EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE 

PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact: [P.V Shah; 703-308-1846]

INSTRUCTIONS: Please utilize this outline in preparing the pesticide petition. In cases where the 

outline element does not apply, please insert “NA-Remove” and maintain the outline. Please do not 

change the margins, font, or format in your pesticide petition. Simply replace the instructions that 

appear in green, i.e., “[insert company name],” with the information specific to your action.

TEMPLATE:

[Technology Sciences Group Inc.]

[IN-10622]

EPA has received a pesticide petition ( ) from [Technology Sciences Group Inc.], [1150 18th

Street NW Suite 1000, Washington DC] proposing, pursuant to section 408(d) of the Federal Food, Drug, 

and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.

(Options (pick one)

to establish an exemption from the requirement of a tolerance for

coco alkyl dimethyl amines

] EPA has determined that the petition contains data or information regarding the elements set forth in 

section 408 (d)(2) of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data 

at this time or whether the data supports granting of the petition. Additional data may be needed before 

EPA rules on the petition.

A. Residue Chemistry [This information is not available, nor required for the establishment of a 

tolerance exemption.]

1. Plant metabolism. [NA-Remove]

2. Analytical method. [NA-Remove]

3. Magnitude of residues. [NA-Remove]

B. Toxicological Profile

1. Acute toxicity. [The oral LD50 in rats was determined to be between 1000 and 1300 mg/kg 

for females. An acute dermal toxicity assay performed on the coco alkyl dimethyl amines was 

reported in rabbits. The LD50 was determined to be 4.29 mL/kg bw, equivalent to 3385 mg/kg bw. 

No studies of acute inhalation toxicity were identified for coco alkyl dimethyl amines. An LC50 of 

>0.6 mg/L was derived in rats for the structurally similar hydroxylated amine. The LC50 of >0.6 

mg/L places this compound into acute inhalation toxicity Category III. Coco alkyl dimethyl amines 

were corrosive to rabbit skin. N,N-dimethyl-1-hexadecanamine, N,N-dimethyl-1-tetradecanamine, 
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and N,N-dimethyl-1-tetradecanamine are compounds that constitute coco alkyl dimethyl amines. All 

three of these compounds were irritating to rabbit eyes.]

 

2. Genotoxicity. [ Ames assays were reported on three dimethyl alkyl amines that together 

comprise a large percentage of coco alkyl dimethyl amines. There was no evidence of mutagenicity 

under the conditions of this study for any of the three compounds. 

An in vivo mammalian erythrocyte micronucleus test of a commercial product containing ~ 70 % 

C12-, 25 % C12-14- and 5 % C16-dimethylalkylamine) was conducted. Significant increases in the 

percentage of micronucleated polychromatic erythrocytes in treated mice were not found. ]

3. Reproductive and developmental toxicity. [A reproductive/developmental toxicity screening 

study (OECD TG 421) of N,N-dimethyl-1-dodecanamine (CAS #112-18-5) was conducted in rats. 

Animals received gavage doses of 0, 50, 150, 300, or 450 mg/kg bw/day of the test compound for 14 

days prior to mating, 14 days during mating, and for females, during pregnancy and lactation. One 

male and two females from the highest dose group died by day 5 and this group was discontinued. In 

the 300 mg/kg bw group, one male and six females died and only one pup was born alive. At the 150 

mg/kg bw dose, two dams died and two dams did not deliver pups. The mean post-implantation loss 

was significantly higher than the controls (50.4% vs. 13.3%) and the mean viability index was 

significantly lower (36.9 % vs. 99.3%).The birth weight of male pups was significantly lower than 

that of controls. Maternal behavior was also affected, as evidenced by an unsevered umbilical cord, 

cannibalization, and lack of care of pups. No reproductive or developmental effects were observed in 

the absence of maternal toxicity. The NOAEL for systemic toxicity and for 

reproductive/developmental toxicity was determined to be 50 mg/kg bw/day.]

4. Subchronic toxicity. [A repeat dose study in rats conducted according to OECD Test 

Guideline 407 was carried out on N,N-dimethyl-1-dodecanamine. Animals received gavage doses of 0, 

50, 150, or 300 mg/kg bw/day N,N-dimethyl-1-dodecanamine for 28 days. At the highest dose, three 

of five females died; nothing significant was observed in the histopathology exams of these animals. 

