U.S. Environmental Protection Agency September, 2010 

Hazard Characterization Document 

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SCREENING-LEVEL HAZARD CHARACTERIZATION 

Fatty Nitrogen Derived Amines Category 

The High Production Volume (HPV) Challenge Program1

 was conceived as a voluntary initiative 

aimed at developing and making publicly available screening-level health and environmental 

effects information on chemicals manufactured in or imported into the United States in quantities 

greater than one million pounds per year. In the Challenge Program, producers and importers of 

HPV chemicals voluntarily sponsored chemicals; sponsorship entailed the identification and 

initial assessment of the adequacy of existing toxicity data/information, conducting new testing if 

adequate data did not exist, and making both new and existing data and information available to 

the public. Each complete data submission contains data on 18 internationally agreed to “SIDS” 

(Screening Information Data Set1,2) endpoints that are screening-level indicators of potential 

hazards (toxicity) for humans or the environment. 

The Environmental Protection Agency’s Office of Pollution Prevention and Toxics (OPPT) is 

evaluating the data submitted in the HPV Challenge Program on approximately 1400 sponsored 

chemicals by developing hazard characterizations (HCs). These HCs consist of an evaluation of 

the quality and completeness of the data set provided in the Challenge Program submissions. 

They are not intended to be definitive statements regarding the possibility of unreasonable risk of 

injury to health or the environment. 

The evaluation is performed according to established EPA guidance2,3 and is based primarily on 

hazard data provided by sponsors; however, in preparing the hazard characterization, EPA 

considered its own comments and public comments on the original submission as well as the 

sponsor’s responses to comments and revisions made to the submission. In order to determine 

whether any new hazard information was developed since the time of the HPV submission, a 

search of the following databases was made from one year prior to the date of the HPV 

Challenge submission to the present: (ChemID to locate available data sources including 

Medline/PubMed, Toxline, HSDB, IRIS, NTP, ATSDR, IARC, EXTOXNET, EPA SRS, etc.), 

STN/CAS online databases (Registry file for locators, ChemAbs for toxicology data, RTECS, 

Merck, etc.) and Science Direct. OPPT’s focus on these specific sources is based on their being 

of high quality, highly relevant to hazard characterization, and publicly available. 

OPPT does not develop HCs for those HPV chemicals which have already been assessed 

internationally through the HPV program of the Organization for Economic Cooperation and 

Development (OECD) and for which Screening Initial Data Set (SIDS) Initial Assessment 

Reports (SIAR) and SIDS Initial Assessment Profiles (SIAP) are available. These documents are 

presented in an international forum that involves review and endorsement by governmental 

authorities around the world. OPPT is an active participant in these meetings and accepts these 

documents as reliable screening-level hazard assessments. 

 

1

 U.S. EPA. High Production Volume (HPV) Challenge Program; http://www.epa.gov/chemrtk/index.htm. 2

 U.S. EPA. HPV Challenge Program – Information Sources; http://www.epa.gov/chemrtk/pubs/general/guidocs.htm. 3

 U.S. EPA. Risk Assessment Guidelines; http://cfpub.epa.gov/ncea/raf/rafguid.cfm. 
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These hazard characterizations are technical documents intended to inform subsequent decisions 

and actions by OPPT. Accordingly, the documents are not written with the goal of informing the 

general public. However, they do provide a vehicle for public access to a concise assessment of 

the raw technical data on HPV chemicals and provide information previously not readily 

available to the public. 
U.S. Environmental Protection Agency September, 2010 

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Chemical Abstract Service 

Registry Number 

(CASRN) 

Chemical Abstract Index 

Name 

Structural Formula 

23 Sponsored Chemicals 

12 Supporting Chemicals 

(See Appendix for CASRN, Name and Structural Formula) 

Summary 

The 23 members of the fatty nitrogen-derived amines category are long-chain alkyl substituted 

amines used in commercial product mixtures. The category consists of primary alkylamines and 

alkyldiamines, dimethylalkylamines, dialkylmethylamines and dialkylamines, and 

trialkylamines. The primary alkylamines and alkyldiamines are solids at room temperature 

(except for CASRN 7173-62-8, which is a liquid), possessing low to moderate vapor pressure 

and low to moderate water solubility. The dialkylmethylamines are all liquids with low to 

moderate vapor pressure and low to moderate water solubility. The dialkylmethylamines and 

dialkylamines are solids (except for CASRN 7396-58-9, which is a liquid) with negligible to low 

vapor pressure and negligible to low water solubility. Finally, the trialkylamines are liquids with 

negligible to low vapor pressure; two (CASRNs 68814-95-9 and 61790-42-9) have negligible 

water solubility while the others (CASRNs 61791-31-9 and 61791-44-4) are expected to be 

dispersible in water. 

Volatilization is not expected to be an important fate process since the FND amines are weak 

bases that will exist as cations in the environment, and cations do not volatilize. Hydrolysis data 

were not available for any members of this category. Generally, amines are expected to 

hydrolyze extremely slowly under environmental conditions; however, these types of surfactants 

are generally not hydrolysable, according to the sponsor. The rate of atmospheric 

photooxidation is considered moderate to rapid for members of this category; however, this is 

not expected to be an important environmental fate process since these substances are not 

expected to exist in the vapor phase in the atmosphere. The overall weight of experimental 

evidence and read across from structurally similar compounds from these studies suggest that all 

members of the FND amines category have low persistence (P1). Most members of the FND 

amines category are expected to have low (B1) bioaccumulation potential (13/23, including all 

four trialkylamines), with 4/23 having a moderate (B2) rating and 6/23 having a high (B3) rating, 

5/6 being primary alkylamines/alkyldiamines. 

Human Health Hazard 

Subcategory I: Non-Hydroxylated FND Amines 

The acute oral toxicity in rodents for the 21 members of this subcategory is low based on studies 

in nine sponsored chemicals in rats. The acute dermal toxicity in animal studies for this 

subcategory is also low based on studies of five sponsored chemicals in rabbits. Oral repeateddose toxicity studies are available for one sponsored chemical (CASRN 4088-22-6) and three 

supporting chemicals (CASRNs 124-30-1, 3159-59-5/36505-83-6, and 61790-33-8). One dermal 

repeated-dose toxicity study is available for a sponsored chemical (CASRN 4088-22-6). In the 

13-week oral gavage study with CASRN 4088-22-6 in rats, there was no NOAEL for systemic 

effects and the following effects were observed at the lowest tested dose of 117 mg/kg/day: 
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decreased body weight gain, organ weight changes, hematological changes and pathological 

changes in the intestine, lymph nodes and ovaries. In a one year study in dogs, CASRN 

124-30-1 (supporting chemical) was administered via a capsule resulting in mortality, decreased 

body weight gain and pathological changes in the intestine at a dose of 15 mg/kg/day; the 

NOAEL for systemic toxicity was 3 mg/kg/day. The supporting chemical, CASRN 

3159-59-5/36505-83-6, was tested in rats and dogs via the oral route. In the two-year dietary rat 

study, there was a decrease in body weight, clinical chemistry changes and pathological changes 

in the intestine and lymph node at 30 mg/kg/day; the NOAEL for systemic toxicity was 

6 mg/kg/day. In the two-year gavage study in dogs, there were no effects observed; the NOAEL 

for systemic toxicity was 12 mg/kg/day (highest dose tested). In the only repeated-dose dermal 

study in the subcategory, rabbits were exposed to the sponsored chemical, CASRN 4088-22-6, 

daily for 13 weeks. Irritation was observed at the two doses used, resulting in no NOAEL for 

this local effect (lowest tested dose of 5 mg/kg/day). The NOAEL for systemic effects was 

5 mg/kg/day, based on the following effects observed at 50 mg/kg/day: decreased body weight, 

slight changes in hematological parameters, and pathological changes in the liver and lymph 

nodes. 

There were no reproductive toxicity studies in any of the 21 sponsored chemicals; however there 

were studies with two supporting chemicals which are used to read-across to the sponsored 

chemicals. In a dietary combined reproductive/developmental toxicity study with CASRN 

61790-33-8, rats dosed with 150 mg/kg/day experienced implantation loss, decreased mating and 

fertility indices, increased precoital time interval and atrophy of corpora lutea; the NOAEL for 

reproductive toxicity was 50 mg/kg/day. In an oral one-generation reproductive toxicity study 

with CASRN 3159-59-5/36505-83-6 in rats, there were no effects on any reproductive 

parameters assessed; the NOAEL for reproductive toxicity was 30 mg/kg/day (highest dose 

tested). 

Oral developmental toxicity studies were available with one sponsored chemical 

(CASRN 4088-22-6) and three supporting chemicals (CASRNs 112-90-3, 3159-59-5/36505-83-

6, and 61790-33-8). In a prenatal oral developmental toxicity study with rabbits using CASRN 

4088-22-6, dams exhibited decreased weight gain at 250 mg/kg/day and above; the NOAEL for 

maternal toxicity was 50 mg/kg/day. Embryolethality at 1000 mg/kg/day could not be 

discounted; the NOAEL for developmental toxicity was 250 mg/kg/day. The combined 

reproductive/developmental toxicity study with the supporting chemical CASRN 61790-33-8 in 

rats resulted in no NOAEL for maternal toxicity (based on decreased body weight at the lowest 

tested dose of 12.5 mg/kg/day) and a NOAEL of 12.5 mg/kg/day for developmental toxicity 

(based on decreased pup body weights at 50 mg/kg/day). There were two oral prenatal 

developmental toxicity studies, one with rats and one with rabbits, using the supporting chemical 

CASRN 112-90-3. In the rat study, maternal toxicity was observed at 40 mg/kg/day (clinical 

signs and a decrease in body weight); the NOAEL for maternal toxicity was 10 mg/kg/day. 

There was no developmental toxicity; the NOAEL for developmental toxicity was 80 mg/kg/day 

(highest dose tested). In the rabbit study, dams exhibited clinical signs and decreased body 

weight at 10 mg/kg/day; the NOAEL for maternal toxicity was 3 mg/kg/day. There was no 

developmental toxicity; the NOAEL for developmental toxicity was 30 mg/kg/day (highest dose 

tested). In two prenatal oral developmental toxicity studies in rats with the supporting chemical 

mixture (CASRN 3159-59-5/36505-83-6), different results were obtained. Taking the two 

studies together, maternal toxicity was observed at 30 mg/kg/day (decreased body weight); the 
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NOAEL for maternal toxicity was of 6 mg/kg/day. Unspecified malformations were seen in rat 

fetuses at 30 mg/kg/day; the NOAEL for developmental toxicity was of 6 mg/kg/day. 

In vitro (using both bacteria and mammalian cells) evaluations of genetic toxicity (gene 

mutations and chromosomal aberrations) were conducted with three sponsored chemicals. In 

vitro data with the supporting chemicals were also for gene mutations (four chemicals) and 

chromosomal aberrations (one chemical); all results were negative. In vivo evaluations of 

chromosomal effects in one sponsored and three supporting chemicals also showed negative 

results. Unscheduled DNA synthesis was not induced in a study of one sponsored chemical. 

The available data in three sponsored chemicals suggest that non-hydroxylated FND amines are 

irritating to both skin and eyes. 

No data gaps were identified under the HPV Challenge Program. 

Subcategory II: Hydroxylated FND Amines 

There are two chemicals (CASRNs 61791-31-9 and 61791-44-4) in this subcategory for human 

health endpoints. With the exception of acute oral toxicity data, data were available for 

CASRN 61791-44-4. Acute oral toxicity of CASRNs 61791-31-9 and 61791-44-4 in rats is low. 

Acute dermal toxicity of CASRN 61791-44-4 in rabbits is moderate. There were both oral and 

dermal repeated dose studies with CASRN 61791-44-4. Different results were obtained 

depending on the formulation tested (see text for details). Oral dietary studies were performed 

with rats (two) and dogs (one). In one 90-day rat study, there were gross and microscopic effects 

in the intestine and lymph nodes at 150 mg/kg/day; the NOAEL for systemic toxicity was 

50 mg/kg/day. In the other 90-day rat study, the NOAEL was 12 mg/kg/day based on decreases 

in body weight gain and histopathological effects on the intestine and lymph nodes at 

400 mg/kg/day. The dog 90-day study resulted in a NOAEL of 13 mg/kg/day based on clinical 

signs, decreased body weight and pathological changes in the intestine and lymph nodes at 

40 mg/kg/day. There were three 28-day dermal toxicity studies in rabbits. Local effects 

(irritation) were observed at all doses tested, with no NOAEL for this effect (lowest dose tested 

was 40 mg/kg/day). There were no systemic effects observed up to the highest dose tested of 

40 mg/kg/day, which is the NOAEL for systemic toxicity for the dermal studies in rabbits. 

There were no reproductive/developmental toxicity data for either subcategory member. Gene 

mutations were not induced in two studies (bacterial and mammalian cells) with 

CASRN 61791-44-4 in vitro. CASRN 61791-44-4 induced chromosomal aberrations in vitro

(with metabolic activation only), and results for chromosomal effects in an in vivo test were 

inconclusive. CASRN 61791-44-4 did not induce unscheduled DNA synthesis. 

The reproductive and developmental toxicity endpoints were identified as data gaps under the 

HPV Challenge Program. 

Hazard to the Environment

The typical 96-h LC50 for fish with the supporting chemical, CASRN 112-90-3, is 0.11 mg/L and 

the typical 48-h EC50 for aquatic invertebrates is 0.011 mg/L. The 96/72-h EC50 values for 

aquatic plants are 0.03 mg/L and 0.04 mg/L for biomass and growth rate, respectively. For 

CASRN 61791-31-9, the 30-d fish chronic value is 0.0179 mg/L and the 21-d aquatic 
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invertebrates value is 0.14 mg/L. 

No data gaps were identified under the HPV Challenge Program. 
U.S. Environmental Protection Agency September, 2010 

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The sponsor, The Nitrogen Derivatives Panel Amines Task Group of the American Chemistry 

Council, submitted a Test Plan and Robust Summaries to EPA for the fatty nitrogen derived 

(FND) amines category on December 23, 2002. EPA posted the submission on the ChemRTK 

HPV Challenge website on January 23, 2003 

(http://www.epa.gov/oppt/chemrtk/pubs/summaries/amines/c14171tc.htm). In the transmittal 

letter associated with the original submission, the sponsor indicated to EPA that a revision of the 

FND amines category would be submitted by December 31, 2003. In letters dated April 29 and 

July 10, 2003, the sponsor informed EPA of their plans to split the original submission into two 

separate submissions, an FND amines category and an FND ether amines category. Revised 

submissions were submitted to EPA on December 29, 2003. EPA posted the FND ether amines 

and FND amines submissions on the ChemRTK HPV Challenge website on March 25, 2004 and 

March 26, 2004, respectively. EPA posted comments on the revised FND ether amines category 

submission to the website on October 26, 2007. EPA did not comment on the revised FND 

amines category. 

The Hazard Characterization for the FND ether amine category is being posted on the EPA 

website at the same time as this one because there is substantial overlap in the chemicals used in 

both categories. The original 2002 submission had 29 sponsored chemicals – the 23 in this 

submission plus six that were split off to form the FND ether amines category (all supporting 

information is available at the same URL used for this submission). Five of the seven supporting 

chemicals identified in the FND ether amines submission are either sponsored (three) or 

supporting (two) chemicals in this submission (identified with an asterisk in the list below). 

The FND amines category consists of 23 sponsored substances and 12 supporting chemicals (see 

Appendix). 

Category Justification

The members of the FND amines category are all aliphatic amines containing one or more longchain alkyl groups. The sponsor’s rationale for grouping these FND amines into a single 

category is based on the surfactant properties of the substances. These properties are expected to 

result in similar environmental fate and toxicological properties of the category members. The 

category members are nonetheless diverse in that they have primary, secondary and tertiary 

amines structures and span a broad range of molecular weights (185 – 752). While 

acknowledging the structural diversity in the FND amines category, the sponsor concludes that 

“there is no pattern of increasing or decreasing environmental fate or toxicity among these 

chemicals” but rather that “there is a consistency of response across the entire Category.” 

EPA agrees that available measured data and estimated values for the melting and boiling points, 

vapor pressure, partition coefficient and water solubility appear to be consistent with molecular 

size within and across structural types and hence support the grouping of the FND amines as a 

category. Data supplied for environmental fate endpoints for sponsored chemicals generally 

support the category, indicating similar susceptibility to and rates of degradation. Thus, for both 

physical-chemical and environmental fate properties, EPA does not believe it is necessary to 

divide the 23 sponsored chemicals into subcategories. The same is also true for environmental 

effect endpoints. 
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For assessment of human health hazards, however, the toxicological properties of the two 

dihydroxy derivatives (CASRNs 61791-31-9 and 61791-44-4) may differ from the other 

category members, at least in longer-term studies, because these two substances are expected to 

be metabolized and excreted differently. In addition, they are expected to be more hydrophilic 

than the other category members. Therefore, EPA has indicated that, for human health effects, 

two subcategories be identified: Subcategory 1, Non-Hydroxylated FND Amines and 

Subcategory 2, Hydroxylated FND Amines. For the purposes of this hazard characterization, 

data may be read-across between only those members of a subcategory and not between 

subcategories. The distribution of subcategories is outlined in Table 1. 

 

Table 1. Subcategories in the FND Amines Category 

HUMAN HEALTH HAZARD ECOTOXICITY 

SPONSORED CHEMICALS 

Subcategory I: Non-Hydroxylated Fatty 

Nitrogen Derived Amines

• CASRN 124-22-1 

• CASRN 143-27-1 

• CASRN 68037-91-2 

• CASRN 68155-38-4 

• CASRN 61790-18-9 

• CASRN 68037-95-6 

• CASRN 61791-55-7 

• CASRN 7173-62-8 

• CASRN 112-75-4 

• CASRN 112-69-6* 

• CASRN 124-28-7* 

• CASRN 61788-95-2 

• CASRN 61788-91-8 

• CASRN 7396-58-9 

• CASRN 67700-99-6 

• CASRN 68153-95-7 

• CASRN 4088-22-6 

• CASRN 61788-63-4 

• CASRN 68783-24-4 

• CASRN 68814-95-9 

• CASRN 61790-42-9 

• CASRN 124-22-1 

• CASRN 143-27-1 

• CASRN 68037-91-2 

• CASRN 68155-38-4 

• CASRN 61790-18-9 

• CASRN 68037-95-6 

• CASRN 61791-55-7 

• CASRN 7173-62-8 

• CASRN 112-75-4 

• CASRN 112-69-6* 

• CASRN 124-28-7* 

• CASRN 61788-95-2 

• CASRN 61788-91-8 

• CASRN 7396-58-9 

• CASRN 67700-99-6 

• CASRN 68153-95-7 

• CASRN 4088-22-6 

• CASRN 61788-63-4 

• CASRN 68783-24-4 

• CASRN 68814-95-9 

• CASRN 61790-42-9 

• CASRN 61791-31-9* 

• CASRN 61791-44-4 

SUPPORTING CHEMICALS

• CASRN 61788-45-2 

• CASRN 124-30-1 

• CASRN 61788-46-3 

• CASRN 61790-33-8 

• CASRN 112-90-3 
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Table 1. Subcategories in the FND Amines Category 

HUMAN HEALTH HAZARD ECOTOXICITY 

• CASRN 112-90-3* 

• CASRN 3151-59-5** 

• CASRN 112-18-5* 

• CASRN 61788-93-0 

• CASRN 28061-69-0 

• CASRN 61788-62-3 

• CASRN 61789-79-5 

• CASRN 61789-76-2 

Subcategory II: Hydroxylated Fatty Nitrogen 

Derived Amines

• CASRN 61791-31-9* 

• CASRN 61791-44-4 

*Supporting chemicals submitted by the industry sponsors of the FND ether amine category that were used in the final FND ether amines hazard 

characterization. 

** Also reported as a 1:1 mixture of 1-hexadecanamine, hydrofluoride and 9-octadecen-1-amine hydrofluoride (CASRN 36505-83-6). 

Justification for Supporting Chemicals 

Twelve non-sponsored chemicals were proposed by the submitter to provide support for this 

category.4 These supporting chemicals are structurally closely related to the FND amines 

sponsored chemicals. None of the supporting chemicals were used in evaluating the physicalchemical properties of the 23 sponsored chemicals because they did not provide data necessary 

to estimate or read-across to the sponsored chemicals. Eleven of the 12 supporting chemicals 

were used for the environmental fate endpoint (specifically biodegradation) – the one not used 

was CASRN 3151-59-5/36505-83-6 because there were no biodegradation data provided for this 

substance. For human health effect endpoints, only those supporting chemicals that provided 

more that just acute toxicity data were used (CASRNs 112-90-3, 124-30-1, 3151-59-5/36505-83-

6 mixture, 61788-46-3, 61790-33-8, and 112-18-5). EPA believes that the acute toxicity data 

available for the other four supporting chemicals (CASRNs 61788-62-3, 61789-79-5, 61788-93-

0 and 61788-45-2) - while useful – were not necessary for characterizing that endpoint for 

human health effects because there are ample data from sponsored chemicals for this endpoint. 

For environmental effects, only one of the 12 supporting chemicals was used (CASRN 112-90-3) 

to fill the acute aquatic toxicity endpoints. The use of this chemical was based on its structure 

being sufficiently representative of the spectrum of structures among the 23 sponsored 

chemicals. In addition, the quality of the acute toxicity studies was high (i.e, use of measured 

concentrations). 

CASRN 112-18-5 was assessed in the OECD HPV program at SIAM 11 (2001). The data are 

available for viewing at: http://www.chem.unep.ch/irptc/sids/OECDSIDS/112185.pdf

 

4

 These chemicals were removed from the original FND amines category because they are sponsored by the 

European Oleochemicals and Allied Products Group (APAG) under the International Council of Chemical 

Associations (ICCA) program 
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1. Chemical Identity

1.1 Identification and Purity

Appendix 1 provides the names and structures for all the sponsored (23) and supporting (12) 

chemicals in the category. Most (15/23 sponsored chemicals; 8/12 supporting chemicals) are 

mixtures for which a representative structure is presented in the Appendix. The following Table 

(“Text Table C”) is taken from p. 5 of the revised Test Plan submitted by the sponsor for the 

FND Amine category. This provides data on the composition of category members in terms of 

chain length and degree of unsaturation. 
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In addition, there are many different formulations that exist for the different 

sponsored/supporting chemical CASRNs. Table 2 provides a list (according to the information 

presented in the robust summaries and only for those substances used in this Hazard 

Characterization) of the formulations. 

Table 2. Formulations of the FND Amines Category 

CASRN FORMULATION 

SPONSORED CHEMICALS 

112-75-4 Farmin DM40, Genamin 14R 302D, ADMA 4 

112-69-6 Armeen DM16D, Farmin DM60, ADMA 6 

124-28-7 Armeed DM18D, Farmin DM80, ADMA 8 

61788-91-8 Armeen DMSD 

4088-22-6 Genamin SH 301, E8220 

61788-63-4 Armeen M2HT, B0390Adogen 243, Adogen 

343 

61791-44-4 Ethomeen T/12, 2EO, Varonic T-220, (POE)20

Tallowamine T-220D, Ethomeen 18/60, 

E1095.01, Varonic T-220D, Genamin S080, 

TAMET Benzoate 

SUPPORTING CHEMICALS 

124-30-1 Genamin 18R 100D 

61788-46-3 Armeen C, Armeen CD, Amine KK, Genamin 

C 100 D 

61790-33-8 Genamin TA 100D, Armeen T, Genamin TA 

100 

112-18-5 Armeen DM12D, ADMA 2, Genamin LA 

302D 

3151-59-5 and 36505-83-6 Hetaflur 

112-90-3 Oleylamine 

1.2 Physical-Chemical Properties

The physical-chemical properties of the FND amines are summarized in Tables 3 through 5. 

