# U.S. Environmental Protection Agency September, 2010

Hazard Characterization Document

1 

# SCREENING-LEVEL HAZ ARD CHARACTERIZATION

Fatty Nitrogen Derived Amines Category

The High Production Volume (HPV) Challenge Program 1 

# was conceived as a voluntary initiative

aimed at developing and making publicly availabl e 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 th e Challenge Program, producers and importers of

HPV chemicals voluntarily sponsored chemicals; sponsorship entailed the identification and

initial assessment of the adequacy of existing to xicity 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 contai ns data on 18 internationa lly agreed to “SIDS”

(Screening Information Data Set 1,2 

# ) 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 Cha llenge Program on approximately 1400 sponsored

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

the quality and completeness of the data set pr ovided 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 guidance 2,3 

# and is based primarily on

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

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

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

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

search of the following databases was made fr om 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 (Regis try 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 ch emicals which have already been assessed

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

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

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

presented in an international forum that i nvolves review and endorsement by governmental

authorities around the world. OPPT is an active pa rticipant 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

.

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization Document

2 These hazard characterizations ar e 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 vehi cle 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

Hazard Characterization Document

3 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. Th e category consists of primary alkylamines and

alkyldiamines, dimethylalkylamines, dialky lmethylamines and dialkylamines, and

trialkylamines. The primary alkylamines and al kyldiamines 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 di alkylmethylamines are all liquids with low to

moderate vapor pressure and lo w to moderate water solubilit y. 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 pre ssure; two (CASRNs 68814-95-9 a nd 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 c onditions; however, these types of surfactants

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

photooxidation is considered moderate to rapid fo r members of this categ ory; however, this is

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

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

evidence and read across from st ructurally 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 (B 1) bioaccumulation potential (13/23, including all

four trialkylamines), with 4/23 having a modera te (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 memb ers 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 chemi cals in rabbits. Oral repeateddose toxicity studies are availa ble 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 chemi cal (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:

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization Document

4 decreased body weight gain, or gan weight changes, hematol ogical changes and pathological

changes in the intestine, lymph nodes and ova ries. 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 th e 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 obser ved at 50 mg/kg/day: decreased body weight,

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

nodes.

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

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

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

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

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

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

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

parameters assessed; the NOAEL for reproductiv e 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. Embryol ethality at 1000 mg/kg/day could not be

discounted; the NOAEL for developmental toxi city 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, on e with rats and one with rabb its, using the supporting chemical

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

signs and a decrease in body we ight); 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 th e rabbit study, dams exhibited cl inical signs and decreased body

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

developmental toxicity; the NOAEL for developmen tal 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), differe nt results were obtained. Taking the two

studies together, maternal toxi city was observed at 30 mg/kg/da y (decreased body weight); the

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization Document

5 NOAEL for maternal toxicity was of 6 mg/kg/day

. 

# Unspecified malformations were seen in rat

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

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

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

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

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

chromosomal effects in one sponsored and th ree supporting chemicals also showed negative

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

The available data in three sponsored chemical s 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 a nd 61791-44-4) in this subcategory for human

health endpoints. With the ex ception of acute oral toxicity da ta, data were available for

CASRN 61791-44-4. Acute oral toxicity of CASR Ns 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 re sults 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, th e NOAEL was 12 mg/kg/da y based on decreases

in body weight gain and histopathological e ffects 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 in testine and lymph nodes at

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

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

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

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

There were no reproductive/develop mental 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 re sults 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 identi fied as data gaps under the

HPV Challenge Program.

Hazard to the Environment

The typical 96-h LC 50 

# for fish with the supporting chemi cal, CASRN 112-90-3, is 0.11 mg/L and

the typical 48-h EC 50 

# for aquatic invertebrates is 0.011 mg/L. The 96/72-h EC 50 

# values for

aquatic plants are 0.03 mg/L and 0.04 mg/L for bi omass 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

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization Document

6 invertebrates value is 0.14 mg/L.

