficacy (See thapter IX) Predt t—S ecific Data 1 quireientS for E) i-Use Products ________ _________ — Must Mditional Data Sthnitted uoder FIFRA Are Data Daes EPA Have 3(c) (2) (B)? If , nonths Haquired Data to partially alIO%&d for sulrznission Site of F This cx totally Satisfy Bibliographic fran pu b1ished date of Citation - Pest Starsiard? Cbrçosition this I quires nt? Citation — Starriarth — - — I s fleas yes 0.5% txlst 00005344 I V ) 00005326, 00005211 1.0% Pressurized yes 00005087 1O Liqui i lice 0.5% D 1.0% PrL yes 00005098 IV ) ticks 0.5% I) yes ( 00l8—00l 10 1.0% PrL yes 00005087 I j bedding fleas 0.5% 0 yes ( 0018—00l IV) 1.0% PrL yes 00005087 10 Co lice 0.5% D no 1.0% PrL 00005088 10 ticks 0.5% D CS0018—001 I X ) 1.0% PrL 00005087 to July, 1981 ------- Footnotes Tables C-3 Efficacy Product—Specific Data Requirements for End—Use Products Coumaphos 1/ Efficacy of the .5% dust formulation for control of lice on dogs and dog bedding is assumed due to extrapolation from efficacy studies done on lice infesting larger agricultural animals and their bedding (MRID 00005352, 05011422, 00005028, 00005033, 00005200). 49 ------- Iv Product Chemistry Product Chemistry SunTnary - cbnica1 Coumaphos ODumaphos is synthesized by reacting diethyl phosphorothi 8 nochloridate with 3- chioro 4 n ethyl-7 hydroxycoiunarin (chiorferron) at 50-100 C and atmospheric pressure, in the presence of a suitable solvent, and acid—binding agent and finely divided copper as a catalyst. After the reaction the mixture is cooled, filtered, the product is recovered by evaporating the solvent (Sittig Manual (1977) r ise Data Crop. Park Ridge! N.J.). In addition confidential data describing the coumaphos manufacturing process have been review by the 1 ency (MRID 00005192). The nolecular structure of counaphos is: CHfCH 2 O\ o_ç’ r”° ‘ c=o CH 3 —CHj—O CH The Agency has reviewed the available information on ultraviolet spectrophotometric n thods (MRID 05004290, 00005188, 00005187) and found them adequate for the identification and quantitation of coumaphos in the technical, manufacturing-use, and end-use products. Methods are also available for the analysis of certain impurities (MRID 00005433, 00005189, 05003798, 00005278). There are 17 inert ingredients used in counaphos end-use products that are not cleared for use on animals under 40 CFR 180.1001(e). 1 gistrants of end-use products with inert ingredients that have not been cleared must either remove the ingredient fran the product or obtain clearance from the 1 gency. The 1v ency has found one inert ingredient, Freon, a chiorofluorocarbon, to be unacceptable for use in end—use pesticide products because of its potential to deplete the ozone layer of the atmosphere (see 43 CFR 11318). Physical and Chemical Properties Some data are available on the physical and chemical properties of axznaphos. D which are not available but which are required to be sutxnitted are listed in the tables in Chapter III. Available data on technical coumaphos are as follows: Color , tan ( or : weak but not unpleasant Me ltinjPz)int : 90 92 0 C So1ubili y insoluble in water, soluble in aromatic solvents, less soluble in alcohols and ketones. Stabi1i : stable under normal use conditions, hydrolyzes slowly under alkaline conditions. 50 ------- Physical State : crystalline solid Boiling I int : 20°C at a prox. 1 x l0 nm Hg Vapor Pressure : 1 x IO urn Hg at 20°C The above physical and chemical properties for technical coumaphos were reported under MRID 00005193, 00005307, 00005417, 00021981, 00005190, 00005526. Sunmary of Major Data Gaps The major data gaps for this chemical are: clarification of ingredient statements, solubility in quantitative anounts, octanol/water partition coefficient, density or specific gravity, pH for the technical product,* certain physical and chemical properties for manufacturing—use and end-use coumaphos products and certain product chemistry data on end-use products. * Depending on solubility in water, which is not known in quantitative terms. 51 ------- V. Environmental Fate Use Profile Couriaphos is an insecticide registered for use on livestock and livestock bedding, poultry, poultry housing, poultry litter, dogs, arid dog bedding. Q-ie technical coumaphos product and three manufacturing—use products are registered. Counaphos is formulated into end-use products as a dust, wettable powder, pressurized liquid, emulsifiable concentrate, ready—to-use pour—on, ready—to—use spray, spray foam, spray concentrate and backrubber oiler. The registration of a new flowable product is pending. Some coumaphos products are applied topically and act to control external pests; others are applied topically but act systemically to control internal parasites. Coumaphos products are sanetimes applied to livestock using dust bags or dip vats • There are several other registered application methods and numerous registered concentrations. Approximately 500,000 lbs. of couinaphos are produced in the United States annually. Approximately 60% is formulated into emulsifiable concentrates and wettable powders, 36% into dusts, 2% into ready—to-use solutions, and 1% into pressurized liquids. Beef cattle account for 87% of coumaphos use arid dairy cattle account for 12%; emulsifiable concentrates and wettable powders are the primary formulations used on cattle. Use on other livestock, poultry, and dogs account for the remaining 1% of coumaphos use. Environmental Fate Surrmery There is one scientifically valid study on the environmental fate of coumaphos. Coumaphos (purity unspecified) applied at 2 and 100 ppu inhibited the respiration of Azotobacter vinelandii , a nitrogen—fixing bacterium, by 50% and 33% respectively (MacRae and Celo 1974, MRID 05005579). The authors did not address the apparent contradiction that higher concentrations result in lower respiratory inhibition. t’ k conclusions about the environmental fate of coumaphos can be drawn fran this study. Exposure Profile Because of the absence of data on the exposure arid environmental fate of couflaphos, it is not possible to quantitatively assess exposure of humans and wildlife to coumaphos. Mixers and applicators of coumaphos formulations are at risk of the highest direct exposures. Dermal arid eye exposure can result f ran splashing during the diluting, mixing, and use of emulsifiable concentrates and wettable powders. Respiratory exposure could occur fran “puff back” during handling of dusts and wettable powders. The potential for respiratory exposure after application cannot be assessed due to the lack of vapor pressure data. 52 ------- The general public and daTlestic animals are exposed to t xui iaphos because it is registered for use a dogs and dog bedding. The use of cournaphos on meat and dairy livestock and poultry also results in dietary exposure to the general public; see Chapter VII, r sidue Chemistry, for a discussion of dietary exposure to counaphos. The use of counaphos-contaminated poultry litter and manure as fertilizer on field and vegetable crops, tree fruit and nut crops, and pasture land, presents the potential for human dietary and non—dietary exposure. This potential was not evaluated due to the lack of data. Suinnary of Major Data Gaps The major data gaps for this chemical are hydrolysis, soil metabolism, leaching, volatility, adsorption/desorption, water dispersal, fish accumulation, photodegradat ion, and canposition and concentration in feces. 53 ------- VI Toxicology Toxicology Sunmary - Technical Coumaphos Acute Toxicity Studies have shown that technical coumaphos has a very high acute oral toxicity and is classified as Toxicology Category 1. Acute oral toxicities in rats have been reported ranging fran 17.1 to 87.0 mg/kg depending on sex, physical form of the chemical, and the method of adfninistration used (Narcisse 1976, MRID 00005496, Johnston and Scott 1965, GSOO18—004, F cht 1958, ( 00l8—003). Subchronic Toxicity Inadequate studies assessing the subchronic toxicity report a no-observable— effect level (NOEL) equal to or less than 2 pu in the diet of adult nongrel dogs and adult Sprague Dawley rats. In the dogs RBC cholinesterase activity was depressed 35% when coumaphos was administered in the diet at 50 ppii for 12 weeks. Serum cholinesterase activity was depressed 18% at 2 ppi , 42% at 5 prrn, 59% at 10 ppn, and 68% at 50 ppii over the same 12 week period. Activity returned to rx)rmal in 3 weeks. I b clinical signs of toxicity were reported (Vaughn, et. al. 1958, MRID 00005384). The dog study does not satisfy the data requirements because the histopathology was inadequate. In the rats RBC cholinesterase activity was depressed at 40 pn after 8 and 16 weeks. Serum cholinesterase activity was depressed in females at 2, 5, and 20 p n at 8 and 16 weeks and in males at 10 çpn at 8 weeks. (Vaughn, et al. 1958, MRID 00005504). The rat study should have been performed on weanling rats to determine the toxicity of couTlaphos during physical and sexual develorment and therefore does not meet data requirements. Chronic Toxicity An acceptable oncogenicity study reported no observed carcinogenic effect fran coumaphos fed at 10 ppn and 20 ppn for ts years in the diet of rats and mice (NCI 1979, MRID 05009938). An inadequate chronic feeding study in rats (Doull, et al. 1960, MRID 00005473) reported a NOEL of 5 wn in the diet. Depression of cholinesterase activity was reported at 10 p n and higher dose levels in serum erythrocytes and sutinaxillary glands. At 25 and 100 ppn there was increased nortality and at 100 p ui fasciculations and infrequent cxnvulsions were reported. The histopathology was inadequate because only S animals per dose were studied and no clinical studies were performed. The study therefore does not meet the data requirements. An inadequate 3 generation nouse reproductive effects study reported a NOEL of 10 ppli. bb effects on reproduction were observed which cx)uld not be attributed to maternal toxicity (Doull, et. al. 1962, MRID 0005148). Die to the inadequate histopathology the study does not meet the data requirements. 54 ------- Data on the metabolism of oo aphos are incanpiete. Four phosphorous- containing metabolities were identified (diethyl phosporothioic acid, phosphoric acid, diethyl phosphoric acid, and de—ethylated derivative of coumaphos) but their time and dose relationship was not quantified. The disposition of the canpiex leaving group was not followed (Krueger, et al. 1959, MRID 05004087, Vickery, MRID 0512220). ‘ Ibxicology Suimiary -— Coumaphos Formulations One study is available on a 50% wettable po ier (WP) formulation which reports an acute LD 5 for male rats of 363 mg/kg (Lamb and Anderson, 1974, MRID 00005416). A second study using a 25% wettable power formulation reported an acute LD of 22.5 mg/kg in male rats and 13.5 mg/kg in female rats (Hecht, 1958, G9Cftil8003). Further testing is required to resolve the apparent contradication in the data, particularly because the 25% WP formulation is reported to be as toxic as sane technical material. An acceptable study shows that a 50% WI ’ formulation has an acute dermal LD of greater than 2 mg/kg placing the formulation in ‘Ibxicity Category III ( mb and Anderson 1974, MRID 00005416). An acceptable eye irritation study on a 50% WI’ formulation showed irritation and corneal damage to persist after 21 days placing the formulation in ‘D3xicity Category I for eye irritation (Lamb and Matzkanin 1975, MRID 00005415). lbxicity Hazard Assessment Technical coumaphos has a very high acute oral toxicity. carcinogenic effect has been report d. The 50% WP has been shown to have a very low acute dermal toxicity but to cause severe eye irritation. Sunmary of Major Data Gaps The major data gaps for this chemical are nost of the acute studies on the technical chemical and end—use products, and, subchronic oral toxicity, subchronic 90 day dermal toxicity, chronic feeding, teratogenicity, reproductive effects, mutagencity, and metabolism on the technical chemical. testing is required on the manufacturing—use products because the testing required on the technical will be used to support the registrability of the manufacturing—use product. 55 ------- VII Residue Chemistry Residue Chernis try - Thchnical Cournaphos Residue Chemistry Profile Coumaphos is an organophosphorus insecticide applied to animals topically in the form of dusts, sprays, dips, and pour—ons. The dusts and liquid formulations act topically as ll as systemically to control certain insects and parasites. The systemic products control internal parasites by the absorption of the active ingredient through the skin (ruminants, non-ruminants, and poultry). The metabolism of coumaphos in animals is adequately defined by the available data. The primary residue of concern is oDumaphos par se and its oxygen analog. (MRtD 05004087, 00005454, 00005323, 05003806, 05012748, 05004483, 00005401, 05003806, 00005332, 00005392, 05100522, 05008968, 00005450). The metaboli of counaphos in plants is not of concern because coumaphos is not applied to crops. Three different analytical procedures have been developed for the detection of coumaphos residues and all have been evaluated in EPA laboratories and found acceptable for the collection of residue data and enforcement of established tolerances. The procedures are 1) spectrofluorophotanetry, 2) gas-i iquid chrcinatography, and a ircdified photofluoranetric method (MRID 05004066, 000005308, 00005328, 00005342, 00005289, 00005438, 00005080, 00005509, 05004211, 05017521, 05006630, 00005437). The available residue data are adequate to support existing tolerances. They include data for coumaphos and its metabolite. These data are cited in Table A— 4 under “Residue Data; Milk, Meat and E#ggs”. Studies conducted with both non-labeled and 32 p-labeled counaphos show that when animals and poultry are treated with couTtaphos according to label recaiinendations, there will be no residues in eggs, milk, meat, fat and neat by- products in excess of the established tolerances. (See Table A-4, “Residue Data; Milk, Meat and Fags”). U.S. tolerances are adequately supported by residue data for coumaphos, 0,0- d iethyi. 