Table 6 provides physical-chemical property data for the six supporting chemicals that are used 

in the human health and environmental effects sections of this hazard assessment. The structures 

are provided in the Appendix. 
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Conclusion: The members of the FND amines category are long-chain alkyl substituted amines 

found in commercial product mixtures. The category consists of primary alkylamines and 

alkyldiamines; dimethylalkylamines; dialkylmethylamines and dialkylamines; and trialkylamines 

(see the Appendix for attribution of chemicals to these groups). The primary alkylamines and 

alkyldiamines are solids at room temperature (except for CASRN 7173-62-8, which is a liquid), 

possessing low to moderate vapor pressure and low to moderate water solubility. The 

dialkylmethylamines are all liquids with low to moderate vapor pressure and low to moderate 

water solubility. The dialkylmethylamines and dialkylamines are solids (except for CASRN 

7396-58-9, which is a liquid) with negligible to low vapor pressure and negligible to low water 

solubility. Finally, the trialkylamines are liquids with negligible to low vapor pressure; two 

(CASRN 68814-95-9 and 61790-42-9) have negligible water solubility while the others (CASRN 

61791-31-9 and 61791-44-4) are expected to be dispersible in water.
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Table 3. Physical-Chemical Properties of Fatty Nitrogen-Derived Amines: Sponsored Chemica

1-Dodecanamine 1-Hexadecan- amine Amines, C14- 18-alkyl2 Amines, C14-18 and C16-18-

unsatd. alkyl2

Amines, soya 

alkyl2

Amines, C16-18 

and C18-unsatd. 

alkyl2

Amines, 

alky

methyl

Property 

Value Value Value Value Value Value Val

CASRN 124-22-1 143-27-1 68037-91-2 68155-38-4 61790-18-9 68037-95-6 61791Molecular Weight 

185 241 213 (typical)2 239 (typical)2 265 (typical)2 241 (typical)2 325 (ty

Physical State 

Solid/liquid3 Solid3 No data No data Solid, paste3 Solid3 Sol

Melting Point 

28.3°C 

(measured) 

46.8°C (measured) No data No data 29.0°C 

(measured)3

No data No d

Boiling Point 

259°C 

(measured) 

322.5°C 

(measured)5

;

330°C 

(measured)6

291.2°C 

(measured, 

typical)5

>300°C 

(estimated)7

>300°C 

(estimated)7

322.5°C 

(measured, 

typical)5

;

330°C 

(measured, 

typical)6

>30

(estimated

Vapor Pressure 

8.05×10-3 mm Hg 

(measured)5

1.33×10-4 mm Hg 

(measured)5

9.74×10-4 mm 

Hg (measured, 

typical)5

2.2×10-4 mm Hg 

(estimated)7

1.3×10-4 mm Hg 

(estimated)7

1.33×10-4 mm Hg 

(measured, 

typical)5

4.9×10-7 

(estimated

Dissociation Constant (pKa) 

10.63 

(measured)5

10.61 (measured)5 10.62 

(measured, 

typical)5

10 (estimated)8 10 (estimated)8 10.6 (measured, 

typical)5

8.7–11 (es

Henry’s Law Constant 

2.5×10-5 atmm3/mol 

(estimated)7

5.3×10-4 atmm3/mol 

(estimated)7

3.0×10-4 atmm3/mol 

(estimated)7 

4.7×10-4 atmm3/mol 

(estimated)7

7.2×10-4 atmm3/mol 

(estimated)7

5.3×10-3 atmm3/mol 

(estimated)7

7.8×10

m3/mol (es
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Table 3. Physical-Chemical Properties of Fatty Nitrogen-Derived Amines: Sponsored Chemica

1-Dodecanamine 1-Hexadecan- amine Amines, C14- 18-alkyl2 Amines, C14-18 and C16-18-

unsatd. alkyl2

Amines, soya 

alkyl2

Amines, C16-18 

and C18-unsatd. 

alkyl2

Amines, 

alky

methyl

Property 

Value Value Value Value Value Value Val

Water Solubility 

78 mg/L 

(measured)5,9

0.31 mg/L 

(estimated)7

1.4 mg/L 

(estimated)7

0.76 mg/L 

(estimated)7

0.13 mg/L 

(estimated)7

0.31 mg/L 

(estimated)7

0.037 

(estimated

Log Kow 4.8 (estimated)7 6.7 (estimated)7 5.8 (estimated)7 6.5 (estimated)7 7.3 (estimated)7 6.7 (estimated)7 7.5 (esti1American Chemistry Council. 2003. Revised Robust Summary and Test Plan for Fatty Nitrogen-derived Amines Category. Available onl

http://www.epa.gov/chemrtk/pubs/summaries/amines/c14171tc.htm as of July 15, 2010. 2 Estimated data provided are based on the typical representative structure; see Appendix for detailed information on the structures. 3 Visek, K. 2003. Amines, Fatty. Kirk-Othmer Encyclopedia of Chemical Technology. John Wiley & Sons, Inc. Article online posting da

4 Estimated based on melting point data. 5 SRC. 2010. The Physical Properties Database (PHYSPROP). SRC: Syracuse, NY. Available online at http://www.srcinc.com/what-we-

16, 2010. 

6 Beilstein search. 2010. 7 U.S. EPA. 2010. Estimation Programs Interface SuiteTM for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Wash

online at http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of July 12, 2010. 8 SPARC Online Calculator. 2008. Version 4.2. Available online at http://ibmlc2.chem.uga.edu/sparc as of July 21, 2010. 9 A measured water solubility value of 2 g/L provided by the sponsor was determined to be semi-quantitative and is not in good agreement w
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

15 

Table 4. Physical-Chemical Properties of Fatty Nitrogen-Derived Amines: Sponsored Chemica

1-Tetradecanamine, N,Ndimethyl- 1-Hexadecan- amine, N,N- dimethyl- 1-Octadecanamine, N,N-dimethyl- Amines, (hydrogenated tallow alkyl) 

dimethyl2

Amines, 

dimethylsoya 

alkyl2

Amines, tri-C8-

10-alkyl2

tris(h

tal

Property 

Value Value Value Value Value Value 

CASRN 112-75-4 112-69-6 124-28-7 61788-95-2 61788-91-8 68814-95-9 6Molecular Weight 

241 270 298 298 (typical)2 294 (typical)2 382 (typical)2 77

Physical State 

Liquid3 Liquid3 Liquid3 Liquid3 Liquid3 Liquid3 

Melting Point 

-6°C 

(measured)3

8°C (measured)3

;

12°C (measured)5

22.9°C (measured) 22.9°C (measured) <25°C (liquid)6 <25°C (liquid) 

Boiling Point 

159–161°C at 

11 mm Hg 

(measured)5

;

289–291°C 

(extrapolated)7

147°C at 2 mm Hg 

(measured)5; 

319°C 

(extrapolated)7

205–208°C at 

16 mm Hg 

(measured)5; 

332–335°C 

(extrapolated)7

205–208°C at 

16 mm Hg 

(measured, 

typical)5; 

332–335°C 

(extrapolated, 

typical)7

>300°C 

(estimated)8

>300°C 

(estimated)8

(e

Vapor Pressure 

2.2×10-3 mm Hg 

(estimated)7

3.3×10-4 mm Hg 

(estimated)7

1.4×10-4 mm Hg 

(estimated)7

1.4×10-4 mm Hg 

(estimated typical)7

3.5×10-5 mm Hg 

(estimated)8

2.7×10-7 mm Hg 

(estimated)8

<1×

(e

Dissociation Constant (pKa) 

7.1 (estimated)10 7.1 (estimated)10 7.5 (estimated)10 7.5 (estimated)10 9.5 (estimated)10 9.2 (estimated)10 7.2 (

Henry’s Law Constant 

1.5×10-3 atmm3/mol 

(estimated)8

2.6×10-3 atmm3/mol 

(estimated)8

4.5×10-3 atmm3/mol 

(estimated)8

4.5×10-3 atmm3/mol 

(estimated)8

3.5×10-3 atmm3/mol 

(estimated)8

3.3×10-2 atmm3/mol 

(estimated)8

69 

(e
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

16 

Table 4. Physical-Chemical Properties of Fatty Nitrogen-Derived Amines: Sponsored Chemica

1-Tetradecanamine, N,Ndimethyl- 1-Hexadecan- amine, N,N- dimethyl- 1-Octadecanamine, N,N-dimethyl- Amines, (hydrogenated tallow alkyl) 

dimethyl2

Amines, 

dimethylsoya 

alkyl2

Amines, tri-C8-

10-alkyl2

tris(h

tal

Property 

Value Value Value Value Value Value 

Water Solubility 

0.98 mg/L 

(estimated)8

0.10 mg/L 

(estimated)8

0.44 mg/L 

(measured)9

0.44 mg/L 

(measured, typical)9

0.02 mg/L 

(estimated)8

8.5×10-6 mg/L 

(estimated)8

<1

(e

Log Kow 6.4 (estimated)8 7.4 (estimated)8 8.4 (estimated)8 8.4 (estimated)8 8.0 (estimated)8 11 (estimated)8 25 1American Chemistry Council. 2003. Revised Robust Summary and Test Plan for Fatty Nitrogen-derived Amines Category. Available on

http://www.epa.gov/chemrtk/pubs/summaries/amines/c14171tc.htm as of July 15, 2010. 2 Estimated data provided are based on the typical representative structure; see Appendix for detailed information on the structures. 3 Visek, K. 2003. Amines, Fatty. Kirk-Othmer Encyclopedia of Chemical Technology. John Wiley & Sons, Inc. Article online posting d

4 Ash, M; Ash, I. 2000. Industrial Sufactants, Electronic Handbook 2000. Synapse Information Resources: Endicott, NY. 5 Beilstein search. 2010. 6 Estimated based on physical state at room temperature. 7 NOMO5. 1987. Programs to Enhance PC-Gems Estimates of Physical Properties for Organic Compounds. The Mitre Corp. 8 U.S. EPA. 2010. Estimation Programs Interface SuiteTM for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Wash

online at http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of July 12, 2010. 

9 Chemicals Inspection and Testing Institute. 1996. Biodegradation and Bioaccumulation Data of Existing Chemicals Based on the CSCL 

Industry Ecology - Toxicology and Information Center. ISBN 4-89074-101-1, pg. 2–36.

10 SPARC Online Calculator. 2008. Version 4.2. Available online at http://ibmlc2.chem.uga.edu/sparc/ as of July 19, 2010. 

11 Due to dispersibility, log Kow cannot be reliably measured or estimated. Source: Toll, J; Sijm, D. 2000. Estimating properties of surfa

Handbook of Property Estimation for Chemicals. Boethling, RS; Mackay, D; eds. Chapter 17. Lewis Publishers: Boca Raton, FL pp. 41
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

17 

Table 5. Physical-Chemical Properties of Fatty Nitrogen-Derived Amines: Sponsored Chemica

1-Decanamine, 

N-decyl-NmethylAmines, di-C14- 18-alkylmethyl2 Amines, di- C12-18-alkyl2 1-Octadecanamine, N-methyl-N- octadecyl- Amines, bis(hydrogenated tallow alkyl)methyl2 Amines, ditallo

alkyl2 

Property 

Value Value Value Value Value Value 

CASRN 7396-58-9 67700-99-6 68153-95-7 4088-22-6 61788-63-4 68783-24-4 Molecular Weight 

312 480 (typical)2 438 (typical)2 536 (typical)2 536 (typical)2 518 (typical)

Physical State 

Liquid3 No data No data Solid3 Solid3 Solid3 

Melting Point 

-6.3°C 

(measured)3

No data No data 48–49°C (measured)4 38°C (measured)3 55.0°C (measure

Boiling Point 

140–145°C at 

1–2 mm Hg 

(measured)5; 

326°C 

(extrapolated)6

>300°C 

(estimated)7

>300°C 

(estimated)7

252–259°C at 0.05 

mm Hg (measured)5

;

541–550°C 

(extrapolated)6

252–259°C at 0.05 mm 

Hg (measured, typical)5

;

541–550°C 

(extrapolated, typical)6

>300°C 

(estimated)7

Vapor Pressure 

1.9×10-4 mm Hg 

(estimated)6

1.9×10-8 mm Hg 

(estimated)7

3.63×10-9 mm 

Hg (estimated)7

1.3×10-9 mm Hg 

(estimated)7

1.3×10-9 mm Hg 

(estimated)7

8.2×10-10 mm H

(estimated)7

Dissociation Constant (pKa) 

8.6 (estimated)8 7.1 (estimated)8 11 (estimated)8 7.1 (estimated)8 7.1 (estimated)8 11 (estimated)

Henry’s Law Constant 

6.0×10-3 atmm3/mol 

(estimated)7

5.8×10-2 atmm3/mol 

(estimated)7

4.6×10-2 atmm3/mol 

(estimated)7

0.56 atm-m3/mol 

(estimated)7

0.56 atm-m3/mol 

(estimated)7

0.20 atm-m3/m

(estimated)7
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

18 

Table 5. Physical-Chemical Properties of Fatty Nitrogen-Derived Amines: Sponsored Chemica

1-Decanamine, 

N-decyl-NmethylAmines, di-C14- 18-alkylmethyl2 Amines, di- C12-18-alkyl2 1-Octadecanamine, N-methyl-N- octadecyl- Amines, bis(hydrogenated tallow alkyl)methyl2 Amines, ditallo

alkyl2 

Property 

Value Value Value Value Value Value 

Water Solubility 

3.3×10-3 mg/L 

(estimated)7

2.6×10-7 mg/L 

(estimated)7

4.6×10-8 mg/L 

(estimated)7

<1×10-10 mg/L 

(estimated)7

0.29 mg/L (measured)9; 

<1×10-10 mg/L 

(estimated)7

<1×10-10 mg/L 

(estimated)7

Log Kow 8.9 (estimated)7 13 (estimated)7 14 (estimated)7 17 (estimated)7 3.15 (measured)9; 

17 (estimated)7

16 (estimated)

1American Chemistry Council. 2003. Revised Robust Summary and Test Plan for Fatty Nitrogen-Derived Amines Category. Availab

http://www.epa.gov/chemrtk/pubs/summaries/amines/c14171tc.htm as of July 15, 2010. 2 Estimated data provided are based on the typical representative structure; see Appendix for detailed information on the structures. 

3 Visek, K. 2003. Amines, Fatty. Kirk-Othmer Encyclopedia of Chemical Technology. John Wiley & Sons, Inc. Article online postin4 Aldrich Chemical Company. 2010. Handbook of Fine Chemicals and Laboratory Equipment, Catalog, p. 1539. 5 Beilstein search. 2010. 6 NOMO5. 1987. Programs to Enhance PC-Gems Estimates of Physical Properties for Organic Compounds. The Mitre Corp. 7 U.S. EPA. 2010. Estimation Programs Interface SuiteTM for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, W

Available online at http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of July 12, 2010. 8 SPARC Online Calculator. 2008. Version 4.2. Available online at http://ibmlc2.chem.uga.edu/sparc/ as of July 19, 2010. 9 The sponsor indicated that there was an apparent concentration-dependent partitioning of the test substance; the reported log 

Kow was 

concentration tested. 

10 Ash, M; Ash, I. 2000. Industrial Sufactants, Electronic Handbook 2000. Synapse Information Resources: Endicott, NY. 11 Due to dispersibility, log Kow cannot be reliably measured or estimated. Source: Toll, J; Sijm, D. 2000. Estimating properties of su

Handbook of Property Estimation for Chemicals. Boethling, RS; Mackay, D; eds. Chapter 17. Lewis Publishers: Boca Raton, FL pp. 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

19 

Table 6. Physical-Chemical Properties of Fatty Nitrogen-Derived Amines: Supporting Chem

9-Octadecen-1-

amine, (9Z)- 

1-Octadecanamine 1-Hexadecanamine, 

hydrofluoride 

Amines, coco alkyl2 Amines, tallow alkyl2 

Property 

Value Value Value Value Value 

CASRN 112-90-3 124-30-1 3151-59-5 61788-46-3 61790-33-8 Molecular Weight 

267 270 262 185 (typical)2 268 (typical)2 

Physical State 

Liquid3 Solid3 No data Liquid3 Solid3 

Melting Point 

21°C (measured) 52.9°C (measured) No data 16.0°C (measured)3 34–40°C (measured); 

25–30°C (measured) 

Boiling Point 

335°C (measured) 346.8°C (measured) >300°C (estimated)4 259°C (measured, 

typical)5

200–230°C (measured – 

too low, may be at reduced 

pressure) 

>300 (estimated)5

Vapor Pressure 

3.0×10-4 mm Hg 

(estimated)6

9.0×10-6 mm Hg 

(measured) 

6.7×10-4 mm Hg 

(estimated)4

8.05×10-3 mm Hg 

(measured, typical)5

<1 mm Hg (measured) 

3×10-4 mm Hg (estimated)5

Dissociation Constant (pKa) 

10.4 (estimated)7 10.6 (measured) No data 10.6 (measured, typical)5 10.4 (estimated)7 

Henry’s Law Constant 

8.2×10-4 atmm3/mol 

(estimated)4

9.4×10-4 atm-m3/mol 

(estimated)4

1.8×10-2 atm-m3/mol 

(estimated)4

2.5×10-5 atm-m3/mol 

(estimated)4

8.2×10-4 atm-m3/mol 

(estimated)4
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

20 

Table 6. Physical-Chemical Properties of Fatty Nitrogen-Derived Amines: Supporting Chem

9-Octadecen-1-

amine, (9Z)- 

1-Octadecanamine 1-Hexadecanamine, 

hydrofluoride 

Amines, coco alkyl2 Amines, tallow alkyl2 

Property 

Value Value Value Value Value 

Water Solubility 

0.08 mg/L 

(estimated)4

2.9×10-2 mg/L 

(estimated)4

Dispersible8 78 mg/L (measured, 

typical)5

0.08 mg/L (estimated)4 

Log Kow 7.5 (estimated)4 7.7 (estimated)4 Not applicable8 4.8 (estimated)4 7.5 (estimated)4 1American Chemistry Council. 2003. Revised Robust Summary and Test Plan for Fatty Nitrogen-derived Amines Category. Availabl

http://www.epa.gov/chemrtk/pubs/summaries/amines/c14171tc.htm as of July 15, 2010. 2 Estimated data provided are based on the typical representative structure; see Appendix for detailed information on the structures. 3 Visek, K. 2003. Amines, Fatty. Kirk-Othmer Encyclopedia of Chemical Technology. John Wiley & Sons, Inc. Article online posti

4 U.S. EPA. 2010. Estimation Programs Interface SuiteTM for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, W

Available online at http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of July 12, 2010. 

5 SRC. 2010. The Physical Properties Database (PHYSPROP). SRC: Syracuse, NY. Available online at http://www.srcinc.com/what

as of July 16, 2010. 

6 NOMO5. 1987. Programs to Enhance PC-Gems Estimates of Physical Properties for Organic Compounds. The Mitre Corp. 7 SPARC Online Calculator. 2008. Version 4.2. Available online at http://ibmlc2.chem.uga.edu/sparc as of July 21, 2010. 8 This chemical may be dispersible as a worst case scenario. Therefore, log Kow cannot be reliably measured or estimated. Source: To

Estimating properties of surface active chemicals. In: Handbook of Property Estimation for Chemicals. Boethling, RS; Mackay, D; edPublishers: Boca Raton, FL. pp. 419–446. 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

21 

2. General Information on Exposure

2.1 Production Volume and Use Pattern

The FND amines category chemicals had an aggregated production and/or import volume in the 

United States between 129.5 million pounds and 534 million pounds in calendar year 2005. 

• CASRN 112-69-6: 10 to <50 million pounds;

• CASRN 112-75-4: 10 to <50 million pounds;

• CASRN 124-22-1: 1 to <10 million pounds;

• CASRN 124-28-7: 10 to <50 million pounds;

• CASRN 143-27-1: 500,000 pounds to <1 million pounds;

• CASRN 4088-22-6: 1 to <10 million pounds;

• CASRN 7173-62-8: 1 to <10 million pounds;

• CASRN 7396-58-9: 10 to <50 million pounds;

• CASRN 61788-63-4: 50 to <100 million pounds;

• CASRN 61788-91-8: 500,000 pounds to <1 million pounds; 

• CASRN 61788-95-2; 1 to <10 million pounds;

• CASRN 61790-18-9: 1 to <10 million pounds;

• CASRN 61790-42-9: < 500,000 pounds;

• CASRN 61791-31-9: 10 to <50 million pounds;

• CASRN 61791-44-4: 1 to <10 million pounds;

• CASRN 61791-55-7: 1 to <10 million pounds;

• CASRN 67700-99-6: 10 to <50 million pounds;

• CASRN 68153-95-7: 500,000 pounds to <1 million pounds;

• CASRN 68155-38-4: 10 to <50 million pounds;

• CASRN 68783-24-4: < 500,000 pounds;

• CASRN 68814-95-9: 1 to <10 million pounds;

CASRN 68037-91-2 and 68037-95-6 were not reported under the 2006 Inventory Update Rule 

(IUR). 

CASRN 112-69-6: 

Non-confidential information in the IUR indicated that the industrial processing and uses of the 

chemical include all other chemical product and preparation manufacturing as intermediates and 

surface active agents; other basic organic chemical manufacturing, pesticide and other 

agricultural chemical manufacturing, soap and cleaning compound manufacturing, general 

warehousing and storage and other chemical and allied products merchant wholesalers as 

intermediates; all other chemical product and preparation manufacturing as process regulators, 

other than polymerization or vulcanization processes. Non-confidential commercial and 

consumer uses of this chemical include “other.” 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

22 

CASRN 112-75-4: 

Non-confidential information in the IUR indicated that the industrial processing and uses of the 

chemical include all other chemical product and preparation manufacturing as intermediates and 

surface active agents; other basic organic chemical manufacturing, pesticide and other 

agricultural chemical manufacturing, and soap and cleaning compound manufacturing as 

intermediates; petroleum refineries as corrosion inhibitors and anti-scaling agents; general 

warehousing and storage as intermediates and not readily obtainable (NRO). Non-confidential 

commercial and consumer uses of this chemical include “other.” 

CASRN 124-22-1 and 61788-63-4: 

Non-confidential information in the IUR indicated that the industrial processing and uses of the 

chemicals include other basic organic chemical manufacturing as surface active agents and 

intermediates; other nonmetallic mineral mining and quarrying and synthetic dye and pigment 

manufacturing as surface active agents. No commercial and consumer uses were reported for 

these chemicals. 

CASRN 124-28-7: 

Non-confidential information in the IUR indicated that the industrial processing and uses of the 

chemical include all other chemical product and preparation manufacturing as surface active 

agents; other basic organic chemical manufacturing and other chemical and allied products 

merchant wholesalers as intermediates. Non-confidential commercial and consumer uses of this 

chemical include “other.” 

CASRN 143-27-1: 

Non-confidential information in the IUR indicated that the industrial processing and uses of the 

chemical include other basic organic chemical manufacturing as intermediates. Commercial and 

consumer uses are claimed confidential. 

CASRN 4088-22-6 and 68814-95-9: 

Industrial processing and uses of these chemicals are claimed confidential. No commercial and 

consumer users were reported. 

CASRN 7173-62-8: 

Non-confidential information in the IUR indicated that the industrial processing and uses of the 

chemical include other basic organic chemical manufacturing as surface active agents, 

intermediates and “other”; other petroleum and coal products manufacturing, plate work and 

fabricated structural product manufacturing, soap and cleaning compound manufacturing, and 

support activities for mining as surface active agents. Non-confidential commercial and 

consumer uses of this chemical include “other.” 

CASRN 7396-58-9: 

Non-confidential information in the IUR indicated that the industrial processing and uses of the 

chemical include all other chemical product and preparation manufacturing as surface active 

agents and process regulators, other than polymerization or vulcanization processes; pesticide 

and other agricultural chemical manufacturing as intermediates. Non-confidential commercial 

and consumer uses of this chemical include wood and wood furniture. 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

23 

CASRN 61788-91-8 and 61788-95-2: 

Non-confidential information in the IUR indicated that the industrial processing and uses of the 

chemicals include other basic organic chemical manufacturing as surface active agents and 

intermediates. No commercial and consumer uses were reported for these chemicals. 