At the middle dose, animals displayed mild adverse behavior, including snout rubbing, but no effects 

on body weight, food consumption, hematology, clinical biochemistry, urinalysis or organ weights. A 

NOAEL of 50 mg/kg/day was determined in this study.]

5. Chronic toxicity. [Chronic studies are not available for coco alkyl dimethyl amines]

6. Animal metabolism. [Studies specific to the metabolic pathway or other toxicokinetic 

properties of coco alkyl dimethyl amines in mammals were not identified in a search of the literature. 

The primary metabolic pathway of coco alkyl dimethyl amines is proposed based on its characteristic 

molecular structure and known metabolic pathways for structurally similar compounds. In 

mammals, hepatic dealkylation readily occurs with secondary and tertiary amines with the methyl 

groups leaving preferentially. Oxidation of the alpha carbon via cytochrome P450, forms a 

carbinolamine intermediate that will spontaneously cleave to form a secondary amine and carbonyl 

compound. Subsequent dealkylation of the secondary amine will take place at a slower rate]

7. Metabolite toxicology. [No metabolites of toxicological concern have been identified.]
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8. Endocrine disruption. [Toxicity related to endocrine disruption was not observed in 

the currently available database and the recent OECD 421 testing.]

C. Aggregate Exposure

1. Dietary exposure. [Concentrations will be less than 0.5% in food use applications of coco 

alkyl dimethyl amine. As a result, humans may be exposed to very low residue levels through the 

diet from food and water.]

i. Food. [Exposure to residues in food are not anticipated to be of toxicological concern 

because the coco alkyl dimethyl amine biodegrades readily in the environment after application, and 

is of low general toxicity. Estimated dietary exposure was based on the assumption that the inert

will be used in all agricultural pesticides at a proposed limit of 0.5% of the spray volume. The 

highest exposed subpopulation was children age 1-2 years old, which had an estimated average 

exposure of 0.0186 mg/kg/day, while the estimated average exposure of the general population was 

0.00496 mg/kg/day. Thus, potential dietary exposure will be low and toxicity is generally low, such 

that a safety finding can be concluded for exposures via the diet.]

ii. Drinking water. [Exposure via drinking water is not expected to be significant. Exposure 

via the drinking water was estimated assuming a concentration of 100 ppb. This estimated exposure 

via drinking water did not contribute significantly to the overall dietary exposure. Thus, potential 

drinking water exposure will be low, such that a safety finding for coco alkyl dimethyl amine can be 

concluded for exposures via the drinking water and the diet combined.]

2. Non-dietary exposure. [Workers may experience dermal exposure during application of 

pesticide products if personal protective clothing is not worn. Humans may also be exposed through 

the use of non-food use pesticidal products. Concentrations of coco alkyl dimethyl amine are less 

than 1.0% and dermal exposure will be limited by the irritation potential of the ingredient. Systemic 

toxicity of coco alkyl dimethyl amine is low. Thus, a safety finding for coco alkyl dimethyl amine can 

be concluded for non-dietary exposures.]

D. Cumulative Effects

[There are no available data or other reliable information that suggests that any toxic effects 

produced by coco alkyl dimethyl amine would be cumulative with those of any other chemical 

compounds. Coco alkyl dimethyl mine does not appear to produce toxic metabolites in common with 

other substances. It is assumed that coco alkyl dimethyl amine does not share a common mechanism

of toxicity with other pesticidal substances.]

E. Safety Determination

1. U.S. population. [There is a reasonable certainty that no harm to humans will result from

the use of coco alkyl dimethyl amine as an inert ingredient in pesticide products. The main effects of 

oral exposure to coco alkyl dimethyl amine are behavioral effects and developmental toxicity at 

maternally toxic dose levels . A NOAEL of 50 mg/kg/day following both 28-day repeat dose testing 

and developmental/reproductive toxicity screening was used to derive the Reference Dose. 

Intraspecies and interspecies uncertainty factors were combined for a total uncertainty factor of 100.

For the total US population, the estimated chronic dietary exposure from food and drinking water 

for coco alkyl dimethyl amine, calculated as 0.5% of all agricultural formulations, is 1.0% of RfD.]

2. Infants and children. [A developmental/reproductive toxicity screening study n rats 

demonstrates that slight developmental effects occurred only at maternally toxic doses. An RfD of 0.5

mg/kg/day was derived for coco alkyl dimethyl amine. The estimated chronic dietary exposure from 

food and drinking water was highest (3.7% of RfD) for children aged 1 to 2 years old.]
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F. International Tolerances

[NA-Remove]