0- ( 3-chloro-4-methyi-2-oxo-211-i-benzopyran-7-yi ) phosphorothioate and its oxygen analog, 0, 0-diethyl 0— (3 -chloro-4-rnethyl-2-oxo-2H—l—benzopyran-7-yl) phosphate, j.n or on raw agricultural products. These tolerances (40 CFR 180.189) are as follows: 1 p xn — in or on meat, fat and meat by-products of cattle, goats, hogs, horses, poultry, and sheep. 0.5 pçzn — in milk fat (reflecting negligible residues in milk). 0.1 ppn — in eggs. 56 ------- Based on the tolerances, the theoretical maximi.in residue contribution (‘ITvIRC) of total coumaphos is calculated to be 0.22 mg/day/i 5 kg (unverified printout of Acceptable Daily Intake, 40 CFR 180.189, cxumaphos, February 9, 1981.) This figure is based on the average adult eating pattern and on the assumption that milk, meat, fat, meat by-products, and eggs contain residues hith meet the respective tolerance levels. T mporary Codex Maximum Residue Levels are 1 pps in poultry and fat of cattle, 0.5 in in fat of sheep, pigs, goats, milk and milk products, and 0.05 çzi in eggs. The P ency is unable to assess the adequacy of the Codex tolerances due to a lack of supporting data. Suirinary of Major Data Gaps There are r data gaps in Residue Chemistry. 57 ------- VIII. Ecological Effects Ecological Effects Surrmary There is one acceptable study on the ecological effects of coumaphos. It shows the 96 hour LC for technical cxurnaphos administered to mature scuds ( GanTnarus Lasc tus ) to be .15 ugh (Sanders 1972, MRID 05017538). This study does not meet the Agency’ s Guidelines for testing because iinnature animals were not used; however, the study is acceptable because it shows that coumaphos is very highly toxic to aquatic invertebrates. There are no acceptable studies on the effects of coumaphos on plants or non—target insects. Surm ary of Major I ta Gaps The data gaps for this chemical are the avian single-dose LD , the avj&i dietary LC , the fish acute LC 50 , and an acute toxicity to uatic invertebra s. 58 ------- Ix Efficacy Efficacy Suirmary The review of coumaphos data is limited to efficacy data only as they relate to public health applications. The Agency has provided for the waiver of efficacy data suhirtission as part of the registration process in all other instances (44 FR 17932; May 11, 1979). The public health applications of cou-naphos are limited to the pesticide’s use to control fleas, lice, and ticks on dogs and dog bedding. Products registered for use on dogs and dog bedding and covered by this Standart are a 0.5% dust and a 1% pressurized liquid. The pressurized liquid product that is .25% counaphos and 0.5% trichlorfon (0,0—Dimethyl 2,2,2— trichloro—l-hydroxyethy]. phosphonate) is a double—active ingredient product and is therefore not registrable under this Standard. Available data indicate that counaphos in various formulations and at a concentration as low as 0.2% is effective in achieving sane degree of control of fleas, lice, and ticks on dogs (MRID GS0018002, 00005087, 00005200, 00005326, 00005344, 00005088, 00005211). Available data also indicate that a 0.5% coumaphos dust formulation controls fleas and ticks on dog bedding, (MRID GSOO I800I). An in vitro laboratory study showed that counaphos ranging in concentration fran .05% to 3.2% is effective against ult fleas ( Xenopsylla cheopis) , effectiveness reaching 100% at the 0.4% concentration, Courilaphos was sanewhat less effective in controlling larvae of X. cheopis ; 100% control was reached at the 3.2% concentration (MRID 05007632). There appear to be several factors which may influence the efficacy of coumaphos. Sane of these factors are: animal hair coat (length and type), method of application, species or type of pest, and arrount of active material applied. Stuart (1959, GSOO18001) noted problems in obtaining control of fleas when hair coat was thick and matted. Genung (GS0018002) presents data which seems to indicate nore rapid control of ticks following application by washing as opposed to counaphos applied as a dust. Stuart and Brewster (MRID 00005086) observed greater ease in controlling fleas as opposed to obtaining similar control of ticks. Stuart (GSOOI800 I) observed “light dusting” of young pups did not result in as rapid or cauplete control as a heavier dusting applied to a:lult animals. 59 ------- Suim ary of Major Data Gaps The data deficiencies for aximaphos are related to the efficacy of the 0.5% dust in controlling lice on dogs and dog bedding. There are st ies which indicate that the 0.5% dust and the 1% dust are effective against lice infesting several species of agricultural animals and their bedding. Sane exemplary studies are &itith and Richards, 1955, (MRID 00005352), Knapp, 1962, (MRID 05011422), Bayvet, 1971, (MRID 00005028), Minter, 1970, (MRID 00005033), and Kohier, 1967, (MRID 00005200). By extrapolation fran the large animal studies, the 1 gency assumes that the 0.5% dust is effective in controlling lice on dogs and dog bedding and thus the absence of data does riot constitute a data gap. 60 ------- Guide to Use of This Bibliography 1. Content of Bibliography . This bibliography contains citations of all the studies reviewed by EPA in arriving at the positions and conclusions stated elsewhere in this Standard. The bibliography is divided into 4 sections: (1) citations that contributed information useful to the review of the chemical and considered to be part of the data base supporting registrations under the standard -— this section is cross—referenced by numerical identifiers, for easy access to studies cited in the Standard; (2) citations examined and judged to be inappropriate for use in developing the Standard; (3) standard reference material; and (4) potentially useful studies identified too late in the process of developing the standard to be considered. The fourth section cites the studies identified by the basic producer as being absent frau the cxinputerized search of the literature. The studies were identified too late to be given a formal review. This section also includes a single citation for a group of studies subaitted in support of a flowable coumaphos product. Any of the studies in Section Four that, upon review, fill data gaps, will then be considered as amendments to the Guidance Package. Primary sources for studies in this bibliography have been the body of data su nitted to EPA and its predecessor agencies in support of past regulatory decisions, and the published technical literature. 2. Units of Entry . The unit of entry in this bibliography is called a “study”. In the case of published materials, this corresponds closely to an article. In the case of unpublished materials sukriitted to the agency, we have sought to identify documents at a level parallel to a published article fran within the typically larger volumes in which they were sukinitted. The resulting “studies” generally have a distinct title (or at least a single subject), can stand alone for purposes of review, and can be described with a conventional bibliographic citation. We have attempted also to unite basic documents and ccnnentaries upon them, treating them as a single study. 3. Identification of Entries . The entries in this bibliography are sorted by author, date of the document, and title. Each entry bears, to the left of the citation, an eight-digit numeric identifier. This number is unique to the citations, and should be used at any time specific reference is required. This number is called the “Master Record Identifier”, or “MRID”. It is r t related to the six-digit “Accession Number”, which has been used to identify volumes of sul:iuuitted data; see paragraph 4(d)(4) below for a further explanation. In a few cases, entries added to the bibliography late in the review may be preceded by a nine-character temporary identifier. This is also to be used whenever a specific reference is needed. 61 ------- 4. Form of the Entry . In addition to the Master Record Identifier (MRID), each entry consists of a bibliographic citation containing standard elements followed, in the case of materials suhi’iitted to EPA, by a description of the earliest known sutinission. The bibliographic conventions used reflect the standards of the American National Standards Institute (ANSI), expanded to provide for certain special needs. Sane explanatory notes of specific elements follow: a. Author . Whenever we could confidently identify one, we have chosen to show a personal author. When no individual was identified, we have shown an identifiable laboratory or testing facility as author. As a last resort, we have shown the first known submitter as author. b. tkcuIr nt Date . When the date appears as four digits with no question marks, we took it directly fran the document. When a four- digit date is followed by a question mark, the bibliographer deduced the date fran evidence in the document. When the date appears as (19??), we were unable to determine or estimate the date of the document. c. Title . This is the third element in the citation. In sane cases it has been necessary for our bibliographers to create or enhance a document title. Any such editorial insertions are contained between square brackets. d. Trailing Parentheses . For studies suhsnitted to us in the past, the trailing parenthese include (in addition to any self-explanatory text) the following elements describing the earliest known submission: (1) Submission Date . IlTunediately following the rd “received” appears the date of the earliest known submission. (2) Administrative Number . The next element, iim ediately following the word “under,” is the registration number, experimental permit number, petition number, or other administrative number associated with the earliest known submission. (3) Submitter . The third element is the submitter, following the phrase “submitted by”. When authorship is defaulted to the submitter, this element is anitted. 62 ------- (4) Volurr Identification . The final element in the trailing parenthesis identifies the EPA accession number of the volume in which the original suliiiuission of the study appears. The six-digit accession number follows the symbol “CDL,” standing for “Company t ta Library.” This accession number is in turn followed by an alphabetic suffix which shows the relative position of the study within the volume. For example, within accession number 123456, the first study would be 123456—A; the second, 123456—B; the 26th, 123456—Z; and the 27th, 123456—AA. ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Coumaphos Section One: Citations Considered to be Part of the Data Base Supporting Registration Under the Standard (References Listed by MRtD Numbers) MRID Citation 00005028 Bayvet (1971) 00005033 Minter, R.W. (1970) 00005034 Huggins, K.G. (1970) 00005040 Olson, T.J. (1971) 00005042 Chemagro Corporation (1971) 00005047 Chemagro Corporation (1967) 00005048 C1 iemagro Corporation (1967) 00005051 Cheinagro Corporation (1968) 00005056 Chemagro Corporation (1963) 00005074 Anderson, C.A. (1959) 00005080 Chemagro Corporation (1969) 00005081 Chemagro Corporation (1969) 00005082 Irx ustria1 Bio—Test Laboratories (1974) 00005087 Stuart, W.R. (1960) 00005088 Bayvet (1961) 00005148 DDu1I, J., R,ot, M., and Cowan, J. (1962) 00005161 Anderson, C.A. (1959) 00005186 Bayvet (19??) 00005187 Chemagro Corporation (1962) 00005188 Chemagro Corporation (1962) 00005189 Chemagro Corporation (1962) 00005190 Young, J.W. (1962) 00005192 Costello, J.R. (19??) 00005193 Chemagro Corporation (1957) 00005195 Anderson, C.A. (1958) 00005200 Kohier, P.11. (1967) 00005207 Bayvet (1967) 00005208 Bayvet (1965) 00005210 Bayvet (1964?) 00005211 Skaptason, J.S., MacI) uga1l, D. (1960) 00005214 Chemagro Corporation (1964) 00005235 Cheinagro Corporation (1964) 00005278 Waskeski, D.M. (1953?) 00005289 Mains, j. (1964) 00005293 themagro Corporation (1966) 00005295 Chemagro Corporation (1966) 00005307 nose, W.B.; White, C.E. (1971) 00005308 Mobay Chemical Corporation (1964) 00005317 Cheinagro Corporation (1964) 00005326 Williams, G.M. (1959) 00005328 Mams, J.M. (1961) 00005329 chemagro Corporation (1963) 00005331 themagro Corporation (1961?) 00005332 Kruegar, H.R.; Casida, JE.; Niedermeier, R.P. (1961) 00005333 chemagro Corporation (1960) 00005336 chemagro corporation (1964?) ------- Office of Pesticide Programs Registration Standard Bibliography Case (350018 Cournaphos Section One: Citations Considered to be Part of the Data Base Suççorting Registration Under the Standard (References Listed by MRID Numbers) MRID Citation 00005338 Chernagro Corporation (1966) 00005339 Chemagro Corporation (1967) 00005342 darns, J.M. (1963) 00005344 Skaptason, J.S. (1959) 00005345 Cheinagro Corporation (1966) 00005352 itith, C.L., Richards, R. (1955) 00005384 Vaoughn, G., E ininger, E., and Ebull, J.. (1958a) 00005392 Cheinagro Corporation (1959) 00005395 k e1man, D. (1958) 00005396 Gronberg, R.R. (1958) 00005399 Gronberg, R.R. (1958) 00005400 Anderson, C.A. (1959) 00005401 Radeleff, R.D.; Claborn, W.V. (19577) 00005402 Bobbins, W.E.; Fbpkins, T.L.; Darrow, D.I.; E}idy, G.W. (1959) 00005415 Lamb, D.W., and Matzkanin, C.S. (1975) 00005416 Lamb, D.W., and £4atzkanin, C.S. (1975) 00005417 Bayvet (1974) 00005433 Caswell, R.L. (1962) 00005435 Cheinagro Corporation (1966) 00005437 Chemagro Corporation (1968) 00005438 Thornton, J.S. (1968) 00005439 Chemagro Corporation (1968) 00005440 Chemagro Corporation (1960?) 00005441 Chemagro Corporation (1961) 00005448 Anderson, C.A. (1959) 00005450 Iburrough, H.W.; Brady, O.E., Jr.; Tinmei:man, J.A.; Arthur, B.W. (1959) 00005451 Anderson, C.A. (1959) 00005453 Anderson, C.A. (1959) 00005454 Eburrough, H.W.; Brady, U.E., Jr.; Tirnmerman, J.A.; Arthur, B.W (1959) 00005456 Chemagro Corporation (1960) 00005473 Ebull, J,, Vesselinovitch, D., Fitch, R., Boot, M., and Meskauskas, J. (1960) 00005479 Gronberg, R.R. (1958) 00005480 Chemagro Corporation (1960) 00005483 Chemagro Corporation (1959?) 00005485 Chemagro Corporation (1962) 00005486 Chemagro Corporation (1962) 00005490 Ditinan, L.?. (1963) 00005491 Chemagro Corporation (1963) 00005492 Chemagro Corporation (1961) 00005493 Chemagro Corporation (1961) 00005496 Narcisse, J.K. (1967) 00005504 Vaughn, G., Deininger, E. and r)Dull, J. (1958b) 65 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Coumaphos Section One: Citations Considered to be Part of the Data Base Supporting Registration Under the Standard (References Listed by MRID Numbers) MRID Citation 00005509 Bayvet (1968) 00005510 Chemagro Corporation (1968) 00005511 Chemagro Corporation (1969) 00005526 Mactxxigall, D. (19??) 