x>EPA United StatM Environmental Protection Agency Off lot of Pesticides and Toxic Substances Washington DC 20460 September 1981 Paiticide* Naphthalene Pesticide Registration Standard ------- Naphthalene REGISTRATION STANDARD Office of Pesticides and Toxic Substances Environmental Protection Agency 401 M Street, S.W. Washington, D.C. 20460 1981 ------- NAPHTHALENE Ackaowledgemen ts I. Special Pesticide Review Division (SPRD) Stephanie Roan Benjamin lemlich Paul Parsons Lynda Priddy II. Technical Support Team A. Hazard Evaluation Division (HED) George Beusch John Jordan Charles Lewis Arthur Schlosser Robert Storherr Ellen Sullivan Allen Vaughan Elizabeth Zucker lead Project Manager Project Manager Project Manager Project Manager Douglas Chambers Hoyt Jamerscn Russell Scarato E. David Thomas Chemist Microbiologist Agronomist Environmental Chemist Chemist Pharmacologist Entomologist Wildlife Biologist B. Benefits and Field Studies Division (BFSD) \fertebrate Biologist Entomologist Ffconomist Supervisory Entomologist Section Head C. Registration Division (RD) Lachman Bhatia William Miller III. Special Acknowledgement A. Special Pesticide Review Division (SPRD) Paul Lapsley Joan Warshawsky Barbara Moore Tonda Hicks Biologist Product Manager Branch Chief Section Head Secretary Clerk Typist ------- TABLE OF CONTENTS Pages I. How to Register Under a Registration Standard 1 A. Organization of the Standard 1 B. Purpose of the Standard 1 C. Requirements to Reregister Under the Standard.... 2 D. "Product-Specific" Data and "Generic" Data 3 E. Data Compensation Requirements Under FIFRA 3(c)(l)(D) 4 F. Obtaining Data to Fill Data Gaps; FIFRA 3(c)(2)(B) 5 G. Amendments to the Standard 6 II. Regulatory Position 8 A. Introduction 8 B. Description of Chemical 8 C. Regulatory Position 8 D. Regulatory Rationale 9 E. Criteria for Registration Under the Standard 10 F. Tolerance Reassessment 14 III. Summary of Data Requirements and Data Gaps 15 A. Table III .A Generic Data Requirements 18 B. Table III.B Product-Specific Data Requirements for Manufacturing-Use Products 26 C. Table III.C Product-Specific Data Requirements for End-Use Products 30 IV. Product Chemistry 35 A. Introduction 35 B. Chemical Identity 35 C. Manufacturing Process 35 D. Product Analytical Methods and Data 36 E. Physical/Chemical Properties 36 F. Summary of Data Gaps 38 V. Environmental Fate 39 A. Use Summary 39 B. Environmental Fate Profile 39 C. Exposure Profile 40 D. Summary of Data Gaps 41 VI. Toxicology 42 A. Toxicology Profile: Technical Naphthalene 42 B. Toxicology Profile: End-Use Naphthalene 43 C. Human Hazard Assessment 44 D.' Summary of Data Gaps 44 ------- VII. Residue Chemistry 45 VIII. Ecological Effects 46 A. Ecological Effects Profile 46 B. Hazard Assessment 47 C. Summary of Data Gaps 47 IX. Efficacy 48 A. Efficacy Profile 48 B. Factors Influencing Efficacy 48 C. Use Sites 48 D. Summary of Data Gaps 49 X. Confidential Annex 50 XI. Bibliography 51 Guide to Use of Bibliography Section 1: Studies Reviewed and Judged Appropriate for the Standard Section 2: Studies Reviewed and Judged Inappropriate for the Standard Section 3: References ------- I. How to Register Under a Registration Standard A. Organization of the Standard This first chapter explains the purpose of a Registration Standard and summarizes 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 would reduce those hazards to acceptable levels. B. Purpose of the Standard Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) provides that "no person in any State may distribute, sell, offer for sale, hold for sale, ship, deliver for shipment, or receive (and having so received) deliver or offer to deliver, to any person any pesticide which is not registered with the Administrator [of EPA]." To approve the registration of a pesticide, the Administrator must find, pursuant to Section 3(c)(5) that: "(A) its composition is such as to warrant the proposed claims for it; (B) its labeling and other material required to be submitted comply 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 commonly 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 submit, 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 two 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 somewhat independently. In the review of products containing similar components, there was little opportunity for retrospective review of the full range of pertinent data available in Agency files and in the public literature. Thus the "product by product" approach was often inefficient and sometimes resulted in inconsistent or incomplete regulatory judgments. 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 from 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 compliance with current requirements. (See FIFRA 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 on a particular active ingredient and its current uses, and sets forth the Agency's comprehensive 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 submission of needed scientific data which the Agency does not now have, compliance with standards of toxicity, composition, labeling, and packaging, and satisfaction of the data compensation provisions of FIFRA Section 3(c)(l)(D). The £ andard 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 competent to use pesticides safely, responsibly, and in accordance with label directions. A restricted-use pesticide can have other regulatory restrictions [40 CFR 162.11(c)(5)] instead of, or in addition to, the certified applicator requirement. 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 compliance with State or local regulations. The Registration Standard review compares 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. C. Requirement to Reregister Under the Standard FIFRA Section 3(g), as amended in 1978, directs EPA to reregister all currently registered products as' expeditously as possible. Congress also agreed that reregistration should be accomplished 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 commerce, must apply for reregistration. His application must contain proposed labeling that complies 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 comply with the procedures for reregistration set forth in the Guidance Package which accompanies this Standard. D. "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, Toxicology, 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, August 22, 1978), as applied to the use patterns of the products to which this Standard applies. Where it appeared that data frcm 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 some cases studies not required by the Guidelines may be needed because of the particular composition 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 some time and are, the Agency believes, relatively familiar to registrants. Data which we have found are needed to evaluate the registrability of some products covered by the Standard may not be needed for the evaluation of other products, depending upon the composition, 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 two basic groups: 1) data that are "product specific," i.e., data that relate only to the properties or effects of a product with a particular composition (or a group of products with closely similar composition); and 2) "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 composition. The Agency requires certain "product specific" data for each product to characterize the product's particular composition and physical/chemical properties (Product Chemistry), and to characterize the product's acute toxicity (which is a function of its total composition). The applicant for registration or reregistration of any product, whether it is a manufacturing- use or end-use product, and without regard to its intended use pattern, must submit 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 composition 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 nay 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 pasticidally active ingredient, but in sane cases a pesticidally inactive, or "inert", ingredient). Some 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 37355]. 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 163.82-1, 43 FR 37363, which requires subchronic oral testing of the active ingredient with -respect to certain use patterns only). Jfaere 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 from 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 compensation [under FIFRA Section 3(c)(l)(D)] or data generation [under Section 3(c)(2)(B)] for "generic" data that is required only with respect to some use patterns, he may elect to delete those use patterns from 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. E. Data Compensation Requirements under FIFRA 3(c)(l)(D) Under FIFRA Section 3(c)(l)(D), an applicant for registration, reregistration, or amended registration must offer to pay compensation for certain existing data the Agency has used in developing the Registration Standard. The data for which compensation must be offered are all data which are described by all of the following criteria: 1) the data were first submitted to EPA (or to its predecessor agencies, USDA or FDA), on or after January 1, 1970? 2) the data were submitted to EPA (or USDA or FDA) by some 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 Registration Standard, taking into account the applicant's product's composition 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) from the duty to offer to pay compensation. (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 from 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 compensation, and must submit with his application the appropriate statements evidencing his compliance with FIFPA Section 3(c)(l)(D). An applicant would never be required to offer to pay for "product specific" data submitted by another firm!TrTinany, if not in most 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 composition of two or more products, another firm's data may suffice to allow EPA to evaluate some 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 submitting data from tests on his own product, and if he chooses that option, he would have to comply 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 not exempted by FIFRA Section 3(c)(2)(D), must comply with the Section 3(c)(l)(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. F. Obtaining Data to Fill "Data Gaps"; FIFRA 3(c)(2)(B) Some 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 submitted to the Agency (or, if submitted, 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 submit those data to EPA. EPA must allow a reasonably sufficient period for this to be accomplished. 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 submitted. A mechanism is provided whereby two 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 specific11 data. In some 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 ' ^-ery 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 some cases note which data that EPA does possess would suffice to satisfy certain "product specific" data requirements for a category of products with closely similar composition 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 submit (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 submit 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 comply with Section 3(c)(2)(B). In addition, FIFRA Section 6(a)(2) requires the registrant to submit factual information raising concerns of possible unreasonable adverse effects of a pesticide. The registrant should notify the Agency of interim results of studies in progess if those results show possible adverse effects. G. Amendments to the Standard Applications for registration which propose uses or formulations that are not presently covered by the Standard, or which present product compositions, product chemistry data, hazard data, toxicity levels, or labeling that do not meet the requirements of the Standard, will automatically 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 amendment to the Standard, or may deny the application for registration on the grounds that the proposed product would 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. Any subsequent data submissions 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 from the Agency. When all the present "data gaps" have been filled and the submitted 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 some inert ingredients and impurities. Independent of the development of any one Standard, the Agency has initiated the evaluation of some 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. ------- II. Regulatory Position A. Introduction This chapter presents the Agency's regulatory position and rationale based on an evaluation of all registered products containing naphthalene as the sole active ingredient with the same use patterns described in this Standard. After briefly describing the