United States
                  Environmental Protection
                  Agency	
 Prevention, Pesticides
 And Toxic Substances
 (7505C)	
EPA-730-F-99-008
July 1999
                   New  Pesticide  Fact  Sheet
                   N-Methylneodecanamide
                   (MNDA)
   DGSCriptJOn Of  Generic Name: N-Methylneodecanamide (MNDA)
    the Chemical  Common Name: MNDA
                  Trade Name:   M-9011
                  EPA Shaughnessy Code (OPP Chemical Code): 079052
                  Chemical Abstracts Service (CAS) Number: 105726-67-8
                  Year of Initial Registration: July 1999
                  Pesticide Type: Insect Repellent
                  Manufacturer: Colgate-Palmolive Company
                              609 River Road,
                             Piscataway, NJ 08855-1343
    Use Patterns  Application Sites:
and Formulations  Types of Formulation:

                  Target Pest:
                  Use Patterns:
Indoor non-food use (residential homes)
For Manufacturing Use in the formulation of multi-
purpose cleaner/insect repellent products only.
Cockroaches (unspecified) and ants (unspecified)
Household floors, walls, bathroom and other non-
food contact surfaces.
Science Findings  Summary Statement:
                       N-Methylneodecanamide (MNDA) technical has a low acute oral (toxicity
                  category IE), dermal (toxicity category HI), and inhalation toxicity (toxicity
                  category IV). It is a slight dermal and ocular irritant (toxicity category IV). It is
                  not a skin sensitizer.
                       There are no data gaps for subchronic toxicity guideline requirements.
                  Subchronic toxicity at the LOAEL in the rat and dog are primarily limited to
                  histologic liver changes. In the dogs, neurotoxicity occurred at doses that
                  evidenced extreme toxicity resulting in lowering the doses.  In the rat and rabbit
                  developmental toxicity occurs only in the presence of maternal toxicity. There is
                  no evidence of reproductive toxicity. There is no evidence of neurotoxicity in the
                  rat subchronic neurotoxicity study and neurotoxicity only occurs at maternally
                  toxicity levels in the combined developmental/developmental neurotoxicity study.

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       Chemical
Characteristics
Technical Grade
      Physical:
      Color:
      Odor:
      Melting Point:
      pH:
      Density:
      Molecular Formula:
      Vapor Pressure:
Liquid
Light grey
Fruity
 N/A
7.8
7.5 Ibs/gal.
                                                             (mw = 185)
                                             1.2X10-3at30C.
 Human Health
   Assessment
TOXICOLOGY CHARACTERISTICS
Acute Toxicity
      In studies using laboratory animals, MNDA technical is of relatively low
acute toxicity: Toxicity Category in for acute oral and acute dermal; and Toxicity
Category IV for primary eye and skin irritation. The technical is not a dermal
sensitizer.
[NOTE: For acute oral, dietary, mammalian:
      Category I = very highly or highly toxic
      Category n = moderately toxic
      Category HI = slightly toxic
      Category IV = practically non-toxic]
The acute toxicity profile table below represents MNDA technical grade/MUP
based on the following table of study results:
Guideline No.
81-1
81-2
81-3
81-4
81-5
81-6
81-8
Study type
Acute Oral
Acute Dermal
Acute Inhalation
Primary Eye Irritation
Primary Skin Irritation
Dermal Sensitization
Acute Neurotoxicity
Results
450mg/kg1800 mg/kg
LC50 > 2.4 mg/L
slight ocular irritant
slight dermal irritant
not a sensitizer
none
m
m
IV
rv
rv


                    Subchronic Toxicity
                    90-day feeding studies - Subchronic toxicity at the LOAEL in the rat (30
                    mg/kg/day) and dog (4.5 mg/kg/day) are primarily limited to histologic liver
                    changes. There was no evidence of neurotoxicity in the Subchronic neurotoxicity
                    study in rats. In the dog, neurotoxicity occurred at much higher doses that also
                    evidenced extreme toxicity.

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90-day dermal toxicity study in rats - In a dermal subchronic toxicity study the
results indicated for males the LOAEL for dermal toxicity is 1000 mg/kg/day and
the NOAEL is 300 mg/kg/day. For females the LOAEL and NOAEL are 100 and
30 mg/kg/day. The NOAEL for systemic toxicity is 1000 mg/kg/day. The
LOAEL was not determined.

Chronic Toxicity and Carcinogenicity
A determination of cancer potential was not made, since there are no chronic
studies for MNDA (As far as toxicology data requirements, the Agency is treating
this proposed registration as a non-food use).  If the use pattern changes,
additional data will be required to satisfy these guideline requirements.