00005528 Bloom, D. (1969) 00005822 Chemagro Corporation (1963) 00005830 Chemagro Corporation (1964) 00005831 Chernagro Corporation (1964) 00005832 Chemagro Corporation (1964) 00005833 Chemagro Corporation (1964) 00005834 Cheinagro Corporation (1964) 00005837 Chemagro Corporation (1961) 00005838 Chemagro Corporation (1961) 00005840 Chemagro Corporation (1960) 00005842 Chemagro Corporation (1960) 00021981 Chemagro Corporation (1964) 00021997 Mobay Chemical Corporation (1966) 050????? Knapp, F.W. (1962) 05002073 Barney, J.E. II (1965) 05002075 Braithwaite, D.P. (1963) 05002340 t mico, J.N. (1966) 05002359 Askew, J.; Ruzicka, J.H.; Wheals, B.B. (1969) 05002360 Keith, L.H.; Alford, A.L. (1969) 05003797 Volpe, Y.; Mallet, Y.N. (1976) 05003798 Waskeski, D.M. (1966) 05003799 Zakrevsky, J.G.: Mallet, V.N. (1975) 05003806 Radeleff, R.D.: Claborn, H.V. (1960) 05004066 Anderson, C.A.: 1 ams, J.M.: McDzugall, D. (1959) 05004087 Krueger, H.R.; Casida, J.E.; Neidermeier, R.P. (1959) 05004089 E1—Refai, A.; 1bpkins, T.L. (1965) 05004211 Bo uan, M.C.; Beroza, M. (1967) 05004290 Kane, P.F.; Cohen, C. J.; Betker, W..R.; MacD3ugall, D. (1960) 05004395 Keith, L.H.; Garrison, A.W., Alford, A.L. (1968) 05004690 Flurwood, I.S. (1966) 05004483 Kaplanis, J.N.; Ibpkins, D.E.; Treiber, G.H. (1959) 05004866 McKinley, W.P.; Read, S.I. (1962) 05005125 Burnett, E.M. (1970) 05005130 Hartmen, C.H. (1966) 05005579 MacRae, IC; Celo, J.S. (1974) 05005830 Matthysse, J.G.; Lisk, D. (1968) 05006145 Ackermann, H. (1969) 05006630 Oehler, D.D.; Eschle, J.L.; Miller, JA.; Claborn, H.V.; Ivey, M.C., (1969) 05006806 Zwieg, G., ed.; Sherma, J., ed. (1972) 05007632 Fox, I., et al. (1966) ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Coumaphos Section One: Citations Considered to be Part of the Data Base Supporting Registration Under the Standard (References Listed by MRtD Numbers) MRID Citation 05008968 D3rough, H.W.; Brady, U.E., Jr.; Tinmerman, L.A.; Arthur, B.W. (1961) 05009242 Sanders, 11.0. (1969) 05009938 National Cancer Institute (NCI) (1979) 05010096 Bo man, M.C., et a]. (1968) 05010317 Babad, H,; Herbert, W.; Goldberg, M.C. (1968) 05010318 1 ss, R.T.; Biros, F.J. (1970) 05100522 DDrough, 11W.; Brady, U.E., Jr. Tininerman, J.A.; Arthur, B.W. (1961) 05012220 Vickery, D.S., and Arthur, B.W. (1960) 05012747 Kasin v, D.D. (1969) 05012748 Kasirr v, D.D. (1969) 05012915 FL O working Party of E cperts on Pesticide Residues (1973) 05013242 Ebrough, H.W.; Brady, U.E., Jr.; TirriTterman, J.A.; Arthur, B.W. (1961) 05014477 Pflugmacher, J.; Ebing, W. (1978) 05016099 Beroza, M.; Bownan, M.C. (1971) 05017521 McLeod, H.A.; Butterfield, A.G.; Lewis, D.; Phillips, W.E.J.; Coffin, D.E. (1975) 05017538 Sanders, H .0. (1972) 05108561 Thornburg, W. (1971) GSOO18001 Stuart, W. (1959) GS0018002 Genung, W. (1959) GS0018003 Hecht, G. (1958) GS0018004 John ton, C.D., and Scott, W.J. (1965) 67 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO I8 Coumaphos Section One: Citations Considered to be Part of the L ta Base Supporting Registration Under the Standard Product Chemistry MRID Citation 05006145 Ackerrnann, H. (1969) Duennshichtchromatographisch—enZymatischer Nachweis phosphororganishcer Insektizige: zum duennschichtechrcraatgraphischen Verhal ten einiger s iterer Insektizide— Thin—layer chranatographic—enzyrnatic determination of organophosphorus insecticides: thin-layer chrc atographic behaviour of sa further insecticides. Journal of Chrar atgraphy 44(2) :414—418. 05010317 Babad, H,; Herbert, W.; (bldberg, M.C. (1968) Nuclear magnetic resonance studies of phosphorus (V) pesticides: Part I — Chemical Shifts of protons as a means of identification of pesticides. Aualytica Chimica Acta 41(2):259—268. 05002073 Barney, J.E. II (1965) New spray tests for detecting organophosphorus canpounds on thin—layer chranatograms. Journal of Chrctnatography 20(2):334—341. 00005208 Bayvet (1965) Confidential Ingredient Statement: Co—Ral 1% Ready—To— Use Spray. (Unpublished Study received June 4, 1965 under 11556— 16; CDL:126968—D). 00005207 Bayvet (1967) Confidential Ingredient Statement: Co—Ral 1% Ready—To— Use Spray. (Unpublished st x y received May 1, 1967 under 11556— 16; CDL:126968—C). 00005417 Bayvet (1974) Co—Ral Formulator’s Manual for Dust Formulations. Unpublished st 1y received Jan. 8, 1975 under 11556—49; CDL;140110—B). 00005528 Bloan, D. (1969) Stability Study: Moorman’s Insecticide Dust with (R) Co-Ral. (Unpublished st x1y received Aug. 22, 1969 under 1157—31; sulinitted by Moorman Manufacturing Co., Quincy, Ill.; CDL:005687—A). 05002075 Brajthwaite, D.P. (1963) Detection of çtiosphorothioate pesticides, Nature (London) 200(4910):101. 00005433 Caswell, R.L. (1962) Report on Co—Ral: Determination of Sulfotepp. Method dated Nov. 15, 1962. Unpublished stir3y received Nov. 15, 1962 under unknown admin. no.; prepared by Chemagro Corp., sul:initted by Bayvet, Shawnee Mission, Kans.; CDL:124758—A). 68 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Coumaphos Section One: Citations Considered to be Part of the Data Base Supporting Registration Under the Standard Product Chemistry MRID Citation 00005193 Chemagro Corporation (1957) Co—Pal (Formerly Bayer 21/199) for Experimental Use Only. Unpublished study received July. 1, 1957 under unknown admin. no.; sutirtitted by Bayvet, Shawnee Mission, Kans.; CDL:l24847—A). 00005838 Chemagro Corporation (1961) Confidential Ingredient Statement: Co- Ral Livestock Duster (5% Dust). (Unpublished study received Mar.29, 1961 under 1F0306; CDL:092586—M). 00005188 Chemagro Corporation (1962) Chemagro Corporation Analytical Method: Assay of chnica1 Co-Pal by Ultraviolet Spectrophotcffle try. Method It4C—2.8 dated July 17, 1962. (Unpublished study received Oct. 24, 1962 under unknown admin. no.; subrtitted by Bayvet, Shawnee Mission, Kans.; CDL:124761—B). 00005187 Chemagro Corporation (1962) Chernagro Corporation Analytical Method: Estimation of Active Ingredient in Co—Pal 25% Wettable Po x3ers by Ultraviolet Spectrophotcinetry. Method TMC-2.6 dated July 25, 1962. Unpublished study received Oct. 24, 1962 under unknown admin. no •; su initted by Bayvet, Shawnee Mission, Kans.; CDL: 124761—A). 00005189 Chemagro Corporation (1962) Chemagro Corporation Analytical Method: Estimation of Chlorferrcn in chnica1 Co-Pal by Ultraviolet Spectrophotanetry. Method ‘I?4C—2.l0, dated June 7, 1962. (Unpublished study received Oct. 24, 1962 under unknown admin. no •; subnitted by Bayvet, Shawnee Mission, Kans •; CDL: 124761—C). 00021981 Chemagro Corporation (1964) Co—Pal Parasiticide. (Unpublished study received Oct. 8, 1968 under unknown admin. no •; sutraitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:006897—A). 00005435 Chemagro Corporation (1966) Confidential Ingredient Statement: Co- Ral 25% Wettable bwder. (Unpublished study received Dec • 21, 1967 under SF0678; CDL:092983—B). 00005345 Chanagro Corporation (1966) Confidential Ingredient Statement: Co- Ral Exulsi fiable Concentrate: (lib . /gal.). (Unpublished study received on unknown date under 1F0306; CDL:092586- L). ‘9 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Coumaphos Section One: Citations Considered to be Part of the Data Base Supporting Registration Under the Standard Product Chemistry MRID Citation 00005192 Costello, J.R. (19??) Co—Pal: operating Procedure. (Unpublished sti.dy received Oct. 24, 1962 under unknown admin • ro.; sutinitted by Bayvet, Shawnee Mission, Kans.; CDL :124761-O). 05002340 Dainico, JN. (1966) The mass spectra of sar organophosphorus pesticide cxmpounds. Journal of the Association of Official Analytical Chemists 49(5):1027—l045. 05013242 Drough, H.W.; Brady, U.E., Jr.; TinTnerman, J.A.; Arthur, B.W. (1961) Residues in tissues and eggs of poultry receiving Co—Pal (Bayer 21/199) in the feed. Journal of Economic Entorrology 54(1) :97—100. 05004089 El-Refal, A.; }bpkins, T.L. (1965) Thin—layer chromatography arid cholinesterase detection of several phosphorothiono insecticides and their oxygen analogs. Journal of P ricu1tural and Food • Chemistry 13(5):477—481. 05005130 Hart nan, C.H. (1966) Phosphorus detector for pesticide analysis, Bulletin of Environmental Contamination and Toxicology l(4):159— 168. 05004290 Kane, P.F., et al. (1960) Assay of Co—Pal in Technical Material and Formulated Products • Journal of Agricultural and Food Chemistry 8(1):26—29. 05012747 Kasiirov, D.C. (1969) Laboratornvi sintez ko—rala, mechenogo po P32 Laboratory synthesis of phosphorus—32 labeled Co—Pal. Th x3y, Vsesoyuznyi Nauchno Issledovatel’skii Institut Veterinarnoi Sariitarii. Transactions, All—Union Scientific Research Institute of Veterinary Sanitation. 32:375—378. 05002360 Keith, L.H.; Alford, A.L. (1969) Supplementary interpretations of the NMR spectra of phosphorus pesticides. Analytica Chimica Acta 44(2):447—448. 05004395 Keith, L.H.; Garrison, A.W., Alford, A.L. (1968) The high resolution NMR spectra of pesticides. Organophosphorus pesticides. Journal of the Association of Official Analytical Chemists 51(5) :1063—1094. 70 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Coumaphos Section One; Citations Considered to be Part of the Data Base Supporting Registration Under the Standard Product Chemistry MRID Citation 00005526 Macflugall, D. (19??) Co—Ral. Pages 83—95, “In”? By ? N.P. (Also “In” unpublished sukxnission received May 1, 1972 under 2749—135; sutinitted by Aceto Chemical Co., Inc., Flushing, N.Y. CDL:025450— A). 05004866 McKinley, W.P.; Bead, S.I. (1962) Esterase inhibition technique for the detection of organophosphorus pesticides. Journal of the Assocation of Official 4gricu1tural Chemists 45(2):467—473. 00021997 Mobay Chemical Corporation (1966) Confidential Ingredient Statement: Co-Ral 5.0% Dust (Livestock Duster). (Unpublished study received Oct. 8, 1968 under unkrown admin. to.; CDL:006897—AG). 05014477 Pflugmacher, J.; ElDing, W. (1978) Zur Kenntnis des E lutionsverhaltens einiger pflanzenschutzmittelWirkstOffklasSen bei der Galchranatographie. Evaluation of the elution behaviour of scum classes of pesticides in gel chranatography. Journal of Chranatography 151(2) :171—197. 00005307 Rose, W.B., White, C.E. (1971) Co—Ral: Formulator’s Manual for Dust Formulations: Report No. 16425. Includes undated method. (Unpublished study receved June 4, 1971 under 3125—101; sukinitted by k bay Chemical Corp., ricultural Div., Kansas City, i; CDL: 025735—A) 05010318 Ross, R.T.; Biros, F.J. (1970) Correlations between 31 chemical shifts and structures of sc organophosphorus pesticides. Analytica Chimica Acta 52(l):139—141. 05003797 Volpe, Y.; Mallet, YN. (1976) A mechanism for the neat—induced fltrrescence of ooumaphos and related cxinpounds and the identification of their metabolities in water. Malytica Chimica Acta 81(l):lll—116. 00005278 Wasleski, D.M. (1953?) Colorimetric determination of Potasan in Coumaphos. Undated method. (Unpublished study received Sep. 20, 1965 under 11556—21; prepared by Chemagro Corp., sulxdtted by Bayvet, Shawnee Mission, Kans,; CDL:124734—A). 05003798 Wasleski, D.M. (1966) Colotmetric determination of Potasan in Coumaphos. Journal of P gricu1tura1 and Food Chemistry 14(2): 156- 158. 71 ------- Office of Pesticide Progran s Registration Standard Bibliography Case GSOO1B Coumaphos Section One: Citations Considered to be Part of the t ta Base Supporting Registration Under the Standard Product Chemistry ME lD Citation 00005278 Waleski, D.M. (1953?) Colorimetric t terminatiori of Potasan in Coumaphos. Undated Method. (Unpublished stedy received Sept. 20, 1965 under 11556—21; prepared by Chemagro Corp., sukxaitted by Bayvet, Shawnee Mission, Kans.; CDL:124734—A). 05003798 Wasleski, D.M. (1966) Colorin tric Determination of Potasan in Coumaphos. Journal of gricu1tura1 and Food Chemistry 14(2) :156-158. 00005190 Young, J.W. (1962) Co—Ral 25% Wettable Possder Field Storage Tests: Report 1 b. 10002. (Unpublished study received Oct. 24, 1962 under unknown admin • rx.; prepared by Chemagro Corp., sutinitted by Bayvet, Shawnee Mission, Kans.; CDL:124761—E). 72 ------- Office of Pesticide Programs Registration Standard Bibliography Case ( SOO18 Coumaphos Section One: Citations Considered to be P rt of the Data Base Supporting Registration Under the Standard Environn nta1 Fate MRID Citation 05005579 MacRae, I.C,; Celo, J.S. (1974) The Effects of Organophosphorus Pesticides on the Respiration of Arotobacter vinelandji. Soil Biology and Biochemistry 6(2) :109—111. 73 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Cournaphos Section One: Citations Considered to be Part of the Data Base Supporting Registration Under the Standard Toxicology MRID Citation 00005148 DDu I1, J., I ot, M., and Cowan, J. 1962. The Effect of Co—Hal in the Diet on the Reproduction of Mice: Report No. 10203. (Unpublished study received March 11, 1963, under unknown administration number; prepared by University of Chicago, Departsr nt of Pharmacology, su itted by Bayvet, Shawnee Mission, Kans.; CDL: 109146—D). 00005473 DDu11, J., Vesselinovitch, D., Fitch, R., Poot, M., and Meskauskas, 3. 1960. Chronic ‘lbxicity of Co—Hal Fed to Rats for a Period of Two Years: Report No. 6089. (Unpublished study received Daceinber 14, 1961, under PP0299; prepared by University of Chicago, t partments of Pharmacology and Pathology, sutii itted by Chemagro Corp., Kansas City, b.; CDL: 09320—Y). GS0018003 Hecht, G. (1958) The Acute ‘Ibxicity of Various Co—Hal Preparations to Rats, Report No 3405a, Farbenfabriken Bayer, West Ge nany, January 28, 1958 (Unpublished study; CDL:090319 and 090320). GS0018004 Johnston, C.D., and Scott, W.J. (1965). GS13005 25W Potentiation Studies with Other Organophosphate Insecticides in the Rat. (Unpublished study received August 5, 1967, under 8F06481; prepared by t,odard Research Corp., suhaitted by Geigy Chemical Corp., Ardsley, N.Y.: CDL:091128—U). 