chemical, this chapter presents the regulatory position and rationale, the criteria by which applications for registration of naphthalene products will be approved and the labeling considerations. A summary of the data requirements is contained in Chapter III. Discussions of the data upon which this regulatory position is based are presented in each of the disciplinary chapters, Chapters IV through IX. B. Description of Chemical Naphthalene is a crystalline solid which is packaged as balls, flakes or pellets. Because naphthalene is used to repel certain public hea.lth pests (bats), proof of its efficacy is a registration requirement (44 FR 27932: May 11, 1979), and is discussed in Chapter IX of this standard. The accepted chemical name for this compound is naphthalene. The Chemical Abstracts Registry (CAS) number 91-20-3 and the EPA Shaughnessy number is 055801. The chemical formula is C10"8- C. Regulatory Position Naphthalene, as described in this Standard, may be registered for sale, distribution, reformulation and use in the United States. The Agency has considered the limited amount of scientific data obtained from the open literature as of June 1981, and the data submitted to the Agency by the registrants through the time of publication of this Standard. Based on review of these limited data, the Agency 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) was met or exceeded for naphthalene and that naphthalene does not appear to cause unreasonable adverse effects when applied in accordance with proper label directions and precautions. Naphthalene products currently registered may be reregistered subject to the conditions imposed for data requirements. New products may be registered under this Standard and are subject to the same requirements. Rsvised label requirements will be addressed in the Guidance Package which accompanies this Standard and in Chapter II.E of this standard (see 40 CFR 162.10 for a detailed description of standard labeling requirements). ------- D. Regulatory Rationale A review of the available data regarding the manufacturing-use and end-use products of naphthalene shows that much information that could be used to support registration .and reregistration is not available. No data were available to assess possible acute or subchronic dermal and/or inhalation effects, primary eye and/or dermal irritation, primary dermal sensitization, teratogenic, reproductive, mutagenic, or onccgenic effects, of naphthalene, and no data were available to determine the ecological effects or the environmental fate of naphthalene. Hie Agency has the prerogative to not only request information to satisfy the data Guidelines proposed in 1978 and 1980, but also to require additional testing under 3(c)(2)(B) of FIFRA). These additional tests may be requested by the Agency if it believes that particular concerns regarding the health or environmental effects of a pesticide must be evaluated. In some cases, this additional testing may be deferred pending the Agency's development of specific test protocols or the completion of other related tests (e.g., tiered testing). It is the policy of the Agency not to request automatically guideline information simply because a particular guideline exists. Each element of the guideline is considered individually with regard to the pesticide's uses, exposure and risk. If the Agency concludes that specific elements of the data guidelines are required to prepare a comprehensive Registration Standard, the data will be requested. Although the data base for naphthalene is incomplete, the Agency has concluded that it should continue registration for this product for the following reasons: 1) No significant adverse effects have been uncovered in the review of studies pertinent to naphthalene when used in accordance with current label instructions. These studies include some which meet guideline data requirements and some which, while failing to meet guideline requirements, provide a level of qualitative information. As a result of examining these studies, the Agency has concluded that there is no immediate cause for regulatory concern. 2) The Pesticide Incident Monitoring System's (PIMS) report #155 of February, 1979,reports 191 accidents involving naphthalene. One hundred and sixty- four of these incidents involved human exposure to naphthalene as a single active ingredient. Forty-nine percent of the accidents resulted from ingestion or suspected ihgestion. In fewer than 1% of the cases, the exposure was reported to be via inhalation. In the remaining (approximately 50%) of the incidents, the route of exposure was unspecified. Ninety-four percent of the 164 incidents were accidents which involved children under five years of age. Case histories reported in the literature also report 48% of the exposures to naphthalene were through ingestion with the other half being through dermal or inhalation routes * The amount of naphthalene ingested ranged from a small portion of one moth ball to ingestion of one or more moth balls. ------- via clothing or blankets. In these incidents the human health effects range from death or henolytic anemia to no reported effects. Kbwever, the incidents where death occured resulted from misuses of the pesticide. If naphthalene is used in accordance with the labeling statements described in Chapter II.E of this standard, risk to the general population from naphthalene is considered to be minimal. 3) The chemical is judged by EPA to be efficacious in repelling bats from attics and wall spaces. 4) In accordance with FIFRA, the Agency's policy is not to cancel routinely the registration of products or to withhold registration merely for the lack of data (see Sections 3(c)(2)(B) and 3(c)(7) of FIFRA). Rather, the publication of this Standard provides a mechanism for identifying data needs, and registration of naphthalene under this Standard allows for the 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 Agency and the registerability of the chemical will be reassessed. E. Criteria for Registration Under the Standard To be subject to this Standard, naphthalene products must meet the following conditions: contain naphthalene as the sole active ingredient and have the same use patterns described in this Standard; bear required labeling; and conform to the acute toxicity limits, product composition, and use pattern requirements stated below. The applicant for registration or reregistration of naphthalene products subject to this Standard must comply with all terms and conditions described in this Standard, including a commitment to fill data gaps on a time schedule specified by the Agency as indicated in Chapter III and, when applicable, offer to pay compensation to the extent required by Sections 3(c)(l)(D) and 3(c)(D) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), as amended, 7 U.S.C. 136(c)(l)(D) and 136(c) (2) (D). As discussed in Chapter I and in the Guidance Package, applicants for registration of naphthalene products under this Standard must contact the Agency for specific instructions, including updated information on data requirements, and companies whose data must be cited and to whom compensation must be offered. 1. Manufacturing-Use Naphthalene a. Acceptable Ranges and Limits i. Product Composition Standard Tb be covered under this Standard, manufacturing-use naphthalene product must conform to the requirements stated below: Active Ingredient: Any percentage acceptable. 10 ------- ii. Acute Toxicity Limits The Agency will consider registration of manufacturing-use naphthalene products in the following toxicity categories indicated by a "yes": I II III IV Acute oral toxicity Yes Yes Yes Yes Acute dermal toxicity Yes Yes Yes Yes Acute inhalation Yes Yes Yes Yes toxicity Primary eye Yes Yes Yes Yes irritation Primary dermal Yes Yes Yes Yes iii. Use Patterns Tto be covered under this Standard, manufacturing-use naphthalene products must be labeled to allow for formulation into end-use insecticides and repellents which are intended only for the following uses: 1) domestic outdoor nonfood (bulb protection); 2) domestic outdoor nonfood (rabbit repellent). 3) domestic indoor nonfood (fumigation); 4) non-domestic indoor (museum specimens); 5) domestic indoor nonfood (bat, bird and rodent repellent) iv. Required labeling All manufacturing-use naphthalene products must bear appropriate labeling as specified in 40 CFR 162.10. The Agency may, after review of data to be submitted under this Standard, impose additional label requirements. Use Pattern Statements All technical and manufacturing-use naphthalene products must list on the label the intended end-uses of formulated products produced from the manufacturing- use products. In accordance with data to be submitted or cited, all naphthalene product labels must bear one or a combination of the following statements: 1) "For Formulation Into Ehd-Use Fumigant Products Intended Only as a Fumigant for Protection of Ornamental Bulbs (nonfood) During Storage and at Time of Planting"; 2) "For Formulation Into Bx3 Use Repellent Products for Control of Rabbits". 11 ------- 3) "For Formulation Into End-Use Indoor Nonfood Fumigant Products Intended for Control of Clothes Moths and Carpet beetles"; 4) "For Formulation Into End-Use Fumigant Products Intended for Fumigation of Museum Specimens"; 5) "For Formulation Into End-Use Repellent Products for Control of Bats, Birds and other Rodents" Ecological Effects Statements The following statement must appear on the label of the manufacturing-use products of naphthalene: "Do not discharge "directly into lakes, streams, ponds or public waters unless in accordance with NPDES permit. For guidance contact your Regional Office of the Environmental Protection Agency." 2. End-Use Naphthalene a. Acceptable Ranges and Limits i. Product Composition Standard To be covered under this Standard naphthalene products must conform to the requirements stated below: Active ingredient: Any percentage acceptable. Inert ingredient: There are no restrictions on inert ingredients when used for nonfood purposes. ii. Acute Toxicity Limits The Agency will consider registration of naphthalene products in the following toxicity categories indicated by a "yes": The Agency will consider registration of products in toxicity categories I and II when all of the acute toxicity data and other required data appropriate for an amended registration are satisfied. Until the acute data are submitted to the Agency, PIMS data will be used to support warning and use label statements. After receipt and review of the requested data, the Agency may require other appropriate data (e.g., exposure studies, impose additional labeling restrictions, special packaging or deny registration). 12 ------- II III IV yes yes yes yes yes yes yes yes yes yes yes yes yes yes yes yes yes yes yes yes Acute oral toxicity* Acute eternal toxicity** Acute inhalation** toxicity Primary eye** irritation Primary dermal** irritation iii. Use Patterns To be registered under this Standard, naphthalene products must he labeled as an insecticide, fumiqant or repellent for one or more of the following nonfood uses: indoor fumigants, museum specimens, bulb protection, rabbits, and, birds bats and tree squirrels. iv. Required Labeling All naphthalene products must bear appropriate labeling as specified in 40 CFR 16.1.10. The Agency may, after review of data ho be submitted under this Standard, require additional label requirements. Ecological Effects Statements The following statement must appear on all naphthalene products used as repellents and for outdoor domestic uses of naphthalene products under the heading "Environmental Hazards": "Do not contaminate water by cleaning of equipment or disposal of wastes". Efficacy Statements To include statements on naphthalene repellent (birds, bats, and tree squirrels product labels relating to how rapidly the pesticide acts after its application or relating to the duration of its effectiveness, the registrant will be required to submit data supporting those claims. Tf claims of rapid manifestation of efficacy and duration of effectiveness are not included on, or are removed from the labels, then no data will be required (see Table TII.C-3 in Chapter III of this Standard). * If the acute oral cn for naphthalene is determined to be 1.5 gAg or less, special packaging may be required. ** If data for naphthalene indicates a toxicity category of I or II, special packaging may be required. 