CASRN 61790-18-9: 

Non-confidential information in the IUR indicated that the industrial processing and uses of the 

chemical include other basic organic chemical manufacturing as surface active agents and 

intermediates; other petroleum and coal products manufacturing, support activities for mining 

and synthetic dyes and pigment manufacturing as surface active agents. No commercial and 

consumer uses were reported. 

CASRN 61790-42-9 and 68783-24-4: 

No industrial processing and uses and commercial and consumer uses were reported for these 

chemicals. 

CASRN 61791-31-9: 

Non-confidential information in the IUR indicated that the industrial processing and uses of the 

chemical include other basic organic chemical manufacturing as surface active agents and 

intermediates; asphalt paving, roofing and saturated materials manufacturing, paper mills, 

pesticide and other agricultural chemical manufacturing, support activities for mining, synthetic 

dye and pigment manufacturing, and soap and cleaning compound manufacturing as surface 

active agents. Non-confidential commercial and consumer uses of the chemical include soaps 

and detergents. 

CASRN 61791-44-4: 

Non-confidential information in the IUR indicated that the industrial processing and uses of the 

chemical include other basic organic chemical manufacturing as surface active agents and 

intermediates; asphalt paving, roofing and saturated materials manufacturing, other petroleum 

and coal products manufacturing, and support activities for mining as surface active agents. No 

commercial and consumer uses were reported. 

CASRN 61791-55-7: 

Non-confidential information in the IUR indicated that the industrial processing and uses of the 

chemical include other basic organic chemical manufacturing as surface active agents and 

intermediates; asphalt paving, roofing and saturated materials manufacturing, other nonmetallic 

mineral mining and quarrying, other petroleum and coal products manufacturing, and support 

activities for mining as surface active agents. No commercial and consumer uses were reported. 

CASRN 67700-99-6, 68153-95-7 and 68155-38-4: 

Industrial processing and uses, and commercial and consumer uses for these chemicals are 

claimed confidential. 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

24 

2.2 Environmental Exposure and Fate

The environmental fate properties are provided in Tables 7 through 12. The structures are 

provided in the Appendix. 

The members of the fatty nitrogen-derived amines category are expected to possess low mobility 

in soil; however, CASRNs 124-22-1, 68814-95-9 and 61790-42-9 possess moderate mobility in 

soil. Experimental biodegradation data are available for 11/23 sponsored chemicals and 11/12 

supporting chemicals (see tables). These data were used to extrapolate to the other members for 

which no data were available. 

In Table 7, acceptable data are available for 3/8 sponsored primary alkylamines and 

alkyldiamines: CASRNs 124-22-1, 143-27-1), and 68037-95-6. All were found to be readily 

biodegradable according to OECD Guideline 301D (closed bottle test), with 55, 85, and 85% 

biodegradation after 28 days, respectively. Inherent biodegradability results from OECD 

Guideline 302B (Zahn-Wellens test) of CASRN 61791-55-7 do not allow a prediction on the 

biodegradability due to the high adsorption in activated sludge. In Table 8, five closely related 

supporting chemicals were all found to be either inherently biodegradable or readily 

biodegradable according to OECD guidelines. 

For the dimethylalkylamines (Table 9), five sponsored chemicals and three supporting chemicals 

are presented. Three sponsored chemicals (CASRNs 112-69-6, 61788-95-2 and 61788-91-8) 

were all considered readily biodegradable. A fourth (CASRN 124-28-7) was reported to be not 

readily biodegradable (49% in 29 days) but was estimated to be inherently biodegradable based 

on the results of a modified Sturm test (OECD 301B) and readily biodegradable (72% in 

4 weeks) by the modified MITI test (OECD 301C). A determination of the biodegradability of 

the fifth sponsored chemical (CASRN 112-75-4) using OECD Guideline 301D was not deemed 

adequate due to results that were inconsistent with other, related chemicals. Thus, the available 

data with the other sponsored chemicals plus the supporting chemicals also reported in Table 7 

suggest that CASRN 112-75-4 is readily biodegradable. 

Biodegradation data are available for only one dimethylalkylamine/dialkylamine sponsored 

chemical (CASRN 61788-63-4); and it was found to be readily biodegradable using a closed 

bottle test (OECD 301D) and a modified Sturm assay (in compliance with Method C5 of the 

European Commission of Communities 84/449/CEE), achieving >100% biodegradation after 28 

days (97.3% pure test substance) and 75% BOD after 28 days (purity not specified), respectively 

(Table 10). However, data were found for three supporting chemicals (Table 11) which indicate 

that these substances are not persistent in the environment. 

In Table 12, the trialkylamines (CASRNs 61791-31-9 and 61791-44-4) were found readily 

biodegradable by OECD 301D closed bottle test, achieving 61 and 52% degradation in 28 days, 

respectively; ethanol, 2,2’-iminobis-, N-tallow alkyl derivs. (98% purity) was classified as 

readily biodegradable because biodegradation proceeded rapidly after an initial lag of 15 days. 

Thjs information is read-across to the other sponsored chemicals in this group. 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

25 

Conclusion: Volatilization is not expected to be an important fate process since the FND 

amines are weak bases that will exist as cations in the environment, and cations do not volatilize. 

Hydrolysis data were not available for any members of this category. Generally, amines are 

expected to hydrolyze extremely slowly under environmental conditions; however, these types of 

surfactants are generally not hydrolysable, according to the sponsor. The rate of atmospheric 

photooxidation is considered moderate to rapid for members of this category; however, this is 

not expected to be an important environmental fate process since these substances are not 

expected to exist in the vapor phase in the atmosphere. The overall weight of experimental 

evidence and read across from structurally similar compounds from these studies suggest that all 

members of the FND amines category have low persistence (P1). As shown in the tables, most 

members of the FND amines category are expected to have low (B1) bioaccumulation potential 

(13/23, including all four trialkylamines), with 4/23 having a moderate (B2) rating and 6/23 

having a high (B3) rating; with 5/6 being primary alkylamines/alkyldiamines.
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

26 

Table 7. Environmental Fate Characteristics of Fatty Nitrogen-Derived Amines: Primary Alkylamines 

SPONSORED 

CHEMICAL 

1-Dodecanamine 

SPONSORED 

CHEMICAL 

1-Hexadecanamine 

SPONSORED 

CHEMICAL 

Amines, C14-18-

alkyl2

SPONSORED 

CHEMICAL 

Amines, C14-18 

and C16-18-

unsatd. alkyl2

SPONSORED 

CHEMICAL Amines, soya 

alkyl2

SPONSORED 

CHEMICAL 

Amines, C16-18 

and C18-unsatd. 

alkyl2

SPON

CHE

Amines

alkylt

en

Property 

Value Value Value Value Value Value V

CASRN 124-22-1 143-27-1 68037-91-2 68155-38-4 61790-18-9 68037-95-6 6179Photodegradation Half-life 

2.8 hours 

(estimated)3

2.5 hours 

(estimated)3

2.6 hours 

(estimated)3

1.2 hours 

(estimated)3

0.80 hours 

(estimated)3

2.5 hours 

(estimated)3

0.4 

(esti

Hydrolysis Halflife Stable Biodegradation 55% in 28 days 

(readily 

biodegradable) 

85% in 28 days 

(readily 

biodegradable)4

No data 

(RA) 

Readily 

Biodegradable 

No data 

(RA) 

Readily 

Biodegradable 

No data 

(RA) 

Readily 

Biodegradable

85% in 28 days 

(readily 

biodegradable)4

Inadeq

(

Re

Biode

Bioaccumulation Factor 

BAF = 900 

(estimated)3

BAF = 2.7×104 

(estimated)3

BAF = 2.7×103 

(estimated)3

BAF = 3.6×104 

(estimated)3

BAF = 3.6×105 

(estimated)3

BAF = 2.7×104 

(estimated)3

BA

(esti

Log Koc 3.7 (estimated)3 4.8 (estimated)3 4.3 (estimated)3 4.8 (estimated)3 5.3 (estimated)3 4.8 (estimated)3 10 (esFugacity (Level III Model)3 

Air (%) 

Water (%) 

Soil (%) 

Sediment (%)

0.6 

22.3 73.5 

3.7 

0.6 

13.8 67.7 17.9 

0.7 

15.7 75.7 

8.0 

0.1 

14.5 65.0 20.4 

<0.1 

13.0 53.3 33.7 

0.6 

13.8 67.7 17.9 

<

8

<
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

27 

Table 7. Environmental Fate Characteristics of Fatty Nitrogen-Derived Amines: Primary Alkylamines 

SPONSORED 

CHEMICAL 

1-Dodecanamine 

SPONSORED 

CHEMICAL 

1-Hexadecanamine 

SPONSORED 

CHEMICAL 

Amines, C14-18-

alkyl2

SPONSORED 

CHEMICAL 

Amines, C14-18 

and C16-18-

unsatd. alkyl2

SPONSORED 

CHEMICAL Amines, soya 

alkyl2

SPONSORED 

CHEMICAL 

Amines, C16-18 

and C18-unsatd. 

alkyl2

SPON

CHE

Amines

alkylt

en

Property 

Value Value Value Value Value Value V

Persistence6 P1 (low) P1 (low) P1 (low) P1 (low) P1 (low) P1 (low) P1 Bioaccumulation6 B1 (low) B3 (high) B2 (moderate) B3 (high) B3 (high) B3 (high) B1 1American Chemistry Council. 2003. Revised Robust Summary and Test Plan for Fatty Nitrogen-Derived Amines Category. Available on

http://www.epa.gov/chemrtk/pubs/summaries/amines/c14171tc.htm as of July 15, 2010. 2 Estimated data provided are based on the typical representative structure; see Appendix for detailed information on the structures. 

3 U.S. EPA. 2010. Estimation Programs Interface SuiteTM for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Wash

online at http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of July 12, 2010. 

4 van Ginkel, CG. 1995. Biodegradability of Cationic Surfactants. In: Biodegradation of Surfactants. Karsa, DR; Porter, MR; eds. Glasgo5 Inherent biodegradability results from the OECD Guideline 302B test do not allow a prediction of the biodegradability of this chemical du

activated sludge. 

6 Federal Register. 1999. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances. Federal Register 64, Number 2

60194–60204. 

RA = Read Across. 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

28 

Table 8. Environmental Fate Characteristics of Fatty Nitrogen-Derived Amines: Primary Alkylamines a

Property SUPPORTING 

CHEMICAL 

9-Octadecen-1- 

amine, (9Z)- 

SUPPORTING 

CHEMICAL 

1-Octadecanamine 

SUPPORTING 

CHEMICAL 

Amines, hydrogenated 

tallow alkyl2

SUPPORTING 

CHEMICAL 

Amines, coco alkyl2

CASRN 112-90-3 124-30-1 61788-45-2 61788-46-3 Photodegradation Half-life 

1.2 hours (estimated)3 2.4 hours (estimated)3 2.4 hours (estimated)3 2.8 hours (estimated)3 

Hydrolysis Half-Life Stable Biodegradation 66% in 28 days (not 

readily biodegradable)4; 

>60% in 12 days 

(inherently 

biodegradable) 

70% in 28 days 

(readily 

biodegradable); 

>60% in 12 days 

(inherently 

biodegradable) 

75% in 28 days (readily 

biodegradable) 

56% in 28 days (readily 

biodegradable)5; 

91.1% as CO2 in 28 days 

(readily biodegradable)6

56

b

Bioaccumulation Factor 

BAF = 2.1×105 

(estimated)3

BAF = 1.1×105 

(estimated)3

BAF = 1.1×105 

(estimated)3

BAF = 900 

(estimated)3

B

Log Koc 5.3 (estimated)3 5.3 (estimated)3 5.3 (estimated)3 3.7 (estimated)3 Fugacity (Level III Model)3 

Air (%) 

Water (%) 

Soil (%) 

Sediment (%)

0.1 

13.9 57.8 28.2 

0.4 

15.3 61.2 23.1 

0.4 

15.3 61.2 23.1 

0.6 

22.3 73.5 

3.7 

Persistence7 P1 (low) P1 (low) P1 (low) P1 (low) Bio-accumulation7 B3 (high) B3 (high) B3 (high) B1 (low) 1American Chemistry Council. 2003. Revised Robust Summary and Test Plan for Fatty Nitrogen-Derived Amines Category. Available online at 

http://www.epa.gov/chemrtk/pubs/summaries/amines/c14171tc.htm as of July 15, 2010. 2 Supporting chemicals. Estimated data provided are based on the typical representative structure; see Appendix for detailed information on the structures. 

3 U.S. EPA. 2010. Estimation Programs Interface SuiteTM for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Washington, DC, USA. Available o

http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of July 12, 2010. 4 60% biodegradation needs to be achieved within a 10-day window following the initial 10% degradation for the substance to be considered readily biodegradable. 

5 Sponsor stated that the test substance was readily biodegradable. However, pass/fail criteria for a Closed Bottle Test (OECD Guideline 301D) is 60% in 28 days. 6 Study was a variant of the OECD Closed Bottle Test using a raw sewage inoculum. The sponsor stated that the test substance was readily biodegradable. 7 Federal Register. 1999. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances. Federal Register 64, Number 213 (November 4, 1999) pp. 60
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

29 

Table 9. Environmental Fate Characteristics of Fatty Nitrogen-Derived Amines: Dimethylalk

SPONSORED 

CHEMICAL 

1-Tetradecanamine, N,NdimethylSPONSORED CHEMICAL 1-Hexadecan- amine, N,N- dimethyl- SPONSORED CHEMICAL 1-Octadecan- amine, N,N- dimethyl- SPONSORED CHEMICAL Amines, (hydrogenated tallow alkyl) 

dimethyl2

SPONSORED 

CHEMICAL 

Amines, 

dimethylsoya 

alkyl2

SUPPORTING 

CHEMICAL 

Octadecen-1-

amine, N,Ndimethyl-3

SUPP

CHE

1-Dode

N,N-d

Property 

Value Value Value Value Value Value V

CASRN 112-75-4 112-69-6 124-28-7 61788-95-2 61788-91-8 28061-69-0 11Photodegradation Half-life4 

1.3 hours 

(estimated) 

1.3 hours 

(estimated) 

1.3 hours 

(estimated) 

1.3 hours 

(estimated) 

0.62 hours 

(estimated) 

1.0 hours 

(estimated) 

1.4 

(est

Hydrolysis Halflife Stable StBiodegradation Inadequate 

Data5 

(RA) 

Readily 

Biodegradable 

59% in 28 days 

(readily 

biodegradable); 

100% in 28 days 

(readily 

biodegradable) 

49% in 29 days 

(inherently 

biodegradable); 

72% in 4 weeks 

(readily 

biodegradable)6

58% in 28 days 

(readily 

biodegradable) 

98% in 28 days 

(readily 

biodegradable) 

50% in 28 days and 

59% in 70 days 

(biodegradable)7

67% i

(r

biode

72% i

(r

biode

Bioaccumulation Factor4 

BAF = 430 

(estimated) 

BAF = 950 

(estimated) 

BAF = 1,400 

(estimated) 

BAF = 1,400 

(estimated) 

BAF = 8,600 

(estimated) 

BAF = 1,300

(estimated) 

BA

(est

Log Koc4 4.3 (estimated) 4.8 (estimated) 5.3 (estimated) 5.3 (estimated) 5.3 (estimated) 5.3 (estimated) 3.8 (eFugacity (Level III Model)4 

Air (%) 

Water (%) 

Soil (%) 

Sediment (%)

0.2 9.7 

80.9 

9.2 

0.2 

10.7 72.5 16.7 

0.1 

14.6 71.9 13.3 

0.1 

14.6 71.9 13.3 

<0.1 

10.8 66.5 22.7 

0.1 

13.1 70.9 15.9 

Persistence8 P1 (low) P1 (low) P1 (low) P1 (low) P1 (low) P1 (low) P1 
U.S. Environmental Protection Agency September, 2010 

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30 

Table 9. Environmental Fate Characteristics of Fatty Nitrogen-Derived Amines: Dimethylalk

SPONSORED 

CHEMICAL 

1-Tetradecanamine, N,NdimethylSPONSORED CHEMICAL 1-Hexadecan- amine, N,N- dimethyl- SPONSORED CHEMICAL 1-Octadecan- amine, N,N- dimethyl- SPONSORED CHEMICAL Amines, (hydrogenated tallow alkyl) 

dimethyl2

SPONSORED 

CHEMICAL 

Amines, 

dimethylsoya 

alkyl2

SUPPORTING 

CHEMICAL 

Octadecen-1-

amine, N,Ndimethyl-3

SUPP

CHE

1-Dode

N,N-d

Property 

Value Value Value Value Value Value V

Bioaccumulation8 B1 (low) B1 (low) B2 (moderate) B2 (moderate) B3 (high) B2 (moderate) B1 1American Chemistry Council. 2003. Revised Robust Summary and Test Plan for Fatty Nitrogen-Derived Amines Category. Available on

http://www.epa.gov/chemrtk/pubs/summaries/amines/c14171tc.htm as of July 15, 2010. 2 Estimated data provided are based on the typical representative structure; see Appendix for detailed information on the structures. 3 Supporting chemicals. 

4 U.S. EPA. 2010. Estimation Programs Interface SuiteTM for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Wash

online at http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of July 12, 2010. 5 Although there is a guideline study (OECD 301D) that reports <2% degradation after 28 days, a determination of the biodegradability cou

results that were inconsistent with related chemicals; it is not considered representative of the biodegradation of this chemical. 6 National Institute of Technology and Evaluation. 2002. Biodegradation and Bioaccumulation of the Existing Chemical Substances under Control Law. Available online at http://www.safe.nite.go.jp/english/kizon/KIZON_start_hazkizon.html as of August 10, 2010. 7 Test substance did not meet the criteria for ready biodegradability in OECD Guideline 301D (closed bottle test); however, the sponsor statshould be classified as biodegradable. 

8 Federal Register. 1999. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances. Federal Register 64, Number 2

60194–60204. 

RA = read across 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

31 

Table 10. Environmental Fate Characteristics of Fatty Nitrogen-Derived Amines : Dimethylalkylamines 

SPONSORED 

CHEMICAL 

1-Decanamine, Ndecyl-N-methylSPONSORED CHEMICAL Amines, di-C14-18- alkylmethyl2 SPONSORED CHEMICAL Amines, di-C12-18- alkyl2 SPONSORED CHEMICAL 1-Octadecanamine, N- methyl-N-octadecyl- SPONSORED CHEMICAL Amines, bis(h

ydro

genated ta

alkyl)methyl2

Property 

Value Value Value Value Value 

CASRN 7396-58-9 67700-99-6 68153-95-7 4088-22-6 61788-63-4 Photodegradation Half-life 

1.2 hours (estimated)3 1.0 hours (estimated)3 1.1 hours (estimated)3 1.0 hours (estimated)3 1.0 hours (estimate

Hydrolysis Halflife Stable Biodegradation No data 

(RA) 

Readily 

Biodegradable 

No data 

(RA) 

Readily Biodegradable

No data 

(RA) 

Readily Biodegradable 

No data 

(RA) 

Readily Biodegradable 

100% in 28 days (re

biodegradable); 

75% in 28 days (rea

biodegradable) 

Bioaccumulation Factor 

BAF = 1,500 

(estimated)3

BAF = 3 (estimated)3 BAF = 83 (estimated)3 BAF = 0.95 (estimated)3 BAF = 0.95 (estima

Log Koc 5.6 (estimated)3 8.7 (estimated)3 8.2 (estimated)3 9.8 (estimated)3 9.8 (estimated)3 Fugacity (Level III Model)3 

Air (%) 

Water (%) 

Soil (%) 

Sediment (%)

0.2 

22.6 70.5 

6.7 

0.1 

17.0 82.9 

<0.1 

0.2 

23.7 76.1 

<0.1 

<0.1 

17 83 

<0.1 

<0.1 

17 83 

<0.1 

Persistence4 P1 (low) P1 (low) P1 (low) P1 (low) P1 (low) Bioaccumulation4 B2 (moderate) B1 (low) B1 (low) B1 (low) B1 (low) 1American Chemistry Council. 2003. Revised Robust Summary and Test Plan for Fatty Nitrogen-Derived Amines Category. Available online at 

http://www.epa.gov/chemrtk/pubs/summaries/amines/c14171tc.htm as of July 15, 2010. 2 Estimated data provided are based on the typical representative structure; see Appendix for detailed information on the structures. 

3 U.S. EPA. 2010. Estimation Programs Interface SuiteTM for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Washington, DC, US

http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of July 12, 2010. 

4 Federal Register. 1999. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances. Federal Register 64, Number 213 (November RA = Read Across
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

32 

Table 11. Environmental Fate Characteristics of Fatty Nitrogen-Derived Amines: Dimethylalkylamines 

Property SUPPORTING CHEMICAL 

Amines, dicoco alkyl2

SUPPORTING CHEMICAL 

Amines, dicoco alkylmethyl2

SUPPORT

Amines, bis(hyd

CASRN 61789-76-2 61788-62-3 6Photodegradation Half-life 

1.1 hours (estimated)3 1.1 hours (estimated)3 1.0 ho

Hydrolysis Half-life Stable Biodegradation 20% in 28 days (not readily biodegradable)4 82% in 28 days (readily biodegradable) 16% in 28 days (nBioaccumulation Factor 

BAF = 2.2×104 (estimated)3 BAF = 420 (estimated)3 BAF = 

Log Koc 6.7 (estimated)3 6.6 (estimated)3 9.8 Fugacity (Level III Model)3 

Air (%) 

Water (%) 

Soil (%) 

Sediment (%)

0.2 

24.1 74.2 

1.5 

0.1 

17.8 80.8 

1.3 

0

1782

<0

Persistence6 P1 (low) P1 (low) Bioaccumulation6 B3 (high) B1 (low) 1American Chemistry Council. 2003. Revised Robust Summary and Test Plan for Fatty Nitrogen-Derived Amines Category. Available on

http://www.epa.gov/chemrtk/pubs/summaries/amines/c14171tc.htm as of July 15, 2010. 2 Supporting chemicals. Estimated data provided are based on the typical representative structures; see Appendix for detailed information o

3 U.S. EPA. 2010. Estimation Programs Interface SuiteTM for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Wash

online at http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of July 12, 2010. 4 The purity of the test substance was 87.8%. The sponsor states that this test result is inconsistent with expected results based on similar ch

had an impact on the bioavailability of the test material since these types of substances are known to adsorb to solids. 

5 The sponsor states that due to inconsistency with related chemicals, it is possible that the solubility of the test substance was inadequate fo

method (OECD Guideline 301F, Respirometric method). 

6 Federal Register. 1999. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances. Federal Register 64, Number 2

60194–60204. 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

33 

Table 12. Environmental Fate Characteristics of Fatty Nitrogen-Derived Amines: Trialkyla

SPONSORED CHEMICAL 

Amines, tri-C8-10-alkyl2

SPONSORED CHEMICAL 

Amines, tris(hydrogenated tallow 

alkyl)2

SPONSORED CHEMICAL 

Ethanol, 2,2'-iminobis-, N-coco 

alkyl derivs.2

SP

Etha

Property 

Value Value Value 

CASRN 68814-95-9 61790-42-9 61791-31-9 Photodegradation Half-life 

1.0 hours (estimated)3 0.8 hours (estimated)3 1.1 hours (estimated)3 

Hydrolysis Half-life Stable Biodegradation No data 

(RA) 

Readily Biodegradable 

No data 

(RA) 

Readily Biodegradable 

61% in 28 days (readily 

biodegradable) 

Bioaccumulation Factor 

BAF = 320 (estimated)3 BAF = 0.89 (estimated)3 BAF = 21 (estimated)3 

Log Koc 6.9 (estimated)3 14 (estimated)3 2.2 (estimated)3 Fugacity (Level III Model)3 

Air (%) 

Water (%) 

Soil (%) 

Sediment (%)

0.2 

24.4 74.9 

0.6 

<0.1 

16 84 

<0.1 

<0.1 

22.1 77.7 

0.2 

Persistence5 P1 (low) P1 (low) P1 (low) Bioaccumulation5 B1 (low) B1 (low) B1 (low) 1American Chemistry Council. 2003. Revised Robust Summary and Test Plan for Fatty Nitrogen-Derived Amines Category. Available on

http://www.epa.gov/chemrtk/pubs/summaries/amines/c14171tc.htm as of July 15, 2010. 2 Estimated data provided are based on the typical representative structure; see Appendix for detailed information on the structures. 