05004087 Krueger, H.R.; Casida, J.E.; Niedermeier, R.P. (1959) Bovine metabolism of organophosphorus insecticides——Metabolism and residues associated with dernial application of Co—Pal to rats, a goat, and a cow. J. Agric. Food Chem. 7:182—188 (26A—0022). 00005416 Lamb, D.W., and Anderson, R.G. 1974. Acute ‘I xicity of Co—Hal 50% Wettable Powder to Rats and Rabbits: Report No. 41817. (Unpublished study received January 8, 1975, under 11556—49; prepared by Mobay Chemical Corp., subnitted by Bayvet, Shawnee Mission, Kans,; CDL:140110—A). O0054l5 Lamb, D.W., and Matzkanin, C.S. (1975). Eye Irritance of Co—Hal 50% Wettable Powder to Rabbits. (Unpublished study received July 29, 1975, under 11556-49; prepared by Mobay Chemical Corp., sul:initted by Bayvet, Shawnee Mission, Kans,; CDLd4O1I1—A). 74 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Coumaphos Section One: Citations Considered to be Part of the Data Base Supporting Registration Under the Standard Toxicology MRID Citation 00005496 Narcisse, J.K. (1967) Final report: A rbtentiation Study in Rats in Vapona with 26 Other Cholinesterase—inhibiting Canpounds: SRI Project B 868—15. (Unpublished study received June 23, 1967, under 201—125; prepared by Stanford Research Institute, subnitted by Shell Chemical Co., Washington, D.C.; CDL:123582—A). 05009938 National Cancer Institute (Nd). (1979). Bioassay of Coumaphos for Possible Carcinogenicity. CAS No. 56—72—4. NCI Carcinogenesis Technical Report Series No. 96, Washington, D.C., DHEW (NIH) Publication No. 79—1346 (26A—0054). 00005384 Vaughn, G.,, Deininger, E., and Deull, J. (1958a) Measurement of the Safe Dietary Level of Co—Ral for flDgs: Report No. 247 2a. (Unpublished study received October 8, 19.59, under 1F0306; prepared by University. of Chicago, Department of Pharmacology, sutmitted by Chemagro Corp., Kansas city, lb. CDL:090325-0). 00005504 Vaughn, G., Deininger, E. and D ull, J. (1958b) The Effects of Diets Containing Co—Ral (Bayer 21/199) on Rats: Report No 2455a. (Unpublised study received September 20, 1960, under 11556—li; prepared by University of Chicago, Department of Pharmacology, sutmitted by Bayvet, Shawnee Mission, Kans,; CDL: 109120—B). 05012220 Vickery, D.S., and Arthur, B.W. (1960) Animal systemic activity, metabolism, stability of Co-Ral (Bayer 21/199.) J. Econ. Entaio. 53:1037—1043. 75 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOOI8 Counaphos Section ( ie: Citations Considered to be Part of the Data Base Supporting Registration Under the Standard Residue Chemistry MRID Citation 00005289 Adams, J. (1964) A Quantitative Method for the Determination of Residues of Co-Ral (O—03-thloro-4-methyl inpelliferoneJ. 0,0— Diethyl phosphor.vthioate) and Chiorferron (3-Chloro-4-methyl-.-7 - hydroxycounarin) in Animal Tissues and Milk: Report No. 13656. Method dated May 6, 1964. (Unpublished study received Aug 18, 1966 under 7F0612; subnitted by Chemagro Corp., Kansas City, r b.; CEL:090796—K). 00005328 k ams, J.M. (1961) A quantitative method for the determination of residues of Co-Pal and thiorferron in animal residues. Report No. 7165. (Unpublished study dated June 13, 1961). Sut nitted by Chemagro Corp., Kansas City, tb.; CDL: None. 00005342 Adams, J.M. (1963) A Quantitative Method for the Determination of Residues of Co-Pal (0—3—thloro-4--methyl unpelliferone) 0,0— Diethyl. phosphorothioate) and Chiorferron C3-Ch1oro-4-n thy1-7- hydroxycounarin) in Animal Tissues and Milk: Report No. 7165, Rev. (pp. 1—6 only; unpublished study received on unkn n date under 1F0306; subuitted by Cheinagro Corp., Kansas City, ! b.; CDL:092586—G). 00005395 Adelman, D. (1958) Summary: Co—Ral Residues in Cattle Fat (Biopsy): Report No. 2408. (Unpublished study including report no. 2447a, received Oct. 8, 1959 under 1F0306; prepared in cooperation with U.S. Agricultural Research Service, sutxnitted by themagro Corp., Kansas City, lb.; CIL:090326—D). 00005448 Anderson, C.A. (1959) Co—Ral Residues in thicken Tissues and Eggs: Report No. 4010. (Unpublished study received Mar 10, 1961 under PP0299; prepared in cooperation with Univ. of California-- Riverside, Agricultural Experiment Station, subuitted by themagro Corp., Kansas City, ?t.; CDL:090337—N). 00005451 Anderson, C.A. (1959) Co—Pal Residues in thicken Tissues: Report No. 4323. (Unpublished study received Mar 10, 1961 under PP0299; prepared in cooperation with Clemson Univ., Dept. of tmo1ogy, subuitted by themagro Corp., Kansas City, Mo ,; CIL:090337—U). 00005453 Anderson, C.A. (1959) Co—Pal Residues in thicken Tissues: Report No. 4421. (Unpublished study received Mar 10, 1961 under PP0299; prepared in cooperation with M ifl Univ., MoDenald College, Dept. of u1try Husbandry, subnitted by themagro Corp., Kansas City, Z’b.; CIL:090337—W). 76 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Cou aphos Section One: Citations Considered to be Part of the Data Base Su orting Registration Under the Standard Residue themistry MRID Citation 00005074 Anderson, C.A. (1959) Co—Ral Residues in Goat Tissues: Report No. 4008. (Unpublished study received Sep 11, 1959 under 11556—21; prepared by th magro Corp., sulinitted by Bayvet, Shawnee Mission, Kans.; CDL:0l1001—A). 00005161 Anderson, C.A. (1959) Co-Ral Residues inibg Tissues: Report No. 3758. (Unpublished study received May 25, 1959 under 11556—21; prepared by themagro Corp., sthnitted by Bayvet, Shawnee Mission, Kans.; CDL:124730—A). 00005400 Anderson, C.A. (1959) Co-Ral Pec idues in }bg Tissues: Report lb. 4009. (Unpublished study received Oct 8, 1959 under 1F0306; suI nitted by themagro Corp., Kansas City, sb.; CDL: 090326-0). 00005195 Anderson, C.A. (1958) A Photofluoranetric Method for the Determination of Co—Ral (Bayer 21/199) Residues in Animal Tissues: Report No. 2216. MethOd dated Aug. 13, 1958. (Unpublished study received Feb. 27, 1976 under 11556-Ex—3; prepared by themagro Corp., suk nitted by Bayvet, Shawnee Mission, Kans.; CDL:224167—E). 05004066 Anderson, C.A.; iams, J.M.; McEXugall, D. (1959) Photofluoranetric method for determination of Co-Ral residues in animal tissues. Journal of 1 ricu1tura1 and Food themistry 7(4):256-259. 05002359 Askew, 3.; Ruzicka, 3.11.; Wheals, B.B. (1969) OrganophosphoruS pesticides: a gas chrunatographic screening technique based on the detection of methylated hydrolysis products. Journal of thranatography 41(2) :180—187. 00005509 Bayvet (1968) Synopsis of Analytical and Residue Information for Spray A lication of Cb-Ral to Dairy Cattle. SutTnary of studies 102084—B through l02084-G. (Unpublished study received Feb. 20, 1970 under 11556—21; CDL:102084—A). 00005186 Bayvet (19??) Residues of Bayvet 21/199 in Fat and Liver Tissues of Cattle Sprayed with The Insecticide. (Unpublished study received on unknown date under unknown adrnin. no.; CDL: 124765—A). 05016099 Beroza, M.; Sc nan, M.C. (1971) Instrunentation in determination of organophosphorus terminal residues. Pages 79-92, •Th” Pesticide Terminal Residues: Invited Papers fran the International Syniposiun on Pesticide Terminal Residues; Feb. 17—19, 1971, Tel Aviv, Israel. Fthted by A.S. Tehori. London: Butter rths. 77 ------- Office of Pesticide Programs Registration Standard Bibliography Case GS0018 Coumaphos Section One: Citations Considered to be Part of the t ta Base Supporting Registration Under the Standard Residue Chemistry MR [ D Citation 05004211 Bowman, M.C.; Beroza, M. (1967) Temperature—progranirted gas chranatography of 20 phosphorus-containing insecticides on 4 different columns arid its application to the analysis of milk and corn silage. Journal of the Association of Official Analytical Chemists 50(6) :1228—1236. 05010096 Bowman, M.C., et al (1968) A Method of Analyzing the 01 of 01 milk Feces of Cows for Coumaphos for Control of Ibuse Fly. 05005125 Burnett, E.M. (1970) Pesticide residues in fat of cattle treated with backrubbers impregnated with coumaphos, methoxychior or DtlT. Pesticide Science l(2):70—72. 00005483 Chemagto Corporation (1959?) Synopsis of Analytical and Residue Information for Cattle, Swine, and P u1try Tissues (Co—Ral——Feed and Salt &3ditives). Suiruiary of studies 090319—U through 090319— Y and 090319—M through 090319—AC. (Unpublished study received Feb. 11, 1964 under PP0299; CDL:090319—U). 00005392 Chemagro Corporation (1959) Synopsis of Metabolic, Analytical Residue, and Taste I ta on Co-Hal. Sumliary of studies 090326—B through 090326—U. (Unpublished study received C t. 8, 1959 under 1F0306; CDL:090326—A). 00005333 Chemagro Corporation (1960) Residue Report: Report ND. 5515. (Unpublished study including report nos. 5533 and 5534, received Sep. 4, 1961 under PP0306; CDL:090321—H). 00005480 Chemagro Corporation (1960) Residue Report: Report ND. 6101. (Unpublished study received Mar. 10, 1961 under PP0299; CDL:090337—1 K). 00005456 Chemagro Corporation (1960) Residue Report: Report ND. 6102. (Unpublished study received Mar. 10, 1961 under PP0299; CDL:090337—AA). 00005840 Chemagro Corporation (1960) Residue Report: ND. 6103. (Unpublished study received Mar. 10, 1961 under PP0299; CDL:090337—AB). 00005842 Chemagro Corporation (1960) Residue Report: Report ND. 6141. (Unpublished study received Mar. 10, 1961 under PP0299; CDL:090337—AJ). 78 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOOI8 Coumaphos Section One: Citations Considered to be Part of the Data Base Supporting Registration Under the Standard Residue Chemistry MRED Citation 00005440 Chemagro Corporation (1960?) Synopsis of Residue Information on Poultry Meat and Bggs (EXist Box, Spray) * Sumary of studies 091185—E and 091185—C. (Unpublished study received June 14, 1968 under 8F0678; CDL:091185—F). 00005837 Chemagro Corporation (1961) Confidential Ingredient Statement: Co- Ral 25% Wettable Powder. (Unpublished study received Mar. 29, 1961 under 1F0306; CDL:092586—I). 00005493 Chemagro Corporation (1961) Ch nagro Confidential Residue Experiment No. ?: Report No. 7167. (Unpublished study received on unknown date under PP0229; CDL:092579—C). 00005492 Chemagro Corporation (1961) Chernagro Corporation Residue Experiment No. SE 205—61—D: Report No. 7166. (Unpublished study received on unknown date under PP0299; CDL: 092579—B). 00005441 Chemagi:o Corporation (1961) Chemagro Confidential Residue Report: Report No. 6101. (Unpublished study including report r s . 6102— 6104, 6141—6142, 7155—7156, 7159, 7166 and 7248, received June 14, 1968 under 8F0678; CDL:091185—G). 00005331 Chemagro Corporation (1961? Synopsis of Analytical and Residue Infotmation on Co—Ral: (Milk). &nrrnary of studies 090321—F through 090321—H. (Unpublished study received Sep. 4, 1961 under PP0306; CDL:090321—E). 00005485 Chemagro Corporation (1962) Residue Experiment ?: Report No. 8300. (Unpublished study received Feb. 11, 1964 under PP0299; CDL:090319—W). 00005486 Chemagro Corporation (1962) Chemagro Corporation Residue Experiment No. KC-209-62H: Report No. 9721. (Unpublished study received Feb. 11, 1964 under PP0299; CDL:090319—X). 00005822 Chemagro Corporation (1963) Chemagro Corporation Residue Experiment No. KC—203—63D: Report No. 11449. (Unpublished study received July 9, 1963 under 11556—21; suI iitted by Bayvet, Shawnee Mission, Karis.; CDL:025716—A). 79 ------- Office of Pesticide Prograns Registration Standard Bibliography Case GSOOI8 Cotmiaphos Section ( ie; Citations Considered to be Part of the Data Base Su çorting Registration Under the Standard Residue Chemistry MRID Citation 00005056 Chemagro Corporation (1963) Cheni gro Corporation Residue Experu ent No. KC-2l5-63D Report No. 12541. (Unpublished study including letter dated Jan. 22 1964 frm G.G. Stetson to G.M. Dwnard, received Jan. 28. 1964 under 11556-21; sut itted by Bayvet Shawnee Mission, Kans.; CDL 025715 A). 00005491 chemagro Corporation (1963) Cheniagro Corporation Residue Experiment No NW-203 62DC Report No. 11447. (Unpublished study received Feb. 11, 1964 under PP0299; CDL 090319—AC). 00005329 Chemagro Corporation (1963) Report No. 10867: thloroferroni. (Unpublished study received on unknown date under PP0306; CDL 09032l C). 00005834 Chemagro Corporation (1964) Chemagro Corporation Residue Experiment No. ?: Report No. 13100. (Unpublished study received Dec. 21, 1967 under 11556 11; suhinitted by Bayvet, Shawnee Mission, Kans.; CDL:121477—G). 00005831 Chemagro Corporation (1964) Chemagro Corporation Residue Experiment No. KC-201-64D: Report No. 13856. (Unpublished study received June 4, 1965 under 11556 16; sulznitted by Bayvet, Shawnee Mission, Kans.; CDL:126094—C). 00005830 Cheinagro Corporation (1964) themagro Corporation Residue Experiment No.KC—200—64D: Report No. 13875. (Unpublished study received June 4, 1965 under 11556 -l6; su nitted by Bayvet, Shawnee Mission, Kans.; CDL:126094—B). 00005832 Chemagro Corporation (1964) Chemagro Corporation Residue Experiment No. KC-202-63D Report No. 12866. (Unpublished study received Dec 21 1967 under 11556 11; subnitted by Bayvet, Shawnee Mission, Kans.; CDL:121477—E). 00005214 Chemagro Corporation (1964) themagro Corporation Residue Experiment No. KC-206, 207—64D: Report No. 14361. (Unpublished study received Dec 21 1967 under 11556 11; subnitted by Bayvet, Shawnee Mission Kans.; CDL:121477—1). 00005317 theniagro Corporation (1964) Chemagro Corporation Residue Experiment No. KC—214-63D: Report No. 12786. (Unpublished study received June 8, 1964 under 3125 124; sutinitted by t.bbay Chemical Corp. 1 qricu1tura1 Div., Kansas City, Mo.; CDL:005791—B). 80 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Cotinaphos Section One Citations Considered to be Part of the t ta Base Supporting Registration Under the Standard Residue Chemistry MRID Citation 00005235 Chemagro Corporation (1964) Chemagro Corporation Residue Experiment No. KC—214-63D: Report No. 12786. (Unpublished study received June 8, 1964 under 11556 25; suthtitted by Bayvet, Shawnee Mission Kansas.; CDL 1 :102326—B). 00005833 Chemagro Corporation (1964) Chemagro Corporation Residue Experiment No. NC-202--63D: Report No. 12867. (Unpublished study received Dec. 21. 1967 under 11556-11; subnitted by Bayvet, Shawnee Mission, Kans.; CDL:121477—F). 00005336 Chemagro Corporation (1964?) Synopsisof Analytical and Residue Information for Spray Application of Co-Ral to Deiry Cattle, Sunmary of studies 09( 21 S through 090321-V. (Unpublished study received on unknown date under PP0306; CDL:090321—R). 