13 ------- Usage Statements The following statements must appear en all naphthalene household fumiqmt products under "Directions for Use" "Items to be stored should be placed in air-tight containers such as garment bags, trunks, or chests." "Keep storage space tightly closed." Precautionary Statements The following statement must appear on all naphthalene household fumiqant products under the heading "Hazard to Humans and Domestic Animals"- Caution May be fatal if swallownd. Keep out of the reach of children. Avoid breathing vapors. When removing articles from storage, clean and air thorouqhly before using. The following statements must appear on all naphthalene outdoor repellent and bulb fumigant products under "Directions for Use": "Do not use in or around vegetable gardens or food crops." F. Tolerance Reassessment The current uses of naphthalene are not subject to a tolerance required under the provisions of the Federal Food. Drug, and Cosmetic Act. Therefore, no tolerance reassessment is necessary for this Standard. 14 ------- III. Summary of Data Requirements and Data Gaps Applicants for registration of naphthalene products must cite or suomit the information identified as required in the tables in this chapter. The tables applicable to end-use products indicate whether the product to be tested is the technical grade or the formulation. Data generated on one formulation may be used to satisfy the data requirement for a substantially similar formulation based on the chemical composition as indicated by the Confidential Statement of Formula (CSF). Information on which product-specific data requirements are already met is available in the Guidance Package. * Preceediijg each requirement, with the exception of Residue Chemistry and Efficacy , is listed the Proposed Guideline which describes the data to be submitted. The tables also list when tho data are required to be submitted. Justification for why the test is required is provided in the Guidelines (see 43 FR 29696 of July 10, 1978; 43 FR 37336 of August 22, 1978; and 45 FR 72948 of November 3, 1980). A discussion of why data additional to that already submitted are necessary, or why data normally required are not necessary for this chemical, is given in 'footnotes to the tables. The specified data requirements are the minimum that will be required. Areas where additional data may be required as the result of tiered testing are indicated (see tables for Toxicology, Residue Chemistry, Environmental Fato and Ecological Effects in this Chapter). Bibliographic citations in the following tables indicate that the listed study accomplishes ono of tho following: 1) provides all the information required by the guideline requirement; 2) provides partial information required by tho guideline requirement; 3) provides specific information that is elaborated on by an accompanying footnote; and 4) a (-) is used to indicate guideline information which is not required because there is no guideline established or because this specific standard does not require the information. * There are currently no Proposed .Guidelines for Efficacy. Refer to Chapter I.D for discussion on tho data requirements for Rosidue Chomistry. 15 ------- Bibliographic citations noted in Chapters IV through IX which are not listed in this Chapter are provided as reference and background material to the reader; they do not relate directly to or satisfy the guideline requirements. The word "yes" under the heading "Does EPA have data to partially or totally satisfy this requirement?" means that the requirement has been satisfied, unless otherwise noted. Table A, Generic Data Requirements, includes those data that pertain to the properties or effects of technical naphthalene as an active ingredient. Thus, these data are relevant to an evaluation of the risks of all products containing naphthalene. Providing data to fill indicated gaps in the data base is the primary responsibility of the registrant(s) of manufacturing-use naphthalene. Registrants of end-use products which are not exempted by FIFRA Section 3(c)(2)(D) are also responsible for the submission of these data. However, applicants for the registration of end-use products containing naphthalene are advised that if the Agency does not receive commitments, within the specified time as indicated in the tables, from manufacturing-use naphthalene registrant(s) to fill data gaps identified for the manufacturing- use product (Table A), manufacturing-use product registrations will be suspended. Formulators must then bear the burden of supplying these data if continued registration of their product is desired. Applicants for the registration or reregistration of manufacturing-use naphthalene products must acknowledge reliance on existing data which fill indicated data requirements under FIFRA Section 3(c)(l)(D). These data are listed under the column "Bibliographic Citation" in this table. Table B, Product-Specific Data Requirements for Manufacturing-Use Products, include those data that relate only to the properties or effects of a product with a specific composition (or substantially similar composition). Thus, these data are required of each product (or substantially similar product) to characterize the product's particular composition and physical/chemical properties, and to characterize the product's acute toxicity. 16 ------- Product composition data, physical/chemical properties and acute toxicity are required for each manufacturing-use product. Providing data to fulfill these requirements is the responsibility of each applicant for the registration or reregistration of a manufacturing-use naphthalene product. If the Agency has data which fulfills this requirement for a particular product(s), then this is indicated in the table and in the Guidance Package accompanying this Standard. Product-specific data need not be acknowledged under FIFRA Section 3(c)(l)(D) unless the Agency has established that one product is substantially similar to another product for which the Agency has received acceptable data. Table C, Product-Specific Data Requirements for End-Use Products, include those data that relate only to the properties or effects of a product with a specific composition (or substantially similar composition). Thus, these data are required of each end use product (or substantially similar product) to characterize the product's particular composition and physical/chemical properties, and to characterize the product's acute toxicity. Product composition data, physical/chemical properties and acute toxicity data are required for each end-use product. Providing data to fulfill these requirements is the responsibility of each applicant for the registration or reregistration of a manufacturing-use naphthalene product. If the Agency has data which fulfills this requirement for a particular product(s), then this is indicated in the table and in the Guidance Package accompanying this Standard. Product-specific data need not be acknowledged under FIFRA Section 3(c)(l)(D) unless the Agency or a registrant has established that one product is substantially similar to another product for which the Agency has received acceptable data. 17 ------- Table III.A-1 Generic Data Requirements for Naphthalene, Product Chemistry =*- (see Chapter IV) Guideline Citation 163.61-7 163.61-8(1) 163.61-8(2) 163.61-8(3) 163.61-8(4) 163.61-8(5) Name of Test Product Analytical Methods and Data Galor Odor Melting Point Solubility Stability Are Data Required Composition for this Standard? Yes Technical Grade 2^ Yes Technical Grade^ Yes Technical Grade^/ Yes Technical Grade^ Yes Technical Grade^ Yes Technical Grade 2/ Does EPA Have Data Bibliographic To Partially Or Citation •totally Satisfy (MRIDf ) This Requirement? No Yes 3^ Yes 3^ Yes 3^ Yes 3£ Yes *l_ Must Additional Data be Submitted Under FIPRA 3(c)2(B)7 If SO, months allowed for submission from published date of standard. Yes, 12 months No No No No No October, 1981 18 ------- Table III.A-1 Generic Data Requirements for Naphthalene, Product Chemistry ^- (See Chapter IV) (Cont'd) Guideline Citation 163.61-8(7) 163.61-8(8) 163.61-8(9) 163.61-8(10) Name of Test Are Data Required for this Standard? Physical Yes State Density or Yes Specific Gravity Boiling Point Yes Vapor Yes Pressure Composition Technical Grade 2£ Technical Grade 2£ Technical Technical Grade y_ Does EPA Have Data To Partially Cr Totally Satisfy This Requirement? Yesl£ Yes *l_ Yes 3/ Yes 3£ Bibliographic Citation (MRIDt ) - 00004900 00004900 _ Must Additional Data be Submitted Under FIFRA 3(C)2(B)7 If so, months allowed for submission from published date of standard. No No No No U. (SctoEer, T9~8l Based on data for technical naphthalene at 99.9% purity or more. Registrants of technical naphthalene with purity of less than 99.9% must submit all data in Table A. All registrants and all applicants for registration or reregistration must submit their supplier's specification sheet for naphthalene. Nominally 100%, refined grade. Crude grades of naphthalene (< 99.9%) require supplier's specifications. Pesticide Manual of the British Crop Protection Council (1974) and/or the Merck Index, 9th ed. (1976) 19 ------- Table III. A-2. Generic Data Requirements for Naphthalene, Environmental Fate (see Chapter V) Guideline Citation Name of Test 163.62-7(b) Hydrolysis 163.62-8(b) Aerobic Soil Metabolism 163.62-8(£) Miorobial Metabolism: (2) Effects of Microbes on Pesticides (3) Effects of Pesticide on Microbes 163.62-8(g) Activated Sludge Metabolism Are Data Required for this Standard? Composition Technical or Radiolabeled Analytical Grade Reserved^ Reserved-2^-^ Reserved^ Does EPA Have Data Ob Partially Cc •totally Satisfy this Requirement? Bibliographic Citation (MRIDf ) No Must Additional Data be Submitted Under FIFRA 3(C)2(B)7 If SO, months allowed for submission from published date of standard. Yes, 48 months October, 1981 20 ------- Toddle III. A-2. Generic Data Requirements for Napthalene, Environmental Fate (see Chapter V) (Cont'd) Guideline Hame of Test Are~Data Required CoSpoeition Does EPA~Have Data BibliographicMusr~AdHiFionar~Dati Citation for this Standard? Do Partially Or Citation be Submitted Under Totally Satisfy (MRIDf ) FIFRA 3(c)2(B)? If so, This Requirement? months allowed for submission from published f date of standard. 163.62-9(d) Adsorption/ reserved Desorption 163.62-10(b) Terrestrial Field Dissipation: (4) Domestic outdoor, reserved parks, ornamental and turf uses October, 1981 21 ------- Table III. A-2 Generic Data Requirements for Naphthalene, Environmental Fate (see Chapter V) (Cont'd) Guideline Citation 163.62-13 Name of Test Storage and Disposal Are Data Required for this Standard? Reserved ^ Composition Does EPA Have Data Ho Partially Or •totally Satisfy This Requirement? - Bibliographic Citation (HRID* ) — Must Additional Data be Submitted Under FIFRA 3(c)2(B)? If so, months allowed for submission from published date of standard. =£- Significant hydrolysis is not expected under guideline test conditions. 2/ — The data are needed to support the outdoor domestic use. — The requirement for the submission of these data is currently being reserved pending the Agency's review and modification of the testing protocols. 4/ — The requirement for the submission of these data is currently being reserved pending the results and review of the aerobic soil metabolismm testing. — Specific data requirements and testing protocols needed to generate these data are being developed. 22 ------- Table III. A-3 Generic Data Requirements for Naphthalene, Toxicology (see Chapter VI) Guideline Citation 163.81-1 163.81-2 163.81-3 163.81-4 163.81-5 163.81-6 163.82-3 163.82-4 163.83-1 Name of Test Acute Oral Toxicity Acute Dermal Toxicity Acute Inhalation Toxicity Primary Eye Irritation Primary Dermal Irritation Dermal Sensitization Subchronic 90-Day Dermal Toxicity Subchronic Inhalation Toxicity Chronic Feeding Are Data for this Yes Yes Yes Yes Yes Yes Yes Yes Yes Required Composition Standard? Technical Grade Technical Grade Technical Grade Technical Grade Technical Grade Technical Grade Technical Grade Technical Grade Technical Grade Does EPA Have Data Bibliographic To Partially Or Citation Totally Satisfy (MRIDt ) This Requirement? No No No No No No No No No Wast be Si FIFRI montl subm: date Wast Additional Data be Submitted Under FIFRA 3(c)2(B)7 If so, months allowed foe submission from published Yes, 12 months IL Yes, 12 months Yes, 12 months Yes, 12 months Yes, 12 months Yes, 12 mmonths Yes, 24 months Reserved -^ October, 1981 23 ------- •Cable III. A-3 Generic Data Requirements for Naphthalene, Toxicology (see Chapter VI) (Cont'd), Guideline Citation 163.83-2 163.83-3 163.83-3 163.84-2,3,4 163.85-1 Name of Test Oncogenicity Teratogenicity Reproduction Mutagenicity Metabolism Are Data Required for this Standard? Yes Ye Reserved -L- Yes Yes Composition Technical Grade Technical Grade Technical Grade Technical Grade Technical Grade Does EPA 'Have Data To Partially Or Totally Satisfy This Requirement? No No No No Yes Bibliographic Must Additional Data Citation be Submitted Under (MRIDf ) FIFRA 3(c)2(B)7 If SO, months allowed for submission from published date of standard. ».