Developmental Toxicity
In the rat and rabbit, there is developmental toxicity only at levels where maternal
toxicity is present. There is no evidence of reproductive toxicity. There is no
evidence of neurotoxicity in the rat dietary subchronic neurotoxicity study.
Developmental neurotoxicity (evaluated in a combined
developmental/developmental neurotoxicity study) does occur at maternally toxic
levels and is limited to transient decreased pup motor activity only in males on
day 18. Some signs of neurotoxicity were present in this study, but only in the
presence of other maternal toxicity signs.

Mutagenicity
The mutagenic test battery demonstrated that MNDA is not mutagenic. Since the
Agency is treating this proposed registration as a non-food use, metabolism data
in laboratory animals  are not required.

OCCUPATIONAL AND RESIDENTIAL EXPOSURE
Occupational Risk Estimates
This product is registered for residential use only. There is concern that this
product may be used by professional house cleaning personnel. Therefore an
intermediate-term and chronic (long-term) risk assessment was conducted for this
scenario.  The Margins of Exposure (MOE) for adult females employed by
professional house cleaning personnel is  150. An acceptable MOE for MNDA is
100.

Residential Risk Estimates
The occupational and residential exposure database is satisfied based on the use of
screening level assessments and information which consists of total deposition
measurements of MNDA. These data were used with the Agency's Standard
Operating Procedures for assessing Residential exposures (SOP) to estimate
non-dietary, hand-to-mouth exposure of young children. Inhalation exposure was

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addressed using the Screening-Level Consumer Inhalation Exposure Software
(SCIES) floor mopping subset to predict post application air concentrations. Both
the SOPs and SCIES are considered screening level assessments. Dermal
exposure was not addressed as the available data indicate MNDA is not toxic via
this route.

Aggregate Risk Estimates
The respective combined (oral, non-dietary and inhalation) screening-level MOE
for children is 170. The combined application and post-application MOE for an
adult female (other than professional house cleaning personnel) (body weight of
60 kg) for mopping floors with MNDA is 2900. Post-application is defined in this
risk assessment as the period immediately after the floor was mopped. A MOE of
100 is considered acceptable.

Human Risk Assessment
The Agency Hazard Identification Assessment Review Committee (HIARC)
evaluated the toxicology data base of MNDA, selected endpoints for occupational
and residential exposure risk assessments, and established endpoints to be used
for short-, intermediate- and, long-term oral exposure (hand-to-mouth for infants
and children). The acute and chronic RfDs were not established since the Agency
is treating this proposed registration as a non-food use. The Agency FQPA Safety
Factor Committee evaluated the hazard and exposure data for MNDA and
determined that the FQPA regulations do not apply to MNDA since the Agency is
treating this proposed registration as a non-food use.  However, the Committee
considered the potential for sensitivity to infants and children due to oral hand-to-
mouth exposure (under FIFRA) and determined that there was no indication of
increased sensitivity.
The HIARC determined that short-, intermediate- and long-term dermal risk
assessments are not required because no  systemic toxicity was seen at 1000
mg/kg/day in a 90-day dermal  toxicity study in rats indicating very low dermal
absorption.
The HIARC established a short-term oral NOAEL (40 mg/kg/day from the
developmental toxicity study in the rat, based on clinical signs and reduced food
consumption at 125 mg/kg/day), and intermediate and long-term oral NOAELs
(1.35 mg/kg/day from the subchronic dog study based on liver changes at 4.52
mg/kg/day) for "Hand-to-Mouth" exposure for infants and children.
The HIARC also determined that a risk assessment for inhalation  exposure is
required for all time periods. Although there is low acute inhalation toxicity
(Toxicity Category IV; and no mortality at 2.4 mg/L), the high vapor pressure of
the technical (1.2xlO~3 torr at 30C) suggests an exposure potential via the
inhalation route. Since there are no subchronic or chronic inhalation toxicity
studies available, the HIARC recommended oral NOAELs for inhalation
exposure risk assessments. The method for route-to-route  extrapolation is

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                         described later in this document. The NOAEL for short-term exposure is 40
                         mg/kg/day based on a developmental toxicity study in the rat and for intermediate-
                         and long-term exposure the NOAEL is 1.35 mg/kg/day based on a subchronic dog
                         study.
                         The HIARC also did not consider MNDA to be of specific neurologic concern
                         since neurologic signs were either marginal, transient or occurred at otherwise
                         toxic doses.
Environmental  Fate
      and Ecological
              Effects
     Characteristics
FQPA Considerations
The Agency FQPA Safety Factor Committee evaluated the hazard and exposure
data for MNDA and determined that the FQPA regulations do not apply to
MNDA since the Agency is treating this proposed registration as a non-food use.
However, the Committee considered the potential for sensitivity to infants and
children due to oral hand-to-mouth exposure (under FIFRA), and determined that
there was no indication of increased sensitivity.