No data gaps were identified under the HPV Challenge Program.

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization Document

7 The sponsor, The Nitrogen Derivatives Panel Am ines 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/p ubs/summaries/amines/c14171tc.htm ). In the transmittal

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

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

July 10, 2003, the sponsor informed EPA of their pl ans to split the origin al 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 comment s 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 sp lit off to form the FND ether amines category (all supporting

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

chemicals identified in the F ND 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 sponsor ed substances and 12 supporting chemicals (see

Appendix).

Category Justification

The members of the FND amines category are all aliphatic amines contai ning 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. Th ese properties are expected to

result in similar environmental fate and toxico logical 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 F ND amines category, the s ponsor concludes that

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

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

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

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

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

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

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

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

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

effect endpoints.

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization Document

8 For assessment of human health hazards, howev er, the toxicological pr operties 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 substa nces are expected to

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

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

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

Subcategory 2, Hydroxylated FND Amines. For th e 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

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization Document

9 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, hydrofluorid e and 9-octadecen-1-amine hy drofluoride (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 structural ly closely related to the FND amines

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

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

were used for the environmental fate endpoint (s pecifically biodegradatio n) – 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 su pporting chemicals that provided

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

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

available for the other four supporting chemicals (CASRNs 6 1788-62-3, 61789-79-5, 61788-93-

0 and 61788-45-2) - while useful – were not n ecessary 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. Th e use of this chemical was based on its structure

being sufficiently representative of the sp ectrum 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 SI AM 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 FN D amines category because they are sponsored by the

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

Associations (ICCA) program

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization Document

10 1. Chemical Identity

1.1 Identification and Purity

Appendix 1 provides the names a nd structures for all the spon sored (23) and supporting (12)

chemicals in the category. Most (15/23 sponsor ed 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 re vised 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 degr ee of unsaturation.

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization Document

11 In addition, there are many different form ulations 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 am ines 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 sec tions of this hazard assessment. The structures

are provided in the Appendix.

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Hazard Characterization Document

12 Conclusion: The members of the FND amines category are long-chain alkyl substituted amines

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

alkyldiamines; dimethylalkylamines; dialkylmethylam ines 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 a nd 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 ne gligible to low vapor pressure and negligible to low water