* Yes, 24 months Reserved -/ Yes^ 05020080 No -*- October, 1981 Acute oral toxicity data are being generated by the National Cancer Institute. Vtien these data have been reviewed and found acceptable, this data requirement may be waived. The need for this data requirement will be assessed when acute inhalation toxicity data are available. Naphthalene is currently undergoing chronic onoogenicity and mutagenicity testing by the National Toxicology Program, (NTP). The EPA and the NTP are coordinating their efforts bo ensure that guideline requirements will be satisfied as a result of these tests. However, if data requirements are not satisfied, the registrants will be required to submit additional data. The reproductive studies are reserved pending the completion of the National Toxicology Program Testing. Upon oonpletion of the National Toxicology Program testing, the Agency will reevaluate the need for reproductive studies on naphthalene (see rationale in Chapter VI.D). ------- Table III. A-4 Generic Data Requirements for Naphthalene, Ecological Effects (see Chapter VIII) Guideline Citation 163.71-1 163.71-2 163.72-1 163.72-2 Name of Test Avian Single Dose Oral U)-. Avian Dietary Fish Acute UgQ Acute Toxicity to Aquatic Invertebrates Are Data Required Composition for this Standard? Yes Technical Grade z£- Technical Grade =*- Technical Grade Yes Technical Grade Does EPA Have Data To Partially Or Totally Satisfy This Requirement? No No NO No Bibliographic Must Additional Data Citation be Submitted Under (MRIDf ) F1FRA 3(c)2(B)7 If so, months allowed for submission from published date of standard. - Yes, 24 months Yes, 24 months Yes, 24 months Yes, 24 months October, 1981 - Given the extremely snail naphthalene exposure to fish and wildlife, upland game species IC^ study is waived. One !£-- study will be required however on a mallard duck. =L Given the extremely small naphthalene exposure to fish and wildlife, the bluegill trout 96 hour UC^ study is waived. Che LC-Q study will be required however on a coldwater fish species (rainbow trout). 25 ------- Table III.B-1 Product-specific Requirements foe Manufacturing-Use Products, Product Chemistry =*- (see Chapter IV).- Guideline Citation 163.61-3 163.61-4 163.61-5 163.61-6 163.61-7 Name of Test Product Identity and Disclosure of Ingredients Description of Manufacturing Process Discussion on Formation of unintentional Ingredients Declaration and Certification of Ingredient Limits Product Analytical Methods and Data Are Data Required Composition for this Standard? Yes Each Manufacturing- Use Product Yes Each Manuf actur ing- Use Product Yes Each Manufacturing- Use Product Yes Each Manufacturing- Use Product Yes -t- Each Manufacturing- Use Product Does EPA Have Data To Partially Qc Totally Satisfy This Requirement? Yes^ Yes^ Partial^ No No Bibliographic Must Additional Data Citation be Submitted Under (MRIDt ) FIFRA 3(c)2(B)7 If SO. months allowed for submission from published date of standard. No 005010379 No 050008684 Yes, 12 months Yes, 8 months Yes, 12 months October, 1981 26 ------- Table III.B-1 Product-Specific Requirements for Manufacturing-Use Products, Product Chemistry =*- (see Chapter IV) (Cont'd) Guideline Citation 163.61-8(7) 163.61-8(8) 163.61-8(12) Name of Test Physical State Density or Specific Gravity Storage Stability Are Data Rec for this Stc Yes Yes Yes Composition 163.61-8(13) Flammability 163.61-8(14) Oxidizing/ Reducing Action Yes Yes Each Manufacturing- Use Product Each Manufacturing- Use Product Each Manufacturing- Use Product Each Manufacturing- Use Product Each Manufacturing- Use Product Does EPA Have Data To Partially Or Totally Satisfy This Requirement? Bibliographic Citation (MRIDt ) No No Must Additional Data be Submitted Under FIFRA 3(c)2(B)7 If so, months allowed for submission from published date of standard. No NO October," 195T 27 ------- Table III.B-1 Product-Specific Requirements for Manufacturing-Use Products, Product Chemistry ^ (see Chapter IV) (Cont'd) Guideline Citation 164.61-8(15) 163.61-8(18) Name of Test Explosiveness Corrosion Characteristics Are Data Required for this Standard? Yes Yes Composition Each Manufacturing- Use Product Each Manufacturing- Use Product Does EPA Have Data To Partially Cr Totally Satisfy This Requirement? No No Bibliographic Citation (MRIDt ) _ _ Must Additional Data be Submitted Under FIFRA 3(C)2(B)7 If so, months allowed for submission from published date of standard. October, 1981" -£- Registrants of new manufacturing use products are not required to submit data if the new product is identical or substantially similar to currently registered manufacturing use products. -£• The Agency has information to fulfill this requirement for currently registered manufacturing-use products; EPA Reg. No. 1475-20 and EPA Reg. No. 9121-3 (information was provided in. the Confidential Statement of Formula (CSF)]. -*- This data requirement is fulfilled for currently registered manufacturing-use products, EPA Reg. No. 1475-20 and EPA Reg. No. 9121-3. -£• For manufacturing use products which contain 99.0% or more naphthalene, this data requirement is considererd to be satisfied (manufacturing use products with 99% active ingredient are considered substantially similar to 99.9% active ingredient naphthalene) All applicants for registration or reregistration are required to submit their supplier's specification sheet for naphthalene. -*- The information required on the technical and manufacturing use products need only be submitted for one product where they are identical. -^ The Agency has information for manufacturing use products containing, at a minimum, 99.9% naphthalene; manufacturing use products with 99.0% active ingredient are considered substantially similar to 99.9% active ingredient naphthalene. -*- Merck Index, 9th edition (1976). Because the manufacturing use naphthalene proucts contain 99.0% or more naphthalene, these data requirements are waived as the information is available in the open literature (See Chapter IV.E). -*- Based upon the physical-chemical characteristics of naphthalene, this requirement is being waived for 99.0% or greater active Ingredient in naphthalene. 28 ------- Table III B-2 Product-Specific Requirements for Manufacturing-Use Products, Toxicology -*- (see Chapter VI) Guideline Citation 163.81-1 163.81-2 163.81-3 163.81-4 163.81-5 163.81-6 Name of Test Are Data Required Composition Does EPA Have Data Bibliographic Must Additional Data for this Standard? To Partially Or Citation be Submitted Under Totally Satisfy (MRIDf ) FIFRA 3(c)2(B)7 If so. This Requirement? months allowed for submission from published date of standard. Acute Oral Toxicity Yes Acute Dermal Toxicity Yes Acute Inhalation Toxicity Yes Primary Eye Yes Irritation Primary Dermal Yes Irritation Dermal Yes Sensitization Bach No - Yes, 12 months ^ Manufacturing- Use Product Each No - Yes, 12 months Manufacturing- Use Product Each No - Yes, 12 months Manufacturing- Use Product Each No - Yes, 12 months Manufacturing- Use Product Each No - Yes, 12 months Manufacturing- Use Product Each No - Yes, 12 months Manufacturing- Use Product October, 1981 • The chemical composition of technical naphthalene and manufacturing use naphthalene are identical. Therefore data submitted in response to the "A Tables" will also satisfy the data requirements on the "B Table*. t • Acute oral toxicity data are being generated by the National Cancer Institute. Vtoen these data nave been reviewed and found acceptable this data requirement may be waived. 29 ------- Table III.C-1 Product-Specific Requirements for End-Use Products, Product Chemistry =*- (See Chapter IV) Guideline Citation 163.61-3 163.61-4 163.61-5 163.61-6 163.61-7 Name of Test Are Data Required for this Standard? Product Identity Yes and Disclosure of Ingredients Description of Yes Manufacturing Process Discussion of Yes ^~ Formation of Unintentional Ingredients Declaration and Yes Certification of ingredient Limits Product Analytical Yes Methods and Data Composition Each Product Each Product Each Product Each Product Each Product Does EPA Have Data To Partially Or Totally Satisfy This Requirement? Yes^ Partial^ Partial No No Bibliographic Must Additional Data Citation be Submitted Under (MRIDI ) FIFRA 3(c)2(B)? If so, months allowed for submission from published date of standard. No Yes, 8 months Yes^ Yes, 8 months Yes, 12 months October, 1981 30 ------- •Table III.C-1 Product-Specific Requirements for End-Use Products, Product Chemistry ^- (see Chapter IV) (Cont'd) Guideline Citation 163.61-8(1) 163.61-8(2) 163.61-8(7) 163.61-8(8) 163.61-8(12) 163.61-8(13) Name of Test Color Odor Physical State Density or Specific Gravity Storage Stability Flanroability Are Data Required for this Standard? Yes Yes Xes Yes Yes Yes Composition Each Product Each Product Each Product Each Product Each Product Each Product Does EPA Have Data Ho Partially Or Totally Satisfy This Requirement? Yes Yea Yes Yes No Yes Bibliographic Must Additional Data Citation be Submitted Under (MRIDf ) FIFRA 3(c)2(B)7 If SO, months allowed for submission from published date of standard. No* No* No* K>* NO^ *to* October, 1981 31 ------- Table 1II.C-1 Product-Specific Requirements for End-Use Products, Product Chemistry =*- (see Chapter IV) (Cont'd) Guideline Citation 163.61-8(14) 163.61-8(15) 163.61-8(18) Name of Vest Oxidizing or Reducing Action Explosiveness Corrosion Characteristics Are Data Required for this Standard? Yes Yes Yes Composition Each Product Each Product Each Product Does EPA Have Data To Partially Or Totally Satisfy This Requirement? No No No Blbliogi Citatior (MRID* - - Must Additional Data be Submitted Under FIFRA 3(c)2(B)7 If SO, months allowed for submission from published date of standard. No 1L October, 1981 -- The chemical composition of technical and manufacturing use naphthalene are substantially similar. Data submitted in response to the A or B Tables will satisfy the data requirements on the C Table unless the active ingredient is less than 99.0% (99.0% naphthalene is considered substantially similar to 99.9% naphthalene). -*- The Agency has information to support all currently registered end-use products containing 99.9% or more active ingredient naphthalene (information is provided in the Confidential Statement of Formula (CSF)]. All naphthalene products containing less than 99.9% naphthalene active ingredient will require an updated Confidential Statement of Formula (CSF). -£- The Agency does not have c^ta describing the formulation process. Data which are available describe the manufacturing process for 99.9% naphthalene. Therefore, this requirement is fulfilled for those end-use products containing 99.9% naphthalene. -^ All applicants for registration or reregistration are required to submit their suppliers specification sheet for naphthalene. -^ For those end-use products which contain 99.9% or more naphthalene, this data requirement is considered as satisfied. -^ Because the end-use naphthalene products contain 99.0% or more naphthalene and are considered substantially similar to 99.9% naphthalene, these data requirements are waived as they are available in the open literature (See Merck Index, 9th edition (1976)). -^ Based upon the physical/chemical characteristics of naphthalene, this requirement is being waived for products containing 99.0% naphthalene (for these data, 99.0% naphthalene end use products are considered substantially similar to 99.9% naphthalene). 32 ------- Table III C-2 Product-Specific Requirements for End-Use Products, Toxicology =*- (see Chapter VI) Guideline Citation 163.81-1 163.81-2 163.81-3 163.81-4 163.81-5 163.81-6 Name of Test Are Data Required Composition Does EPA 'Have Data Bibliographic for this Standard? To Partially Or Citation Totally Satisfy (MRIDf ) This Requirement? Acute Oral Toxicity Yes Acute Dermal Toxicity Yes Acute Inhalation Toxicity Yes Primary Eye Yes Irritation Primary Dermal Yes Irritation Dermal Yes • Sensitization Each No Product Each No Product Each No Product Each No Product Each No Product Each No Product Must Additional Data be Submitted Under FIFRA 3(c)2(B)7 If so, months allowed for submission from published date of standard. Yes, 12 months =f- Yes, 12 months Yes, 12 months Yes, 12 months Yes, 12 months Yes, 12 months October, 1981 -*- The chemical composition of technical and manufacturing use naphthalene are substantially similar. Therefore data submitted in response to the A or B Tables will satisfy the data requirements on the C Table unless the active ingredient is less than 99.0% (99.0% naphthalene is considered substantially similar to 99.9% naphthalene). -^ Acute oral toxicity data are being generated by the National Cancer Institute. Vhen these data have been reviewed and found acceptable this data requirement may be waived. 