3 U.S. EPA. 2008. Estimation Programs Interface Suite

TM for Microsoft® Windows, v3.20. United States Environmental Protection Agency

Available online at http://www.epa.gov/opptintr/exposure/pubs/episuite.htm as of August 10, 2010. 

4 The sponsor classified the test substance as readily biodegradable because biodegradation proceeded rapidly after an initial lag of 15 days. 5 Federal Register. 1999. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances. Federal Register 64, Number 2

60194–60204. 

RA = Read Across 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

34 

3. Human Health Hazard 

The human health data are summarized in Tables 13 to 16. The tables also indicate where data 

for tested category members are read-across (RA) to untested members of the category. 

Acute Oral Toxicity 

Subcategory I: Non-Hydroxylated FND Amines 

Dodecylamine (CASRN 124-22-1)

Wistar rats (5/sex/dose) were administered dodecylamine via gavage at 2000 mg/kg and 

observed for 14 days. There were no mortalities. 

LD50 > 2000 mg/kg 

N-Tallow alkyltrimethylenediamines (CASRN 61791-55-7) 

Sprague-Dawley rats (5/sex/dose) were administered amines, N-tallow alkyltrimethylenedi- in 

arachis oil via gavage at 5000 mg/kg and observed for 14 days. One male and one female died. 

LD50 > 5000 mg/kg 

N,N-Dimethyl-1-tetradecanamine (CASRN 112-75-4) 

(1) CD strain rats (5/sex/dose) were administered N,N-dimethyl-1-tetradecanamine (“Farmin 

DM40”) in corn oil via gavage at 500 or 2000 mg/kg and observed for 14 days. Mortalities 

occurred at 2000 mg/kg (2/5). The LD50 was calculated based on the slope of the dose-response 

curve. 

LD50 = 2116 mg/kg 

(2) Wistar rats (5 females/dose; 5 males at 1400 mg/kg) were administered N,N-dimethyl-1-

tetradecanamine (“Genamin 14R 302D”) in sesame oil via gavage at 1250, 1400 or 1600 mg/kg 

and observed for 14 days. Mortalities occurred in females at all dose levels; 20, 80 and 100% at 

1250, 1400 and 1600 mg/kg. 

LD50 = 1320 mg/kg 

(3) Wistar rats (10 males/dose) were administered N,N-dimethyl-1-tetradecanamine (“ADMA 

4”) via gavage at 300, 600, 1220 or 5000 mg/kg and observed for 14 days. Mortalities occurred 

at 600 (2/10), 1220 (9/10) and 5000 (10/10) mg/kg. This study is a TSCATS submission and can 

be retrieved by typing in the CASRN at the following link: http://www.srcinc.com/what-wedo/databaseforms.aspx?id=384 . 

LD50 = 720 mg/kg 

N,N-Dimethyl-1-hexadecanamine (CASRN 112-69-6

(1) Albino rats (5/sex/dose) were administered N,N-dimethyl-1-hexadecanamine (“Armeen 

DM16D”) via gavage at 0.50, 0.75, 1.0, 2.0, 4.0 or 8.0 mL/kg (the first four dose levels diluted in 

10% gum Arabic and the highest two not diluted) and observed for 14 days. Mortality was 100% 

at 2, 4 and 8 mL/kg; 90% at 1 mL/kg; 20% at 0.75 and 10% at 0.5 mL/kg. The LD50 value was 

0.80 mL/kg. 

LD50 = 641 mg/kg [calculated using a density of 0.801 g/mL] 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

35 

(2) Sprague-Dawley rats (5/sex/dose) were administered N,N-dimethyl-1-hexadecanamine via 

gavage at 2000 mg/kg and observed for 14 days. Moralities occurred at 2000 mg/kg (three males 

and one female). 

LD50 > 2000 mg/kg (combined) 

(3) CD rats (5/sex/dose) were administered N,N-dimethyl-1-hexadecanamine(“Farmin DM60”) 

in corn oil via gavage at 500 or 2000 mg/kg and observed for 14 days. No animals died at 

500 mg/kg, but all animals died at 2000 mg/kg. 

LD50 = 1015 mg/kg (combined) 

(4) Wistar rats (10 males/dose) were administered N,N-dimethyl-1-hexadecanamine (“ADMA 

6”) via gavage at 150, 300, 600, 1220 and 5000 mg/kg and observed for 14 days. Mortalities 

occurred at all doses above 150 mg/kg: 300 (1/10), 600 (4/10) and all animals (10/10) at the 

highest two doses. This study is a TSCATS submission and can be retrieved by typing in the 

CASRN at the following link: http://www.srcinc.com/what-we-do/databaseforms.aspx?id=384 . 

LD50 = 620 mg/kg (males) 

N,N-Dimethyl-1-octadecanamine (CASRN 124-28-7) 

(1) Albino rats (5/sex/dose) were administered N,N-dimethyl-1-octadecanamine (“Armeen 

DM18D”) via gavage at 0.5, 0.75, 1.0, 2.0, 4.0 or 8.0 mL/kg (the first four dose levels diluted in 

10% gum Arabic and the highest two levels were not diluted) and observed for 14 days. 

Mortalities occurred at ≥ 0.75 mL/kg. Mortality was 100% at 2, 4 and 8 mL/kg; 70% at 1 

mL/kg; 50% at 0.75 and 0% at 0.5 mL/kg. The LD50 value was 0.78 mL/kg. 

LD50 = 624 mg/kg [calculated using a density of 0.8 g/mL] 

(2) Sprague-Dawley rats (5/sex/dose) were administered N,N-dimethyl-1-octadecanamine 

(“Farmin DM80”) in corn oil via gavage at 500 or 2000 mg/kg and observed for 14 days. 

Mortalities occurred at the highest dose (2/5 males and 2/5 females). The LD50 value was 

calculated using Probit analysis. 

LD50 = 2116 mg/kg (combined) 

Amines, hydrogenated tallow alkyl dimethyl (CASRN 61788-95-2) 

Sprague-Dawley rats (5/sex/dose) were administered amines, hydrogenated tallow alkyl dimethyl 

in arachis oil via gavage at 2000 mg/kg and observed for 14 days. One male and one female died. 

LD50 > 2000 mg/kg 

Amines, dimethylsoya alkyl (CASRN 61788-91-8) 

Albino rats (5/sex/dose) were administered amines, dimethylsoya alkyl (“Armeen DMSD”) in 

gum arabic (except for two highest dose groups, which were given with no vehicle) via gavage at 

0.5, 0.75, 1.0, 2.0, 4.0 or 8.0 mL/kg and observed for 14 days. Mortalities occurred at ≥ 0.75 

mL/kg; 0, 30 and 80% at 0.5, 0.75 and 1 mL/kg, respectively and 100% at 2, 4 and 8 mL/kg. 

The LD50 was 0.835 mL/kg. 

LD50 = 835 mg/kg [based on the density of chemical ~ 1 g/mL] 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

36 

1-Octadecanamine, N-methyl-N-octadecyl (CASRN 4088-22-6) 

(1) Wistar rats (5/sex/dose) were administered 1-octadecanamine, N-methyl-N-octadecyl 

(“Genamin SH 301”) in sesame oil via gavage at 2000 mg/kg and observed for 14 days. No 

mortalities occurred. 

LD50 > 2000 mg/kg 

(2) Sprague-Dawley rats (5/sex/dose) were administered 1-octadecanamine, N-methyl-Noctadecyl (“E8220”) via gavage at 5000 mg/kg and observed for 14 days. No mortalities 

occurred. 

LD50 > 5000 mg/kg

Dihydrogenated tallow methylamine (CASRN 61788-63-4) 

(1) Sprague-Dawley rats (5/sex/dose) were administered dihydrogenated tallow methylamine 

(“Armeen M2HT”) in methyl cellulose via gavage at 5.0 g/kg and observed for 14 days. No 

mortalities occurred. 

LD50 > 5000 mg/kg 

(2) Sprague-Dawley rats (5/sex/dose) were administered dihydrogenated tallow methylamine 

(“B0390Adogen 243”) in mineral oil via gavage at 15 g/kg and observed for 14 days. No 

mortalities occurred. 

LD50 > 15000 mg/kg 

Octadecylamine (CASRN 124-30-1, supporting chemical) 

Wistar rats (5/sex/dose) were administered octadecylamine (“Genamin 18 R 100D”) in sesame 

oil via gavage at 2000 mg/kg and observed for 14 days. One mortality occurred at 2000 mg/kg. 

LD50 > 2000 mg/kg 

Coco alkyl amines (CASRN 61788-46-3, supporting chemical) 

(1) Wistar rats (5/sex/dose) were administered coco alkyl amines (“Armeen C”) in arachis oil via 

gavage at doses ranging from 0.5 to 2.0 g/kg and observed for 14 days. Mortalities occurred at 

all dose levels and it was 11, 20, 40 and 100% at 0.5, 1, 1.5 and 2 g/kg, respectively. 

LD50 = 1300 mg/kg (combined) 

 

(2) In two studies, Sprague-Dawley albino rats (5/sex/dose) were administered coco alkyl amines 

(“Armeend CD”) in distilled water via gavage at doses between 1.8 and 6.0 g/kg and observed 

for 14 days. Mortalities occurred at ≥ 2.56 g/kg in the first test and no mortalities occurred in the 

second test at 6.0 g/kg. 

LD50 = 2040 – > 6000 mg/kg 

Tallow alkyl amines (CASRN 61790-33-8, supporting chemical) 

(1) Wistar rats (5/sex/dose) were administered tallow alkyl amines (“Genamin TA 100D”) in 

sesame oil via gavage at 2000 mg/kg (females and males) or 2500 mg/kg (males only) and 

observed for 14 days. One male in each treated groups died and no females died. 

LD50 > 2000 mg/kg 

 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

37 

(2) WISW–SPF TNO rats (5/sex/dose) were administered tallow alkyl amines (“Armeen T”) at 

1.5, 2.5, 3.5 and 5.0 mL/kg and observed for 14 days. Mortalities occurred at all dose levels and 

was 20, 50, 70 and 100% at 1.5, 2.5, 3.5 and 5.0 mL/kg. The LD50 was 2.4 mL/kg. 

LD50 = 1944 mg/kg (combined) [calculated using a density of 0.81 g/mL]

Cis-9-Octadecenylamine (CASRN 112-90-3, supporting chemical) 

Sprague-Dawley rats (5/sex/dose) were administered cis-9-octadecenylamine via gavage at 200, 

500, 1000 or 2000 mg/kg and observed for 14 days. Mortalities occurred at 200 and ≥ 1000 

mg/kg and it was 10%, 0%, 20% and 70% at 200, 500, 1000 and 2000 mg/kg, espectively. 

LD50 = 1689 mg/kg (combined) 

N,N-Dimethyl-1-dodecanamine (CASRN 112-18-5, supporting chemical) 

(1) Male Wistar rats (10 dose) were administered N,N-dimethyl-1-dodecanamine (“Armeen 

DM12D”) via gavage at doses of 0.60 – 5.0 g/kg and observed for 14 days. Mortalities 

occurred at ≥ 0.96 g/kg and it was 0, 30, 70, 100 and 100% at 0.6, 0.96, 1.54, 2.47, and 5.0 g/kg. 

LD50 = 1220 mg/kg

(2) Male Wistar rats (10 dose) were administered N,N-dimethyl-1-dodecanamine (“ADMA 2”) 

in either Mazola oil or no vehicle via gavage at doses of 0.072 – 5.0 g/kg and observed for 14 

days. Mortalities occurred at ≥ 0.30 g/kg and it was 0, 20, 60, and 100% at 0.072, 0.3, 1.22 and 

5.0 g/kg, respectivley. 

LD50 = 790 mg/kg

Subcategory II: Hydroxylated FND Amines 

N-Coco alkyl derivatives of 2,2’-iminobis ethanol (CASRN 61791-31-9) 

Wistar rats (3/sex/dose) were administered N-coco alkyl derivatives of 2,2’-iminobis ethanol via 

gavage at 5.0, 6.3, 7.01, 7.94 or 10.0 g/kg and observed for 14 days. Mortalities occurred at all 

doses: 1/6 at 5.0 g/kg; 3/6 at both 6.3 and 7.01 g/kg; 4/6 at 7.94 g/kg; and 6/6 at 10.0 g/kg. 

LD50 ~ 6300 mg/kg

N-Tallow alkyl derivatives of 2,2’-iminobis ethanol (CASRN 61791-44-4) 

Six studies show the variation in acute oral toxicity that is likely due to formulated product 

and/or vehicle used. 

(1) Sprague-Dawley rats (1 – 3/sex/dose) were administered N-tallow alkyl derivatives of 

2,2’-iminobis ethanol (“Ethomeen T/12”) in methyl cellulose via gavage at doses ranging from 

0.8 to 5.0 g/kg and observed for 14 days. Mortalities occurred at ≥ 1.26 g/kg. 

LD50 = 1200 mg/kg (females) and 1500 mg/kg (males)

(2) Sprague-Dawley rats (5/sex/dose) were administered N-tallow alkyl derivatives of 

2,2’-iminobis ethanol (“2EO”) in arachis oil via gavage at a dose of 2000 mg/kg and observed 

for 14 days. There were no mortalities. 

LD50 > 2000 mg/kg 

(3) Albino Sprague-Dawley rats (5/sex/dose) were administered N-tallow alkyl derivatives of 

2,2’-iminobis ethanol (“Varonic T-220”) via gavage at doses ranging from 0.547 to 1.071 g/kg 
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38 

and observed for 14 days. Mortalities occurred at ≥0.765 g/kg; 0, 40, 50 and 80% at 0.547, 

0.765, 0.918 and 1.071 g/kg, respectively. 

LD50 = 890 mg/kg

(4) Albino Sprague-Dawley rats (5/sex/dose) were administered N-tallow alkyl derivatives of 

2,2’-iminobis ethanol (“Varonic T-220”) via gavage at doses ranging from 160 to 6250 mg/kg 

and observed for 14 days. Mortalities occurred at ≥ 400 mg/kg; 0, 20, 80, 100 and 100% at 160, 

400, 1000, 2500 and 6250 mg/kg, respectively. 

LD50 = 630 mg/kg

(5) Albino Sprague-Dawley rats (5/sex/dose) were administered N-tallow alkyl derivatives of 

2,2’-iminobis ethanol (“(POE)20 Tallowamine T-220D”) via gavage at doses ranging from 0.69 

to 1.36 g/kg and observed for 14 days. Mortalities occurred at ≥ 0.97 g/kg; 0, 20, 50, and 90% at 

0.69, 0.97, 1.17 and 1.36 g/kg, respectively. 

LD50 = 1150 mg/kg

(6) Albino Sprague-Dawley rats (5/sex/dose) were administered N-tallow alkyl derivatives of 

2,2’-iminobis ethanol (“Ethomeen 18/60”) in distilled water via gavage at a dose of 15.0 g/kg 

and observed for 14 days. There were two mortalities (one male and one female). 

LD50 > 15,000 mg/kg

Acute Inhalation Toxicity 

Subcategory I: Non-Hydroxylated FND Amines 

Coco alkyl amines (CASRN 61788-46-3, supporting chemical) 

Male Sprague-Dawley rats (10/dose) were exposed to coco alkyl amines (“Armeen C”) via 

whole-body inhalation at vapor concentrations of 0.063 and 0.099 mg/L for one hour and were 

observed for 14 days. There were no mortalities. 

LC50 > 0.099 mg/L (one hour exposure)

Subcategory II: Hydroxylated FND Amines 

N-Tallow alkyl derivatives of 2,2’-iminobis ethanol (CASRN 61791-44-4) 

Sprague-Dawley rats (5/sex/dose) were exposed to N-tallow alkyl derivatives of 2,2’-iminobis 

ethanol via whole body inhalation at an aerosol concentration of 0.6 mg/L (generated by heating) 

for four hours and were observed for 14 days. There were no mortalities. 

LC50 > 0.6 mg/L

Acute Dermal Toxicity 

Subcategory I: Non-Hydroxylated FND Amines 

N,N-Dimethyl-1-tetradecanamine (CASRN 112-75-4) 

New Zealand White rabbits (4/dose) (number per sex not stated) were administered N,Ndimethyl-1-tetradecanamine (“ADMA 4”) via the dermal route at 2680, 5200, 10,200 or 20,000 

mg/kg under occluded conditions for 24 hours and observed for 14 days. Skin abrasions were 

made on half of the animals. Mortalities occurred at all dose levels: 2680 mg/kg (1/4), 5200 
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39 

(2/4) and all animals (4/4) at the highest two dose levels. (TSCATS: 

http://www.srcinc.com/what-we-do/databaseforms.aspx?id=384) 

LD50 = 4400 mg/kg 

N,N-Dimethyl-1-hexadecanamine (CASRN 112-69-6) 

New Zealand White rabbits (4/dose) (sex not stated) were administered N,N-dimethyl-1-

hexadecanamine (“Armeen DM16D”, undiluted) via the dermal route at 4.0, 6.0 or 8.0 mL/kg 

under occluded conditions for 24 hours and observed for 14 days. Mortalities occurred at all 

doses; 50, 75 and 100% at 4, 6 and 8 mL/kg, respectively. The LD50 value was 4.29 mL/kg. 

LD50 ~ 3432 mg/kg [calculated using a density of 0.8 g/mL] 

N,N-Dimethyl-1-octadecanamine (CASRN 124-28-7) 

(1) New Zealand White rabbits (4/dose) (sex not stated) were administered N,N-dimethyl-1-

octaadecanamine (“Armeen DM18D”, undiluted) via the dermal route at 4, 6 or 8 mL/kg under 

occluded conditions for 24 hours and observed for 14 days. Mortalities occurred at all doses; 50, 

75 and 100% at 4, 6 and 8 mL/kg, respectively. The LD50 value was 4.29 mL/kg. 

LD50 ~ 3432 mg/kg [calculated using a density of 0.8 g/mL] 

(2) New Zealand White rabbits (4/dose) (sex not stated) were administered N,N-dimethyl-1-

octaadecanamine (“ADMA 8”) via the dermal route at 1000, 4000 or 16,000 mg/kg under 

occluded conditions for 24 hours and observed for 14 days. Mortalities occurred at the mid (1/4) 

and high (3/4) dose levels. (TSCATS: http://www.srcinc.com/what-wedo/databaseforms.aspx?id=384) 

LD50 = 8000 mg/kg 

Amines, dimethylsoya alkyl (CASRN 61788-91-8) 

New Zealand White rabbits (4/dose) (sex not stated) were administered amines, dimethylsoya 

alkyl (“Armeen DMSD”, undiluted) via the dermal route at 2, 4 or 8 mL/kg under occluded 

conditions for 24 hours and observed for 14 days. Mortalities occurred at ≥ 4 mL/kg; 0, 75, 

100% at 2, 4, 8 mL/kg, respectively. The LD50 value was 3.0 mL/kg. 

LD50 ~ 2400 mg/kg [calculated using a density of 0.8 g/mL] 

1-Octadecanamine, N-methyl-N-octadecyl (CASRN 4088-22-6) 

New Zealand White rabbits (3/sex/dose) were administered 1-octadecanamine, N-methyl-Noctadecyl (“E8220”, undiluted/wax-like solid) via the dermal route at 2 g/kg under occluded 

conditions for 24 hours and observed for 14 days. The skin on half of the animals was abraded. 

Mortalities occurred at 2 g/kg (one male and one female). 

LD50 > 2000 mg/kg 

Coco alkyl amines (CASRN 61788-46-3, supporting chemical)

(1) In two rabbit studies, New Zealand White rabbits (3/sex/dose) were administered coco alkyl 

amines (“Armeen CD”, undiluted) via the dermal route at 2.0 mL/kg under occluded conditions 

for 24 hours and observed for 14 days. One male and two females per group had their skin 

abraded for the study. No mortalities occurred in either the abraded or intact animals in one 

study and one intact male died in the second study (the latter was considered not treatmentrelated). 

LD50 > 2000 mg/kg [density of chemical is ~ 1 g/mL] 
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40 

(2) Sprague-Dawley rats (2/sex/dose) were administered coco alkyl amines (“Amine KK”) via 

the dermal route at doses of 500 (neat substance) or 2000 (in distilled water) mg/kg under 

occluded conditions for 24 hours and observed for 14 days. No mortalities occurred. 

LD50 > 2000 mg/kg

N,N-Dimethyl-1-dodecanamine (CASRN 112-18-5, supporting chemical) 

New Zealand White rabbits (4/dose) (females and males; number per sex not stated)were 

administered N,N-dimethyl-1-dodecanamine (“ADMA 2”) via the dermal route at 20.0, 10.2, 5.2 

or 2.68 g/kg under occluded conditions for 24 hours and observed for 14 days. Abrasions were 

made on half the animals. Mortalities occurred at all dose levels; 50, 25, 100 and 100% at 2.68, 

5.20, 10.2 and 20.0 g/kg, respectively. 

LD50 ~ 5000 mg/kg 

Subcategory II: Hydroxylated FND Amines 

N-Tallow alkyl derivatives of 2,2’-iminobis ethanol (CASRN 61791-44-4) 

In four different studies, New Zealand White rabbits (3/sex/dose) were administered N-tallow 

alkyl derivatives of 2,2’-iminobis ethanol via the dermal route at 2 mL/kg (undiluted) under 

occluded conditions for 24 hours and observed for 14 days. Three different formulations were 

used: Varonic T-220D, Varonic T-220 (two studies; one of which had half the animals exposed 

to a 50% dilution of the test material) and Ethomeen 18/60. In all studies, half the animals had 

their skin abraded and the other half had intact skin. Mortalities occurred in only one of the two 

studies with Varonic T-220 (4/6 animals died – all in undiluted groups and no difference 

between intact and abraded skin). For the purposes of this hazard characterization, the LD50 will 

be conservatively estimated to be the only dose level tested. 

LD50 ~ 1600 mg/kg [one study only; calculated using a density of 0.8 g/mL] 

Repeated-Dose Toxicity 

Subcategory I: Non-Hydroxylated FND Amines 

1-Octadecanamine, N-methyl-N-octadecyl (CASRN 4088-22-6) 

(1) Sprague-Dawley CD rats (20/sex/dose) were administered 1-octadecanamine, N-methyl-Noctadecyl daily for 13 weeks via the diet. Original doses were 0, 0.15, 0.5 and 1.5% w/w, but 

after 4 weeks, the doses were adjusted to 0, 0.15, 0.4 and 1.0% w/w due to marked depression of 

body weight gain at the high dose. Mean doses over weeks 1 – 13 were 117, 343 or 936 

mg/kg/day (males) and 139, 406 or 1076 mg/kg/day (females). There were no mortalities. 

Alopecia was observed in the high-dose group. Body weight gains of rats in all dosed groups 

were lower than controls (but statistically significant only at the mid and high doses). Food 

consumption and food conversion efficiency were decreased at the high dose. The absolute 

weights of most organs (no specific information provided) were decreased in the high (males and 

females) and mid (males) dose groups. Relative weights of liver, testes, kidneys and lungs were 

increased in all treated groups (no specific information provided). Significant increased 

leukocyte counts and reductions in hemoglobin concentration were seen in all dosed groups. 

Significant reductions in packed cell volume were seen in the mid- and high-dose groups. 

Accumulation of histiocytes with foamy cytoplasm was found in all dose groups in the lamina 

propria of the jejunum, in the mesenteric lymph nodes and to a lesser extent in other tissues. 

Degenerative changes were also seen in the lymph nodes at the high dose and some animals 
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41 

(doses unclear) had peritonitis. In the ovaries, foamy interstitial cells were detected in all dosed 

groups. 