solubility. Finally, the trialkylamines are liqui ds 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.U.S. Environmental Protection Agency September, 2010Hazard Characterization document13Table 3. Physical-Chemical Properties of Fatty Nitrogen-Derived Amines: Sponsored Chemicals (1 of 3)11-Dodecanamine1-Hexadecan-amineAmines, C14-18-alkyl2Amines, C14-18and C16-18-unsatd. alkyl2Amines, soyaalkyl2Amines, C16-18and C18-unsatd.alkyl2Amines, N-tallowalkyltrimethylenedi-21,3-Propanediamine,N1-(9Z)-9-octadecen-1-ylPropertyValueValueValueValueValueValueValueValueCASRN 124-22-1 143-27-1 68037-91-2 68155-38-4 61790-18-9 68037-95-6 61791-55-7 7173-62-8MolecularWeight185 241 213 (typical)2239 (typical)2265 (typical)2241 (typical)2325 (typical)2325PhysicalStateSolid/liquid3Solid3No data No data Solid, paste3Solid3Solid3Liquid3MeltingPoint28.3°C(measured)46.8°C (measured) No data No data 29.0°C(measured)3No data No data <25°C (liquid)4BoilingPoint259°C(measured)322.5°C(measured)5;330°C(measured)6291.2°C(measured,typical)5>300°C(estimated)7>300°C(estimated)7322.5°C(measured,typical)5;330°C(measured,typical)6>300°C(estimated, typical)7>300°C(estimated)7VaporPressure8.05×10-3mm Hg(measured)51.33×10-4mm Hg(measured)59.74×10-4mmHg (measured,typical)52.2×10-4mm Hg(estimated)71.3×10-4mm Hg(estimated)71.33×10-4mm Hg(measured,typical)54.9×10-7mm Hg(estimated, typical)74.9×10-7mm Hg(estimated)7DissociationConstant(pKa)10.63(measured)510.61 (measured)510.62(measured,typical)510 (estimated)810 (estimated)810.6 (measured,typical)58.7–11 (estimated)811 (estimated)8Henry’sLawConstant2.5×10-5atmm3/mol(estimated)75.3×10-4atmm3/mol(estimated)73.0×10-4atmm3/mol(estimated)74.7×10-4atmm3/mol(estimated)77.2×10-4atmm3/mol(estimated)75.3×10-3atmm3/mol(estimated)77.8×10-5atmm3/mol (estimated)73.3×10-7atmm3/mol (estimated)7U.S. Environmental Protection Agency September, 2010Hazard Characterization document14Table 3. Physical-Chemical Properties of Fatty Nitrogen-Derived Amines: Sponsored Chemicals (1 of 3)11-Dodecanamine1-Hexadecan-amineAmines, C14-18-alkyl2Amines, C14-18and C16-18-unsatd. alkyl2Amines, soyaalkyl2Amines, C16-18and C18-unsatd.alkyl2Amines, N-tallowalkyltrimethylenedi-21,3-Propanediamine,N1-(9Z)-9-octadecen-1-ylPropertyValueValueValueValueValueValueValueValueWaterSolubility78 mg/L(measured)5,90.31 mg/L(estimated)71.4 mg/L(estimated)70.76 mg/L(estimated)70.13 mg/L(estimated)70.31 mg/L(estimated)70.037mg/L(estimated, typical)70.037 mg/L(estimated)7Log Kow4.8 (estimated)76.7 (estimated)75.8 (estimated)76.5 (estimated)77.3 (estimated)76.7 (estimated)77.5 (estimated)77.5 (estimated)71American Chemistry Council. 2003. Revised Robust Summary and Test Plan for Fatty Nitrogen-derived Amines Category. Availableonline athttp://www.epa.gov/chemrtk/pubs/summaries/amines/c14171tc.htmas of July 15, 2010.2Estimated data provided are based on the typical representative structure; see Appendix for detailed information on the structures.3Visek, K. 2003. Amines, Fatty. Kirk-Othmer Encyclopedia ofChemical Technology. John Wiley & Sons, Inc. Article online posting date: August 15, 2003.4Estimated based on melting point data.5SRC. 2010. The Physical Properties Database (PHYSPROP). SRC: Syracuse, NY. Available online athttp://www.srcinc.com/what-we-do/free-demos.aspxas of July16, 2010.6Beilstein search. 2010.7U.S. EPA. 2010. EstimationPrograms Interface SuiteTM for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Washington, DC, USA. Availableonline athttp://www.epa.gov/opptintr/exposure/pubs/episuitedl.htmas of July 12, 2010.8SPARC Online Calculator. 