00005293 Chemagro Corporation (1966) Chemagro Corporation Residues Experiment No. KC—3400-66D: Report No. 17971. (Unpublished study received Aug. 18 1966 under 7F0612; CDL 090796 Q) 00005295 Che!nagro Corporation (1966) themagro Corporation Residue Exeriment No. KC -340l 66H: Report No. 18522. (Unpublished study received Aug. 18, 1966 under 7F0612; CDL;090796—S). 00005338 Chemagro Corporation (1966) Synopsis of Analytical and Residue Information for [ xist Application to Cattle. Suninary of studies 092586 B, 092586 D through 092586-E and 092586 G. (Unpublished study including supplement, received Mar. 18, 1968 under 1F0306; CIL:092586 A). 00005047 themagro Corporation (1967) Chemagro Corporation Residue Experiment No. KC—201—66D: Report No. 20654. (Unpublished study received Dec. 15, 1967 under 11556 19; su itted by Bayvet, Shawnee Mission, Kans,; CDL:014008—D). 00005339 Chemagro Corporation (1967) Chemagro Corporation Residue Experiment No. KC—201—67D: Report No. 20599. (Unpublished study including report nos. 20651, 20663 and 20677, received Mar. 18, 1968 under 1F0306; CDL:092586—B). 00005048 Chemagro Corporation (1967) Chemagro Corporation Residue Experiment No. KC-300—66H: Report tb. 20964. (Unpublished study received Dec. 15, 1967 under 11556 19; subnitted by Bayvet, Shawnee Mission, Kans.; CDL:0l4008—E). 81 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOOJ.8 Coumaphos Section One: Citations Considered to be Part of the L ta Base Supporting Registration Under the Standard Residue Chemistry MRID Citation 00005051 Chemagro Corporation (1968) Chemagro Corporation Residue Experiment No. ?: Report No. 23942. (Unpublished study received July 23, 1970 under 11556 16; subnitted by Bayvet, Shawnee Mission, Kans.; CDL:007188-A). 00005439 Chemagro Corporation (1968) Chemagro Corporation Residue Experiment No. KC—203 --68D: Report No. 22808. (Unpublished study including report nos. 22809 --228fl. received June 14, 1968 under 8F0678; CDL:091185—D). 00005510 Chemagro Corporation (1968) Recovery of Co—Ral f aii Milk: Report No. 22697. (UnpUblished study received Feb. 20, 1970 under 11556 -21; suthiitted by Bay iet, Shawnee Mission, Kans.; CDLI 102084 E). 00005437 Chemagro Corporation (1968) Synopsis of Analytical and Residue Information on Application of Cowiaphos (Co-Ral, Baymix, Meldane) to Poultry. St.mnary of studies 092983-B, 092983—C, and 091185-B through 091185-E. (Unpublished study received June 14, 1968 under 8F0678; CDL:091185-A). 00005511 Chemagro Corporation (1969) Chemagro Corporation Residue Experiment No. KC-200-68D: Report No. 24050. (Unpublished study received Feb. 20, 1970 under 11556—21; sukinitted by Bayvet, Shawnee Mission, Kans.; C1L102084 F). 00005080 Chemagro Corporation (1969) Synopsis of analytical and residue information for spray application of Co—Ral to dairy cattle. suninary of studies 006078-B through 006078-G. (Unpublished study received Feb. 20, 1970 under 11556-21; sul uitted by Bayvet, Shawnee MiSsion, Kans.; CDLI: 006078—A). 00005081 Chemagro Corporation (1969) Chernagro Corporation Residue Experiment No KC—201--68D: Report No. 24216. (Unpublished study received Feb. 20, 1970 under 11556 21; sukinitted by Bayvet, Shawnee Mission, Kans.; CDL:006078-G). 00005042 Chemagro Corporation (1971) Chemagro Corporation Residue Experiment Nos. AU 70G—810, All 71G-818: Report No. 30331. (Unpublished study received Oct. 29.. 1971 under 11556-4; suthdtted by Bayvet, Shawnee Mission, Kans.; CDL:010122—F). 82 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Cotii aphos Section e: Citations Considered to be Part of the t ta Base Supporting Registration Under the Standard Residue Chemistry MRID Citation 00005490 Ditman, L.P. (1963) Chemagro Corporation Residue Experiment . EC— 200-63D: Report r . 11372. (Unpublished study received Feb. 11, 1964 under PP0299; prepared by Univ. of Maryland, Dept. of Entanology, Insecticide Laboratory, sthnitted by Chemagro Corp., Kansas City, !b.; CDL:090319—AB). 00005450 D3urrongh, H.W.; Brady, O.E., Jr.; Tininerman, J.A.; Arthur, B.W. (1959) Magnitude and Nature of Residues in Tissues and E jgs of Poultry EXIsted with 32P Co-Ral: Progress Report: Report No. 4209. (Unpublished study received Mar. 10, 1961 under PP0299; prepared by Alabama Polytechnic Institute, Dept. of Zoology- Entcztology, subuitted by Chemagro Corp., Kansas City, lb.; CDL: 090337—1) 00005454 Eburrough, H.W,; Brady, U.E., Jr.; Tininerman, J.A.; Arthur, B.W. (1959) Magnitude and Nature of Residues in Tissues and Bggs of Poultry Receiving 32P Co-Ral: Mixed in the Feed: Progress Report: Report lb. 4425. (Unpublished study received Mar. 10, 1961 under PP0299; prepared by Alabama Polytechnic Institute, Dept. of Zoology-Entarology, suhuitted by th nagro Corp., Kansas City, lb.; CDL 1 :090337—X). 05008968 Dzrough, H.W.; Brady, U.E., Jr.; Timerman, L.A., Arthur, B.W. (1961) Residues in tissues and eggs of poultry dusted with Co- Ral (Bayer 21/199). Journal of E) onanic Entanology 54(1):25—30. 05013242 D rough, H.W.; Brady, U.E., Jr.; Tininerman, J.A.; Arthur, B.W. (1961) Residues in tissues and eggs of poultry receiving Co-Ral (Bager 21/199) in the feed. Journal of Econanic &itanology 54(1) :97—100. 05012915 FPL) rking Party of Experts on Pesticide Residues (1973) Counaphos. Pages 211—217, “In” 1972 Evaluations of Sane Pesticide Residues in Fbod. By the FN) Working Party of Experts on Pesticide Residues and the WHO Expert Oxinittee on Pesticide Residues • Geneva, Switzerland: br1d Health Organization, (WHO pesticide residues series no. 2). 00005396 Gronberg, R.R. (1958) Co—Ral Residues in Cattle Tissues: Report No.2409. (Unpublished study received Oct. 8, 1959 under 1F0306; prepared in oooperation with U.S. J riculturaI Research Service, sukinitted by themagro Corp., Kansas City, Mo.; CDL:090326-E). 83 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Coumaphos Section One: Citations Considered to be Part of the Data Base Supporting Registration Under the Standard Residue Chemistry MRID Citation 00005399 Gronberg, R.R. (1958) Co—Ral Residues in Cattle Tissues: Report bb.2556. (Unpublished stedy received Oct. 8, 1959 under 1F0306; prepared in oDoperation with Science Service Laboratory, Live- stock Insect Section, suhnitted by Chemagro Corp., Kansas City, b.; CDL:090326—I). 00005479 Gronberg, R.R. (1958) Co—Ral Residues in Cattle Tissues: Report I’b.2409. (Unpublished stuiy including report no. 2447a, received Feb. 14, 1961 under PP0299; prepared in ocoperation with U. S. Dept. of l ricuiture, sulinitted by Chemagro Corp., Kansas City, Yb.; CDL:090320—AH). 05004690 Hurwood, I.S. (1966) Studies on pesticide residues—i—Excretion of pesticides in milk following dermal treatment of dairy cattle with coumaphos and dioxathion. Queensland Journal of P ricultura1 and Animal Sciences 23(4):555—562. 00005082 Industrial Bio-Test Laboratories (1974) Chemagro Division of Baychem Corporation Residue Experiment: AH—74A—929: Report Yb. 40709. (Unpublished stu5y received June 20, 1974 under 11556—21; prepared for Baychem Corp., sutmitted by Bayvet, Sha e Mission, Kans; CDL:009815—A). 05004483 Kaplanjs, J,N.; 1bpkins, D.E.; Treiber, G.H. (1959) Dermal and oral treatments of cattle with phosphorus—32—labe led Co—Ral, Journal of Ps ricultural and Food Chemistry 7(7):483—486. 05012748 Kasinov, D.D. (1969) Metabolism ko-rala v organi te krolikov i krupnogo rogatogo skota. Co-Ral metabolism in rabbits and cattle. Pr x1y, Vsesoyuznyi Nauchno-Issledovatel’skii Institut Veterinarnoi Sanitarii. Transactions, All—Union Scientific Research Institute of Veterinary Sanitation. 32:379—387. 050???? Knapp, F.W. (1962) 1 ultry tolerance to excessive amounts of Co—Ral dust. 05004087 Krueger, H.R.; Casida, J.E.; Niedermeier, R.P. (1959) Bovine metabolism of organophosphorus insecticides—Metabolism and residues associated with dermal application of Co—Ral to rats, a goat, and a cow. J. Agric. Food Chem. 7:182—188 (26A—0022). 84 ------- Office of Pesticide Programs Registration Standard Bibliography Case GS0018 Coumaphos Section One: Citations Considered to be Part of the t ta Base Supporting Registration Under the Standard Residue Chemistry MRtD Citation 00005332 Kruegar, H.R.; Casida, J.E.; Niedermeier, R.P. (1961) Co—Pal Residues in Cows Milk Following a Single Spray 1 pplication: Report 1b. 2213(a). (Unpublished study received Sep. 4, 1961 under PP0306; prepared by Univ. of Wisconsin, t pts. of Entci ology and 1 iry Husbandry, sutrnitted by Chemagro Corp., Kansas City, tb.; CDL:090321—F). 05005830 Matthysse, J.G.; Lisk, D. (1968) Residues of diazinori, coumaphos, Ciodrin, methoxychior, and rotenone in cow’s milk frau treatments similar to those used for ectoparasite and fly control on dairy cattle, with notes on safety of diazinon and Ciodrin to calves. Journal of Fconc*nic Entcirology 61(5):1394—1398. 05017521 McLeod, H.A.; Butterfield, A.G.; Lewis, D.; Phillips, W.E.J.; Coffin, D.E. (1975) Gas—liquid chrcsnatography system with flame ionization, phosphorus, sulfur, nitrogen, and electron capture detectors operating simultaneously for pesticide residue analysis. na1ytical Chemistry 47(4):674—679. 00005308 !bbay Chemical Corporation.(l964) Synopsis of 1i na1ytica1 and Residue Infoim aticn on Co-Pal. Sumnary of study 005791—B. (Unpublished study received June 8, 1964 under 3125—124; CDL:005791—A). 05006630 Oehler, D.D.; Eschle, J.L.; Miller, J.A.; Claborn, H.V.; Ivey, M.C. (1969) Residues in milk resulting frau ultra-low-volume sprays of malathion, methoxychior, coumaphos, ronnel, or Gardona for control of the horn fly. Journal of Ec,onc*uic Enta logy 62(6) :1481—1483. 00005040 Olson, T.J. (1971) A Gas Chranatographic Confirmatory Residue Procedure for Cr) Co-Pal and its Oxygen Anaolg: Report tb. 30279. Method dated 1 june 16, 1971. (Unpublished study received Oct. 29, 1971 under 11556—4; prepared by Chemagro Corp., suk iuitted by Bayvet, Shawnee Mission, Kans •; CDL: 010l22—D). 00005401 Radeleff, R.D.; Claborn, H.V. (1957?) Ecreticri of Co-Pal by t actating I iry Cattle: Report tb • 4161 • Undated method. (Unpublished study received Oct. 8, 1959 under 1F0306; prepared by U.S. P ricultural Research Service, E tawlogy Research Div. in cooperation with animal Disease and Parasite Research Div., sutinitted by Chemagro Corp., Kansas City, lb.; CDL: 090326—P). 85 ------- Office of Pesticide Programs Peg istration Standard Bibliography Case GSO 018 Cou’riaphos Section C ie: Citations Considered to be Part of the t ta Base Su orting Registration Under the Standard Residue Chemistry MRID Citation 05003806 Radeleff R.D.; Claborn, H.V. (1960) Excretion of Co-Ral in the milk of dairy cattle. Journal of i gricu1tura1 and Food Chemistry. 8(6):437 439. 00005402 1 bbins, W.E.; }bpkins, T.L.; L rr , D.I.; Eddy, G.W. (1959) Studies with P-32-Bayer 21/199 sprayed on cattle. Journal of Econanic Entaiiology 52(2):214—217. (Report no. 4168; also “In”unpublished sthTtission received Oct. 8, 1959 under 1F0306; sukxnitted by Chemagro Corp., Kansas City, Mo.; CDL:090326-R). 00005323 Padrigues, J.L. (1958?) Report for Year Ending December 31, 1958: Preliminary Results of Experiments with Co_Pal for Controlling Insect Pests of thickens: Report tb. 4460. (Unpublished study received Dec. 16, 1959 under 1F0306; prepared by Univ. of California-Riverside, 1 ricu1tura1 Experiment Station and Citrus Experiment Station, Dept. of Entciiology, sutinitted by Cheinagro Corp., Kansas City tb.; CDL:092080-K). 05108561 Thornburg, W. (1971) Pesticide residues. Analytical Chemistry 43(5) :145162. 00005438 Thornton, J.S. (1968) Determination of Co—Ral in )ggs by Thermionic fluission Flame Gas Chrcii atography: Report tb. 2052. Method dated Feb. 20, 1968. (Unpublished study including report no. 22053, received June 14, 1968 under 8F0678, sutinitted by themagro Corp., Kansas City Mo.; CDL 09l185C). 05003799 Zakrevsky J.G.; Mallet, V.N. (1975) Determination of coumaphos and its oxygen analog in eggs by in situ fluorcinetry. Journal of the Association of Official Analytical Chemists 58(3):554—556. 05006806 Zweig, G., ed.; Sherma, J., ed. (1972) Co—Ral (Counaphos). Pages 332—339, “In” Analytical Methods for Pesticides and Plant Grci ’ith Regulators. Vol. VI Gas thrar tographic Analysis. New York: Academic Press. 86 ------- Office of Pesticide Programs Registration Standard Bibliography Case C OOl8 Coumaphos Section One: Citations Considered to be Part of the Data Base Supporting Registration Under the Standard Ecological Effect MRID Citation 05009242 Sanders, H.O. (1969) ‘Ibxicity of Pesticides to the Crustacean Ganu arus lacustris . Washington, D.C: U.S. Bureau of Sport Fisheries and Wildlife; Technical Paper 25. 05017538 Sanders, H.O. (1972) ‘Dzxicity of Scine Insecticides to Four Species of Malacostracan Crustaceans ( Ganmarus fasciatus) . Washington, D.C. U.S. Dapt. of the Interior, Fish and Wildlife Service, Bureau of Sport Fisheries and Wildlife; Technical Paper 66. 87 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Coumaphos Section One: Citations Considered to be Part of the Data Base Supporting Registration Under the Standard Efficacy MRID Citation 00005088 Bayvet. (1961) Synopsis of Biological Performance of Co—Pal on flDgs by ‘Ibpical Application. Suirniary of studies 014009—A through 014009—B and 014009—D through 014009—F. Unpublished study received Apr. 25, 1961 under 11556—22; CDL:014009—C). 00005028 Bayvet. (1971) Synopsis of Biological Performance of Co—Pal 1% Dust ministered to Cattle with Shaker Cans for the Control of Cattle Lice and Horn Flies. Suim ary of studies 004549-B through 004549— M. (Unpublished study received Oct. 29, 1971 under 11556—4; CDL: 004549—A). 05007632 Fox, I. et al. (1966) Ibxicity of Various Insecticides to Xenopsylla cheopis. American Journal of Tropical Medicine and Hygiene . 15(4):611—613. — ________ ________ _______ GS0018002 Genung, W. (1959) Letter and Table 1 scribing Control of Brown Dug Tick. Bayvet Division, Cutter Laboratories, Inc.; Report No. 3948. (Unpublished study). 05011422 Knapp, F.W. (1962) Co-Pal as a Litter and Nest Dust to Control the Chicken Body Louse. Journal of Econcinic EntczTology . 55(4): 571— 572. 