LOAEL ~ 117 mg/kg/day (based on decrease body weight gain, increased weights of liver, 

testes, kidneys and lungs, hematologic changes, accumulation of histiocytes with foamy 

cytoplasm in jejunum and lymph nodes and foamy interstitial cells in the ovaries) 

NOAEL = Not established

(2) New Zealand White rabbits (5/sex/dose) were administered 1-octadecanamine, N-methyl-Noctadecyl once daily, 5 days/week, for 13 weeks via dermal application. Doses were 0 (carrier 

control), 5 or 50 mg/kg/day. The test material (and vehicle control – polyethylene glycol) were 

applied to non-abraded skin with a syringe and left for seven hours before removal (presence of a 

covering was not noted in the summary). Clinical observations included skin sensitivity to touch 

and raised vesicles at the exposure site. Group mean body weight of the 50 mg/kg/day group 

was reduced compared to controls. Skin irritation was present in both dose groups, with a higher 

severity at the high dose level. In addition to the reduction in body weight, other, mild systemic 

effects observed at the high dose group were: decreased hemoglobin concentration, red blood 

cell count and packed cell volume (females); pathological changes in the liver (increased 

incidence of intralobular leukocyte foci) and the presence of epithelioid cells in the mesenteric 

lymph node. 

LOAEL (systemic) = 50 mg/kg/day (based on decreased body weight, slight changes in 

hematology parameters, and pathological changes in the liver and lymph node) 

NOAEL (systemic) = 5 mg/kg/day

LOAEL (local) = 5 mg/kg/day (based on skin irritation, skin sensitivity to touch and raised 

vesicles at the exposure site) 

NOAEL (local) = Not established

Octadecylamine (CASRN 124-30-1, supporting chemical) 

Mongrel dogs (3/dose) (male and female number per group not specified) were administered 

octadecylamine (containing 20% hexadecylamine) once daily, 5 days/week for 1 year via a 

capsule administered orally at doses of 0, 0.6, 3.0 or 15.0 mg/kg/day. One dog treated with 15 

mg/kg/day of the test substance died after 22 weeks of treatment. Weight gains were smaller in 

the 15 mg/kg/day group than controls. No significant hematological effects considered to be 

treatment-related were observed. Pale staining was observed in the tips of the villi of the small 

intestinal mucosa of two dogs treated with 15 mg/kg/day and sinuses of the mesenteric lymph 

nodes were filled with pale foamy histiocytes. No significant changes in organ characteristics 

were observed. 

LOAEL = 15 mg/kg/day (based on mortality, decreased weight gain and intestinal pathological 

changes) 

NOAEL = 3 mg/kg/day 

Hexadecylamine hydrofluoride (CASRN3151-59-5) and 9-Octadecen-1-amine hydrofluoride 

(CASRN 36505-83-6) (a 1:1 mixture, supporting chemical)

(1) Long-Evans rats (70/sex/dose) were administered the test substance (“Hetaflur”) via the diet 

at doses of 1.2, 6 and 30 mg/kg/day continuously for two years. There were two control groups 

(further explanation not provided in the robust summary). The following effects were observed 

in the high dose group only (except where noted): significant decrease in body weight and food 
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42 

consumption (both sexes); changes in a variety of clinical chemistry values (decreases in serum 

glutamic pyruvic transaminase (females), alkaline phosphatase (females, also females in middose group), total protein (females), calcium (males and females), cholesterol (males) and 

triglycerides (males and females); increases in relative liver and adrenal (males) and kidney 

(females) weights and decreases in absolute liver (both sexes) and kidney (males) weights. No 

such effects were reported for the low and mid dose groups. The description of histopathological 

damage was extensive, but the dose levels were not always stated. Ankylosis (stiffness of joints) 

occurred in a few animals at each dose. Enlarged mesenteric lymph nodes and yellow 

discoloration of the small intestine were observed, with incidence dependent on dose (but no 

details were presented on numbers seen at each dose). Reticuloendothelial cell hypertrophy 

and/or hyperplasia were also observed, with no information on which doses resulted in these 

effects. Reproductive organs were examined histologically. 

LOAEL ~ 30 mg/kg/day (based on decreased body weight, changes in various clinical 

chemistry parameters and histopathological changes in the small intestine and lymph nodes) 

NOAEL ~ 6 mg/kg/day

(2) Beagle dogs (six/sex/dose) were administered the test substance (“Hetaflur”) via gavage at 

doses of 1.2, 6 and 12 mg/kg/day for two years. The high dose was 30 mg/kg/day for the first 

five weeks, with a two-week interlude before dosing with the new high dose of 12 mg/kg/day. 

For the first five weeks, dogs experienced excessive salivation before and after dosing, diarrhea 

and emesis. Other than the effects noted for the first five weeks at 30 mg/kg/day, there were no 

other effects observed at any dose on body weight, food consumption, hematology, clinical 

chemistry (except for decreased protein levels in females), organ weight/histopathology 

(including the reproductive organs) for the remainder of the two year study. 

NOAEL = 12 mg/kg/day (highest dose tested) 

Amines, tallow alkyl (CASRN 61790-33-8, supporting chemical) 

Sprague-Dawley rats (5/sex/dose) were administered amines, tallow alkyl (“Genamin TA 

100D”) once daily for 28 days via gavage at doses of 0, 12.5, 50 or 150 mg/kg/day. One 

mortality occurred in the 50 mg/kg/day group and five mortalities occurred in the 150 mg/kg/day 

group. Significant decreases in body weights, body weight gains and food consumption were 

shown in groups treated with 50 and 150 mg/kg/day. Salivation (all animals in the mid- and 

high-dose groups) and piloerection (all animals at the high dose group and females only at the 

mid-dose group) were observed. A variety of hematology and clinical chemistry differences 

were observed between treated and control groups. Decreases in the following parameters were 

seen in one or both sexes at both the mid and high doses (unless noted): mean corpuscular 

volume (MCV), bilirubin, albumin/globulin ratio, total protein/, creatinine (high dose only), 

cholesterol (high dose only) and blood glucose (high dose only). Increases in the following were 

also seen in one or both sexes at the mid and high doses (unless noted): ALAT activity, white 

blood cells, platelets, prothrombin time, red blood cells, ASAT (high dose only), GGT (high 

dose only) and BUN (high dose only). The only hematology/clinical chemistry findings 

observed in the low dose group were decreased MCV in females and increased ALAT and 

decreased potassium and bilirubin in males. In the high dose group, absolute weights of liver 

and kidneys (males only) and heart and thymus (both sexes) were decreased. Again in the high 

dose group, the relative weights were increased in the following organs: brain, adrenals and liver 

(both sexes); kidney (females); and testes and epididymides (males). In the mid-dose group, the 
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43 

absolute liver and kidney weights were decreased in males and the relative kidney weight was 

increased in females. Histological changes at 12.5, 50 and 150 mg/kg/day included histiocytosis 

(with vacuolization of histiocytes) in both the small intestine and the lymph nodes in both sexes. 

Additional histopathological changes were at the mid and high dose level in the liver (necrosis), 

lungs (inflammation), and thymus (depletion of lymphocytes). 

LOAEL = 12.5 mg/kg/day (based on changes in hematology and clinical chemistry and 

histopathological effects in the small intestine and lymph nodes) 

NOAEL = Not established 

Subcategory II: Hydroxylated FND Amines 

N-Tallow alkyl derivatives of 2,2’-iminobis ethanol (CASRN 61791-44-4) 

(1) Wistar SPF rats (17 rats/sex/high dose and 25/sex/all other doses) were administered Ntallow alkyl derivatives of 2,2’-iminobis (“Ethomeen T/12”) daily for 90 days via the diet at 

concentrations of 0, 170, 500, 1500 or 4500 ppm (approximately 0, 15, 50, 150 or 450 

mg/kg/day). Seven of the high dose rats were sacrificed at intervals up to 6 weeks from the 

beginning of the test. There were no mortalities. High dose rats lost hair and generally were 

lethargic throughout the study. No clinical observations were noted in rats at any other dietary 

level. Body weight gain was inhibited at 450 mg/kg/day and partly inhibited at 150 mg/kg/day. 

The palatability of the diet (basis not indicated) was decreased at 150 and 450 mg/kg/day. No 

hematological abnormalities were detected at any dose. No significant differences were seen 

between treated and control group organ weights. Gross macroscopic observations at necropsy 

were seen only at 450 mg/kg/day and consisted of yellow coloration of the stomach and bowel 

contents and thickening and yellow coloration of the mucosa of the small intestine and the 

regional mesenteric nodes. Microscopic findings observed in high and mid-dose animals were 

engorgement of the villi and lamina propria of the small intestine with swollen foamy 

macrophages. Similar macrophages were present in Peyer’s patches and in regional lymph 

nodes. 

LOAEL ~ 150 mg/kg/day (based on gross and microscopic effects on the small intestinal and 

lymph nodes) 

NOAEL ~ 50 mg/kg/day

(2) Crl:CD(SD)BR rats (20/sex/dose) were administered N-tallow alkyl derivatives of 2,2’-

iminobis ethanol (“E1095.01”) daily for 13 weeks via the diet at concentrations of 0.001, 0.015, 

or 0.5% in feed (approximate doses of 0, 0.8, 12 or 400 mg/kg/day). One death (control female) 

and a high incidence of hair loss across all groups were not considered treatment related. Body 

weight gain was slightly reduced at the mid (males only) and high (males and females) levels. 

There were no effects on food consumption or biologically significant differences in hematology 

or organ weights between treatment and control groups. Histiocytosis in the jejunum and 

mesenteric lymph nodes at 400 mg/kg/day was the only treatment-related histopathological 

finding. 

LOAEL ~ 400 mg/kg/day (based on reduced body weight gain and histopathologic effects on 

the small intestine and lymph nodes) 

NOAEL ~ 12 mg/kg/day

(3) Beagle dogs (4/dose, distribution by sex not indicated) were administered N-tallow alkyl 

derivatives of 2,2’-iminobis ethanol (“Ethomeen T/12”) via the diet at doses of 0, 13, 40 or 120 
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44 

mg/kg/day for 90 days. No deaths occurred. Vomiting of the meal was seen in dogs at 40 and 

120 mg/kg/day, but not at 13 mg/kg/day. Treatment of the 120 mg/kg/day group was 

discontinued after 5 – 6 weeks due to poor health and the loss of approximately 20% of body 

weight. Mid-dose males showed a decrease in body weight (significance not provided). At 

120 mg/kg/day, females showed hypochromic anemia and males showed slight elevation in 

blood urea and serum alkaline phosphate. No treatment-related findings were noted for 

urinalysis and no gross lesions were observed. Increased incidences of foamy macrophages in 

the small intestine and regional lymph nodes were found at 40 and 120 mg/kg/day. 

LOAEL ~ 40 mg/kg/day (based on decreased body weight [males] and pathological changes in 

the small intestine and regional lymph nodes) 

NOAEL ~ 13 mg/kg/day

(4) New Zealand White rabbits (5/sex/dose) were administered N-tallow alkyl derivatives of 

2,2’-iminobis ethanol (“Varonic T-220D”) dermally at doses of 0 or 2% w/v (40 mg/kg/day) 5 

days/week for 4 weeks. Distilled water was used as the vehicle and skin was prepared by 

clipping and abrasion before each application (which was done with a syringe and gentle rubbing 

with a glass rod and left for seven hours). Abrasion was discontinued if skin became fissured. In 

addition to body weight and hematology, only liver and kidney weights were obtained. 

Reproductive organs and skin were examined histologically; it is not clear which other organs 

were examined microscopically. Dermal irritation was most severe in Week 2, during which all 

groups exhibited moderate to severe erythema and edema, slight to moderate atonia, slight to 

marked desquamation, moderate coriaceousness and slight to severe fissuring of the exposure 

sites. No dermal irritation was observed in the control group. No significant differences in 

individual body or organ weights of treated rabbits relative to the control rabbits were observed. 

No treatment-related changes in hematological values were observed. Histologically, mild to 

moderate hyperplasia of the epidermis and mild inflammatory changes of the outer dermis were 

observed at the exposure sites of treated animals (specific groups not noted). 

LOAEL (local) ~ 40 mg/kg/day (only dose tested)

NOAEL (systemic) ~ 40 mg/kg/day (only dose tested)

(5) New Zealand albino rabbits (5/sex/dose) were administered N-tallow alkyl derivatives of 

2,2’-iminobis (“Varonic T-220”) dermally at doses of 0 or 10% w/v (reduced to 2% w/v after 

two treatments due to severe skin reactions; 200 mg/kg/day reduced to 40 mg/kg/day) 5 

days/week for 4 weeks. Although initially the skin was abraded, once the concentration dropped, 

abrading the skin discontinued. In addition to body weight and hematology, liver and kidney 

were weighed. Several tissues, including skin, were examined histologically. The test substance 

produced severe irritation (erythema to edema, atonia, desquamation) and a high sheen 

appearance following the sloughing of eschar tissue during the course of the study. Body weight 

losses were seen in 6 of 10 treated animals by the end of week 1, after which steady weight gain 

was noted. Anorexia was noted in three animals. Those same three animals, along with two 

others, displayed signs of rales (histopathology showed signs of focal inflammatory respiratory 

tract disease). No biologically significant, treatment-related effects on hematology were 

observed in the treated animals. Additionally, necropsy confirmed treatment-related cutaneous 

morphological alterations. Females exhibited decreased kidney weight. 

LOAEL (local) ~ 40 mg/kg/day (only dose tested)) 

NOAEL (systemic) ~ 40 mg/kg/day (only dose tested)) 
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(6) There were four dermal toxicity studies presented in the HPV submission. The two 

summarized above are 28-day studies. A 90-day study was terminated after 17 days and so is not 

presented here. In that study, rabbits were exposed (shaved, intact skin) to either 0.1 or 0.5% of 

the test substance (N-tallow alkyl derivatives of 2,2’-iminobis ethanol) in distilled water for 

seven hours after each application. After 17 days, five (1/10 low dose, 4/10 high dose) treated 

animals and one control had died or were sacrificed. The decision to stop the study was based on 

moderate/marked skin irritation that precluded an assessment of systemic toxicity because of the 

likely effect the irritation would have on absorption. In addition to the terminated 90-day study, 

one 28-day study is not presented because it resulted in excessive numbers of deaths that 

precluded evaluation of treatment-related effects. 

Reproductive Toxicity 

Subcategory I: Non-Hydroxylated FND Amines 

Tallow alkyl amines (CASRN 61790-33-8, supporting chemical) 

In a reproductive/developmental screening test, Sprague-Dawley Crl:CD(SD)BR rats 

(10/sex/dose) were administered tallow alkyl amines (“Genamin TA 100”) in sesame oil via 

gavage at doses of 0, 12.5, 50 or 150 mg/kg/day for a 14 day premating period and throughout 

mating, gestation and up to day 3 of lactation for females (~ 54 days); and through the premating and mating periods for males (28 days). One mortality per sex was observed in the 50 

mg/kg/day group and 50% mortality occurred in both sexes at 150 mg/kg/day; all were 

considered treatment-related. Clinical signs were observed at high (salivation, hunched posture, 

incidental soft stools and piloerection) and mid (salivation) doses. A dose-related decrease in 

premating body weight gains was observed in the 50 and 150 mg/kg/day groups (all animals) and 

it was also seen in all doses in females during gestation. A decrease in gestational and lactational 

body weights was observed in females in the mid and high, and low and mid dose groups, 

respectively. Food consumption was decreased in both sexes at 50 and 150 mg/kg/day. Females 

in the 50 and 150 mg/kg/day groups also had decreased food consumption during gestation. At 

150 mg/kg/day, the mating index (43% vs. 100% in controls) and fertility index (33% vs. 100% 

in controls) were decreased and the precoital interval (13.5 days vs. 2.3 days in controls) was 

increased. Implantation loss was 100% at 150 mg/kg/day. Gestation duration in the high dose 

females was also affected (no specifics provided). Males at 150 mg/kg/day showed increased 

relative weights of epididymis and testes (and decreased absolute weight of epididymis) and 

tubular degeneration with decreased spermatogenesis in the testes was seen in one male. 

Atrophy of corpora lutea was seen in 8 of 10 females at 150 mg/kg/day. 

LOAEL (parental toxicity) = 12.5 mg/kg/day (based on decreased body weight during 

gestation) 

NOAEL (parental toxicity) = Not established 

LOAEL (reproductive toxicity) = 150 mg/kg/day (based on implantation loss, decreased 

mating and fertility indices, increased precoital time, atrophy of corpora lutea) 

NOAEL (reproductive toxicity) = 50 mg/kg/day 
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46 

9-Octadecen-1-amine, hydrofluoride (CASRN 3151-59-5, supporting chemical) and 9-

octadecen-1-amine, hydrofluoride (CASRN 36505-83-6, supporting chemical), 1:1 mixture 

In a one-generation study, Long-Evans rats (10 males and 20 females/group) were administered a 

1:1 mixture of 9-octadecen-1-amine, hydrofluoride and 9-octadecen-1-amine, hydrofluoride 

(“Hetaflur”) in methylcellulose via gavage at doses of 0, 1.2, 6.0 or 30.0 mg/kg/day for a 60-day 

(males) or 15-day (females) premating period and throughout mating, gestation and lactation for 

females. Half of the females were sacrificed on gestation day 13 and examined for the evidence 

and status of embryos. The other half were allowed to deliver and the pups were followed 

through lactation day 21. A decrease in mean body weight gain was observed in males in the 

high-dose group when compared to the control group. There were no adverse effects on the 

following parameters: mortality, female body weight gain or overall weight, mating 

performance, estrous cycles, pregnancy rates, lengths of gestation, intrauterine deaths, 

implantation efficiencies, implantation number per litter size or gross pathology results. 

NOAEL (parental toxicity) = 30 mg/kg/day (highest dose tested) 

NOAEL (reproductive toxicity) = 30 mg/kg/day (highest dose tested) 

Subcategory II: Hydroxylated FND Amines

No data available for this endpoint. 

Developmental Toxicity 

Subcategory I: Non-Hydroxylated FND Amines 

1-Octadecanamine, N-methyl-N-octadecyl- (CASRN 4088-22-6) 

Pregnant New Zealand White rabbits (16/dose) were administered 1-octadecanamine, N-methylN-octadecyl- in corn oil via gavage at doses of 0, 50, 250 or 1000 mg/kgd/day for days 6 through 

18 of gestation. At 250 and 1000 mg/kg/day, maternal body weight gain was significantly lower 

during days 12 through 18 of gestation. No treatment-related effects were found on pregnancy 

rate, mortality, abortions or gestation length. There was a high post-implantation loss seen in the 

high dose group, but it was not significant given the unusually high loss observed in controls. 

No treatment-related effects were found on fetal size, fetal sex or mortalities; however, slight 

reductions in fetal weight at 250 and 1000 mg/kg/day were observed. The robust summary states 

that possible embryolethality at 1000 mg/kg/day cannot be disregarded. 

LOAEL (maternal toxicity) = 250 mg/kg/day (based on decreased weight gain during 

gestation) 

NOAEL (maternal toxicity) = 50 mg/kg/day 

LOAEL (developmental toxicity) = 1000 mg/kg/day (based on possible embryolethality) 

NOAEL (developmental toxicity) = 250 mg/kg/day 

Tallow alkyl amines (CASRN 61790-33-8, supporting chemical) 

In a reproductive/developmental screening test describe above, Sprague-Dawley Crl:CD(SD)BR 

rats (10/sex/group) were administered tallow alkyl amines (“Genamin TA 100”) in sesame oil 

via gavage at doses of 0, 12.5, 50 or 150 mg/kg/day (protocol, systemic and reproductive effects 

described previously). There were no litters in the high dose group. Pup body weights were 

decreased in the mid-dose group. There were no treatment-related effects on the sex ratio, 

viability index, survival or visible abnormalities for the 12.5 and 50 mg/kg/day groups. 
U.S. Environmental Protection Agency September, 2010 

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47 

LOAEL (maternal toxicity) = 12.5 mg/kg/day (based on decreased body weight during 

gestation) 

NOAEL (maternal toxicity) = Not established 

LOAEL (developmental toxicity) = 50 mg/kg/day (decreased pup body weight) 

NOAEL (developmental toxicity) = 12.5 mg/kg/day 

Cis-9-Octadecenylamine (CASRN 112-90-3, supporting chemical) 

(1) Pregnant Sprague-Dawley rats (28/dose) were administered cis-9-octadecenylamine 

(“Oleylamine”) in corn oil via gavage at doses of 0, 10, 40 or 80 mg/kg/day for days 6 through 

15 of gestation. Clinical signs (rales, salivation, soft stools, diarrhea, few/abnormal colored 

feces, fecal/urine staining and unkempt appearance) of toxicity were observed in the 40 and 80 

mg/kg/day dose groups. High dose animals also presented emaciation, rough coat, and dark red 

material around the eyes/nose/mouth. Dose-dependent body weight losses or reduced weight 

gain, and reduction in food consumption, occurred during the treatment period in the 40 and 80 

mg/kg/day dose groups. No other maternal effects were noted, including no effects on the 

gastrointestinal tract. There were no effects on any fetal parameter evaluated (fetal external, 

visceral or skeletal examinations). 

LOAEL (maternal toxicity) = 40 mg/kg/day (based on clinical signs, decreased body weight) 

NOAEL (maternal toxicity) = 10 mg/kg/day 

NOAEL (developmental toxicity) = 80 mg/kg/day (highest dose tested) 

(2) New Zealand White rabbits (22 artificially-inseminated females/group) were administered 

cis-9-octadecenylamine (“Oleylamine”) in corn oil via gavage at doses of 0, 3, 10 or 30 

mg/kg/day for days 6 through 18 of gestation. Two females died in the high-dose group. 

Clinical signs (irritation of the lips and chin, labored breathing and rales) of toxicity were 

observed at 10 and 30 mg/kg/day. Dose-dependent body weight losses or reduced gains and 

reduced food consumption occurred at the 10 and 30 mg/kg/day groups (significant only in the 

high dose group). There were no effects on the gastrointestinal tract of the does. There were no 

treatment-related effects on the fetuses examined. 

LOAEL (maternal toxicity) = 10 mg/kg/day (based on clinical signs, reduced body weight) 

NOAEL (maternal toxicity) = 3 mg/kg/day 

NOAEL (developmental toxicity) = 30 mg/kg/day (highest dose tested) 

9-Octadecen-1-amine, hydrofluoride (CASRN 3151-59-5, supporting chemical) and 9-

octadecen-1-amine, hydrofluoride (CASRN 36505-83-6, supporting chemical), 1:1 mixture 

(1) Pregnant Long-Evans rats (20/dose) were administered 9-octadecen-1-amine, hydrofluoride 

and 9-octadecen-1-amine, hydrofluoride, 1:1 mixture (“Hetaflur”) in methylcellulose via gavage 

at doses of 0, 1.2, 6.0 and 30.0 mg/kg/day for days 6 through 15 of gestation. No adverse effects 

were found on maternal body weight, pregnancy rate, mortality, abortions, gestation length, 

implantation efficiency or resorptions. No treatment-related effects were found on fetal survival, 

size, sex ratio or incidence of ossification. There were sporadic malformations seen in the 

treated groups (total incidence was 0, 0.6, 0.5, and 3.1% in control, low, mid and high dose, 

respectively). No other information was provided in the robust summary. 

NOAEL (maternal toxicity) = 30 mg/kg/day (highest dose tested) 

LOAEL (developmental toxicity) = 30 mg/kg/day (based on unspecified malformations) 

NOAEL (developmental toxicity) = 6 mg/kg/day 
U.S. Environmental Protection Agency September, 2010 

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48 

(2) To clarify the results of the study described above in which sporadic fetal malformations 

were observed, the same test substance was administered under identical conditions as those 

described above. In this study, there was a significant decrease in the mean weight gains of the 

high-dose group dams. No other adverse effects were found on pregnancy rate, mortality, 

gestation length, implantation efficiency or resorptions. No treatment-related effects were found 

on fetal size, fetal sex, incidence of ossification, incidence of malformations or mortalities. 