2008. Version 4.2. Available online athttp://ibmlc2.chem.uga.edu/sparcas of July 21, 2010.9A measured water solubility value of 2 g/L provided by the sponsor was determined to be semi-quantitative and is not in good agreement with other measured data.U.S. Environmental Protection Agency September, 2010Hazard Characterization document15Table 4. Physical-Chemical Properties of Fatty Nitrogen-Derived Amines: Sponsored Chemicals (2 of 3)11-Tetradecanamine, N,Ndimethyl-1-Hexadecan-amine, N,N-dimethyl-1-Octadecanamine,N,N-dimethyl-Amines,(hydrogenatedtallow alkyl)dimethyl2Amines,dimethylsoyaalkyl2Amines, tri-C8-10-alkyl2Amines,tris(hydrogenatedtallow alkyl)2Ethanol, 2,2'-iminobis-, Ncoco alkylderivs.2PropertyValueValueValueValueValueValueValueValueCASRN 112-75-4 112-69-6 124-28-7 61788-95-2 61788-91-8 68814-95-9 61790-42-9 61791-31-9MolecularWeight241 270 298 298 (typical)2294 (typical)2382 (typical)2774 (typical)2273 (typical)2PhysicalStateLiquid3Liquid3Liquid3Liquid3Liquid3Liquid3No data Liquid4MeltingPoint-6°C(measured)38°C (measured)3;12°C (measured)522.9°C (measured) 22.9°C(measured) <25°C (liquid)6<25°C (liquid) No data -5°C(measured)4BoilingPoint159–161°C at11 mm Hg(measured)5;289–291°C(extrapolated)7147°C at 2 mm Hg(measured)5;319°C(extrapolated)7205–208°C at16 mm Hg(measured)5;332–335°C(extrapolated)7205–208°C at16 mm Hg(measured,typical)5;332–335°C(extrapolated,typical)7>300°C(estimated)8>300°C(estimated)8>300°C(estimated)8179–183°C at 2mm Hg(measured,typical)5;358–363°C(extrapolated,typical)7VaporPressure2.2×10-3mm Hg(estimated)73.3×10-4mm Hg(estimated)71.4×10-4mm Hg(estimated)71.4×10-4mm Hg(estimated typical)73.5×10-5mm Hg(estimated)82.7×10-7mm Hg(estimated)8<1×10-10mm Hg(estimated)82.3×10-5mmHg (estimated,typical)7DissociationConstant(pKa)7.1 (estimated)107.1 (estimated)107.5 (estimated)107.5 (estimated)109.5 (estimated)109.2 (estimated)107.2 (estimated)106.2(estimated)10Henry’sLawConstant1.5×10-3atmm3/mol(estimated)82.6×10-3atmm3/mol(estimated)84.5×10-3atmm3/mol(estimated)84.5×10-3atmm3/mol(estimated)83.5×10-3atmm3/mol(estimated)83.3×10-2atmm3/mol(estimated)869 atm-m3/mol(estimated)81.9×10-9atmm3/mol(estimated)8U.S. Environmental Protection Agency September, 2010Hazard Characterization document16Table 4. Physical-Chemical Properties of Fatty Nitrogen-Derived Amines: Sponsored Chemicals (2 of 3)11-Tetradecanamine, N,Ndimethyl-1-Hexadecan-amine, N,N-dimethyl-1-Octadecanamine,N,N-dimethyl-Amines,(hydrogenatedtallow alkyl)dimethyl2Amines,dimethylsoyaalkyl2Amines, tri-C8-10-alkyl2Amines,tris(hydrogenatedtallow alkyl)2Ethanol, 2,2'-iminobis-, Ncoco alkylderivs.2PropertyValueValueValueValueValueValueValueValueWaterSolubility0.98 mg/L(estimated)80.10 mg/L(estimated)80.44 mg/L(measured)90.44 mg/L(measured, typical)90.02 mg/L(estimated)88.5×10-6mg/L(estimated)8<1×10-10mg/L(estimated)8Dispersible4Log Kow6.4 (estimated)87.4 (estimated)88.4 (estimated)88.4 (estimated)88.0 (estimated)811 (estimated)825 (estimated)8Not applicable111American Chemistry Council. 2003. Revised Robust Summary and Test Plan for Fatty Nitrogen-derived Amines Category. Availableonline athttp://www.epa.gov/chemrtk/pubs/summaries/amines/c14171tc.htmas of July 15, 2010.2Estimated data provided are based on the typical representative structure; see Appendix for detailed information on the structures.3Visek, K. 2003. Amines, Fatty. Kirk-Othmer Encyclopedia ofChemical Technology. John Wiley & Sons, Inc. Article online posting date: August 15, 2003.4Ash, M; Ash, I. 2000. Industrial Sufactants, Electronic Handbook 2000. Synapse Information Resources: Endicott, NY.5Beilstein search. 