00005200 Kohier, P.H. (1967) Louse Control Studies Using Dust Bags Containing Co—Pal (1% and 5%) and Tiguvon (5%): Report I b. 220696. (Unpublished study received Jan. 16, 1970 under 11556—15; prepared by South Dakota State Univ. 1 gricultura1 Experiment Station, for Mabay Chemical Corp., subnitted by Bayvet, Shawnee Mission, Kans.; CDL:007l68—C). 00005033 Minter, R.W. (1970) Evaluation of 1% Co—Pal Dust in Shaker Cans for Louse Control in Cattle. Report It,. 29365. (Unpublished study received Oct. 29, 1971 under 11556-4; prepared for Chemagro Corp., sutinitted by Bayvet, Shawnee Mission, Kansas.; CDL:004549— H). 00005344 Skaptason, J.S. (1959) Co—Pal Treatnent of Dugs. Report No. 4474. (Unpublished study received Dac. 16, 1959 under 1F0306; sutm itted by Chemagro Corp., Kansas City, Mo.; CDL:092080-Q). 88 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Coumaphos Section One: Citations Considered to be Part of the Deta Base Supporting Registration Under the Standard Efficacy MRID Citation 00005211 Skaptason, J.S.; MacDougall, D. (1960) Co-Pal—-A Dog Tolerance Study: Report 1 b. 5133. Includes method dated Oct. 1, 1958 entitled: Determination of Blood Cholinesterase Activity of tho1é Blood of Cattle. (Unpublished study including report ro. 2598, received Apr. 22, 1960 under 11556—12; prepared by Cheinagro Corp., sutmitted by Bayvet, Shawnee Mission, Kans.; CDL:109077—B). 00005352 Smith, C.L.; Richards, R. (1955) Evaluations of Sane New Insecticides cn Livestock and ibultry. Journal of Econanic Entonology , 48(5):566—568. (Report ro. 1190; also “In” unpublished sutmission received Apr. 4, 1958 under 1F0306; sukxnitted by Chemagro Corp., Kansas City, lb.; CDL:092081—F). CSOO1800 I Stuart, W. (1959) Control of Pests on Dogs. Bayvet Division, Cutter Laboratories, Inc., Report tb. 4467. (Unpublished study). 00005087 Stuart, W.R. (1960) Sumary of Dog Dipping Operations with Co—Pal Suspensions. (Unpublished study including report ros. 6398—6404 and letter dated Dec. 14, 1960 fran W.R. Stuart to Posemarie von Rumker, received Apr. 25, 1961 under 11556—22, prepared for Cheinagro Corp., suk:mitted by Bayvet, Shawnee Mission, Kans.; CDL: 014009—B). 00005326 Williams, G.M. (1959). Co—Pal Treatment of Dog: Report lb. 4473. (Unpublished study received Dec. 16, 1959 under 1F0306; subnitted by Chemagro Corp., Kansas City, f ’b •; CDL: 092080—0). 89 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOOI8 Counaphos Section Two: Studies Examined and Jixiged ¶Eb Be Inappropriate for Use in Developing the Standard MRID Citation 05011414 kikiris, T.R., Jr., Kropf, D.H., and V&x,ds, S.G. (1963). Residue deposition of Co—Hal in the tissues of back—line—treated cattle. J. Econ. Entanol. 56:759—761. 00005484 Niderson, C.A. (1959) Co—Hal residues in chicken tissues: Report . 3765. (UnpubliShed study received Feb. 11, 1964 under PP0299; prepared in cooperation with Univ. of Hawaii, Dept. of Enta logy, sutinitted by themagro Corp., Kansas City, pt).; CDL:090319—V). 00005447 Anderson, C.A. (1959) Co—Hal residues in chicken tissues: Report . 3869(b). (Unpublished study received Mar. 10, 1961 under PP0299; prepared in cooperation with Univ. of California—— Riverside, Dept. of Entomology, sul nitted by Chemagro Corp., Kansas City, pb.; CDL:090337—K). 05004394 Askew, J.; Ruzicka, J.H.; Wheals, B.B. (1969) A general method for the determination of or anophosphorus pesticide residues in river waters and effluents by gas, thin-layer and gel chromatography. Analyst 94(11l7):275—283. 05011413 Axtell, R.C. (1966) Comparative ‘Ibxicities of Insecticides to Ibuse Fly Larvae and Macrocheles muscaedomestica , a Mite Predator of the Ibuse Fly. Journal of Economic Ent i o1ogy 59(5): 1128—1130. 05002073 Barney, J. E., II (1965) N w Spray Tests for Detecting Organo— phosphorus Cc*npounds on Thin-Layer thrcinatogr ns. Journal of Chromatography 20(2) :334—341. 00005075 Bayvet (1960) Suçplement to Sulinary of Performance Reports on Co- Ral in Dip Vats for Fleeceworm Control, and as a Dest on Degs and Rultry. Sumary of studies 014019—C through 014019—D. (Unpublished study received Feb. 25, 1960 under 11556—21; CDL:014019—A). 00005213 Bayvet (1963) Synopsis of analytical and residue information for cattle, swine, annd poultry tissues: (Co-Hal——Feed and Salt kiditives). (Unpublished study received Dec. 21, 1967 under 11556—11, CDL:121477—A). 90 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO I8 Coumaphos Section Two: Studies Examined and Judged ‘lb Be Inappropriate for Use in Developing the Standard MRLD Citation 00005210 Bayvet (1964?) Co—Ral 1% Ready—to-Use Fly Spray. Sununary of studies 126094—B and 126094—C. (Unpublished study received June 4, 1965 under 11556-16; CDL:126094—A). 00005170 Bayvet (1965) Supplement to Synopsis of Biological Performance of Co- Ral 0.25% Neguvon 0.5% Pressurized Spray for Ectoparasite Control on Degs. 00005045 Bayvet (1967) Synopsis of analytical and residue information for dust application to cattle. Suninary of studies 014008—B through 014008—G. (Unpublished study received Dec. 15, 1967 under 11556—19; CDL:014008—A). 05004061 Bellows, R.A., Rumsey, T.S., Kasson, CW., Bond, J., Warnick, E.J., and Pahnish, 0. F. (1975). Effects of organic phosphate systemic insecticides on bovine embryonic survival and developnent. Pm. J. Vet. Res. 36:1133—1140. 05008969 Blune, R.R., et al. (1976) Effects of Residues of Certain Anthelmintics in Bovine Manure on Onthophagus gazella , a non- target organism. Southwestern Entonologist 2(1) :100—103. 00005378 Bombinski, T.J., and t*.iBois, K.P. (1975). 1 ute ¶Ibxicity and Pharmacological Effects of 0, 0—Diethyl—0-Diethyl—0— C 3—chloro-4— methyl—7-counarinyl)phosphorothioate (Bayer 21/199): Report Ne. 1924. (Unpublished study received August 31, 1959, under 1F0306; prepared by University of Chicago, Department of Pharmacology, subnitted by themagro Corp., Kansas City, rb.; CDL:090324-K). 05004554 Bourne, S. (1978) Preservation of organophosphorus pesticides in water samples. Journal of Environmental Science and Health, Part B 13(2):75—86. 05004291 Brodeur, J., and DiBois, K.P. (1963) Comparison of acute toxicity of antichloinesterase insecticides to weanling and adult male rats. Proc. Soc. Exp. Biol. Med. 114:509—511. 05004213 Brun, G.L.; Mallet, V. (1973) Detection of organophosphorus pesticides by in situ fluoranetry on thin—layer chranatograms. Journal of Chromatography 80(1):117—123. 91 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Coui aphos Section Two: Studies Examined and Judged ‘lb Be Inappropriate for Use in Developing the Standard MRID Citation 05005128 Brun, G.L..; Surette, D.; Mallet, V. (1973) A new method for the detection of orgarophosphorus pesticides by in situ fluora’netry on thin-layer chrciuatograms. International Journal of E viroflmental Analytical Chemistry 3(1) :61—71. 05009310 Burchfield, H.P.; Storrs, E.E. (1975) Analysis for organophosphorus insecticides and metabolities. Journal of Chranatographic Science 13(5) :202—211. 05003134 Burke, J.A.; blswade, W. (1966) A gas chranatographic column for pesticide residue analysis: retention times and response data. Journal of the Association of Official Analytical Ch nists 49(2) :374—385. 05005125 Burnet, E.M. (1970) Pesticide residues in fat of cattle treated with backrubbers impregnated with cotinaphos, rnethoxychlor or OUT. Pestic. Sci. l(2):70—72. 05010348 Carlson, C.A. (1966) Effects of Three Organophosphorus Insecticides on Imature Hexagenia and Hydropsycle of the Upper MisSiSSippi River. Transaction of the American Fisheries Society 95(1) :1-5. 05013389 Caserio, G.; Mascherpa, G.; Marubini, E. (1970) ssib1e applications of Artemia sauna as a test animal for detecting organophosphorus pesticides in meat. Archicio Veterinario Italiano. Italian Archives of Veterinary f dicine 21(1):49—61. 00005163 Cheinagro Corporation (1962) Paper Chranatographic I su1ts in Co- Ral. (Unpublished study including letter dated Nov. 21, 1962 fran D. MacD t a1l to T.H. Harris, received Nov. 26, 1962 under unknown ac3min. no.; suthtitted by Bayvet, Shawnee Mission, Kans •; CDL: 124751—A) 00005489 Chemagro Corporation (1963) Chemagro Corporation I sidue Experiment No. EC—212—62D: I port No. 11358. (Unpublished study received Feb. 11, 1964 under PP0299; CDL:090319—AA). 00005330 themagro Corporation (1963) theinagro Corporation Residue Experiment No. KC—201—63D: Report No. 10923. (Unpublished study received on unknown date under PP0306; CDL:090321—D). 92 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Counaphos Section Two: Studies Examined and Judged ‘lb Be Ina ropriate for Use in Developing the Standard MRID Citation 00005448 themagro Corporation (1963) The effect of frozen storage at 0 to - 10 0 F on Co-Hal residues in milk: Report No. 11164. (Unpublished study received F b. 11, 1964 under PP0299; CIL:090319—Z). 00005341 Chcmagro Corporation (1963) The Effect of Storage at 40 0 F On Co- Hal Residues in Milk: Report b. 11212. (UrLpublished study received on unkn n date under 1F0306; CDL:092586—F). 00005162 themagro Corporation (1964) themagro Corporation Analytical Method: Determination of DIYr in Co—Hal 25% Wettable sder by Dehydrohalogenation. Method Th C—2.33 dated Mar. 3, 1964. (Unpublished study received Mar. 3, 1964 under 11556—21; suthu.tted by Bayvet, Shawnee Mission, Kans.; CDL:124851—A). 00005836 Chemagro Corporation (1965) Recovery o Co-Ral frciu milk: Report No. 16197. (Unpublished study received Aug. 18, 1966 under 7F0612; CDL 1 :090796—M). 00005337 Chemagro Corporation (1966) Chemagro Corporation Residue Experiment No. KC—200-67D: Report No. 19234. (Unpublished study including report nos. 19235 and 19351, received on unkn n date under PP0306; CDL:090321—V). 00005046 themagro Corporation (1966) Recovery of Co-Ral fran milk: Report No. 19235. (Unpublished study received Dec. 15, 1967 under 115546-19; sukxnitted by Bayvet, Shawnee Mission, Kans.; CDL:014008—C). 00005436 Chemagro Corporation (1967?) Reasonable grounds in su ort of the petition: Co .inaphos. (Unpublished study received Dec. 21, 1967 under 8F0678; CD [ :092983—C). 00005041 themagro Corporation (1971) Recovery of Co—Pal from Swine: Report No. 30330. (Unpublished study received Oct. 29, 1971 under 11556— 4; sukinitted by Bayvet, Shawnee Mission, Kans.; CDL:010122—E). 05004292 Clear, M,H; Fowler, F.R.; Solly, S.R.B.; Ritchie, A.R. (1977) Detection of organorphosphorus and carbamate pesticides in adipose tissue by thin-layer and gas-liquid chranatgraphy. New Zealand Journal of Science 20(2):221—224, 93 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Counaphos Section Two: Studies Examined and Judged ‘lb Be Inappropriate for Use in Developing the Standard MRID Citation 05004068 Coppage, D.L., Braidich, TE. (1976) River Pollution and Anticholinesterase Pqents. Water Research 10(l):19—24. 00021983 tale, L.B. (1968). Co—Ral. (Unpublished study received ( tober 8, 1968, under unknown administrative number; suI nitted by tbbay Chemical Corp., Kansas City, Mo.; CDL:006897—E). 00005487 Ditman, L. P. (1962) Chemagro Corporation Residue Experiment b. EC— 2l2-62H: Report 9912a. (Unpublished study received Feb. 11, 1964 under PP0299; prepared by Univ. of Maryland, Dept. of & tcinology, Insecticide Laboratory, sukxnitted by themagro Corp., Kansas City, Mo.; CDL:090319—Y). 00005107 DDrko, N.M. (1964). Co—Ral E.C. 1 lb/gal Cattle ‘lbxicity Trial: Report b&. 13684. (Unpublished study received August 24, 1964, under 11556-23; prepared by themagro Corp., su}xtitted by Bayvet, Shawnee Mission, Kans.; CDL:007104—S). 00005335 n u11, J. and Root, M. (1966), Effect of Co—Ral in the Diet on the Blood Cholinesterase Activity of Male and Female Degs: Report . 18726. (Unpublished study received on unknown date under PP0306; prepared by University of Chicago, ‘lbxicity Laboratory, sukxnitted by Chemagro Corp., Kansas City, Mo.; CDL:090321—Q). 00005147 D)u11, J., Root, M., and Cowan, J. (1962). Ninety—Lay Feeding Studies with Co—Ral in Male and Female Rats and DDgs Fed a Milk Diet: Report ib. 10200. (Unpublished study received March 11, 1963, under unknown administration number; prepared by University of Chicago, Department of Pharmacology; sutinitted by Bayvet, Shawnee Mission, Kans.; CDL:l09146—C), 94 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO I8 Counaphos Section Two: Studies E caxnined and Judged To Be Inappropriate for Use in t ve1oping the Standard MRID Citation 00005462 IliBois, K.P. (1958). The I) rma1 Toxicity of Co—Ral and Piperonyl Butoxide Given Simultaneoously [ sic] to Rats: Report No. 2635. (Unpublished study received February 14, 1961, under PP0299; prepared by University of Chicago, D partinent of Pharmacology, sutinitted by themagro Corp., Kansas City, Mo.; CDL:090320-C). 00005382 IliBois, K.P. (1958). The 1 rma1 Toxicity of Co—Ral (Bayer 21/199) to Rats: Report No. 2452. (Unpublished study received October 8, 1959, under 1F0306, prepared by University of Chicago, D partment of Pharmacology, suk nitted by themagro Corp., Kansas City, Mo.; CDL: 090325—ti) 00005146 DiBois, KP. (1962). Comparison of the Toxicity of Co—Ral to Normal and Partially Hepatectanized Female Rats: Report No. 10116. (Unpublished study received March 11, 1963, under unknc n administration nunber; prepared by University of Chicago, fl partznent of Pharmacology, sifriitted by Bayvet, Shawnee Mission, Kans.; CDL:109146—B). 00005507 DiBois, K.P. and Raymund, A. B. (1961). The licute Ibxicity of Bayer 39007 and Bayer 37344 in Catbination with Sane Other Anticholinesterase Insecticides to Rats: Report No. 7879. (Unpublished study received June 10, 1964, under 3125—148; prepared by University of Chicago, L partment of Pharmacology, su)initted by Mobay Chemical Corp., qricu1tura1 Division, Kansas City, tb.; CDL:050503—A). 05008663 thing, W. (1967) N w spray reagents for the selective thin—layer chranatographic determination of pesticides containing nitrogen groups. Chimia 21(3):132—133. 05006314 Eschle, James L., O h1ein, D.D., Hogan, B.F., and Ivey, M.C. Counaphos on cable type backrubbers: control of horn flies and determination of residues in milk of dairy cattle. Jour. Econanic Entonology, Vol. 66, No. 1, 290—291. 05008484 FN) rking party of experts on pesticide residues. 1975. 05013961 Faulkner, t..C., Carroll, E.J., and Benjamin, M. (1964). Effect of counaphos on bulls. J. Mt. Vet. Med. Assoc. 