33 ------- Table III C-3 Product-Specific Requirements for End-Use Products, Efficacy (see Chapter IX) Site Name of Pest Are Data Required" for this Standard? Composition Does EPA Have Data "R> Partially Cr Totally Satisfy This Requirement? Bibliographic Citation (MRIDt ) " Must Additional Data be Submitted Under FIFRA 3(c)2(B)7 If SO, months allowed for submission from published date of standard. Attics Bats Yes Each Between Product Attics Birds, including Yes Each Between Pigeons, Starlings, Product Walls Sparrows Yes GS0022025, No -^ GS0022026, GS0022028, GS0022029, GS0022030, GS0022031, GS0022032, GS0022033, GS0022034, Yes GS0022025, No -^ GS0022026, GS0022028 GS0022029, GS0022030, GS0022031, GS0022032, G50022033, GS0022034, October, 1981 Registrants will be required to supply supporting data to include claims on a product label relating to the period between application of the pesticide and manifestation of its efficacy or relating to the duration of effectiveness. 34 ------- IV. Product Chemistry A. Introduction The Agency published "Proposed Guidelines for Registering Pesticides" which explains the minimum product chemistry requirements for registering pesticide products in the United States (see 43 FR 29696, July 10, 1978). The Agency requires information on chemical identity, manufacturing process, active ingredient limits in pesticides products, product analytical method and data, and physical/chemical properties, in order to assess a pesticide's product chemistry. In the case of naphthalene, the information required on the technical and manufacturing use products need only be submitted for one product. This is because the chemical composition of technical naphthalene and the manufacturing use product are considered identical (99.9 - 100% active ingredient (a.i.)). Further, most of the end-use products also have the same chemical composition as the manufacturing-use products. When this is the case, or where the 99.0% a.i. is considered substantially similar to the 99.9% a.i. The data submitted for the technical material may also be used to support the registration of the end-use products. With regard to product chemistry, there are a few end use products which vary slightly in chemical composition from the manufacturing-use product. For these end-use products separate data requirements may be required. These data requirements are identified in Tables III.A-1, III.B-1, and III.C-1. B. Chemical Identity The Agency requires identifying information including chemical names, product names, and numerical codes of all substances known or assumed to be present in pesticide products. As discussed in Chapter II.B, naphthalene is the chemical name, and is the name by which this chemical substance is generally known. The empirical formula for naphthalene is C10Hg (Martin and Miles, 1953, MRID #005010941); it has a molecular weight of 128.16 and its chemical structure is shown below: The Chemical Abstracts Registry (CAS) number for naphthalene is 91-20-3, and the EPA Shaughnessy number is 055801. Thus, the nomenclature of naphthalene has been adequately defined. C. Manufacturing Process Because the process by which the pesticide is produced influences the nature and amount of potentially toxic impurities, a detailed description of the manufacturing process is required. Prior to 1961 naphthalene was derived from coal tar, and from 1961 to the present it has been derived from crude petroleum (Ballard, 1965, MRID# 005010379; Liepins, et al.,1977, MRIDf 005008684). It is obtained from 35 ------- petroleum distillates by a hydrodealkylation process (removal of an attached alkyl group by saturation of the fragments with hydrogen using a catalyst and high temperatures as in the Hydeal and Unidak Process). Hie resulting product may be further fractionated and/or cooled to induce crystallization. Filtration or centrifugation yields the crude naphthalene. Purification may be achieved by pressing, or washing with sulfuric acid, formaldehyde, alkali, and water with redistillation or sublimation (for high purity), (Ballard, 1965, MRID# 005010379; Liepins, et al.,1977, 0050008684). Naphthalene is commercially available as an industrial chemical and is purchased by registrants for use in their pesticide products. IJhder these conditions, the requirements regarding a description of the manufacturing process have been adequately defined. However, the requirement of the Proposed Guidelines as to the description of impurities that exceed 0.1% may or may not be fulfilled depending on the purity of the naphthalene. For any degree of purity less than 99.9%, the description of impurities data requirements are not fulfilled and a data gap exists. All applicants/registrants must furnish the Agency with a copy of their supplier's specifications on the composition of naphthalene. In addition, the Guidelines require upper and lower limits be established for each active ingredient in a pesticide product and require registrants to certify that the limits will be maintained for all quantities of the product sold or distributed in commerce (40 CFR Section [163.61-6). Upper and lower limits have not been established and certified for any product containing naphthalene. Refined grades at nominally 100% purity are usually used in fumigants and single active ingredient repellents. For purpose of this Standard, only products containing naphthalene as the sole active ingredient are considered. The Confidential Annex lists the available products which have naphthalene as the sole active ingredient. D. Product Analytical Methods and Data No analytical methods have been submitted to the Agency to determine naphthalene in any pesticide product. Many methods are described in the literature and some of them may be adopted to satisfy this guideline requirement. However, the lack of data submitted for this purpose constitutes a data gap. The Agency needs analytical methods for naphthalene analysis in the manufacturing-use product and in the end-use formulations because these products may contain inert ingredients which affect the chemical analytical results; the available literature describes the analytical analysis of naphthalene in the pure state. If the percentage of active ingredient is the same for both the manufacturing use and end use products, only one analytical method need be submitted. E. Physical/Chemical Properties Naphthalene may be repackaged or reformulated. Thus, for* the purposes of this Standard, naphthalene may be considered,a technical material, a manufacturing-use product, an end-use product, or an active ingredient of an end-use product. As discussed in Chapter IV.A, technical grade and manufacturing-use naphthalene products are identical in composition and the end- use or formulated products of naphthalene may also be identical to the manufacturing-use products. For the purpose of the standard,, this is considered the case if the end use product's active ingredient is 99.9% 36 ------- or greater naphthalene. Formulated products whose active ingredients range from 99.0 to 99.9% naphthalene are considered substantially similar and some of the data used to support the technical naphthalene will also be used to support the end-use products see Tables III.A-1, III.B-1 and III.C-1. Because naphthalene used in pesticide products is in a high state of purity, the usual requirements for physical chemical properties are waived when these are available in the literature. Color: Odor; Melting Point; Solubility; Stability; Physical state; Colorless (white)* Aromatic* 80.0°C (Nowak, 1975, MRID #000004900), 80.2C°* Solubility in water is 30 ppm at room temperature. One gram dissolves in 13 ml methanol or ethanol, and in 3.5 ml benzene or toluene.* Inflammable, and stable.* Crystals, flakes, powder, balls or cakes.* Density or specific gravity; 1.162* Boiling point; Vapor Pressure; Flash Point: 217.9 C at 760 mm Hg.* 4.92 x 10 mm Hg at 20 C (Volatilizes at room temperature; sublimes above melting temperature)*, Open cup, 174°F (79°C)* Closed cup, 190°F (88°C)* * "Pesticide Manual of the British Crop Protection Council," H. Martin and C.B. Worthing, ed.r 9th edition, London, England (1974); and "Merck Index", 9th ed., Merck and Co., Rahway, N.J. (1976). \ 37 ------- F. Summary of Data Gaps The possible formulation of unintentional ingredients is a data gap for manufacturing-use and end-use naphthalene. All applicants for registration or reregistration are required to submit their suppliers' specification sheet for naphthalene. The upper and lower limits for naphthalene have not been established and certified for manufacturing- and end-use products containing naphthalene. In addition, a description of the formulation process of the end- use products has not been submitted to the Agency. Analytical methods for naphthalene in the technical material and naphthalene in end-use formulations have not been submitted to the Agency. The storage stability, oxidizing or reducing action, explosiveness, and corrosion characteristics data requirements on the manufacturing- and end-use products which contain 99.0% or more naphthalene are waived based on the Agency's knowledge of the physical-chemical characteristics of naphthalene. 38 ------- 7. Bw iron mental Fate A. Use Summary Naphthalene is a general household insecticidal fumigant for use against clothes moths and carpet beetles. Minor use patterns of naphthalene are: protection of bulbs during storage and planting; fumigation of museum specimens (dried insects and stuffed animals); and a repellent of bats, pigeons, sparrows, squirrels and starlings in dormers and eaves, and rabbits in nardens. Naphthalene has no registered food uses. The percentages of naphthalene in tine various formulations are as follows: crystalline naphthalene: 99.99, 99.75, 99.50, and 99.0%; Pellet/tableted naphthalene: 99.50%. The remaining 0.01 to 1.0% are essential oils and perfumes. Crystalline naphthalene is used in tine form of flakes, balls and cakes predominantly for control of clothes mothes and carpet beetles. Irss than 1% of tine pesticidal use of naphthalene is used as a repellent or to protect bulbs during storage and planting or to repel rabbits from gardens. Th0 household' fumigant rates of application range from 1.0 Ibs naphthalene/100 cu. ft. to A.O lbs/100 cu ft. The recommended frequency of application is 6 months or is unspecified. The rates of application to protect stored bulbs range from 3.75 Ibs naphthalene per 100 cu. ft. to 4.0 lbs/100 cu. ft. The frequency of application is once before storing. The rate of application for treatment of bulbs at planting is unspecified. The recommended frequency of application is a single application par planting. The rate of application for repellents in eaves and dormers is 5.0 Ibs naphthalene/2000 cu ft. The frequency of application is unspecified. The Agency estimates that the total pesticidal usage of naphthalene as a single active ingredient is between 6 to 10 million Ibs/year*. The quantity of naphthalene used for protection of bulbs during storage and planting** and the single active ingredient repellent uses are minor use patterns. At one time naphthalene was used more widely in noth control; however commercial competition from p-dichlorobenzene, moth proofing material, and the increasina substitution of synthetic fibers for wool have resulted in a steady decline in the demand for naphthalene as a pesticide. B. Bwircnmental Fate Profile The available data are insufficient to assess tine environmental fate of naphthalene. Preliminary studies showed bioaccumulaticn factors for Hytilus edulis (blue mussel), Daphnia pulex, and Grassestrea virginica (oyster) of 25-40, 130, * Scarato, R., "Preliminary Quantitative Usage Analysis of Naphthalene", EAB, BFSD, EPA 1980 ** Personal communication with registrants. 39 ------- 6,000, respectively, after exposure to £ 1 ppm naphthalene (Southworth et al.; 1978, MRID #005018634; Hansen et aT., 1978, MRTD #005019904; lee .et aT., 1978, MRin #005006779). SeveraT species of marine/estuarine copepods, including Calanus helgolandicus and Eurytemora affinis, were also shovn to readily accumulate naphthalene (Comer et al , 1976, MRID #005007545, Harris e^ad., 1977, MRID #005009021, and Harris" et al_., 1977, MRID #005006550). Jn all these species, depuration was rapid. Available volatility data indicate that crystalline naphthalene (99.9% active inqredient) volatilizes at a rate of 1.86 q/surface m /h when air temperature and speed are 15-19 C aid 0-2 m/s, respectively (Bramscn , 1960, MRID #005017183). Naphthalene dissolved in water volatilizes with a half-life of 3 and 8 hours at 25 and 19 C, respectively (Mackay and Wblkoff, 1973, MRID #005005660 and Soto et al., 1977, MRID #005006598). The use patterns and low volume usaqe for the outdoor domestic uses of naphthalene en ornamental plants and as a rabbit repellent indicate that larqe quantities of this chemical will not be introduced into or on the soil. In addition , loss of naphthalene via volatilization and microbial metabolism would tend to limit the persistence of naphthalene in or on soil. (Mackay and Wblkoff, 1973, MRID #005005660; Shtein,et al., 1976, MRTD #005012039; Soto, et aJ_., 1977, MRID #005006598; CemiglTa and Gibscn , 1977, MRID #005005354; Cemiglia and Gibson 1978, MRID # 005005353; Gemiglia, et al.,1978, MRID #005005937; Cm dell and Traxler, J973, MRID #005007776; CTh3ell and Traxler, 1973, MRID #005012107; Cundell and Traxler, 1976, MRID #005008688; Kaneko, et al., .1969, MRID #005014797; Kvasnikov, et al., 1Q70, MRID *005016326; Eosane, et_ a_l_. , 1974, MRID #005006197, TJssaTe, et al., 1976, MRTD #005006198; Lopatick, 197/1, MRID #005015494; SkrydbTh and Starovoitov. 