Specific incidence data were not provided. 

LOAEL (maternal toxicity) = 30 mg/kg/day (based on body weight) 

NOAEL (maternal toxicity) = 6 mg/kg/day 

NOAEL (developmental toxicity) = 30 mg/kg/day (highest dose tested) 

(3) Pregnant Long-Evans rats (20/dose) were administered 9-octadecen-1-amine, hydrofluoride 

and 9-octadecen-1-amine, hydrofluoride, 1:1 mixture (“Hetaflur”) in methylcellulose via gavage 

at doses of 0, 1.2, 6.0 and 30.0 mg/kg/day from gestation day 15 through lactation day 21. As a 

Segment III test, does were allowed to deliver and the offspring were followed through lactation. 

No significant adverse effects were found on maternal body weight (there was a slight reduction 

in body weight gain in high dose does only during lactation), pregnancy rate, mortality, gestation 

length, implantation efficiency or resorptions, live-birth index, postnatal viability, sex ratios or 

soft-tissue malformations. No significant treatment-related effects were found on fetal size 

(there was reduced mean fetal weights in all treated groups on lactation day 0, but not 

statistically significant compared with controls), fetal sex, incidence of ossification, incidence of 

malformations or mortalities. EPA considers this study of limited utility because dosing does not 

capture organogenesis in its entirety. 

NOAEL (maternal toxicity) = 30 mg/kg/day (highest dose tested)

NOAEL (developmental toxicity) = 30 mg/kg/day (highest dose tested)

Subcategory II: Hydroxylated FND Amines 

No data available for this endpoint. 

Genetic Toxicity – Gene Mutation 

In vitro 

Subcategory I: Non-Hydroxylated FND Amines 

Salmonella typhimurium assays were performed with three sponsored chemicals (CASRNs 112-

75-4, 112-69-6 and 124-28-7), however in each case only two bacterial strains were tested. The 

guidelines require at least five different Salmonella strains (or four Salmonella strains and one E. 

coli strain) since each strain identifies a different type of possible mutation. Therefore, for the 

purposes of the US HPV Challenge Program, these data were considered inadequate for this 

endpoint. 
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Hexadecylamine (CASRN 143-27-1) 

Hexadecylamine was tested in Salmonella typhimurium strains TA97, TA98, TA100 and 

TA1535 at concentrations of 0.3, 1.0, 3.0, 10, 33, 66 or 100 μg/plate, with and without metabolic 

activation. Both positive and negative controls were used. Cytotoxicity was not noted. Control 

responses were not provided. 

CASRN 143-27-1 was not mutagenic in this assay. 

1-Octadecanamine, N-methyl-N-octadecyl (CASRN 4088-22-6) 

1-Octadecanamine, N-methyl-N-octadecyl (“Genamin SH 301”) was tested in Salmonella 

typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 and Escherichia coli strain 

WP2uvrA at concentrations of 4, 20, 100, 500, 2500 and 5000 μg/plate with and without 

metabolic activation. Both positive and negative controls were used. Cytotoxicity was not 

observed at any concentration. Control responses were not provided. 

CASRN 4088-22-6 was not mutagenic in these assays. 

Dihydrogenated tallow methylamine (CASRN 61788-63-4) 

(1) Dihydrogenated tallow methylamine (“Adogen 343”) was tested in Salmonella typhimurium

strains TA98, TA100, TA1535, TA1537 and TA1538 at concentrations of 0.33, 1.0, 3.3, 10, 33 

and 100 μg/plate with and without metabolic activation. Both positive and negative controls 

were used. Cytotoxicity was observed at concentrations greater than or equal to 10 μg/plate. 

Precipitate was observed at all concentrations. Control responses were not provided. 

CASRN 61788-63-4 was not mutagenic in this assay. 

(2) Dihydrogenated tallow methylamine (“Adogen 343”) was tested in L5178Y TK+/1mouse 

lymphoma cells at concentrations of 0.33, 1.0, 3.3, 10, 33 and 100μg/plate with and without 

metabolic activation. Both positive and negative controls were used. Cytotoxicity was observed 

at 1 μL/mL without and 10 μL/mL in with metabolic activation (data assumed to have been in a 

dose-range finding study since the units are different). Control responses were not provided. 

CASRN 61788-63-4 was not mutagenic in this assay. 

1-Octadecyl amine (CASRN 124-30-1, supporting chemical) 

(1) 1-Octadecyl amine was tested in Salmonella typhimurium strains TA97, TA98, TA100 and 

TA1535 at concentrations of 0, 100, 333, 1000 or 6666 μg/plate with and without metabolic 

activation. Both positive and negative controls were used. Evidence of cytotoxicity was not 

noted; but precipitate was observed at 333 and 1000 ug/plate (no mention of 6666 ug/plate). 

Positive control responses were as expected. 

CASRN 124-30-1 was not mutagenic in this assay. 

(2) 1-Octadecyl amine (“Genamine 18 R 100 D”) was tested in Salmonella typhimurium strains 

TA98, TA100, TA1535, TA1537 and TA1538 and Escherichia coli strain WP2uvrA at 

concentrations of 0, 4, 20, 100, 500, 2500 or 10,000 μg/plate (experiment 1) and concentrations 

of 0, 4, 20, 100, 500, 2500 and 5000 μg/plate (experiment 2), with and without metabolic 

activation. Both positive and negative controls were used in each study. Cytotoxicity occurred 

at 100 μg/plate and there was a visible precipitate at concentrations of 500 ug/plate and higher. 

Control responses were not provided. 

CASRN 124-30-1 was not mutagenic in this assay. 
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Coco alkyl amine (CASRN 61788-46-3, supporting chemical) 

Coco alkyl amine (“Genamin C 100 D”) was tested in Salmonella typhimurium strains TA98, 

TA100, TA1535, TA1537 and TA1538 and Escherichia coli strain WP2uvrA at concentrations 

of 0.16, 0.8, 4, 20, 100, 500, 2500 or 10,000 μg/plate with and without metabolic activation. 

Both positive and negative controls were used in each study. Cytotoxicity was observed at 

concentrations > 20 μg/plate with Salmonella typhimurium and > 100 μg/plate with Escherichia 

coli. Control responses were not provided. 

CASRN 61788-46-3 was not mutagenic in these assays. 

Tallow alkyl amine (CASRN 61790-33-8, supporting chemical) 

Tallow alkyl amine (“Genamin TA 100 D”) was tested in Salmonella typhimurium strains TA98, 

TA100, TA1535, TA1537 and TA1538 and Escherichia coli strain WP2uvrA at concentrations 

of 0.16 – 10,000 μg/plate with and without metabolic activation. Both positive and negative 

controls were used in each study. Cytotoxicity was observed at concentrations ≥ 20 μg/plate. 

Control responses were not provided. 

CASRN 61790-33-8 was not mutagenic in these assays. 

Cis-9-octadecenylamine (CASRN 112-90-3, supporting chemical) 

(1) In a reverse mutation assay, cis-9-octadecenylamine was tested in Salmonella typhimurium

strains TA98, TA100, TA1535, TA1537 and TA1538 at concentrations of 0.2, 1, 5, 10 and 15 

μg/plate without metabolic activation and 2, 10, 25, 50 and 100 μg/plate with metabolic 

activation. Both positive and negative controls were used in each study. Cytotoxicity was 

observed at concentrations of 100 μg/plate with activation and ≥ 15 μg/plate without activation 

(based on a previous study). Control responses were not provided. 

CASRN 112-90-3 was not mutagenic in these assays. 

(2) Cis-9-octadecenylamine was tested in Chinese hamster ovary cells in an HGPRT mutation 

assay at concentrations of 0.1 – 2 nL/mL (without metabolic activation, first assay) and 5 – 9 

nL/mL (with metabolic activation, first assay); and 1 – 2.5 nL/mL (without metabolic activation, 

second assay in duplicate) and 7 – 10 nL/mL (with metabolic activation, second assay in 

duplicate). Both positive and negative controls were used in each study. No mutagenic activity 

was induced by cis-9-octadecenylamine in any strain. Cytotoxicity was observed at 2.5 nL/mL 

in the absence of activation and at 10.0 nL/mL in the presence of activation. In these three 

assays, an increase in mutant frequency was observed on two occasions, but were not reproduced 

in the other two assays (i.e., at the highest dose of 2 nL/mL without activation and 9 nL/mL with 

activation in the first assay, but not in the other two; and in one assay at a concentration not 

stated, but apparently not reproduced in the other two assays). Control responses were not 

provided. 

CASRN 112-90-3 was not mutagenic in this assay. 

(3) Cis-9-octadecenylamine was tested in L5178Y TK+/- mouse lymphoma cells at 

concentrations of 0.13 – 0.32 nL/mL [without activation] or 1.2 – 13 nL/mL [with activation] 

(first assay); of 0.13 – 1.8 nL/mL [without activation] or 1.3 – 13 nL/mL [with activation] 

(second assay); and 0.2 - 1 nL/mL [without activation] or 1.5 – 11.0 nL/mL [with activation] 

(third [confirmatory] assay). Both positive and negative controls were used in each study. 
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Cytotoxicity was observed in each assay at concentrations greater than or equal to the highest 

concentration tested. Control responses were not provided. 

CASRN 112-90-3 was not mutagenic in this assay. 

Subcategory II: Hydroxylated FND Amines 

N-Tallow alkyl derivatives of 2,2’-iminobis ethanol (CASRN 61791-44-4) 

(1) N-Tallow alkyl derivatives of 2,2’-iminobis ethanol (“Genamin S080”) was tested in 

Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 at concentrations 

of 0.0008, 0.02, 0.04 and 0.08 μg/plate with and without metabolic activation. Both positive and 

negative controls were used. Slight cytotoxicity was observed at 0.1 μL/plate in a dose-rangefinding study. Control responses were not provided. 

CASRN 61791-44-4 was not mutagenic in this assay. 

(2) N-Tallow alkyl derivatives of 2,2’-iminobis ethanol (“TAMET Benzoate”) was tested in 

Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 at concentrations 

of 2.0, 10, 50, 100 and 200 μg/plate with and without metabolic activation. Both positive and 

negative controls were used. Slight cytotoxicity was observed at 305 μg/plate in a dose-range 

finding study. Control responses were not provided. 

CASRN 61791-44-4 was not mutagenic in this assay. 

 

(3)N-Tallow alkyl derivatives of 2,2’-iminobis ethanol (“Varonic T-220”) was tested in 

Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 at concentrations 

of 0.0008, 0.004, 0.002, 0.04 and 0.08 μL/plate with and without metabolic activation. Both 

positive and negative controls were used. There was no cytoxicity. Control responses were not 

provided. 

CASRN 61791-44-4 was not mutagenic in this assay. 

(4) N-tallow alkyl derivatives of 2,2’-iminobis ethanol (“Varonic T-220”) was tested in L5178Y 

TK+/- mouse lymphoma cells at concentrations of 0.33, 1.0, 3.3, 10, 33 and 100 μg/plate with 

and without metabolic activation. Both positive and negative controls were used. Complete 

cytotoxicity was observed at 0.1 μL/mL (equivalent to 100 ug/mL) without and 10 μL/mL 

(equivalent to 10000 ug/mL) with metabolic activation. Control responses were not provided. 

CASRN 61791-44-4 was not mutagenic in this assay. 

Genetic Toxicity – Chromosomal Aberrations 

In vitro 

Subcategory I: Non-Hydroxylated FND Amines 

Cis-9-Octadecenylamine (CASRN 112-90-3, supporting chemical) 

(1) Cis-9-octadecenylamine was tested in Chinese hamster ovary cells at concentrations of 0.05, 

0.15, 0.5, 1.5 and 5.0 nL/mL without metabolic activation and 0.2, 0.6, 2.0, 6.0 and 20.0 nL/mL 

with metabolic activation. Both positive and negative controls were used in each study. 

Cytotoxicity was observed at 5.0 nL/mL without metabolic activation and 20.0 nL/mL with 

metabolic activation. Control responses were not provided. 

CASRN 112-90-3 did not increase the number of chromosomal aberrations in this assay. 
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Subcategory II: Hydroxylated FND Amines 

N-Tallow alkyl derivatives of 2,2’-iminobis ethanol (CASRN 61791-44-4) 

N-Tallow alkyl derivatives of 2,2’-iminobis ethanol (“Varonic T-220”) was tested in Chinese 

hamster ovary cells at concentrations of 0.005 – 0.03 μL/mL (without activation) and 0.05 – 0.3 

uL/mL (with activation). Both positive and negative controls were used. Cytotoxic 

concentrations were > 0.01 and > 0.03 μL/mL for the without and with metabolic activation 

assays, respectively. Controls responded appropriately. 

CASRN 61791-44-4 induced chromosomal aberrations with metabolic activation, and did 

not induce chromosomal aberrations without metabolic activation in this assay 

In vivo 

Subcategory I: Non-Hydroxylated FND Amines 

N,N-Dimethyl-1-dodecanamine (CASRN 112-18-5, supporting chemical) 

In an erythrocyte micronucleus test, HsdWin:NMRI mice (5/sex/group) were administered N,Ndimethyl-1-dodecanamine (“Genamin LA 302D”) in sesame oil via gavage at doses of 120, 400 

or 1200 mg/kg daily for two days (total of two doses). Both positive and negative controls were 

used. The robust summary states that 6/10 mice died prematurely in the high dose group, but 

they were replaced and the new animals survived. Controls responded appropriately. 

CASRN 112-18-5 did not increase the number of micronucleated cells in this assay. 

Tallow alkyl amine (CASRN 61790-33-8, supporting chemical) 

Tallow alkyl amine (in sesame oil) was administered to Sprague-Dawley rats (5/sex/group) in a 

single dose of 2000 mg/kg by gavage in a rat micronucleus test in bone marrow cells. Both 

positive and negative controls were used. One male died at 48 hours. Genotoxic effects were 

not observed in the test group. Control responses were appropriate. 

CASRN 61790-33-8 did not increase the number of micronucleated cells in this assay. 

Cis-9-Octadecenylamine (CASRN 112-90-3, supporting chemical) 

ICR mice (5/sex/group) were administered cis-9-octadecenylamine (in corn oil) at doses of 500, 

2500 or 5000 mg/kg via gavage in a cytogenetics assay. Both positive and negative controls 

were used. One female died prematurely. Control responses were appropriate. 

CASRN 112-90-3 did not increase the number of chromosome aberrations in this assay. 

Subcategory II: Hydroxylated FND Amines 

N-Tallow alkyl derivatives of 2,2’-iminobis ethanol (CASRN 61791-44-4) 

(1) Sprague-Dawley rats (5/sex/group) were administered N-tallow alkyl derivatives of 2,2’-

iminobis ethanol (“Varonic T-220”) in water by gavage at doses of 39, 130 or 390 mg/kg/day 

daily for five days in a cytogenicity study. Both positive and negative controls were used. 

Controls responded appropriately. 

CASRN 61791-44-4 did not induce chromosome aberrations in this assay. 

(2) In an erythrocyte micronucleus test, CD1 mice (15/sex/group) were administered N-tallow 

alkyl derivatives of 2,2’-iminobis ethanol (“15% TAMET solution with 5% H3PO4 in water”) via 

gavage at a single dose of 10860 mg/kg/day. Five mice/sex were sacrificed at 24, 48 and 72 

hours. Both positive and negative controls were used. One treated male died. Although there 
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53 

were no biologically significant increases in the number of micronucleated polychromatic 

erythrocytes, there was apparent toxicity to the bone marrow. Because of this toxicity in the 

bone marrow, three dose levels should have been employed – in accordance with OECD/OCSPP 

guidelines for this assay. Controls responded appropriately. 

CASRN 61791-44-4 did not increase the number of micronucleated cells in this assay, but 

the result is considered inconclusive. 

Genetic Toxicity – Other 

In vitro 

Subcategory I: Non-Hydroxylated FND Amines 

Dihydrogenated tallow methylamine (CASRN 61788-63-4) 

In an unscheduled DNA synthesis test, dihydrogenated tallow methylamine (“Adogen 343”) was 

tested in Sprague-Dawley hepatocyte primary cell cultures at concentrations of 32.1, 41.7, 54.2, 

70.4, 91.6, 119.0, 154.8, 201.2, 261.5 and 340 μg/mL. Both positive and negative controls were 

used. Cytotoxicity was observed only at the highest concentration (340 ug/mL). Controls 

responded appropriately. 

CASRN 61788-63-4 did not induce unscheduled DNA synthesis in this assay. 

Subcategory II: Hydroxylated FND Amines 

N-Tallow alkyl derivatives of 2,2’-iminobis ethanol (CASRN 61791-44-4) 

In two studies of unscheduled DNA synthesis tests, N-tallow alkyl derivatives of 2,2’-iminobis 

ethanol (“Varonic T-220”) was tested in Sprague-Dawley hepatocyte primary cell cultures at ten 

concentrations between 0.035 × 10-4 – 1.0 × 10-4 μL/mL (experiment 1) and an unspecified 

number of concentrations between 0.008 × 10-4 – 0.23 × 10-4 μL/mL (experiment 2). Both 

positive and negative controls were used in each study. Due to excessive toxicity – and 

questionable UDS results - in the first experiment, the second test was conducted. Overall, 

cytotoxicity was observed at ≥ 0.052 × 10-4 μL/mL. Controls responded appropriately. 

CASRN 61791-44-4 did not induce unscheduled DNA synthesis in this assay. 

Additional Information 

Skin Irritation 

Subcategory I: Non-Hydroxylated FND Amines 

N,N-Dimethyl-1-hexadecanamine (CASRN 112-69-6) 

New Zealand White rabbits (6/dose) were administered N,N-dimethyl-1-hexadecanamine 

(“ADMA 6”) on shaved skin at a dose of 0.5 grams and the skin was occluded for 4 hours. After 

four hours, the covering was removed, the area washed with water and the animals were 

examined at that time and then at 24 and 48 hours Corrosivity and skin irritation (moderate to 

severe erythema and edema) was observed at 48 hours (but not @ 4 or 24 hours) following 

exposure in 5/6 animals. This study is a TSCATS submission and can be retrieved by typing in 

the CASRN at the following link: http://www.srcinc.com/what-wedo/databaseforms.aspx?id=384 . 

CASRN 112-69-6 was corrosive to rabbit skin in this assay.
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N,N-Dimethyl-1-tetradecanamine (CASRN 112-75-4) 

New Zealand White rabbits (6/dose) were administered N,N-dimethyl-1-tetradecanamine 

(“ADMA 2”) on shaved skin at at a dose of 0.5 ml and the skin was occluded for 4 hours. After 

four hours, the covering was removed, the area washed with water and the animals were 

examined at that time and then at 24 and 48 hours. No corrosivity or skin irritation was observed 

following exposure. This study is a TSCATS submission and can be retrieved by typing in the 

CASRN at the following link: http://www.srcinc.com/what-we-do/databaseforms.aspx?id=384 . 

CASRN 112-75-4 was not irritating to rabbit skin in this assay.

N,N-Dimethyl-1-octadecanamine (CASRN 124-28-7) 

New Zealand White rabbits (6/dose) were administered N,N-dimethyl-1-octadecanamine 

(“ADMA 8”)on shaved skin at a dose of 0.5 mL and the skin was occluded for 4 hours. After 

four hours, the covering was removed, the area washed with water and the animals were 

examined at that time and then at 24 and 48 hours Corrosivity and skin irritation (moderate to 

severe erythema and edema) was observed at 24 and 48 hours (but not @ 4 hours) following 

exposure in all six animals. This study is a TSCATS submission and can be retrieved by typing 

in the CASRN at the following link: http://www.srcinc.com/what-wedo/databaseforms.aspx?id=384.

CASRN 124-28-7 was corrosive to rabbit skin in this assay.

Eye Irritation 

Subcategory I: Non-Hydroxylated FND Amines 

N,N-Dimethyl-1-hexadecanamine (CASRN 112-69-6) 

New Zealand White rabbits (6/dose) were administered N,N-dimethyl-1-hexadecanamine 

(“ADMA 6”) at 0.1 mL in one eye and the other eye served as the control. Animals were 

evaluated at 24, 48 and 72 hours following dosing. The study in rabbits showed irritation 

following exposure. This study is a TSCATS submission and can be retrieved by typing in the 

CASRN at the following link: http://www.srcinc.com/what-we-do/databaseforms.aspx?id=384.

CASRN 112-69-6 was irritating to rabbit eyes in this assay. 

N,N-Dimethyl-1-tetradecanamine (CASRN 112-75-4) 

New Zealand White rabbits (6/dose) were administered N,N-dimethyl-1-tetradecanamine 

(“ADMA 4”) at 0.1 mL in one eye and the other eye served as the control. Animals were 

evaluated at 24, 48 and 72 hours following dosing. The study in rabbits showed irritation 

following exposure. This study is a TSCATS submission and can be retrieved by typing in the 

CASRN at the following link: http://www.srcinc.com/what-we-do/databaseforms.aspx?id=384.

CASRN 112-75-4 was irritating to rabbit eyes in this assay.
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

55 

N,N-Dimethyl-1-octadecanamine (CASRN 124-28-7) 

New Zealand White rabbits (6/dose) were administered N,N-dimethyl-1-octadecanamine 

(“ADMA 8”) at 0.1 mL in one eye and the other eye served as the control. Animals were 

evaluated at 24, 48 and 72 hours following dosing. The study in rabbits showed irritation 

following exposure. This study is a TSCATS submission and can be retrieved by typing in the 

CASRN at the following link: http://www.srcinc.com/what-we-do/databaseforms.aspx?id=384.

CASRN 124-28-7 was irritating to rabbit eyes in this assay.

Conclusion: 

Subcategory I: Non-Hydroxylated FND Amines 

The acute oral toxicity in rodents for the 21 members of this subcategory is low based on studies 

in nine sponsored chemicals in rats. The acute dermal toxicity in animal studies for this 

subcategory is also low based on studies of five sponsored chemicals in rabbits. Oral repeateddose toxicity studies are available for one sponsored chemical (CASRN 4088-22-6) and three 

supporting chemicals (CASRNs 124-30-1, 3159-59-5/36505-83-6, and 61790-33-8). One dermal 

repeated-dose toxicity study is available for a sponsored chemical (CASRN 4088-22-6). In the 

13-week oral gavage study with CASRN 4088-22-6 in rats, there was no NOAEL for systemic 

effects and the following effects were observed at the lowest tested dose of 117 mg/kg/day: 

decreased body weight gain, organ weight changes, hematological changes and pathological 

changes in the intestine, lymph nodes and ovaries. In a one year study in dogs, CASRN 

124-30-1 (supporting chemical) was administered via a capsule resulting in mortality, decreased 

body weight gain and pathological changes in the intestine at a dose of 15 mg/kg/day; the 

NOAEL for systemic toxicity was 3 mg/kg/day. The supporting chemical, CASRN 

3159-59-5/36505-83-6, was tested in rats and dogs via the oral route. In the two-year dietary rat 

study, there was a decrease in body weight, clinical chemistry changes and pathological changes 

in the intestine and lymph node at 30 mg/kg/day; the NOAEL for systemic toxicity was 

6 mg/kg/day. In the two-year gavage study in dogs, there were no effects observed; the NOAEL 

for systemic toxicity was 12 mg/kg/day (highest dose tested). In the only repeated-dose dermal 

study in the subcategory, rabbits were exposed to the sponsored chemical, CASRN 4088-22-6, 

daily for 13 weeks. Irritation was observed at the two doses used, resulting in no NOAEL for 

this local effect (lowest tested dose of 5 mg/kg/day). The NOAEL for systemic effects was 

5 mg/kg/day, based on the following effects observed at 50 mg/kg/day: decreased body weight, 

slight changes in hematological parameters, and pathological changes in the liver and lymph 

nodes. 