145(5):456—459. 95 ------- Office of Pesticide PrograiT s Registration Standard Bibliography Case GSOO18 Cou iaphos Section Two: Studies Examined and Judged ‘BD Be Inappropriate for Use in Developing the Standard MRID Citation 05008680 Ferrari, A. (1972) Pesticide residues occurring in animal meats. Clinical Veterinary Science 95(5):143—152. 05004478 Galley, D.J. (1972) Persistence of Some Organophosphorus Insecticides in Henhouse Litter. Pesticide Science 3(1):1l9—123. 05002142 Getz, M.E. (1963) The determination of organophosphate pesticides and their residue by paper chranatography. Pages 9-25, “In” Residue Reviews: Residues of Pesticides and Other Foreign Chemicals in F ods arid Feeds. Vol. 2. Edited by F.A. Gunther. New York: Springer. 05004085 Copal, T., Oehme, F.W. and St. Qiicr, V. (1976). Influence of dietary protein on the effect of counaphos and trifluprçinazine interaction in sheep. Pm. J. Vet. Res. 37(10):1143—1152. 05016223 Grechka, G.A. (1973). [ Functional activity of the adrenal cortex of calves treated with Co-Ral and Sevin suspensions.] Trudy Stavropol’ Skogo Sel’skokhozyaistvennogo Institue V (XXXVI):181— 184. (Translated from Russian). 05016224 Grechka, G.A. (1973). [ Investigation of the influence of Co—Pal and Sevin on the cholesterol level in the blood of cattle.] Trudy Stavropol’ Skogo Sel’skokhozyaistvennogo Institue V (XXXVI);l85— 188. (Translated fran Russian). 05006440 G.ilbransen, B., Laws, L., and Connell, J.A. (1977). Effect of dipping on the growth rate of grazing cattle. Qieensland J. Agric. Azthn. Sci. 34(l):99—101. 05005506 Haufe, WO., and Thanpson, C.O.M. (1964) Weight changes in cattle on dry range in relation to chemical treatments for fly control. Can. J. Anim. Sci. 44(3):272—280. 00005475 blland, L.M., Faulkner, L., MacDzu al1, D., Skaptason, J.S. (1961). The Effect on Fertility of Spraying Cattle with Co—Pal: Report tao. 6186. (Unpublished study received February 14, 1961, under PP0299; prepared by Colorado State University, sutinitted by themagro Corp., Kansas City, tt.; CDL:090320-AA). 96 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOOI8 Counaphos Section TWO: Studies D amined and Judged ¶1%D Be Inappropriate for Use in Developing the Standard MRID Citation 00005034 Huggins, K.G. (1970) Evaluation of Co—Pal 1% dust in shaker cans forhorn fly control on beef cows and calves. themagro Corporation Report No. 29511. 05006182 Hunt, L.M., and McCarty, R.T. (1972). Effects of sane organophorphorus insecticides on vitamin E and other blood constituents and on the apparent inducement of diarrhea in neonatal calves. Bull. iviron. Contain. ‘Ibxicol. 8(5):297—305. 00005083 Industrial Bio— st Laboratories (1974) Recovery of (R) Co—Pal fran beef fat: Report No. 40706. (Unpublished study received June 20, 1974 under 11556—21; prepared for Baychem Corp., sutinitted by Bayvet, Shawnee Mission, Kans.; CDL:009815—B). 00005470 Jackson, J,B., Druniond, R.O., Buck,W.B., and Hunt, L.M. (1960). lbxicity of organic phosphorus insecticides to horses. J. Econ. taiol. 53(4):602—604. (Report No. 5937; also in unpublished sutinission received February 14, 1961, under PP0299; sutinitted by themagro Corp., Kansas City, Missouri; CDL: 090320V). 05004303 Kadin, M. (1960). Systemic effects of Co—Pal and coralox: Q ocular instillation in the rabbit, dog and hunan. 11fl. J. hthalImD1. 59(4): 622—627. 05004483 Kaplanis, J.N., Lbpkins, D.E.., and Treiber, G.H. (1959). Derifial and oral treatments of cattle with phosphorus-32-labeled Co-Pal. J. 1 gric. Ebod them. 7(7):483—486. 05005516 Katz, M. (1961) Acute ‘Ibxicity of Sane Organic Insecticides to Three Species of Salnonids and the Threespine Stickleback. Transaction of the l merican Fisheries Society 90:264—268. 05011426 than, M.A., Kramer, T., and Avery, R.J. (1961). Organophosphate poisoning in cattle with particular reference to Co-Pal. Can. Vet. J. 2(6):207—211. 05005518 Khan, M.A., and Lawson, J.E. (1965). Suniner treatments for cattle grub control and their effects on horn flies and cattle ight gains. Can. J. AnIm. Sci. 45(1):43—50. 05013391 Knapp, F.W., and Krause, G.F. (1960). Control of the northern fowl mite, Ornithonyssus sylviarurri (C— and F—), with Rennel, Bayer L13/59 and Bayer 21/199. J • Econ • E itaio1 • 53(1): 4—5. 97 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOOI8 Counaphos Section Two: Studies Examined and Judged ‘ lb Be Inappropriate for Use in Developing the Standard MRID Citation 05008682 Korolev, A.A., Skigan, S.A., Vitsitskaya, B.R., and Sechenov, I.M. (1972). [ The effect of ozonatian on the anticholinester— ase activity of several organophosphorus pesticides.] Gig. Sanit. 37(8):99—10l (Translated from Russian). 05004555 Kreitzer, J.F.; Spann, J.W. (1963) Tests of Pesticidal Synergi n with Young Pheasants and Japanese Quail. Bulletin of Environmental Contamination and ‘ lbxicology 9(4) : 2! 5256. 05004077 Lin, T., and Drouh, H.W. (1974). Influence of insecticide exposure on the in vivo and in vitro metabolic activity of rats. Arch. Environ. Contain. lbxicol. 2(4):364—377. 05005504 Lindquist, v.A., Burns, E.C., Pant, C.P., and DaI n, P.A. (1958). Fate of 32—labeled Bayer 21/199 in the white rat. J. Econ. Enta 1. 51(2):204—206. 00005281 MacI)ugall, D. (1960) Supplement to synopsis of metabolic, analytical, residue, and taste data on Co—Ral (poultry): Supplement ? b • 1: Report • 4996 • (Unpublished study received Mar. 18, 1960 under 11556—21; prepared by themagro Corp., su initted by Bayvet, Shawnee Mission, Kans,; CDL:101730—B). 00005343 MacI uga1l, D.; Loeffler, W. (1960) Determination of Co—Ral residues in milk (Recovery I)ita): Report f b. 5572. (Unpublished study received Mar. 29, 1961 under 1F0306; sutxnitted by themagro Corp., Kansas City, fib.; CDL:092586—J). 05004556 Mallet, V.; Brun, G.L. (1974) A rapid and reliable in situ spectrophotofluoranetric method for the anlaysis of Co-Ral and Bayrusil in lake and sewage water. Bulletin of Environmental Contamination and ‘ lbxicology 12(6) :739—744. 05004309 Mallet, V. N.; Volpe, Y. (1978) Degradation of counaphos in distilled water as a function of pH. Analytica thiinica ta 97(2) :415-418. 05012621 Malone, J.C. (1962). The toxicity of Coroxon/pheno-thiazine and cx)unaphos/phenothiazine. Res. Vet. Sci. 3(1): 18—33. 98 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Counaphos Section Two: Studies E camined and Judged ‘lb Be Inappropriate for Use in Developing the Standard MIUD : itation 05004557 Matthyssc, J.G. (1974) Insecticides Used on Dairy Cattle and Dairy Brans: ¶lbxicity to Man and Cattle, Hazards to the Consuner and the Environment. Journal of Milk and Food Technology 37(5) :255- 264. 00005169 McGrath, H.B. (1961). ¶lblerance of Degs to Daily Application of Co-Pal 1%-Neguvon 2% Pressurized Spray: 1 port b. 7900. (Unpublished study received January 9, 1962, under 11556—2, prepared by themagro Corp., sulxiitted by Bayvet, Shawnee Mission, Kans.; CDL:014015—B). 05012916 Miklovich, N. (1974). Oitbreaks of poisoning caused by a phosphate ester insecticide of lc , toxicity in dam?stic animals (couiiaphos). Tieraerztliche. Unschau 29(2) :85—86, 88—89, 92. (Translated fran German). 05012621 Malone, J.C. (1962). The toxicity of Coroxon/pheno-thiazine 05004314 bscioni, A.D., Engel, J.L., and Casida, J.E. (1977). Kynurenine fonnamidase inhibition as a possible mechani n for certain teratogenic effects of organophosphorus and methylcarbamate insecticides in chicken embryos. Biochem. Pharmacol. 26:2251- 2258. 05002567 Mozier, J.O. (1969). advances in cattle ectoparasite control with a discussion of sane problems related to treatment with systemic insecticides. 3. 1 m. Vet. Med. Assoc. 154(l0):1206—1213. 05011425/ Mozier, J.O., and Allen, A.D. (1969). ‘Ibxicity Evaluation of 00005167 Co—Pal 0.5 lb/gal flnulsifiable Concentrate: Paport b. 25343. (Unpublished study received January 23, 1970, under 11556—26; prepared by themagro Corp., su1x itted by Bayvet, Shawnee Mission, Kans.; CDL:014012—B). 00005404 Mozier, J. 0. (1964) Evaluation of ttability and odor of Co—Pal— Neguvon (0.25%—0.5%) pressurized spray: I port lb. 14596. (Unpublished study received Jan. 18, 1965 under 11556—29; prepared by themagro Corp., sutinitted by Bayvet, Shawnee Mission, Kans,; CD1 .i:lO9118—A). 99 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOOI8 Counaphos Section Two: Studies Examined and Judged ¶1 Be Inappropriate for Use in Developing the Standard MRID Citation 00005380 Murphy, S.D., and DuBois, K.P. (1958). The Subacute ¶Ibxicity of Co—Ral (0, 0-d iethyl-0—3--chloro-4-methyl 7 -counarinyl—phos- phorothioate; Bayer 21/199) to Rats: Report t . 2205. (Un- published study received March 3, 1958, under 1F0306; prepared by University of thicago, Department of Pharmacology, submitted by Chemagro Corp., Kansas City, MO.; CDL:090324-M). 05019241 Nangniot, P. (1964) Determination of traces of phosphoric esters by oscillatory polarography. nalytica Chimica Acta 31(2):166—174. 05005578 Nelson, D.L., Mezier, 3.0., White, R.G., and Allen, A.D. (1968). The pharmacological effect of Baymix (coumaphos) on poultry. Poult. Sci. 47(3):960—962. 05013409 Nepolklonov, A.A.; Metelitsa, V.K. (1970) Bizymic agardiffusion method for detecting organophosphorus insecticide residues in products of animal origin. Transactions, All—Union Scientific Research Institute of Veterinary Sanitation, 1 35:383—390. 05010755/ cbersteiner, E.J., and Sharma, R.P. (1978). Evaluation of cyto— 05019564 toxic responses caused by selected organophosphorus esters in chick sympathetic ganglia cultures. Can. J. Carp. Med. 42:80—99. 05004865 O’Neill, D.K.; Alexander, A.E. (1965) Physico—chemical studies of pesticides. IV. Solubilised pesticides. Journal of the Science of Ftod and k riculture 16(l2):750—759. 05006444 Palmer, J.S. (1963). ‘Ibxicologic effects of dual applications of Bayer 21/199 and toxaphene on yearling cattle and young calves. Vet. Med. 58(ll):872—874. 05012210 Palmer, J.S., and Radeleff, R.D. (1963). The toxicologic effects of dual applications of Bayer 21/199 and an arsenical solution on cattle and calves. 3. Pm. Vet. Med. Assoc. 143(11) :1208—1210. 05011425 Palmer, J.S., and Danz, J.W. (1964). Iblerance of Brabman cattle to organic phosphorus insecticides. 3. Am. Vet. Med. Assoc. 144(12) :143—145. 100 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOOJ.8 Couiiaphos Section Two: Studies Examined and Judged ‘D Be Inappropriate for Use in Developing the Standard MRID Citation 05005224 Pickering, W.L, and Malone, J.C. (1967). The acute toxicity of dichioroalkyl aryl phosphates in relation to chemical structure. Biochem. F’harmacol. 16(7):1183—1194. 05000801 Proctor, N.H., Noscioni, A.D., and Casida, J.E. (1976). thicken embryo NAD levels lc ered by teratogenic organophosphorus and methylcarbamate insecticides. Biochem. Pharmacol. 25(7) :757—762. 05009731 Radeleff, R.D. (1969) Asses ent of the safety of drugs as used in animal feeds. Pages 193—19 5, “In” Evaluation of Drugs for Use in Animal Feeds. Washington, D.C.: National Academy of Sciences. (National Research Council Publication Sb. 1679). 00005393 Radeleff, R.D., and &bers, R.H. (1957?) Report of Ibxicological Studies of Co-Hal (Bayer Canpound 21/199) in Cattle: Report No. 1952. (Unpublished study received October 8, 1959, under 1F0306; prepared by U.S. Ngricultural Research Service, suixtitted by themagro Corp., Kansas City, tb.; CDL:090326-B). 00005446 Riehl, L.A. (1959) 0,0-diethyl O-(8—ch1oro-4-methyl—7—cou ariny1) phosphorothioate (Co-Hal) residues in chickens: Report No. 3869a. (Unpublished study received Mar. 10, 1961 under PP0299; prepared in cxoperation with Univ. of California--Riverside, gricultura1 Experiment Station and Citrus Experii nt Station, Dept. of Ehta o1ogy, sulinitted by themagro Corp., Kansas City, tb.; CLD:09)337—J). 00005841 fl,bbins, WE., Ibpk i .ns, T.L.; and Darrow, D.L. (1959). Synergistic acticn of piperonyl butoxide with Bayer 21/199 and its corres- ponding phosphate in mice. J. Feon. D tai 1. 52:660-663 (Report No. 4375; also in unpublished suixtission received February 4, 1961, udner PP0299; sul3nitted by themagro Corp., Kansas City, tb.; CDL:090320—M). 05006417 1 se, E, and Sherman, M. (1960)., The effect of selected insecti- cides on growth and egg production when adminsitratered rsic) continuously in the feed. Rult. Sci. 39:1203—1211. 05014459 Is, J.D. (1958). Co—Hal poisoning in a Hereford bull. South- western Vet. 12(l):66—67. 101 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Co inaphos Section ‘Iwo: Studies Examined and Judged ‘lb Be Inappropriate for Use in Developing the Standard MRID Citation 05016568 Sa, L.N. de; Nazario, W. (1967) The chranatography of the pesticide •sj p 1 • (“l½suntol”) (ester o,O-diethyl—0—30chloro 4—methyl—2- oxo_2H —l—benzo ?rone—7—ilphoSPhothiOate) in veterinary toxicology. Review of the Faculty of Pharmacy and Biochemistry of the University of Sao Paulo, 5(2):485—491. 00020560 Schafer, E.W. (1972) The Acute Oral ‘Ibxicity of 369 Pesticidal, Pharmaceutical, and Other Chemicals to Wild Birds. ¶Ibxicology and Applied Pharmacology 21(?):315—330. 00006794 Scott, W.J., and Beliles, R.P. (1965). Phosalone: Lk)tentiation Studies in the Rat with Marketed Pesticides. (Unpublished study received December 15, 1966, under 7G0575; prepared by *xx3ard Research Corp., suI itted by thiçman Chemical Co., Inc . ., Burlingame, Calif., CDL:090729—I). 05001015 Shafik, M.T., et. a!. (1971) A Method for Confirmation of Organophosphorus Canpounds at the Residue Level. Bulletin of Environn nta1 Contamination and ¶ibxicology 6(1) :55—56. — 05016445 Shaw, F.R., nith, C.T., Anderson, D.L., Fischang, W.J., Ziener, W.H., and Hurny, J. (1964). The effects of counaphos on poultry and its residues in tissues and eggs. .3. Econ. & taio1. 57 (4 ) : 516—518 00007191 Sherman, II. (1967). Acute Oral Potentiation Studies with S— Methyl-N-- ((methylcarbanoyl)oxyl thioacetimidate [ INX-1179). Haskell Laboratory Report . 160-67. (Unpublished study received on unknown date under 352—342; sulzttitted by E.I. DePont de mours and Co., Wilmington, Del.; CDL: 0504 28—D). 05004687 Sherman, M., and Ross, E. (1961). Acute and subacute toxicity of insecticides to chicks. ‘lbxicol. Appi. Pharmacol. 3 :521—533. 