1975, MRTD #005015998; Slavnina, 1970, MRTD #005017304; Starovoitov, et a_U, 1974- 1975, MRID #005009267; Traxler, 1973, MRID #005017184; and Walker and Colwell, 1976, MRID #005005371). C. Exposure Profile A human exposure profile cannot be generated at the present time (September, 1981) because of the scarcity of data. The principal population at risk is expected to be the homeowner, as the major use of naphthalene is for clothes moth control. The Agency estimates that 26 x 10 persons use fumigants to protect household articles and one third of these products contain naphthalene.- The volatility of naphthalene enhances the potential for respiratory exposure. Respiratory exposure to naphthalene is expected to be the highest when the compound is used indoors. However, no data are available to assess the level of such exposure (Branson , 1960, MRID #005017183). Dermal exposure while handling naphthalene also cannot be assessed due to lack of data. Although data on the exposure of humans via contamination of groundwater from pesticide use is not available, the potential appears to be low, due to the limited outdoor use of naphthalene. In summary, no data are available to quantify the magnitude of dermal and respiratory naphthalene exposure to persons handling and applying naphthalene, and to persons living or working in treated areas (museums). 40 ------- D. Sunmary of Data Gaps The environmental fate data gaps for the outdoor domestic use of naphthalene are: hydrolysis, aerobic soil metabolism, terrestrial field dissipation, and adsorption/desorption. Hydrolysis data will not be required as naphthalene is not expected to hydrolyze sifhificantly under test conditions. Further, due to the limited outdoor use of naphthalene, only aerobic soil metabolism data are required at this time, (see Tab.le III.A-2). The terrestrial field dissipation and adsorption/desorption data requirements are reserved pending the results of the aerobic soil metabolism testing. Vhile there are no data available to assess human exposure to naphthalene, the Agency is not requesting human exposure data at this time. There are data gaps for disposal and storage, microbial metabolism and activated sludge. However, pending the Agencys1 review and possible modification and development of the testing protocols, it is currently not necessary to satisfy these data gaps. Further testing details are in Table III. A-2. 41 ------- VI. Toxicology A. Toxicology Profile: Technical Naphthalene No data were available to assess the acute dermal and acute inhalation toxicities of naphthalene. ]h a supplementary study* by Mams (1930, MRID #005015698), 4 rats were given 2.5-3g naphthalene (in paraffin) orally and 1 death was observed. These data suggest that the acute oral toxicity of naphthalene is low; however the study is insufficient to fulfill the acute oral toxicity testing requirement for naphthalene No data were available to assess the primary dermal irritation and the dermal sensitization potential of naphthalene. Insufficient data were available with respect to the eye irritation potential of naphthalene, fri a study by D'Asaro Bicndo (1973, MRID #005019746), rabbits with partially removed nictitating membranes exhibited severe eye irritation whan exposed to the vapors of naphthalene for 3 or 10 minutes. However, the inadequacies in the methodology used in this study precludes the use of the study to assess the primary eye irritation potential for naphthalene. The subchronic toxicity of naphthalene could not be adequately assessed. In a subchronic oral toxicity study in rats, the maximum tolerated dose was estimated to be 200 mgAg/day, (Battelle Columbus laboratories, 1980, MRID *GS0022023 and GS0022024). However, subchronic oral toxicity testing is not required for naphthalene since repeated human exposure through the oral route is unlikely with this pesticide. No subchronic dermal toxicity data were available for naphthalene, and no data were available to assess the subchronic inhalation toxicity of naphthalene. An assessment of the subchronic inhalation data requirement will be made once data for acute inhalation toxicity are available. * "Supplementary" studies and/or "supplementary" data provide some valid information, but do not satisfy a Guideline requirement. ** Acute oral toxicity data may be available from the NCI and these data may satisfy the acute toxicity testing requirement. 42 ------- Insufficient data were available to assess the chronic effects of naphthalene. H a study by Schmaehl (1955, MRID #005015285), rats fed 10 to 20 mg of naphthalene in the diet, 6 tiroes per week, for approximately 700 days, or 20 mg of naphthalene given to rats by intraperitcneal or subcutaneous injection once a week for 40 weeks, did not produce toxicity, tumors, or affect the life span. While this study was inadequate to permit an assessment of the chronic toxicity of naphthalene due to deficiencies in reporting and methodology, the data suggested that chronic low dose exposure to naphthalene is we] 1-tolerated in rats. Naphthalene is scheduled to be tested by the National Toxicology Program for oncogenicity, chronic feeding, and mutagenicity.As of publication of this standard, (September 1981) no data were available to assess the mutagenic potential of naphthalene. When the NTP testing is completed, the Agency will evaluate it to determine if the results satisfy the FIFRA guideline testing requirements for oncogen icity, chronic feeding and mutagen icity. No data were available to assess the teratological potential or the reproductive toxicity potential of naphthalene. Teratology testing in two mammalian species is required. The reproductive toxicity data requirement is being held in reserve until all of the acute and chronic toxicity data mentioned above as well as teratology data requested from the registrants are available. At that time, a toxicological assessment can be made of the need for a reproductive test. A number of investigators have provided supplementary information about the metabolism of naphthalene in rats, rabbits, mice, hamsters, guinea pigs, and humans. Table VI. 1 lists naphthalene metabolites that have been identified in the urine of naphthalene-dosed animals. Adequate data were available to assess the metabolism of radiolabeled naphthalene in rats. ]h a study by Chen and Dorough (1979, MRID #005020080) it was demonstrated that the metabolism of naphthalene occurs by (at least) a two phase elimination process. In the initial rapid phase, approximately 74% of the naphthalene is eliminated; urinary exretion accounts for approximately fiO% of this elimination while fecal excretion accounts for approximately 14%. The major urinary metabolite is N- acetyl-S-(l,2-dihydro-2-hydroxyl-l-naphthyl) cysteine, a premercapturic acid. Tissue accumulation (greater than 20%) accounts for the s]ow elimination of naphthalene in the second phase. While these and additional in vitro studies indicate the presence of metabolic intermediates of naphthalene which may be of toxicological concern, the full significance of these materials cannot be evaluated until the chronic testing data are available for review. B. Toxicology Profile: Bid-Use Naphthalene The Confidential Statements of Formula do not indicate an anticipated change in toxicity due to inert ingredients; see Chapter IV, Introduction, for rationale. Separate discussions or profiles of naphthalene end-use products, therefore, will not be included in this standard. 43 ------- TABIE VI.1 NMWTHAI£NE URINARY METABOLITES Metabalites Babbit Guinea Pig Mice Rat Hamster Han Citation 1-Kaphtol 2-Waphthol l,2-dihydro-l,2-dihydroxy naphthalene 1-naphthyl sulfate 1-naphthylmercapturic acid 1-naphthylgluooeiduronic acid 1 , 2-dihydrt>-2-hydroxy-l-naphthyl- glucosiduronic acid 1 , 2-dihydro-l , 2-dihydroxy-l-naphthal sulfate H-acetyl-S-( 1 , 2-dihydro-2-nydroxy- 1-naphthyl )-L-cysteine 2-hydroxy-l-naphthyl sulfate l-hydroxy-2-naphthyl sulfate 1 , 2-dihydroxynaphthalene 1 , 2-naphthaquinone 1 , 4-naphthaquinone nethylthionaphthalene 1,3,5 1 1,5 1 1 1 1,3,4 1 4 1 1,3 2 5 5 5 4 1 1,3,7, 8,10 1 1,7,8 1 1,7,8 1 1,3 1 6 1 1,3 1,10 10 5 5,10 5 3,8 7,8 1 - HRID: 005005367 9 2 - MRID: 005005368 9fll 3 « MRID: 005006213 4 « HRID: 005006208 5 - HRID: 005006209 6 • HRID: 005007954 7 - HRID: 005005671 8 - HRID: 005005672 9 - HRID: 005005949 10 - HRID: 00502080 11 - MRID: 005012927 5 9 9 ------- C. Human Hazard Assessment: Naphthalene The use of naphthalene may result in human exposure through the dermal and inhalation routes. However, at present, no adequate exposure or toxicology data are available to perform a human hazard assessment on naphthalene. Supplementary data describing the cataractogenic and hemolytic effects of naphthalene were available. Naphthalene-induced cataracts have been produced experimantally in rats and rabbits; rabbits appear to be tine more sensitive species. Single high oral doses of naphthalene (l-3g) have been shown to cause eye damage and/or opacities in rabbits as early as 6 hours to one week following treatment. (Adams, 1930, MRTD t005015698 and Pirie,-1968, MRTD #0050005197). In humans, the hemolytic properties of naphthalene have been well documented. Case histories report incidents of acute hemolytic anemia in humans following naphthalene poisoning. Ifersons with glucose-6-phosphate dehydroganase deficiencies appear to be more susceptable to this type of toxicity. In addition, naphthalene induced acute hemolytic anemia has been observed experimentally in dogs (Zuelzer and Apt, 1949, MRID #005005235'; and Mackell et al., 1951, MRID * 005005949). It should be noted that this effect has generally been observed, following high dose exposure or misuses of the pesticide. D. Summary of Data Gaps The data gaps for technical grade and end-use naphthalene are acute oral toxicity, acute dermal toxicity, acute inhalation toxicity, primary eye irritation, primary dermal irritation , and dermal sensitization. The data gaps for technical naphthalene are teratogenicity, and subchronic dermal toxicity. Chcogenicity (in the rat and mouse), chronic feeding, mutagenicity and reproduction data are also insufficient to meet the guidelines requirements and would normally be required. Naphthalene, however, is scheduled to be tested under the National Toxicology Program. This testing will most likely encompass the required oncogen icity, mutagen icity and chronic feeding studies. Therefore, at this time the Agency will not require oncogen icity, chronic feeding, and mutagen icity studies.* In addition , the Agency has decided to reserve its decision to require reproductive testing with naphthalene -until the results of all the above cited studies are available, and a toxicological assessment of the need for a reproductive test can be made. * If naphthalene is not tested under the NTP, the registrants may be required to submit the outstanding chronic studies. 44 ------- VII. Residue Chemistry An allowable residue level (tolerance) for specific chemicals is determined by the Agency for the commodities on which they may occur. Since no naphthalene product is currently registered for use on food or feed crops, its use should not result in such residues. Therefore, there are no residue chemistry data requirements for this chemical. 45 ------- VIII. Ecological Effects A. Ecological Effects Profile No acceptable data were available for the evaluation of manufacturing-use* and end-use products of naphthalone with respect to effects en non-target fish and wildlife species. Several studies did provide supplementary information on the potential effects of crystalline naphthalene on non-target plants. Forty-three plait types showed no effect in the greenhouse when exposed to air saturated to 13% with naphthalene vapors. These plants included vegetables, grassesr and ornamentals. However, slight to severe injury was observed on soybeans, buckwheat, aid tabasco pepper (Hartzell 1930, MRID #005007239). In another study, one variety of chrysanthemum showed no adverse effects when sprayed with a 50% solution of naphthalene. A second variety was not adversely affected when a 100% solution was used (Kofranek, 1967. MRID *005015700). In a third study, naphthalene mixed with maize seed and stored for several months caused no adverse effects on germination (Moutia, 1943, MRID #005009023). * Technical naphthalene and manufacturing-use naphthalene are considered to be substantially similar. 