There were no reproductive toxicity studies in any of the 21 sponsored chemicals; however there 

were studies with two supporting chemicals which are used to read-across to the sponsored 

chemicals. In a dietary combined reproductive/developmental toxicity study with CASRN 

61790-33-8, rats dosed with 150 mg/kg/day experienced implantation loss, decreased mating and 

fertility indices, increased precoital time interval and atrophy of corpora lutea; the NOAEL for 

reproductive toxicity was 50 mg/kg/day. In an oral one-generation reproductive toxicity study 

with CASRN 3159-59-5/36505-83-6 in rats, there were no effects on any reproductive 

parameters assessed; the NOAEL for reproductive toxicity was 30 mg/kg/day (highest dose 

tested). 

Oral developmental toxicity studies were available with one sponsored chemical 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

56 

(CASRN 4088-22-6) and three supporting chemicals (CASRNs 112-90-3, 3159-59-5/36505-83-

6, and 61790-33-8). In a prenatal oral developmental toxicity study with rabbits using CASRN 

4088-22-6, dams exhibited decreased weight gain at 250 mg/kg/day and above; the NOAEL for 

maternal toxicity was 50 mg/kg/day. Embryolethality at 1000 mg/kg/day could not be 

discounted; the NOAEL for developmental toxicity was 250 mg/kg/day. The combined 

reproductive/developmental toxicity study with the supporting chemical CASRN 61790-33-8 in 

rats resulted in no NOAEL for maternal toxicity (based on decreased body weight at the lowest 

tested dose of 12.5 mg/kg/day) and a NOAEL of 12.5 mg/kg/day for developmental toxicity 

(based on decreased pup body weights at 50 mg/kg/day). There were two oral prenatal 

developmental toxicity studies, one with rats and one with rabbits, using the supporting chemical 

CASRN 112-90-3. In the rat study, maternal toxicity was observed at 40 mg/kg/day (clinical 

signs and a decrease in body weight); the NOAEL for maternal toxicity was 10 mg/kg/day. 

There was no developmental toxicity; the NOAEL for developmental toxicity was 80 mg/kg/day 

(highest dose tested). In the rabbit study, dams exhibited clinical signs and decreased body 

weight at 10 mg/kg/day; the NOAEL for maternal toxicity was 3 mg/kg/day. There was no 

developmental toxicity; the NOAEL for developmental toxicity was 30 mg/kg/day (highest dose 

tested). In two prenatal oral developmental toxicity studies in rats with the supporting chemical 

mixture (CASRN 3159-59-5/36505-83-6), different results were obtained. Taking the two 

studies together, maternal toxicity was observed at 30 mg/kg/day (decreased body weight); the 

NOAEL for maternal toxicity was of 6 mg/kg/day. Unspecified malformations were seen in rat 

fetuses at 30 mg/kg/day; the NOAEL for developmental toxicity was of 6 mg/kg/day. 

In vitro (using both bacteria and mammalian cells) evaluations of genetic toxicity (gene 

mutations and chromosomal aberrations) were conducted with three sponsored chemicals. In 

vitro data with the supporting chemicals were also for gene mutations (four chemicals) and 

chromosomal aberrations (one chemical); all results were negative. In vivo evaluations of 

chromosomal effects in one sponsored and three supporting chemicals also showed negative 

results. Unscheduled DNA synthesis was not induced in a study of one sponsored chemical. 

The available data in three sponsored chemicals suggest that non-hydroxylated FND amines are 

irritating to both skin and eyes. 

Subcategory II: Hydroxylated FND Amines 

There are two chemicals (CASRNs 61791-31-9 and 61791-44-4) in this subcategory for human 

health endpoints. With the exception of acute oral toxicity data, data were available for 

CASRN 61791-44-4. Acute oral toxicity of CASRNs 61791-31-9 and 61791-44-4 in rats is low. 

Acute dermal toxicity of CASRN 61791-44-4 in rabbits is moderate. There were both oral and 

dermal repeated dose studies with CASRN 61791-44-4. Different results were obtained 

depending on the formulation tested (see text for details). Oral dietary studies were performed 

with rats (two) and dogs (one). In one 90-day rat study, there were gross and microscopic effects 

in the intestine and lymph nodes at 150 mg/kg/day; the NOAEL for systemic toxicity was 

50 mg/kg/day. In the other 90-day rat study, the NOAEL was 12 mg/kg/day based on decreases 

in body weight gain and histopathological effects on the intestine and lymph nodes at 

400 mg/kg/day. The dog 90-day study resulted in a NOAEL of 13 mg/kg/day based on clinical 

signs, decreased body weight and pathological changes in the intestine and lymph nodes at 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

57 

40 mg/kg/day. There were three 28-day dermal toxicity studies in rabbits. Local effects 

(irritation) were observed at all doses tested, with no NOAEL for this effect (lowest dose tested 

was 40 mg/kg/day). There were no systemic effects observed up to the highest dose tested of 

40 mg/kg/day, which is the NOAEL for systemic toxicity for the dermal studies in rabbits. 

There were no reproductive/developmental toxicity data for either subcategory member. Gene 

mutations were not induced in two studies (bacterial and mammalian cells) with 

CASRN 61791-44-4 in vitro. CASRN 61791-44-4 induced chromosomal aberrations in vitro

(with metabolic activation only), and results for chromosomal effects in an in vivo test were 

inconclusive. CASRN 61791-44-4 did not induce unscheduled DNA synthesis. 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

58 

Table 13. Summary Table of the Screening Information Data Set as Submitted under the U.S. HPV Ch

Human Health Data

Subcategory 1: Non-Hydroxylated FND Amines 

Endpoints Dodecylamine 

(124-22-1) 

Hexadecylamine 

(143-27-1) 

N-(9Z)-octadecenyl1,3-propanediamine 

(7173-62-8)

C14 – 

18-alkyl 

amines 

(68037-91-2)

C16 – 18

and C18-

unsaturated 

alkyl amines

(68037-95-6)

C14 – 18

and C16 – 

18-unsaturated 

alkyl amines

(68155-38-4)

Soya alkyl 

amines 

(61790-18-9)

N,N-Dimethyl1-hexadecanamine 

(112-69-6) 

N,N-Dimethyl-1-

tetradecanamine 

(112-75-4) 

N,N-Dimethyl- 1-

octadecanamine 

(124-28-7) 

m

(6

SPONSORED CHEMICALS 

Acute Oral Toxicity LD50 (mg/kg) > 2000 

No Data 

620 

(RA) 

No Data 

620 

(RA) 

No Data 

620 

(RA) 

No Data 

620 

(RA) 

No Data 

620 

(RA) 

No Data 

620 

(RA)

620 - >20001 720 - 21161 624 - 21161 

Acute Dermal Toxicity LD50 (mg/kg) 

No Data 

> 2000 

(RA) 

No Data 

> 2000 

(RA) 

No Data 

> 2000 

(RA) 

No Data 

> 2000 

(RA) 

No Data 

> 2000 

(RA) 

No Data 

> 2000 

(RA) 

No Data 

> 2000 

(RA) 

3432 4400 3432-80001

Repeated-Dose Toxicity Oral (mg/kg/day) NOAEL/ LOAEL (systemic) 

No Data 

NOAEL = 

Not 

Established 

LOAEL = 

12.5 

(RA) 

No Data 

NOAEL = 

Not 

Established 

LOAEL = 

12.5 

(RA) 

No Data 

NOAEL = 

Not 

Established

LOAEL = 

12.5 

(RA) 

No Data 

NOAEL = 

Not 

Established 

LOAEL = 

12.5 

(RA) 

No Data 

NOAEL = 

Not 

Established

LOAEL = 

12.5 

(RA) 

No Data 

NOAEL = 

Not 

Established 

LOAEL = 

12.5 

(RA) 

No Data 

NOAEL = 

Not 

Established

LOAEL = 

12.5 

(RA) 

No Data 

NOAEL = 

Not 

Established 

LOAEL = 

12.5 

(RA) 

No Data 

NOAEL = 

Not 

Established 

LOAEL = 

12.5 

(RA) 

No Data 

NOAEL = 

Not 

Established 

LOAEL = 

12.5 

(RA) 

N

E

L

Repeated-Dose Toxicity Dermal (mg/kg/day) NOAEL/LOAEL (systemic) 

No Data 

NOAEL = 5 

LOAEL = 50 

(RA) 

No Data 

NOAEL = 5 

LOAEL = 50 

(RA) 

No Data 

NOAEL = 5

LOAEL = 50

(RA) 

No Data 

NOAEL = 5

LOAEL = 50

(RA) 

No Data 

NOAEL = 5

LOAEL = 50

(RA) 

No Data 

NOAEL = 5

LOAEL = 50

(RA) 

No Data 

NOAEL = 5

LOAEL = 50

(RA) 

No Data 

NOAEL = 5

LOAEL = 50

(RA) 

No Data 

NOAEL = 5

LOAEL = 50

(RA) 

No Data 

NOAEL = 5

LOAEL = 50

(RA) 

N

L

Reproductive Toxicity Oral (mg/kg/day) NOAEL/LOAEL 

Reproductive 

Toxicity 

No Data 

NOAEL = 

50 

LOAEL = 

150 

(RA) 

No Data 

NOAEL = 

50 

LOAEL = 

150 

(RA) 

No Data 

NOAEL = 

50 

LOAEL = 

150 

(RA) 

No Data 

NOAEL = 

50 

LOAEL = 

150 

(RA) 

No Data 

NOAEL = 

50 

LOAEL = 

150 

(RA) 

No Data 

NOAEL = 

50 

LOAEL = 

150 

(RA) 

No Data 

NOAEL = 

50 

LOAEL = 

150 

(RA) 

No Data 

NOAEL = 

50 

LOAEL = 

150 

(RA) 

No Data 

NOAEL = 

50 

LOAEL = 

150 

(RA) 

No Data 

NOAEL = 

50 

LOAEL = 

150 

(RA) 

N

L
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

59 

Table 13. Summary Table of the Screening Information Data Set as Submitted under the U.S. HPV Ch

Human Health Data

Subcategory 1: Non-Hydroxylated FND Amines 

Endpoints Dodecylamine 

(124-22-1) 

Hexadecylamine 

(143-27-1) 

N-(9Z)-octadecenyl1,3-propanediamine 

(7173-62-8)

C14 – 

18-alkyl 

amines 

(68037-91-2)

C16 – 18

and C18-

unsaturated 

alkyl amines

(68037-95-6)

C14 – 18

and C16 – 

18-unsaturated 

alkyl amines

(68155-38-4)

Soya alkyl 

amines 

(61790-18-9)

N,N-Dimethyl1-hexadecanamine 

(112-69-6) 

N,N-Dimethyl-1-

tetradecanamine 

(112-75-4) 

N,N-Dimethyl- 1-

octadecanamine 

(124-28-7) 

m

(6

Developmental Toxicity Oral (mg/kg/day) NOAEL/LOAEL 

Maternal 

Toxicity 

Developmental 

Toxicity 

No Data 

(rat) 

NOAEL = 6 

LOAEL = 30 

NOAEL = 6 

LOAEL = 30 

(RA) 

No Data 

(rat) 

NOAEL = 6 

LOAEL = 30 

NOAEL = 6 

LOAEL = 30 

(RA) 

No Data 

(rat) 

NOAEL = 6

LOAEL = 30

NOAEL = 6

LOAEL = 30 

(RA) 

No Data 

(rat) 

NOAEL = 6

LOAEL = 30

NOAEL = 6

LOAEL = 30 

(RA) 

No Data 

(rat) 

NOAEL = 6

LOAEL = 30

NOAEL = 6

LOAEL = 30 

(RA) 

No Data 

(rat) 

NOAEL = 6

LOAEL = 30

NOAEL = 6

LOAEL = 30 

(RA) 

No Data 

(rat) 

NOAEL = 6

LOAEL = 30

NOAEL = 6

LOAEL = 30 

(RA) 

No Data 

(rat) 

NOAEL = 6

LOAEL = 30

NOAEL = 6

LOAEL = 30 

(RA) 

No Data 

(rat) 

NOAEL = 6

LOAEL = 30

NOAEL = 6

LOAEL = 30 

(RA) 

No Data 

(rat) 

NOAEL = 6

LOAEL = 30

NOAEL = 6

LOAEL = 30 

(RA) 

N

L

N

LO

Genetic Toxicity – Gene Mutation In vitro

No Data 

Negative 

(RA) 

Negative 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA)

No Data 

Negative 

(RA)

No Data 

Negative 

(RA)

Genetic Toxicity – Chromosomal Aberrations In vitro

_

_

_

_

_

_

_

_

_

_

Genetic Toxicity – Chromosomal Aberrations In vivo 

No Data 

Negative 

(RA)

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

Genetic Toxicity – Other Unscheduled DNA synthesis In vitro 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

60 

Table 13. Summary Table of the Screening Information Data Set as Submitted under the U.S. HPV Ch

Human Health Data

Subcategory 1: Non-Hydroxylated FND Amines 

Endpoints Dodecylamine 

(124-22-1) 

Hexadecylamine 

(143-27-1) 

N-(9Z)-octadecenyl1,3-propanediamine 

(7173-62-8)

C14 – 

18-alkyl 

amines 

(68037-91-2)

C16 – 18

and C18-

unsaturated 

alkyl amines

(68037-95-6)

C14 – 18

and C16 – 

18-unsaturated 

alkyl amines

(68155-38-4)

Soya alkyl 

amines 

(61790-18-9)

N,N-Dimethyl1-hexadecanamine 

(112-69-6) 

N,N-Dimethyl-1-

tetradecanamine 

(112-75-4) 

N,N-Dimethyl- 1-

octadecanamine 

(124-28-7) 

m

(6

Additional Information 

Skin irritation 

Eye irritation

— — 

— — 

— — 

— — 

— — 

— — 

— — 

Positive Positive 

Negative 

Positive 

Positive Positive 

Measured data in bold text; (RA) = Read Across; — indicates that endpoint was not addressed for this substance 1 A range is presented due to different responses depending on the formulation used. Please see appropriate text for individual values. 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

61 

Table 14. Summary Table of the Screening Information Data Set as Submitted under the U.S. HPV Ch

Human Health Data 

Subcategory 1: Non-Hydroxylated FND Amines 

Endpoints N-MethylN-octadecyl1-octadecanamine 

(4088-22-6) 

Dihydrogenated 

tallow methylamine

(61788-63-4) 

Di-C14 – 18-

alkylmethyl 

amines 

(67700-99-6) 

Di-C12 – 

18-alkyl amines 

(68153-95-7) 

Ditallow alkyl 

amines 

(68783-24-4) 

N-DecylN-methyl1-decanamine 

(7396-58-9) 

Tri-C8 – 

am

(6881

SPONSORED CHEMICALS 

Acute Oral Toxicity LD50 (mg/kg) > 2000, >50001 > 5000, >15,0001

No Data 

620 

(RA) 

No Data 

620 

(RA) 

No Data 

620 

(RA) 

No Data 

620 

(RA) 

No 

6

(R

Acute Dermal Toxicity LD50 (mg/kg) > 2000 

No Data 

> 2000 

(RA) 

No Data 

> 2000 

(RA) 

No Data 

> 2000 

(RA) 

No Data 

> 2000 

(RA) 

No Data 

> 2000 

(RA) 

No 

> 2

(R

Repeated-Dose Toxicity Oral (mg/kg/day) NOAEL/LOAEL 

(rat) 

NOAEL = Not 

established 

LOAEL = 117

No Data 

NOAEL = Not 

Established 

LOAEL = 12.5 

(RA) 

No Data 

NOAEL = Not 

Established 

LOAEL = 12.5 

(RA) 

No Data 

NOAEL = Not 

Established 

LOAEL = 12.5 

(RA) 

No Data 

NOAEL = Not 

Established 

LOAEL = 12.5 

(RA) 

No Data 

NOAEL = Not 

Established 

LOAEL = 12.5 

(RA) 

No 

NOAE

Estab

LOAEL 

(R

Repeated-Dose Toxicity Dermal (mg/kg/day) NOAEL/LOAEL 

(rabbit) 

NOAEL = 5 

LOAEL = 50

No Data 

NOAEL = 5 

LOAEL = 50 

(RA) 

No Data 

NOAEL = 5 

LOAEL = 50 

(RA) 

No Data 

NOAEL = 5 

LOAEL = 50 

(RA) 

No Data 

NOAEL = 5 

LOAEL = 50 

(RA) 

No Data 

NOAEL = 5 

LOAEL = 50 

(RA) 

No 

NOA

LOAE

(R

Reproductive Toxicity Oral (mg/kg/day) NOAEL/LOAEL 

Reproductive 

Toxicity 

No Data 

NOAEL = 50 

LOAEL = 150 

(RA) 

No Data 

NOAEL = 50 

LOAEL = 150 

(RA) 

No Data 

NOAEL = 50 

LOAEL = 150 

(RA) 

No Data 

NOAEL = 50 

LOAEL = 150 

(RA) 

No Data 

NOAEL = 50 

LOAEL = 150 

(RA) 

No Data 

NOAEL = 50 

LOAEL = 150 

(RA) 

No 

NOAE

LOAE

(R
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

62 

Table 14. Summary Table of the Screening Information Data Set as Submitted under the U.S. HPV Ch

Human Health Data 

Subcategory 1: Non-Hydroxylated FND Amines 

Endpoints N-MethylN-octadecyl1-octadecanamine 

(4088-22-6) 

Dihydrogenated 

tallow methylamine

(61788-63-4) 

Di-C14 – 18-

alkylmethyl 

amines 

(67700-99-6) 

Di-C12 – 

18-alkyl amines 

(68153-95-7) 

Ditallow alkyl 

amines 

(68783-24-4) 

N-DecylN-methyl1-decanamine 

(7396-58-9) 

Tri-C8 – 

am

(6881

Developmental Toxicity Oral (mg/kg/day) 

NOAEL/LOAEL 

Maternal Toxicity 

Developmental 

Toxicity 

(rabbit) 

NOAEL = 50 

LOAEL = 250 

NOAEL = 250 

LOAEL = 1000 

No Data 

(rat) 

NOAEL = 6 

LOAEL = 30 

NOAEL = 6 

LOAEL = 30 

(RA) 

No Data 

(rat) 

NOAEL = 6 

LOAEL = 30 

NOAEL = 6 

LOAEL = 30 

(RA) 

No Data 

(rat) 

NOAEL = 6 

LOAEL = 30 

NOAEL = 6 

LOAEL = 30 

(RA) 

No Data 

(rat) 

NOAEL = 6 

LOAEL = 30 

NOAEL = 6 

LOAEL = 30 

(RA) 

No Data 

(rat) 

NOAEL = 6 

LOAEL = 30 

NOAEL = 6 

LOAEL = 30 

(RA) 

No 

(r

NOA

LOAE

NOA

LOAE

(R

Genetic Toxicity – Gene Mutation In vitro

Negative Negative 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No 

Neg

(R

Genetic Toxicity – Chromosomal Aberrations In vitro

_

_

_

_

_

_

Genetic Toxicity – Chromosomal Aberrations In vivo

No Data 

Negative 

(RA) 

Negative 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No 

Neg

(R

Genetic Toxicity – Other Unscheduled DNA synthesis In vitro

No Data 

Negative 

(RA) 

Negative 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No Data 

Negative 

(RA) 

No 

Neg

(R

Measured data in bold text; (RA) = Read Across; — indicates that endpoint was not addressed for this substance 1 A range is presented due to different responses depending on the formulation used. Please see appropriate text for individual values. 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

63 

Table 15. Summary Table of the Screening Information Data Set as Submitted under the U.S. HPV Ch

Human Health Data 

Subcategory I: Non-Hydroxylated FND Amines 

Hyd

Endpoints SUPPORTING 

CHEMICAL 

Cis-9-octadecylamine 

(112-90-3) 

SUPPORTING 

CHEMICAL 

Octadecylamine 

(124-30-1) 

SUPPORTING 

CHEMICAL 

Hexadecylamine 

hydrofluoride 

(3151-59-5) and 

9-Octadecen-1-

amine 

hydrofluoride 

(36505-83-6), 1:1 

mixture 

SUPPORTING 

CHEMICAL 

Coco alkyl 

amines 

(61788-46-3) 

SUPPORTING 

CHEMICAL 

Tallow alkyl 

amines 

(61790-33-8) 

SUPPORTING 

CHEMICAL 

N,N-Dimethyl1-dodecanamine 

(112-18-5) 

SPON

CHEM

N-Co

deriva

2,2’-im

eth

(6179

Acute Oral Toxicity LD50 (mg/kg) 1689 > 2000 _ 1300 - >60001 1944 790 - 12201 > 5Acute Dermal Toxicity LD50 (mg/kg) _ _ _ > 2000 _ 5000 

No 

 ~ 

(R

Repeated-Dose Toxicity Oral (mg/kg/day) NOAEL/LOAEL (systemic) 

_ (dog) 

NOAEL = 3 

LOAEL = 15 

(rat) 

NOAEL = 6 

LOAEL = 30 

(dog) 

NOAEL = 12 

(highest dose 

tested) 

_ 

NOAEL = Not 

Established 

LOAEL = 12.5

_ No 

(r

NOAE

LOAE

(d

NOAE

LOAE

(R

Repeated-Dose Toxicity Dermal (mg/kg/day) NOAEL/LOAEL (systemic) 

_ _ _ _ _ _ 

No 

NOAE

 (R
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

64 

Table 15. Summary Table of the Screening Information Data Set as Submitted under the U.S. HPV Ch

Human Health Data 

Subcategory I: Non-Hydroxylated FND Amines 

Hyd

Endpoints SUPPORTING 

CHEMICAL 

Cis-9-octadecylamine 

(112-90-3) 

SUPPORTING 

CHEMICAL 

Octadecylamine 

(124-30-1) 

SUPPORTING 

CHEMICAL 

Hexadecylamine 

hydrofluoride 

(3151-59-5) and 

9-Octadecen-1-

amine 

hydrofluoride 

(36505-83-6), 1:1 

mixture 

SUPPORTING 

CHEMICAL 

Coco alkyl 

amines 

(61788-46-3) 

SUPPORTING 

CHEMICAL 

Tallow alkyl 

amines 

(61790-33-8) 

SUPPORTING 

CHEMICAL 

N,N-Dimethyl1-dodecanamine 

(112-18-5) 

SPON

CHEM

N-Co

deriva

2,2’-im

eth

(6179

Reproductive Toxicity Oral (mg/kg/day) NOAEL/LOAEL 

Reproductive Toxicity 

_ _ 

(rat) 

NOAEL = 30 

(highest dose 

tested) 

_ 

(rat) 

NOAEL = 50 

LOAEL = 150 

_ No 

Developmental Toxicity Oral (mg/kg/day) NOAEL/LOAEL 

Maternal Toxicity 

Developmental 

Toxicity 

Maternal Toxicity 

Developmental 

Toxicity 

(rat) 

NOAEL = 10 

LOAEL = 40 

NOAEL = 80 

(highest dose 

tested) 

(rabbit) 

NOAEL = 3 

LOAEL = 10 

NOAEL = 30 

(highest dose 

tested) 

_ 

(rat) 

NOAEL = 6 

LOAEL = 30 

NOAEL = 6 

LOAEL = 30 

_ 

(rat) 

NOAEL = Not 

Established 

LOAEL = 12.5 

NOAEL = 12.5 

LOAEL = 50

_ No 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

65 

Table 15. Summary Table of the Screening Information Data Set as Submitted under the U.S. HPV Ch

Human Health Data 

Subcategory I: Non-Hydroxylated FND Amines 

Hyd

Endpoints SUPPORTING 

CHEMICAL 

Cis-9-octadecylamine 

(112-90-3) 

SUPPORTING 

CHEMICAL 

Octadecylamine 

(124-30-1) 

SUPPORTING 

CHEMICAL 

Hexadecylamine 

hydrofluoride 

(3151-59-5) and 

9-Octadecen-1-

amine 

hydrofluoride 

(36505-83-6), 1:1 

mixture 

SUPPORTING 

CHEMICAL 

Coco alkyl 

amines 

(61788-46-3) 

SUPPORTING 

CHEMICAL 

Tallow alkyl 

amines 

(61790-33-8) 

SUPPORTING 

CHEMICAL 

N,N-Dimethyl1-dodecanamine 

(112-18-5) 

SPON

CHEM

N-Co

deriva

2,2’-im

eth

(6179

Genetic Toxicity – Gene Mutation In vitro

Negative Negative 

_ 

Negative Negative 

_ No 

Neg

(R

Genetic Toxicity – Chromosomal Aberrations In vitro

Negative

_ _ _ _ _ No 

Pos

(R

Genetic Toxicity – Chromosomal Aberrations In vivo

 Negative 

_ _ _ 

Negative Negative

No 

Incon

(R

Genetic Toxicity – Other UDS In vitro

_ _ _ _ _ _ 

No 

Neg

(R

Measured data in bold; (RA) = Read Across; – endpoint not evaluated for this substance; w= with activation; w/o = without activation 1 A range is presented due to different responses depending on the formulation used. Please see appropriate text for individual values. 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

66 

4. Hazard to the Environment

A summary of aquatic toxicity data submitted for SIDS endpoints is provided in Table 16. The 

tables also indicate where data for tested category members are read-across (RA) to untested 

members of the category. 