The Agency has reviewed the proposed Section 3 registration for the indoor use
of MNDA as a multi-purpose cleaner- insect repellent. Based on the ecological
effects data submitted by the registrant, the Agency concluded that the product
should pose no risks to terrestrial and aquatic organisms from the proposed use
pattern. The use should provide non-target organisms extremely limited access to
the chemical.
                         ENVIRONMENTAL FATE
                         No data is needed at present for this indoor-non food use site. Submitted
                         hydrolysis data indicates that MNDA is a nominal concentration of 30 mg/L,
                         hydrolytically stable in pH 5, 7, and 9 sterile, aqueous buffer solutions incubated
                         in darkness at 25 C 1 for 30 days.

                         Ecological Effects Likelihood of Adverse Effects on Non-Target Organisms
                         Terrestrial Organism Toxicity Avian Subacute Dietary Toxicity  The LC50 s
                         fall above 5000 ppm, MNDA is practically non-toxic to avian species on a
                         subacute dietary basis. Since the avian dietary studies indicate MNDA is not
                         toxic, no further avian testing is needed for the proposed indoor use.
                         Aquatic Organism Toxicity
                         Freshwater Fish Acute Toxicity
                         The LC50's fall in the range of 72.0-90.0 ppm, MNDA is slightly toxic to
                         freshwater fish on an acute basis. The guideline (72-1) is not fulfilled until
                         information on % AI of the test material is submitted. A supplemental 14-day
                         semi-static toxicity study indicate that the LOEC was 39 ppm and the NOEC was

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                20 ppm. Therefore, prolonged exposure does not significantly increase the hazard
                of this chemical to fish.

                Freshwater Invertebrates
                The LC50/EC50 is 130 mg/L, MNDA is practically non-toxic to aquatic
                invertebrates on an acute basis. The guideline (72-2) is not fulfilled until the % AI
                used under test conditions is submitted.

                Invertebrate life-cycle
                A study indicates that the MATC of 54.8 mg/L, a LOEC of 77.9 mg/L and a
                NOEC of 38.5 mg/L with the most sensitive endpoints affected being
                reproduction and growth. An invertebrate life-cycle study is not required for the
                proposed indoor use of MNDA.

                Toxicity to Plants
                Phytotoxicity data is not required for the proposed indoor use of MNDA although
                two plant studies were submitted.
                A study using freshwater green algae resulted in a 120 hr EC50 of 8.1 mg/L and an
                NOEC of 0.11 ppm.

                Ecological Effects Risk Assessment
                The Agency  has reviewed the proposed Section 3 registration for the use of
                MNDA. Based on the ecological effects data submitted by the registrant, the
                Agency concludes that the product should pose no risks to terrestrial and aquatic
                organisms from the proposed use pattern. The proposed use should provide non-
                target organisms extremely  limited access to the chemical.

 Data Gaps   Toxicology
                The toxicology data base on MNDA is adequate as defined for a non-food use
                chemical in 40 CFRPart 158. There is additional confirmatory data required
                from the registrant for two developmental studies, and these data are not
                expected to alter the conclusions of the studies.
                Environmental Fate
                The percent active ingredient of the test material is required as supplemental
                information to upgrade 3 studies to a guideline acceptable status.
RGQlllatOry   Technical/MUP Product -  The Agency has determined that the database has
Conclusion   ^een adequately addressed by the registrant to grant a conditional Section
                3(c)(5)(b) registration on the technical/MUP product. Additional confirmatory
                data is required to upgrade all studies to guideline acceptable status.

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   For More
Information
CONTACT PERSON:
Richard J. Gebken Reviewer, PM-10
Insecticide Branch , Registration Division (7505C)
Office of Pesticide Programs
U.S. EPA, 401 M St. SW
Washington, DC 20460
                Office Location and Telephone Number:
                Rm. 201, Crystal Mall # 2
                1921 Jefferson Davis Highway
                Arlington, VA 22202
                (703) 305-6701
                     Electronic copies of the this fact sheet are available on the Internet. See
                http://www.epa.gov/opprdOOI/factsheets/
                     Printed copies of this  fact sheet can be obtained from EPA's National
                Center for Environmental Publications and Information (EPA/NCEPI), PO Box
                42419, Cincinnati, OH  45242-2419, telephone 1-800-490-9198;  fax 513-489-
                8695.
                     For more information about EPA's pesticide registration program, MNDA,
                or of individual products containing MNDA, please contact the Registration
                Division (7505C), OPP, US EPA, Washington, DC 20460, telephone 703-305-
                5446.
                     For information about the health effects of pesticides, or for assistance in
                recognizing and managing pesticide poisoning symptoms, please contact the
                National Pesticides Telecommunications Network (NPTN).  Call toll-free 1-800-
                858-7378, from 6:30 a.m. to 4:30 p.m. Pacific Time, or 9:30 a.m. to 7:30 p.m.
                Eastern Standard Time,  seven days a week.

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