46 ------- B. Hazard Assessment There are two outdoor uses of naphthalene in a single active ingredient formulation. Crystalline naphthalene is used to protect bulbs during storage and at the time of planting, and to repel rabbits from gardens. It is possible that exposure to non-target terrestrial, wildlife could result from crystals being ingested directly or alonq with typical dietary matter. Hawever, because of its repellency characteristics and its localized use, it is highly unlikely that these outdoor end-uses of naphthalene would have any unreasonable effects on populations of non-target terrestrial wildlife. Also, end-use naphthalene products would not be expected to reach the aquatic environment in significant amounts; thus fish and other aquatic organisms will most probably not be seriously affected under the current fumigation and repellent use patterns. It should be noted that naphthalene is also used as a repellent of pigeons, sparrows, squirrels and bats within dormers and eaves of buildinqs, however, this is not considered on outdoor use. There is some information on the effects of naphthalene vapors on ornamental plants. Species such as Calendula officinal is, Centaurea imperialis, Cyclamen indicum, Fuchsia speciosa, Callistephus chinensis (China aster), Hnysalis fracnheti , rose seedlings and geranium were not adversely affected when exposed to naphthalene vapors at 13% saturation in a greenhouse. Based on the current minor outdoor use patterns, it is unlikely that non-target plants would be exposed to hazardous concentrations of naphthalene vapors in the field. Due to the limited acceptable information available, a detailed hazard assessment for technical (manufacturing-use) or end-use products of naphthalene cannot be made for non-target animal and plant species. C. Summary of Data Gaps Six basic studies are generally required when a pesticide has outdoor uses. Given the extremely small exposure expected to fish and wildlife resulting from the use patterns of naphthalene, the bluegill Qfi IC^ and the upland game species LCcn requirements can be waived. The following four studies will still be required: 1) The Avian Single Dose Oral LD_n . This studv should he performed on either an upland avian species (preferably bobwhite quail or ring-necked pheasant) or a wild waterfowl species (preferably the mallard duck); 2) The Avian Dietary I£5Q . Che eight-day dietary LC^g study is required. The study should be performed on a mallard duck. 3) Fish Acute Toxicity . Che 96-hour LC5Q study should be performed. The study should use a coldwater fish species (preferably rainbow trout) and; 4) Acute Toxicity to Aquatic Invertebrates. Che 48-hour LCen study should be performed. The preferred species for this study is Daphnia magna. 47 ------- IX. Efficacy A. Efficacy Profile The review of naphthalene data and the identification of data qaps are limited to efficacy data only as it relates to public health applications. The Agency has provided for the waiver of efficacy data submission as a part of the registration process in all other instances (44 FR 27932? May 11, 1979). Supportive efficacy information will be required for products intended for use inside premises to repel pests of public health significance such as bats and birds. According to Marsh and Howard (1977, MRID *GS0022030), there are no known studies or "good information" as of the date of this Registration Standard (September 1981) which addresses the topic of naphthalene's efficacy as a bat or bird repellent in public health uses. Due to the lack of experimental data on the subject, the" efficacy of naphthalene could not be determined. However, all information reported regarding the efficacy of naphthalene has been assessed, based primarily on statements made by authors in published articles. B. Factors Influencing Efficacy Several factors can affect the efficacy of naphthalene as a repellent. 'The concentration of naphthalene fumes in a treatment area seems to be the pivotal factor. A relatively confined treatment area, such as a fairly tight attic or a space between walls, greatly improves the chance of repelling birds and bats from these areas. The reduced ventilation of the repellent fumes allows the concentration of the fumes to build up in these areas, (Constantine, 1.97P, GS0022028; Marsh and Howard, 1977, GS0022030; Clark 1975, GS0022026. Also, the amount of naphthalene actually applied to a treatment area directly affects the concentration of tine repellent fumes in the area. C. Use Sites 1. Attics; Wall Voids The articles reviewed by the Agency on the efficacy of naphthalene agree on one point. The efficacy of n phthalene to control bats whidn are considered public health problems is contingent upon the repellent being applied in enclosed spaces such as attics and wall voids. 2. Target Pests Pests currently on federally-registered naphthalene labels are often listed in general terms. The terms "birds" and "bats" are used along with some specific bird names (i.e., pigeons, starlings, and sparrows). Since naphthalene is used as a repellent, which implies lack of toxicity to target pests, and since articles reviewed by the Agency seem to indicate that tine repellency of naphthalene for public health uses does not vary significantly between species of birds or bats, the Agency believes that the general terms "bats" and "birds" are acceptable for these products. 48 ------- a. Bats (Chiroptera) Because bats leave their roosts at night, they are less resistant to be in g repelled by naphthalene as night time nears. Conversely, it is harder to repel bats from a roost during the day and, therefore, this oould require a higher canceltration of naphthalene fumes to do so. Bats' olfactory senses are developed sufficiently to enable them to smell naphthalene, although the primary mode of repellent action appears to be its irritation of the bats' mucous membranes. Dosage recommendations in the literature range from 2 to 5 poinds of naphthalene for the "average" bat roost in dwellings (Ccnstantine, 1979, GS0022028; Marsh and Howard, 1977, GS0022030; Silver, 1935, GS0022034), to 5 pounds of naphthalene per 2000 cubic feet of enclosed space (Clark 1975, GS0022026). b. Birds, including Pigeon (Cplumba livia), Starling f Stum us vulgaris), and Sparrow (Passer domesticus) Although no specific dosage information was found in the literature, current label instruction recommend using 8 oz. of naphthalene for every 200 cu. ft. to repel birds. Due to the scarcity of pertinent information, claims of efficacy for the bird repellent uses are not unequivocally supported by the currently available literature. D. Summary of Data Gaps The reviewed literature supports general claims of repellency for public health related uses of naphthalene. The existing information does not support claims relating to the length of the initiatory period (the period between application of the pesticide and manifestation of its efficacy) or claims relating to the duration of effectiveness of naphthalene products. If these claims are not currently on the product labels then registrants will not be required to submit data supporting the claims. Tn order to keep the aforementioned claims on an existing label or to add such claims to a label, these data will he required, (see table IIT.C-2). 49 ------- X. Confidential Mnex Persons wishing to read the on tents of this annex, which contains Confidential Business Information . are requested to contact the thited States Environmental Protection Agency for further details. 50 ------- XI. Bibliography A. Guide to Use of This Biblioqraphy 1. Cm tent of Biblioqraphy 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 3 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; 2) citations examined and judged to be inappropriate for use in developing the standard; and 3) standard reference material. Primary sources for studies in this bibliography have been the body of data submitted 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 submitted to the Agency, the Agency has sought to identify documents at a level parallel to a published article from within the typically larger volumes in which they were submitted. 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. The Agency has attempted also to unite basic documents and commentaries 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 proper, an nine-digit identifier. This number is unique to the citation, and should be used at any time specific reference is required. This number is called the "Master Record Identifier", or "MRID". It is not related to the six-digit "Accession Number" which has been used to identify volumes of submitted data; see paragraph 4(d(4) below for a further explanation. 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 submitted to EPA, by a description of the earliest toiown submission. The bibliographic conventions used reflect the standards for the American National Standards Institute (ANSI), expanded to provide for certain special needs. Some explanatory notes of specific elements follow: a. Author Vhenever the Agency could confidently identify one, the Agency has chosen to show a personal author. Whm no individual was identified, the Agency has shown an identifiable laboratory or testing facility as author. As a last resort, the Agency has shown the first known submitter as author. 51 ------- b. Document Date When tiie date appears as four digits with no question marks, the Ago-icy took it directly from the document. When a four-digit date is followed by a questicn mark, tiie bibliographer deduced the date from evidence i"i the document. When the date appears as (19??), the Agency was unable to determine or estimate the date of the document. c. Title This is the third element in the citation. Jn some cases it has been necessary for the Agency bibliographers to create or enhance a document title. Any such editorial insertions are contained between square brackets. d. Trailing Parenthesis For studies submitted to us .in the past, the trailing parenthesis include (in addition to any self-explanatory known submission. 1) Submission Date . Immediately following the word 'received1 appears the date of the earliest knowi submission. 2) Administrative Number . The next element, immediately 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 by1. When authorship is defaulted to the submitter, this element is omitted. 4) Volume Identification . The final element in the trailing parenthesis identifies the EPA accession number of the volume in which the original submission of the study appears. The six- digit accession number follows the symbol 'CDL1, standing for "Company Data 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 2fith, 123455-Z; and the 27th 123456-AA. 52 ------- OFFICE OF PESTICIDE PROGRAMS REGISTRATION STANDARD BIBLIOGRAPHY Case GS0022 Naphthalene Section 1 Citations Considered to be Part of the Data Base Supporting Registrations Under the Standard Product Chemistry 005010379 005008684 005010941 000004900 Ballard, H.D., Jr. (1965) Naphthalene from petroleum. Petroleum Chemistry and Refining 10:219-273. Advances in Liepins, R.; Mixcn, P.? Hudak, C.; Parsons, T.B. (1977) Industrial Process Profiles for environmental Use: Chapter 6. The Industrial Organic Chemicals Industry. Cincinnati, Ohio: U.S. Environmental Protection Agency, Industrial Environmental Research Laboratory. (Environmental protection technology series no. EPA-600/2-77-023f; available from: NTIS, Springfield, VA; PB-281 478) Martin, H.; MMes, J.R.W. (1953) Guide to the Chemicals Used in Crop Protection. 2nd ed. Ottawa, Ontario, Canada: Canada Department of Agriculture. Nowak, L.M. (1975) Interim Material Safety Data Sheet for Naphtha- lene. (Unpublished study received May 6, 1977 under unknown admin, no.; prepared by Ashland Oil, Inc., submitted by Renova Chemical Co., St. Louis, Mo.; CDL:229765-A) ------- OFFICE OF PESTICIDE PROGRAMS REGISTRATION STANDARD BIBLIOGRAPHY Case GS0022 Naphthalene Section 1 Citations Considered to be Part of the Data Base Supporting Registrations thder the Standard Bivircnmantal Fate 005017183 005005354 005005353 005005937 005007776 005012107 005008688 005019904 005014797 Bramson, L.M. (1960) K voprosam ob isparyaemosti naphtalina i eqo predelno dopustimoi ccncentracii. [The volatility of naphthalene and its maximum permissible concentration in the atmosphere of industrial premises.1 Gigiena Truda i Professional "n ye Zabolevan iya. [Labor Hygiene and Occupational Diseases.] 