Acute Toxicity to Fish 

Dodecylamine (CASRN 124-22-1) 

In four studies, Zebra fish (Brachydanio rerio) were exposed to the test substance (CASRN 124-

22-1) at nominal concentrations of 0, 0.25, 0.35, 0.5, 0.71, 1.0, 1.8, 2.5 and 3.5 mg/L under static 

conditions for 96 hours. Measured concentrations were not determined. Mortality was 100% at 

concentrations ≥ 0.5 mg/L. 

96-h LC50 = 0.42 mg/L 

 N,N-Dimethyl-1-tetradecanamine (CASRN 112-75-4) 

(1) Rainbow trout (Oncorhynchus mykiss) were exposed to the test substance (CASRN 112-75-4) 

at nominal concentrations of 0.1, 0.32, 1.0, 3.2, 10, 32 and 100 mg/L under static conditions for 

96 hours. Measured concentrations were not determined. Mortality was 100% at concentrations 

≥1.0 mg/L. 

96-h LC50 = 0.18 mg/L 

(2) In two studies, Zebra fish (Brachydanio rerio) were exposed to the test substance (CASRN 

112-75-4) at nominal concentrations of 0.01 (study 2 only), 0.1 and 1 mg/L under static 

conditions for 96 hours. Measured concentrations were not stated. Mortality was 100% at 1 

mg/L (study 1) and 0.1 and 1 mg/L (study 2). 

96-h LC50 > 0.01 and < 0.1 mg/L 

(3) Zebra fish (Brachydanio rerio) were exposed to the test substance (CASRN 112-75-4) at 

nominal concentrations of 0.032, 0.058, 0.10, 0.18, 0.32, 0.58 and 1 mg/L under static-renewal 

conditions for 96 hours. Measured concentrations were not determined. Mortalities were 

observed at concentrations ≥ 0.58 mg/L. 

96-h LC50 = 0.35 mg/L 

N,N-Dimethyl-1-hexadecanamine (CASRN 112-69-6) 

(1) Rainbow trout (Oncorhynchus mykiss) were exposed to the test substance (CASRN 112-69-6) 

at nominal concentrations of 0.1, 0.32, 1.0, 3.2, 10, 32 and 100 mg/L under static conditions for 

96 hours. Measured concentrations were not determined. Mortality was 100% at ≥ 3.2 mg/L 

96-h LC50 = 0.18 mg/L 

(2) Zebra fish (Brachydanio rerio) were exposed to the test substance (CASRN 112-69-6) at 

nominal concentrations of 0.1, 1.0 and 10 mg/L under static conditions for 96 hours. Measured 

concentrations were not provided. Mortalities were observed at ≥1.0 mg/L 

96-h LC50 > 0.1 and < 1 mg/L 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

67 

N,N-Dimethyl-1-octadecanamine (CASRN 124-28-7) 

(1) Rainbow trout (Oncorhynchus mykiss) were exposed to the test substance (CASRN 124-28-7) 

at nominal concentrations of 0.1, 0.32, 1.0, 3.2, 10, 32 and 100 mg/L under static conditions for 

96 hours. Measured concentrations were not determined. Mortalities were observed at ≥1.0 

mg/L. 

96-h LC50 = 0.18 mg/L 

(2) Zebra fish (Brachydanio rerio) were exposed to the test substance (CASRN 124-28-7) at 

nominal concentrations of 0.1 and 1.0 mg/L under static conditions for 96 hours. Measured 

concentrations were not provided. Mortalities were observed at both dose levels. 

96-h LC50 > 0.1 and < 1.0 mg/L 

Dimethyl soya alkyl amines (CASRN 61788-91-8) 

The study submitted was inadequate. 

N-Methyl-N-octadecyl-1-octadecanamine (CASRN 4088-22-6) 

The study submitted was inadequate. 

Dihydrogenated tallow methylamine (CASRN 61788-63-4) 

Two submitted studies were inadequate. 

Cis-9-Octadecenylamine (CASRN 112-90-3, supporting chemical) 

Fathead minnow (Pimephales promelas) were exposed to the test substance (CASRN 112-90-3) 

at nominal concentrations of 0.05, 0.09, 0.15, 0.27 and 0.49 mg/L under static conditions for 96 

hours. Measured concentrations were 0.032, 0.12 (0.27 mg/L nominal concentration not 

provided) and 0.40 mg/L. Mortality was 100% at ≥ 0.15 mg/L. 

96-h LC50 = 0.11 mg/L 

Chronic Toxicity to Fish 

N-Coco alkyl derivatives of 2,2’-iminobis ethanol (CASRN 61791-31-9) 

Zebra fish (Brachydanio rerio) were exposed to the test substance (CASRN 61791-31-9) at 

measured concentrations of 0.027, 0.049, 0.050, 0.11 and 0.15 mg/L under flow-through 

conditions for 28 days. Larvae survival was the only indicator of an effect. Survival of larvae at 

0.11 and 0.15 mg/L was less than controls. 

30-d LC50 = 0.0179 mg/L 

Acute Toxicity to Aquatic Invertebrates 

N,N-Dimethyl-1-octadecanamine (CASRN 124-28-7) 

Mysid shrimp (Mysidopsis bahia) were exposed to the test substance (CASRN 124-28-7) at 

nominal concentrations of 0.052, 0.088, 0.140, 0.240 and 0.400 mg/L under static conditions for 

96 hours. Measured concentrations were not determined. Mortalities occurred at ≥ 0.052 mg/L. 

96-h LC50 = 0.074 mg/L 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

68 

Dihydrogenated tallow methylamine (CASRN 61788-63-4) 

The eight studies submitted were inadequate. 

Cis-9-Octadecenylamine (CASRN 112-90-3, supporting chemical) 

Waterfleas (Daphnia magna) were exposed to the test substance (CASRN 112-90-3) at nominal 

concentrations of 0.006, 0.011, 0.023, 0.045 and 0.090 mg/L under static conditions for 48 hours. 

Measured concentrations for the nominal solutions of 0.011, 0.023 and 0.090 mg/L were 0.007, 

0.010, 0.011 and 0.048 mg/L. 

48-h EC50 = 0.011 mg/L 

N-Coco alkyl derivatives of 2,2’-iminobis ethanol (CASRN 61791-31-9) 

Waterfleas (Daphnia magna) were exposed to the test substance (CASRN 61791-31-9) at 

nominal concentrations of 0.29, 0.37, 0.48, 0.62, 0.28, 1.0, 1.3 and 1.7 mg/L under static 

conditions for 48 hours. Measured concentrations were not determined. 

48-h LC50 = 0.38 mg/L 

Chronic Toxicity to Aquatic Invertebrates 

N-Coco alkyl derivatives of 2,2’-iminobis ethanol (CASRN 61791-31-9) 

(1) Waterfleas (Daphnia magna) were exposed to the test substance (CASRN 61791-31-9) at 

nominal concentrations of 0.0018, 0.0032, 0.0056, 0.010, 0.018, 0.032, 0.056, 0.10, 0.18 or 0.32 

mg/L under static conditions for 21 days. Survival and reproduction of Daphnia magna was 

measured over the exposure period. Measured concentrations were determined, but not reported. 

The growth and condition of the test organism was poor compared to controls in the 0.18 and 

0.32 mg/L groups. Reproduction was lower in the 0.18 and 0.32 mg/L groups. 

21-d LC50 = 0.15 mg/L 

(2) Waterfleas (Daphnia magna) were exposed to the test substance (CASRN 61791-31-9) at 

nominal concentrations of 0.036, 0.058, 0.101, 0.195 or 0.477 mg/L under static conditions for 

21 days. Survival and reproduction of Daphnia magna was measured over the exposure period. 

Measured concentrations were not determined. The growth and condition of the test organism 

was poor compared to controls in the 0.195 and 0.477 mg/L groups. Reproduction appeared 

impaired in the 0.477 mg/L group. Daily production and mean length of F0 survivors in the 

0.101 and 0.195 mg/L groups were lower than controls. 

21-d LC50 = 0.14 mg/L 

Toxicity to Aquatic Plants 

Dihydrogenated tallow methylamine (CASRN 61788-63-4) 

Green algae (Pseudokirchneriella subcapitata) were exposed to the test substance (CASRN 

61788-63-4) at nominal concentrations of 0.010, 0.030, 0.090, 0.270 or 0.810 mg/L under static 

conditions for 72 hours. Measured concentrations were not determined. Test result details not 

provided. 

72-h EC50 = 0.05 mg/L (biomass) 

72-h EC50 = 0.12 mg/L (growth rate) 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

69 

N,N-Dimethyl-1-octadecanamine (CASRN 124-28-7) 

The study submitted was inadequate. 

Cis-9-Octadecenylamine (CASRN 112-90-3, supporting chemical) 

Green algae (Pseudokirchneriella subcapitata) were exposed to the test substance (CASRN 112-

90-3) at nominal concentrations of 0.01, 0.02, 0.04, 0.08 or 0.15 mg/L under static conditions for 

96 hours. Measured concentrations in control, 0.01, 0.04 and 0.15 mg/L were 0, ND, 0.016, 

0.011 and ND mg/L. 

96-h EC50 = 0.03 mg/L (biomass) 

96-h EC50 = 0.04 mg/L (growth rate) 

Conclusion: The typical 96-h LC50 for fish with the supporting chemical, CASRN 112-90-3, is 

0.11 mg/L and the typical 48-h EC50 for aquatic invertebrates is 0.011 mg/L. The 96/72-h EC50

values for aquatic plants are 0.03 mg/L and 0.04 mg/L for biomass and growth rate, respectively. 

For CASRN 61791-31-9, the 30-d fish chronic value is 0.0179 mg/L and the 21-d aquatic 

invertebrates value is 0.14 mg/L. 
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

70 

Table 16. Summary Table of the Screening Information Data Set as Submitted under the U.S. HPV Ch

 Aquatic Toxicity Data 

Endpoints Dodecylamine 

(124-22-1) 

Hexadecylamine 

(143-27-1) 

N-(9Z)-octadecenyl1,3-propanedia

mine 

(7173-62-8) 

C14 – 

18-alkyl 

amines 

(68037-91-2)

C16 – 18 and 

C18-

unsaturated 

alkyl amines

(68037-95-6)

C14 – 18 and 

C16 – 18-unsaturated 

alkyl amines

(68155-38-4)

Soya alkyl 

amines 

(61790-18-9)

N,N-Dimethy

l-1-hexadecanamine 

(112-69-6) 

N,N-Dimethyl1-tetradecanamine 

(112-75-4) 

N,N-Dimethyl1-octadecanamine 

(124-28-7) 

m

(

SPONSORED CHEMICALS 

Fish 96-h LC50

(mg/L)

0.42 (m) 

No Data 

0.11 

(RA) 

No Data 

0.11 

(RA) 

No Data 

0.11 

(RA) 

No Data 

0.11 

(RA) 

No Data 

0.11 

(RA) 

No Data 

0.11 

(RA) 

0.18 0.18 (m) 0.18 

Aquatic Invertebrates 48-h EC50

(mg/L)

No Data 

0.011 

(RA) 

No Data 

0.011 

(RA) 

No Data 

0.011 

(RA) 

No Data 

0.011 

(RA) 

No Data 

0.011 

(RA) 

No Data 

0.011 

(RA) 

No Data 

0.011 

(RA) 

No Data 

0.011 

(RA) 

No Data 

0.011 

(RA) 

0.074 

Aquatic Plants 72/96-h EC50

(mg/L) Biomass Growth rate

No Data 

0.03 0.04 

(RA) 

No Data 

0.03 0.04 

(RA) 

No Data 

0.03 0.04 

(RA) 

No Data 

0.03 0.04 

(RA) 

No Data 

0.03 0.04 

(RA) 

No Data 

0.03 0.04 

(RA) 

No Data 

0.03 0.04 

(RA) 

No Data 

0.03 0.04 

(RA) 

No Data 

0.03 0.04 

(RA) 

No adequate 

data 

0.03 0.04 

(RA)

Chronic Toxicity to Fish 21-d EC50

(mg/L) 

No Data 

0.0179 

(RA)

No Data 

0.0179 

(RA)

No Data 

0.0179 

(RA)

No Data 

0.0179 

(RA)

No Data 

0.0179 

(RA)

No Data 

0.0179 

(RA)

No Data 

0.0179 

(RA)

No Data 

0.0179 

(RA)

No Data 

0.0179 

(RA)

No Data 

0.0179 

(RA)

Chronic Toxicity to Invertebrates 21-d EC50

(mg/L)

No Data 

0.14 

(RA)

No Data 

0.14 

(RA)

No Data 

0.14 

(RA)

No Data 

0.14 

(RA)

No Data 

0.14 

(RA)

No Data 

0.14 

(RA)

No Data 

0.14 

(RA)

No Data 

0.14 

(RA)

No Data 

0.14 

(RA)

No Data 

0.14 

(RA)

bold = measured data (i.e., derived from testing); (RA) = Read Across; – indicates that endpoint was not evaluated for this substance
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

71 

Table 16. Summary Table of the Screening Information Data Set as Submitted under the U.S. HPV Ch

 Aquatic Toxicity Data 

Endpoints N-MethylN-octadecyl1-octadecanamine 

(4088-22-6) 

Dihydrogenated tallow 

methylamine 

(61788-63-4) 

Di-C14 – 

18-alkylmethy

l amines 

(67700-99-6) 

Di-C12 – 

18-alkyl 

amines 

(68153-95-7) 

Ditallow alkyl 

amines 

(68783-24-4) 

N-decylN-methyl1-decanamine 

(7396-58-9) 

Tri-C8 –

10-alkyl 

amines 

(68814-95-9) 

Tris-

(hydrogenated 

tallow alkyl) 

amines 

(61790-42-9) 

Cis-9-o

decylam

(112-9

suppor

chemic

SPONSORED CHEMICALS SUPPOR

CHEMI

Fish 96-h LC50

(mg/L)

No adequate 

data 

0.11 

(RA) 

No adequate 

data 

0.11 

(RA)

No Data 

0.11 

(RA) 

No Data 

0.11 

(RA) 

No Data 

0.11 

(RA) 

No Data 

0.11 

(RA) 

No Data 

0.11 

(RA) 

No Data 

0.11 

(RA) 

0.11 

Aquatic Invertebrates 48-h EC50

(mg/L)

No Data 

0.011 

(RA) 

No adequate 

data 

0.011 

(RA)

No Data 

0.011 

(RA) 

No Data 

0.11 

(RA) 

No Data 

0.11 

(RA) 

No Data 

0.11 

(RA) 

No Data 

0.11 

(RA) 

No Data 

0.11 

(RA) 

0.01

Aquatic Plants 72/96-h EC50

(mg/L) Biomass Growth rate 

No Data 

0.03 0.04 

(RA) 

0.05 0.12 

(72-h) 

No Data 

0.03 0.04 

(RA) 

No Data 

0.03 0.04 

(RA) 

No Data 

0.03 0.04 

(RA) 

No Data 

0.03 0.04 

(RA) 

No Data 

0.03 0.04 

(RA) 

No Data 

0.03 0.04 

(RA) 

0.03 0.04 

(96-h

Chronic Toxicity to Fish 21-d EC50

(mg/L) 

No Data 

0.0179 

(RA)

No Data 

0.0179 

(RA)

No Data 

0.0179 

(RA)

No Data 

0.0179 

(RA)

No Data 

0.0179 

(RA)

No Data 

0.0179 

(RA)

No Data 

0.0179 

(RA)

No Data 

0.0179 

(RA)

_ 

Chronic Toxicity to Invertebrates 21-d EC50

(mg/L)

No Data 

0.14 

(RA)

No Data 

0.14 

(RA)

No Data 

0.14 

(RA)

No Data 

0.14 

(RA)

No Data 

0.14 

(RA)

No Data 

0.14 

(RA)

No Data 

0.14 

(RA)

No Data 

0.14 

(RA)

_ 

bold = measured data (i.e., derived from testing); (RA) = Read Across; – indicates that endpoint was not evaluated for this substance
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

72 

APPENDIX 1: Structures for FND Amines Category 

SPONSORED CHEMICALS

Name CASRN Structure 

Subcategory I: Hydroxylated FND Amines (21) 

1-Dodecanamine 124-22-1 

H2N CH3

1-Hexadecanamine 143-27-1 

H2N CH3

Amines, C14-18-

alkyl 

68037-

91-2 H2N CH3

Representative structure1 (1-tetradecanamine, CASRN 2016-42-4) 

Amines, C14-18 

and C16-18-

unsatd. alkyl 

68155-

38-4 H2N

CH3

Representative structure1

Amines, soya 

alkyl 

61790-

18-9 

H2N

CH3

Representative structure2

Amines, C16-18 

and C18-unsatd. 

Alkyl 

68037-

95-6 H2N CH3

Representative structure3 (1-hexadecanamine, CASRN 143-27-1) 

Amines, Ntallow 

alkyltrimethylene

di61791-

55-7 HN

CH3

NH2

Representative structure4

1,3-Propanediamine, N1-(9Z)-

9-octadecen-1-

yl7173-62-

8 N

H

H2N

CH3

1-Tetradecanamine, N,Ndimethyl112-75-4 

N

CH3

H3C CH3

1-Hexadecanamine, N,Ndimethyl112-69-6 

N CH3

CH3

H3C
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

73 

SPONSORED CHEMICALS

Name CASRN Structure 

1-Octadecanamine, N,Ndimethyl124-28-7 

N CH3

CH3

H3C

Amines, 

(hydrogenated 

tallow 

alkyl)dimethyl 

61788-

95-2 N CH3

CH3

H3C

Representative structure5 (1-Octadecanamine, N,N-dimethyl-, CASRN 124-28-7) 

Amines, 

dimethylsoya 

alkyl 

61788-

91-8 N CH3

H3C

CH3

Representative structure2

1-Decanamine, 

N-decyl-Nmethyl7396-58-9 

N

CH3

H3C CH3

Amines, di-C14-

18-alkylmethyl 

67700-

99-6 N CH3

CH3

H3C

Representative structure1

Amines, di-C12-

18-alkyl 

68153-

95-7 HN CH3

CH3

Representative structure1

1-Octadecanamine, Nmethyl-Noctadecyl4088-22-

6 N CH3

CH3

H3C

Amines, 

bis(hydrogenated 

tallow 

alkyl)methyl 

61788-

63-4 N CH3

CH3

H3C

Representative structure5 (1-octadecanamine, N-methyl-N-octadecyl-, CASRN 4088-22-6) 

Amines, ditallow 

alkyl 

68783-

24-4 HN

CH3

CH3

Representative structure4
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

74 

SPONSORED CHEMICALS

Name CASRN Structure 

Amines, tri-C8-

10-alkyl 

68814-

95-9 H3C N CH3

CH3

Representative structure1

Amines, 

tris(hydrogenated 

tallow alkyl) 

61790-

42-9 

N

H3C

CH3

CH3

Representative structure5

Subcategory II: Hydroxylated FND Amines (2) 

Ethanol, 2,2'-

iminobis-, Ncoco alkyl 

derivs. 

61791-

31-9 N CH3

OH

OH

Representative structure6

Ethanol, 2,2'-

iminobis-, Ntallow alkyl 

derivs. 

61791-

44-4 N

OH

OH

CH3

Representative structure4
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

75 

Supporting Chemicals (All for Subcategory I – Nonhydroxylated FND Amines) 

Name CASRN Structure 

9-Octadecen-1-

amine, (9Z)- 

112-90-3 

H2N

CH3

1-

Octadecanamin

e 

124-30-1 

H2N CH3

1-

Hexadecanami

ne, 

hydrofluoride 

3151-59-5 

N

+ CH3

H

H H

F

Amines, 

hydrogenated 

tallow alkyl 

61788-45-2 

H2N CH3

Representative structure5

 (1-Octadecanamine, CASRN 124-30-1) 

Amines, coco 

alkyl 

61788-46-3 

H2N CH3

Representative structure6 (1-Dodecanamine, CASRN 124-22-1) 

Amines, tallow 

alkyl 

61790-33-8 

H2N

CH3

Representative structure4 (9-Octadecen-1-amine, (9Z)-, CASRN 112-90-3) 

Octadecen-1-

amine, N,Ndimethyl28061-69-0 

H2C N

CH3

CH3

Representative structure, position of double bond unspecified 

1-

Dodecanamine, 

N,N-dimethyl112-18-5 

N CH3

CH3

H3C

Amines, coco 

alkyldimethyl 

61788-93-0 

N CH3

CH3

H3C

Representative structure6 (1-Dodecanamine, N,N-dimethyl-, CASRN 112-18-5) 

Amines, dicoco 

alkyl 

61789-76-2 

HN CH3

CH3

Representative structure6
U.S. Environmental Protection Agency September, 2010 

Hazard Characterization document 

76 

Supporting Chemicals (All for Subcategory I – Nonhydroxylated FND Amines) 

Name CASRN Structure 

Amines, dicoco 

alkylmethyl 

61788-62-3 

N CH3

CH3

H3C

Representative structure6

Amines, 

bis(hydrogenat

ed tallow alkyl) 

61789-79-5 

HN CH3

CH3

Representative structure5

1

Average chain length is used for the representative structure. 

2

For soya fatty amine mixtures, the sponsor provides the following distribution: 43–56% linoleic amine; 20–30% 

oleic amine; 8–14% linolenic amine; 7–11% palmitic amine; 2–7% stearic amine. The representative structures 

shown for soy fatty amines contain a diunsaturated 18 carbon chain length, as it is the highest concentration in the 

mixture according to the sponsor. 

3

The chain length and degree of unsaturation are not specified by the sponsor for CASRN 68037-95-6 (Amines, 

C16-18 and C18-unsatd. alkyl). The representative structure shown is for the 16 carbon chain unsaturated alkyl 

amine. 

4

For tallow fatty amine mixtures, the sponsor provides the following distribution: 35–46% oleic amine; 20–37% 

palmitic amine; 14–21% stearic amine; 4–10% linoleic amine. The representative structures shown for tallow fatty 

amines contain a monounsaturated 18 carbon chain length, as it is the highest concentration in the mixture 

according to the sponsor. 

5

For hydrogenated tallow fatty amine mixtures, the sponsor provides the following distribution: 49–67% stearic 

amine; 23–46% palmitic amine; 1–6% myristic amine. The representative structures shown for hydrogenated 

tallow fatty amines contain a saturated 18 carbon chain length, as it is the highest concentration in the mixture 

according to the sponsor. 

6

 For coco (coconut) fatty amine mixtures, the sponsor provides the following distribution: 44–53% lauric amine; 

13–19% myristic amine; 8–11% palmitic amine; 5–10% decanoic amine; 5–9% octanoic amine; 5–8% linoleic 

amine. The representative structures shown for coco fatty amines contain a saturated 12 carbon chain length, as it 

is the highest concentration in the mixture according to the sponsor.