05005123 Silvestri, R., Himes, J.A., and Edds, G.T. (1975). Repeated oral administration of couriaphos in sheep: Effects on erythrocyte acetyicholinesterase and other constituents. Am. J. Vet. Res, 36(3):283—287. 102 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Counaphos Section Two: Studios Examined and Judged ‘lb Be Inappropriate for Use in Developing the Standard MRID Citation 00005211 Skaptason, J.S., and MacDeugall, D. (1960). Co—Ral——A D g ‘Iblerance Study: Report No. 5133. (Unpublished study received April 22, 1960, under 11556-12; prepared by Chemagro Corp., sutinitted by Bayvet, Shawnee Mission, Kans.; CDL:109077—B). 00005086 Skaptason, J.S. (1960). The Devleoçinent of Co—Ral Aerosol for Use of Degs. Report No. 6085. (Unpublished study received April 25, 1961 under 11556—22; prepared by themagro Corp., suk ittitted by Bayvet, Shawnee Mission, Kans.; CDL:014009—A). 00005277 Stauffer Chemical C pany (19??) Storage stability of veterinary formulations. (Unpublished study received Mar. 13, 1962 under unknown admin. no.; CDL:121480—C). 05005617 Stijve, T.; Cardinale, E. (1971) Esterase inhibition technique for the detection of organophorphorus pesticides on thin-layer chranatograms. Mitteilungen aus dem Gebiete der Lebebsrnittleluntersuchung und Hygiene 62(1):25—31. 00005215 U.S. Fish and Wildlife Service, Fish Control Laboratory (19??) Survival of Fishes at 12C. in Nenty—four Hours: Report No. 12947. 00013539 U.S. Fish and Wildlife Service (19??) Pesticide—Wildlife Studies, 1963: A Review of Fish and Wildlife Service Investigations during the Calendar Year. U.S. Dept. of the Interior Circular 199, . 24, 26, 28. 00005388 Vaughn, G., Deininger, E., and Deull, J. (1958). Effect of Diets Containing Co-Ral and Malathion on the Blood Cholinesterase Activity of lbgs: Report No. 2618. (Unpublished study received October 8, 1959, under 1F0306; prepared by University of Chicago, Department of Pharmacology, subnitted by themagro Corp., Kansas City, rb.; CDL:090325—S). 00005160 Vaughn, G., Deininger, E., and Deull, J. (1958). The Subacute ‘ lbxicity of 3-thloro-4-methyl uthelliferone to Rats: Report ? o. 2660a. (Unpublished study received August 11, 1959, under 11556—21; prepared by University of Chicago, Department of Pharmacology, subuitted by Bayvet, Shawnee Mission, Kans.; CDt :l00066—A). 1It 3 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Coumaphos Section Two: Studies Examined and Judged lb Be Inappropriate for Use in Developing the Standard MRID Citation 00005148 Vesselinovitch, D., Fitch, F., Meskauskas, J., and D ,u1l, J. (1962). Gross and ijistopathologic Cbservations in the Tissues of the Offspring of Mice Fed Diets Containing Co-Pal: Report No. 10204. (Unpublished study received March 11, 1963, under unknown administration nunber; prepared by University of Chicago, Depart- ments of Pathology and Pharmacology, subnitted by Bayvet, Shawnee Mission, Kans.; CDL:109146—E). 00005150 Vesselinovitch, D., Fitch, F.W., Meskauskas, J., and Deull, 3. (1963). Gross and Histopathologic Observations in the Tissues of Rats Fed a Milk Diet Containing Co—Pal for Ninety Deys: Report tb. 10606. (Unpublished study received March 11, 1963, under unknown administration number; prepared by University of Chicago, Departments of Pathology and Phannacology; submitted by Bayvet, Shawnee Mission, Kans.; CDL:109146—F). 05017904 Villeneuve, D.C. (1971) A review of enzymatic techniques for pesticide residue analysis. Pages 27—38, “In” Pesticides Identification at the Residue Level. Washington, D.C.: f erican Chemical Society Publications. (1 3vances in chemistry series no. 104). 05012896 Washuettl, J. (1974) Pesticides in milk and milk products. Wiener Tieraerztliche Monatsschrift 61(2) :44—51. 05008665 Weilborn, T.L., Jr. (1971) lbxicity of Some Compounds to Striped Bass Fingerlings. Progressive Fish — Culturist 33(1):32—36. 00005130 White, R.G., and Allen, S.D. (1964). The Effects of lbpical 1 pp1ication of Co-Ral, Malathion, and Sevin on Laying Hens Being Fed a Ration Containing Co-Pal: Report No. 15146. (Unpublished study received July 2, 1968, under unknown administration number; prepared by themagro Corp., submitted by Bayvet, Shawnee Mission, Kans.; CDL:221922—F). 00005406 White, R.G., t’bzier, 3.0., and Mullee, M.T. (1964). Evaluation of Co-Ral—Neguvon (0.25%—05%) Pressurized Spray for lbxicity and Effctiveness on Cats: I port tb. 15083. (Unpublished study received June 23, 1965, under 11556-29; prepared by themagro Corp., submitted by Bayvet, Shawnee Mision, Kans •; CDL:l00 161—B). 104 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO I8 Coiinaphos Section Two: Studies Examined and Judged ‘lb Be Inappropriate for Use in Developing the Standard MRID Citation 00005495 Williams, H.A. (1962). ¶lbxicity Differences in Calves Sprayed with 0.75% Co—Ral and 0.75% Co—Ral plus 0.5%, 1%, 2%, or 4% Sulfo TEPP: Report tb. 10023. (Unpublished study received January 14, 1963, under 11556-21; prepared by Chemagro Corp., su1 iiitted by Bayvet, Shawnee Mission, Kans.; CDL:230468—A). 00013554 Witherup, S., and Schiect, H. (1963). The Ininediate Ibxicity of Vapona, Ciodrin, and Bidrin in Various Co thinations with Other Organophosphorous Insecticides. (Unpubi shed study received April 16, 1965, under 5H].748; prepared by Univer- sity of Cincinnati, Department of Preventive Medicine and Industrial Health, Kettering Laboratory, sulinit ted by Shell Chemical Co., Washington, DC; CDL:221616—L). 00005334 lvin, A.A. (1966). Report to Chemagro Corporation: Three Generation Reproduction Study on Co-Ral white Leghorn thickens: Report 1 b. 17838. (Unpublished study received on unknown date under PP0306; prepared by Industrial BiO— ¶I st Laboratories, Inc., suk itted by themagro Corp., KansaS City, t’b.; CDL:090321—P). 05005121 Wright, F.C., Hunt, L.M., and Palmer, J.S. (1966). The biOchefliCal effects of counaphos and three oxixnes on certain enz ne systems and blood protein elements in cattle. Pin. 3. Vet. Res. 27:177 185. 05004051 Younger, R.L., and Wright, F.C. (1971). Acute CounaphoS tOXiCOSiS in cattle: Antidotal therapy with pralidox xne chloride and atropine, and related alterations of blood and serun enzymatic activities. Am. J. Vet. Res. 32:1053—1063. 05004281 Zweig, G.; Devine, J.M. (1969) Determination of organophOsphOruS pesticides in water. Pages 17-36, “In” Residue Reviews. k)1. 26. New York; Springer. 105 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Co inaphos Section Three: Standard Reference Material Used in .Support of this Standard MRID Citation GS0020024 Bontoyan, W., ed. (1976) Manual of Chemical Methods for Pesticide and t vices. U.S. Environmental Protection 1 gency, Office of Pesticide Programs, ¶I chnical Services Division, Chemical and Biological Investigations Branch. (Available fran Association of Official Analytical Chemists, Arlington, VA). 005000301 Cutting, W.C. (1967) Insecticides, repellents and rodenticides. Pages l32-140d, “In” Handbook of Pharmacology, 3rd Edition. New York: Appleton—Century—Crofts. 005005417 tuvidson, L.M.; Feairs, R.H. (1966) Applied insect control: chemical. Pages 72—100, “In” Insect Pests of Farm, Garden and Orchard. 6th ed. New York: John Wiley. 005007048 Fairchild, E.J., ed. (1977) ricu1tura1 chemicals and Pesticides: A Subfile of the NIC H Registry of ¶Ibxic Effects of chemical Substances. Cincinnati, Ctzio: National Institute for Occupational Safety and Health. (Pagination includes 46 pages numbered i—xlvi; available from: NI’IS, Springfield, VA: P6—274 748). GSOOI8006 Farm Chemicals Handbook (1979). Mister Publishing Co., Willoughly, O.H. 44094 005010941 Martin, II.; Miles, J.R.W. (1953) Guide to the chemicals Used in Crop Protection, 2r ed. Ottawa, C itario, Canada: Canads tupartment of ricu1tura1. GSOOI8007 Pesticide Chemical Use Pattern Profile for Counaphos. USEPA Office of Pesticide Prograii s, Benefits arid Field Studies Division, August 1979 (26A—0052c). GS0018005 Schutte, W.D., Preliminary ( 1antitative Usage Analyses of Counaphos (1980) Econanic Analysis Branch, Benefits and Field Studies Division, Office of Pesticide Programs, U.S. E) ivironmental Protection 1 ency. 106 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOO18 Counaphos Section Four: Studies Identified ‘ibo Late to be Included in the Standard MRID Citation GS0018012 A kins, T.R. (1961) Co—Hal Residues in Cattle Tissues. Bayvet Division, Cutter Laboratories, Inc. Report No. 7346. EPA CDL accession ruther 102334? Originally submitted 10/17/61. GS0018013 Anderson, C.A. (1959) Co—Hal Residues in Chicken B3gs. Bayvet Division, Cutter Laboratories, Inc. Report No. 3712. EPA CDL accession number 102332? Orginally submitted 12/11/59. GS0018014 Anderson, C.A. (1959) Co—Hal Residues in Sheep Tissues. Bayvet Division, Cutter Laboratories, Inc. Report No. 3665. EPA CDL accession number 090326. Orginally submitted 10/12/59. GS0018015 Anderson, C.A. (1960) Co—Hal Residues in Milk. Bayvet Division, Cutter Laboratories, Inc. Report No. 5533. EPA CDL accession number 102327? Orginally submitted 9/28/60. GS0018016 Anderson, C.A. (1961) Co—Hal Residues in Calf (Tissues). Bayvet Division, Cutter Laboratories, Inc. Report No. 7263. EPA CDL, accession number 102334? Orginally submitted 10/17/61. GS0018008 Bayvet Div., Cutter J bs 1 Inc. (E cember 1979) Ibxicology and Metabolism Co-Hal (cc ,Lllaphos) Fl able Cattle Insecticide (Bay Vb 9328 Flowablo). EPA accession No. 241573. This contains 22 individual reports of studies conducted by or for Bayvet, Cutter or Mobay, in support of the registration application for Bay Vb 9328 Flowable. GS0018017 Booth, A. et al. (1958) Urinary Metabolites of Couflarin and 0- Counaric Acid. Bayvet Division, Cutter Laboratories, Inc. Report No. 3714. EPA CDL accession number 090320. Originally submitted 2/20/61. GS0018018 Burns, J.J ., et. al. (1952) The Isolation and Characterization of a Metabolic Product of 3,3 ‘—Carboxymethylene—bis- ( 4-h roxy— counarin) Ethyl Ester Tranexan) fran Human Urine. Bayvet Division, Cutter Laboratories, Inc. Report No. 6196. EPA CDL accession number 090320. Originally submitted 3/20/61. GS0018019 th nagro Corporation (1963) Recovery of Chiorferron fran Milk. Bayvt Division, Cutter Laboratories, Inc. Report No. 10673. EPA CDL accession nt.uther 090321. Originally submitted 3/13/61. 107 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOOI8 Counaphos Section Four: Studies Identified ‘lt)O Late to be Included in the Standard MRID Citation GS0018020 Chemagro Corporation (1964) Co—Ral Chiorferron Residues in Cattle Tissues. Bayvet Division, Cutter Laboratories, Inc. Report No. 13,912. EPA CbL accession number 102335. Originally sutznitted 8/17/64. GS0018021 Chemagro Corporation (1964) Co—Ral and Chiorferron Residues in Cattle Tissues. Cutter Laboratories, Inc. Report No. 13913. EPA CDL accession number unknown. Originally su}znitted 8/17/64. GS0018022 themagro Corporation (1966) Trichlorfon Residues in Cattle Tissues — Other Chemicals Used--Co—Hal. Bayvet Division, Cutter Laboratories, Inc. Report No. 18495. EPA CDL accession number 006072? Originally sulndtted 9/8/66. GS0018023 themagro Corporation (1966) Trichiorfon Residues in Milk, Other Chemicals Used—--Co—Ral. Bayvet Division, Cutter Laboratories, Inc. Report No. 17970. EPA CDL accession number 006072? Originally subnitted 9/8/66. GS0018024 Chemagro Corporation (1967) Co—Ral and Chiorferron Residues in Milk. Bayvet Division, Cutter Laboratories, Inc. Report No. 20651. EPA CDL accession number unknown. Originally sulxdtted 7/20/67. GS0018025 Chemagro Corporation (1967) Co-Ral and Chlorferron Residues in Milk. Bayvet Division, Cutter Laboratories, Inc. Report No. 20663. EPA CDL accession number unknown. Originally sthnitted 7/20/67. GS0018026 Chemagro Corporation (1967) Co—Hal aix ] Chiorferron Residues in Milk. Bayvet Division, Cutter Laboratories, Inc. Report No. 20677. EPA CDL accession number unknown. Originally sui iitted 7/20/67. CS0018027 CheTnagro Corporation (1967) Co-Hal Residues in Milk. Bayvet Division, Cutter Laboratories, Inc. Report No. 21110. EPA CDL accession number 006072. Originally suk nitted 1/2/68. 108 ------- Office of Pesticide Programs Registration Standard Bibliography Case GSOOI8 Counaphos Section Four: Studies Identified ‘Ibo Late to be Included in the Standard MRID Citation GS0018028 chemagro Corporation (1967) Trichlorfon Residues in Milk. Other Chemicals Used-—Co--Pal and Fenthion. Bayvet Division, Cutter Laboratories, Inc. Report No. 21289. EPA CDL accession number 006072? Originally submitted 9/8/66. GS0018029 Chemagro Corporation (1968) Co—Pal Residues in Bggs. Bayvet Division, Cutter Laboratories, Inc. Report No. 22809. EPA CDL accession nuther unknown. Originally submitted 7/15/6 8. GS0018030 Chemagro Corporation (1968) Co-Pal Residues in Bgs. Bayvet Divisin, Cutter Laboratories, Inc. Report ND. 22810. EPA CDL accession number unknown. Originally submitted 7/15/68. GSOO.L8031 Chemagro Corporation (1968) Co—Pal Residues in E)ggs. Bayvet Division, Cutter Laboratories, Inc. Report No. 22811. EPA CDL accession number unknown. Originally submitted 7/15/68. GS0018032 Dahm, P.A. (1960) Co—Pal Residues in Milk. Bayvet Division, Cutter Laboratories, Inc. Report lb. 5515. EPA CDL accession number 102327? Originally submitted 9/28/60. GS0018033 Drough, H.W. and Arthur, B.W. (1960) Distribution, Excretion, and Solubility Properties of P—32 Phosphoric Acid Fed to Laying Hens. Bayvet Division, Cutter Laboratories, Inc. Report ND. 5226. EPA CDL accession number 090320. Orginally submitted 2/20/61. GS0018034 aiBois, K.P. and Plazak, G. (1959) Studies on the ¶Dxicity and Anticholinesterase Action of the Oxygen Analogue of Có-Ral. Bayvet Division Cutter Laboratories, Inc. Report ND. 3922. EPA CDL accession number 090325. Originally submitted 4/21/60. GS0018035 aiBois, K.P. and Schmalgemeier, D. (1959) The 1 bsence of Acute ltxicity of thiorferron to Rats. Bayvet Division, Cutter Laboratories, Inc. Report lb. 3555. CAP CDL accession number 090325. Originally submitted 4/21/60. GS0018036 Helms, H. (1962) Co—Ral Residues in Swine Tissues. Bayvet Division, Cutter Laboratories, Inc. Report No. 9883. EPA CDL accession number 090319. Originally submitted 12/21/67. 109 ------- |