4(6):50-52. Cemiglia, C.E.; Gibson, D.T. (1977) Metabolism of naphthalene by Curtn inghamella elegans. Applied and Environmental Microbiology 34(4):363-370. Cemiglia, C.E.; Gibson, D.T. (1978) Metabolism of naphthalene by cell extracts of Cum inghamella elegans . Archives of Biochemistry and Biophysics 186(1):121-127. Cemiglia, C.E.; Hebert, R.L.; Szaniszlo, P.J.; Gibson, D.T. (1978) Fingal transformation of naphthalene. Archives of Microbiology 117(2):135-143. Cindell, A.M.; Traxler, R.W. (1973) Microbial degradation of petroleum at low temperature. Marine Pollution Bulletin 4(8)-.125-127. Cindell, A.M.; Traxler, R.W. (1973) The isolation aid characterization of hydrocarbon-utilizing bacteria from Chedabucto Bay, Nova Scotia. Pages 421-426, "Sn Proceedings of Joint Conference on Prevention and Control ofTH.1 Spills; Mar 13-15, Washington, D.C. Washington, D.C.: American Petroleum Institute. Cindell, A.M.; Traxler, R.W. (1976) Psychrophilic hydrocarbon-degrading bacteria from Narragansett Bay, Island, U.S.A. Material und Organismen 11(1):1-17. Rhode Hansen, N.; Jensen, V.B.; Appelquist, H.; Morch, E. (1978) Ihe uptake and release of petroleum hydrocarbons by the marine mussel Mytilus edulis. Progress in Water Technology 10(5/6):351-359. Kaneko, Y.; Saino, Y.; Hoi, S. (1969) Biseibutsu ni yoru takan hokozoku tankasuiso no taisha ni kansuru kenkyu (Dainippo) S-210, 592 kin no fuenansuren taisha. [Studies on the metabolism of polynuclear aromatic hydrocarbons by microorganisms: II. Ehenanthrene metabolism of strain S-210 and 592.] Nippon Nogei Kagaku Kaishi. [Journal of the Agricultural Chemical Society of Japan.] 43(1):21-27. ------- OFFICE OF PESTICIDE PROGRAMS REGISTRATION STANDARD BIBLIOGRAPHY Case GS0022 Naphthalene Section 1 Citations Considered to be Part of the Data Base Supporting Registrations Older the Standard Eh vi ran mental Fate Continued 005016326 Kvasnikov, E.I.; Tin'yanova, N.Z.; Krivitskii, I.P. (1970) Naftalinokyslyuyuchi bakteriyi zakhidnoukrayins'kykh naftorodovyshch. [Naphthalene-oxidizing bacteria of the western Ukrainian oil-bearing deposits.] Mikrobiologichnii Zhumal (Kiev), fJournal of Microbiology. 1 32(3):294-297. 005006779 lee, R.F.; Gardner, W.S.; Anderson, J.W.; Blaylock, J.W.; Barwell-Clarke, J. (1978) Fate of polycyclic aromatic hydrocarbons in controlled ecosystem enclosures. Environmental Science and Technology 12(7):832-838. 005006197 Innsane, B.K.; Barua, P.K.; Singh, H.D.; Mathur, R.K.; Baruah, J.N.; lyengar, M.S. (1974) Formation of salicylic acid from naphthalene by microorganisms: Part I—Studies on isolation, characterization and growth of bacterial isolates utilizing naphthalene. Indian Journal of Experimental Biology 12(2):158-161. 005006198 Lcnsane, B.K.; Vadalkar, K.; Singh, H.D.; Baruah, J.N. (1976) Hydrocarbon utilization by Brevibacterium, Azotomonas, Protaminobacter ium, Mycococcus and Aeromonas spp. Indian Journal of Experimental Biology 14(6):734-736. 005015494 Lopatik, M.D. (1964) Izuchenie sposobnosti mikobakterii okislyaf uglevodorody. [Hydrocarbon-oxidizing capacity of mycobacteria. 1 Mikrobiologiya. [Microbiology. 1 XXXIIK 2): 236-238. 005005660 Mackay, D.; Wblkoff, A.W. (1973) Rate of evaporation of low-solubility contaminants from water bodies to atmosphere. Bivironmantal Science and Technology 7(7):611-614. 005012039 Shtein, A.L.; Dumova, M.S.; Trcndina, G.I. (1976) Issledovanie ravnovesiya naftalina, ammiaka i piridina pri malykh kontsentratsiyach mezhdu rodoi i rozduchom. [Equilibrium distribution of naphthalene, ammonia, and pyridine in low concentrations between water and air.] Zhumal Prikladnoi Khimii. [Journal of Applied Chemistry.] 49(3):650-651. 005015998 Skryabin, G.K.j Starovoitov, I.I. (1975) ft\ alternative pathway of naphthalene catabolism in Pseudomonas fluorescens. Doklady Biochemistry (Biglish Translation.) 221 (1/6): 141-143. ------- OFFICE OF PESTICIDE PROGRAMS REGISTRATION STANDARD BIBLIOGRAPHY Case GS0022 Naphthalene Section 1 Citations Considered to be Part of the Data Base Supporting Registrations Under the Standard Environmental Fate Continued 005017304 Slavnina, G.P. (1970) Bakterii, ispol'zuyushchiye aromaticheskiye uglevodorodi. [Bacteria which utilize aromatic hydrocarbons.1 Trudy, Vsesoyuznyi Nauchno-Issledovatel'skii Institut Yadernoi Geofiziki i Geokhimii. [Transactions, All-Union Scientific Research Institute of Nuclear Geophysics and Geochemistry.1 (8):247-254. 005006598 Soto, C.; Hellebust, J.A.; Hutchinson, T.C. (1977) Effect of naphthalene and aqueous crude oil extracts on the green flagellate Chlamydomonas angulosa. III. Changes in cellular composition. Canadian Journal of Botany 55(22):2765-2777. 005018634 Southworth, G.R.; Beauchamp, J.J.; Schmieder, P.K. (1978) Bioaccumulation potential of polycyclic aromatic hydrocarbons in Daphnia pulex. Water Research 12(11):973-977. 005009267 Starovoitov, I.I.; Nefedova, M.Y.; Yakovlev, G.I.; Zyakun, A.M.; Adanin, V.M. (1975) Gentisic acid as a microbiological oxidation product of naphthalene. Bulletin of the Academy of Sciences of the USSR, Division of Chemical Science. A translation of: Izvestiya Akademii Nauk SSSR, Seriya Khimicheskaya 24(9):1974-1975. 005017184 Traxler, R.W. (1973) Bacteria] degradation of petroleum materials in low temperature marine environments. Pages 163-170, In The Microbial Degradation of Oil Pollutants, Proceedings of a Workshop; Dec 4-6, 1972, Georgia State University, Atlanta, Georgia. Edited by D.G. Ahearn and S.P. Meyers. Baton Rouge, La.: Louisiana State University, Center for Wetland Resources. (Sea Grant publication no. LSU-SG-73-01; available from: NTIS, Springfield, VA; COM-74-11013) 005005371 Walker, J.D.; Colwell, R.R. (1976) Measuring the potential activity of hydrocarbon-degrading bacteria. Applied and Environmental Microbiology 31(2):189-197. ------- OFFICE OF PESTICIDE PRDGAMS REGISTRATION STANDARD BIBLIOGRAPHY Case GS0022 Naphthalene Citations Considered to be Part of the Data Base Supporting Registrations Under the Standard Toxicology 005015698 Adams, D.R. (1930) A study of the correlation between the biochemical and intra-ocular changes induced in rabbits by the administration of naphthalene. British Journal of Ophthalmology 14 (11): 545-576. GS0022024 Battelle's Columbus Laboratories, Subcontract No. 76-34-106002, March 4, 1980. Subchrcnic Toxicity Studyzt Naphthalene (C52904) in Fischer 344 Rats. GS0022023 Battelle's Columbus laboratories, Subcontact No. 76-34-106002, March 4, 1980. Subchrcnic Toxicity Study? Naphthalene (C52904) in B6C3F1 Mice. 005006208 Boyland, E.; Sims, P. (1957) Metabolism of polycyclic compounds: 11. The omversion of naphthalene into 2-hydroxy-l-naphthyl sulphate in the rabbit. Biochemical Journal 66(1):38-40. 005006209 Boyland, E.; Sims, P. (1958) Metabolism of polycyclic compounds: 12. An acid-labile precursor of 1-naphthylmercapturic acid and naphthol: an N-acetyl-S- (1:2-dihydrchydroxjnaphthy 1) -L-cysteine. Biochemical Journal 68(3):440-447. 005006213 Boyland, E.; Wiltshire, G.H. (1953) Metabolism of polycyclic compounds: 7. The metabolism of naphthalene, 1-naphthol and l:2-dihydroxy-l:2-dihydrcnaphthalene by animals. Biochemical Journal 53(4):636-641. 005020080 Chen, K.C.; Borough, H.W. (1979) Glutathicne and mercapturic acid ccn jugations in the metabolism of naphthalene and 1-naphtyl N-fflethylcarbamate (carbaryl). 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(1951) Acute hemolytic anemia due to ingesticn of naphthalene noth balls. Pediatrics 7:722-728. 005007954 Marsden, C.M.; Yoing, L. (1958) Biochemical studies of toxic agents: 10. Observations on the metabolism of 355 labelled mercapturic acids. Biochemical Journal 69(2)?257-265. 005005197 Pirie, A. (1968) Pathology in the eye of the naphthalene-fed rabbit. Experimental Eye Research 7(3):354-357. 005012927 Prochorow, M.; Nowotarska, T. (1965) Cztery przypadki zatrucia naftalina niemowlat. [Four cases of naphthalene poisoning in infants.! Pediatria Pol ska. [Polish Pediatrics.! XL(9):999-1000. 005015285 Schmaehl, D. (1955) Pruefing von Naphthalin end Anthracen auf cancerogene Wirkung an Ratten. (Testing of naphthalene and anthracene for carcinogenic effect in rats.] Zeitschrift fuer Krebsforsching 60(6):697-710. 005005672 Stillwell, W.G.; Bouwsma, O.J.; Homing, M.G. (1978) Formation in vivo of deuterated methylthio metabolites of naphthalene from L-methicnine (methyl-d-). Research Gormanications in Chemical Pathology and Biarmacology 22(2):329-343. 005005671 Stillwell, W.G.; Bouwsma, O.J.; Thenot, J.P.; Homing, M.G.; Griffin, G.W.; Ishikawa, K.; Takaku, M. (1978) Methylthio metabolites of naphthalene excreted by the rat. Research Comminications in Chemical Pathology and Eharmacology 20(3):509-530. 005005235 Zuelzer, W.W.; Apt, L. (1949) Acute hemolytic anemia due to naphthalene poisoning: a clinical and experimental study. Journal of the American Medical Association 141(3):185-190. ------- OFFICE OF PESTCIDE PROGAMS REGISTRATION STANDARD BIBLIOGRAPHY Case GS0022 Naphthalene Section 1 Citations Considered to be Part of the Data Base Supporting Registrations Under the Standard Ecological Effects 005007545 Corner, E.D.S.; Harris, R.P.; Kilvington, C.C.; O'Hara, S.C.M. (1976) Petroleum compounds in the marine food web: short-term experiments on the fate of naphthalene in Calanus. Journal of the Marine Biological Association of the United Kingdom 56(1):121-133. 005009021 Harris, R.P.; Berdugo, V.; Corner, E.D.S.; Kilvington, C.C.; O'Hara, S.C.M. (1977) Factors affecting the retention of a petroleum hydrocarbon by marine planktonic copepcds. P&ges 286-304, Jh Fate and Effects of Petroleum Hydrocarbons in Marine Organisms and Ecosystems. Edited by D.A. Wolfe. Elmsford, N.Y.: Pergammon Press. 005006550 Harris, R.P.; Berdugo V.; O'Hara, S.C.M.; Corner, E.D.S. (1977) Accumulation of 14C-l-naphthalene by an oceanic and an estuarine copepod during long-term exposure to low-level concentrations. Marine Biology 42(3):187-195. 005007239 Hartzell, A.; Wilcoxon, F. (1930) Naphthalene fumigation at controlled concentrations. Journal of Economic Entomology 23:608-618. 005015700 Kofranek, A.M.; Markiewicz, L. (1967) Selected naphthalenes as disbudding agents for chrysanthemums: part 2 of a 2-part discussion. Florists' Review 140(3617):20-21,54-57. 005009023 Moutia, L.A.; Mamet, R. (1943) Experiments on the storage of maize seeds. Revue Agricole et Sucriere de 1'Ile Maurice ------- NRID OFFICE OF PESTICIDE PROGRAMS REGISTRATION STANDARD BIBLIOGRAPHY Case GS0022 Naphthalene Section 1 Citations Considered To Be Part Of The Data Base Supporting Registration thder The Standard Efficacy Citation GS0022025 Anon. (1949). Bird Repellents. Pest Control 17(12):20. GS0022026 Clark, D. O. (1975). Vertebrate Pest Control Handbook. Cal. Bept. of Food and Agri., Div. of Plant Industry; pp. 508-1. GS0022028 Cbnstantine, D. G. (1979). Rabies and Bat Management. Bull. Soc. Vector Ecol. 4:1-9. GS0022029 Ebeling, W. (1975). Urben_Entomology. thiv. of Cal. Div. of Agri. Sci. pp. 603. GS0022030 Marsh, R. E. Howard, W.E. (1977). Vertebrate Control Manual. Pest Control 45(10):34. GS0022031 Murphy, K.T. (1975). Bat Problem Abated Temprarily. The Patriot Ledger. Wed., July 9, pp. 16. GS0022032 Scott, H. G. (1961). Bats: Public Health Importance, Identification, and Control. Pest Control 29(8): 23-29. GS0022033 Scott, H. G. (1961). Pigeons: Public Health Importance and Control. Pest Control 29(9):9 & 60-61. GS0022034 Silver, J. (1935). Eliminate Bats from Buildings. USDA leaflet 109:4-5. 005000993 British Crop Protection Council (1974) Pesticide Manual: Basic Information on the Chemicals Used as Active Components of Pesticides. Edited by H. Martin and C. R. Worthing. 4th ed. London, England: British Crop Protection Council. GS0018006 Farm Chemicals Handbook (1979). Meister Publishing Co., Willoughly, OH. 44094 ------- OFFICE OF PESTICIDE PROGRAMS REGISTRATION STANDARD BIBLIOGRAPHY Case GS0022 Naphthalene Section 2 Citations Examined and Judged to be Inappropriate For Use in Developing the standard Registrations Under the Standard 005006685 Abbott, B.J.; Gerhardt, P. (1970) Dialysis fermentation. I. Enhanced production of salicylic acid from naphthalene by Pseudomonas fluorescens. 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American Journal of Obstetrics and Gynecology 78(3):519-521. 005006873 Apgar, F.A., inventor; Sinclair Refining Co., assignee (1955) Naphthalene purification by washing with a surface active agent. U.S. patent 2,704,779. Mar 22. 4 p. Cl. 260-674. 005009183 Armstrong, W.E.; Densham, A.B.; Griffith, R.H., inventors; Gas Light and Coke Co., assignee (1951) Improvements in or relating to the purification of naphthalene. British patent specification 651,154. Mar 14. 3 p. 005012274 Ashland Oil and Refining Co., assignee (1962) Improvements in or relating to the recovery of naphthalene from petroleum fractions. British patent specification 889,789. Feb 21. 9 p. Int. Cl. C 07c. 005006697 Asselin, G.F.; Erickson, R.A. (1962) Benzene and naphthalene from petroleum by the Hydeal process. Chemical Engineering Progress 58(4):47-52. 005006864 Asselin, G.F.; Erickson, R.A. (1962) Dealkylation puts petroleum industry into the benzene-naphthalene business. 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(Available from; NTIS, Springfield, VA; PB-296 786). •U.S. GOVBMWEHT PRINTING OFFICE: 1981—361-082/267 ------- |