2010.6Estimated based on physical state at room temperature.7NOMO5. 1987. Programs to Enhance PC-Gems Estimates of Physical Properties for Organic Compounds. The Mitre Corp.8U.S. EPA. 2010. EstimationPrograms Interface SuiteTM for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Washington, DC, USA. Availableonline athttp://www.epa.gov/opptintr/exposure/pubs/episuitedl.htmas of July 12, 2010.9Chemicals Inspection and Testing Institute.1996. Biodegradation and BioaccumulationData of Existing Chemicals Based on theCSCL Japan. Japan ChemicalIndustry Ecology - Toxicology and Information Center. ISBN 4-89074-101-1, pg. 2–36.10SPARC Online Calculator. 2008. Version 4.2. Available online athttp://ibmlc2.chem.uga.edu/sparc/as of July 19, 2010.11Due to dispersibility, log Kow cannot be reliably measured orestimated. Source: Toll, J; Sijm, D. 2000. Estimating properties of surface active chemicals. In:Handbook of Property Estimation for Chemicals. Boethling, RS; Mackay, D; eds. Chapter 17. Lewis Publishers: Boca Raton, FLpp. 419-446.U.S. Environmental Protection Agency September, 2010Hazard Characterization document17Table 5. Physical-Chemical Properties of Fatty Nitrogen-Derived Amines: Sponsored Chemicals (3 of 3)11-Decanamine,N-decyl-NmethylAmines, di-C14-18-alkylmethyl2Amines, di-C12-18-alkyl21-Octadecanamine,N-methyl-N-octadecyl-Amines,bis(hydrogenatedtallow alkyl)methyl2Amines, ditallowalkyl2Ethanol, 2,2'-iminobis-, N-tallowalkyl derivs.2PropertyValueValueValueValueValueValueValueCASRN 7396-58-9 67700-99-6 68153-95-7 4088-22-6 61788-63-4 68783-24-4 61791-44-4MolecularWeight312 480 (typical)2438 (typical)2536 (typical)2536 (typical)2518 (typical)2356 (typical)2PhysicalStateLiquid3No data No data Solid3Solid3Solid3No dataMeltingPoint-6.3°C(measured)3No data No data 48–49°C (measured)438°C (measured)355.0°C (measured)3No dataBoilingPoint140–145°C at1–2 mm Hg(measured)5;326°C(extrapolated)6>300°C(estimated)7>300°C(estimated)7252–259°C at 0.05mm Hg (measured)5;541–550°C(extrapolated)6252–259°C at 0.05 mmHg (measured, typical)5;541–550°C(extrapolated, typical)6>300°C(estimated)7230–232°C at 1 mmHg (measured,typical)5;439–441°C(extrapolated, typical)6VaporPressure1.9×10-4mm Hg(estimated)61.9×10-8mm Hg(estimated)73.63×10-9mmHg (estimated)71.3×10-9mm Hg(estimated)71.3×10-9mm Hg(estimated)78.2×10-10mm Hg(estimated)7<1×10-10mm Hg(estimated)7Dissociation Constant(pKa)8.6 (estimated)87.1 (estimated)811 (estimated)87.1 (estimated)87.1 (estimated)811 (estimated)88.0 (estimated)8Henry’sLawConstant6.0×10-3atmm3/mol(estimated)75.8×10-2atmm3/mol(estimated)74.6×10-2atmm3/mol(estimated)70.56 atm-m3/mol(estimated)70.56 atm-m3/mol(estimated)70.20 atm-m3/mol(estimated)79.4×10-9atm-m3/mol(estimated)7U.S. Environmental Protection Agency September, 2010Hazard Characterization document18Table 5. Physical-Chemical Properties of Fatty Nitrogen-Derived Amines: Sponsored Chemicals (3 of 3)11-Decanamine,N-decyl-NmethylAmines, di-C14-18-alkylmethyl2Amines, di-C12-18-alkyl21-Octadecanamine,N-methyl-N-octadecyl-Amines,bis(hydrogenatedtallow alkyl)methyl2Amines, ditallowalkyl2Ethanol, 2,2'-iminobis-, N-tallowalkyl derivs.2PropertyValueValueValueValueValueValueValueWaterSolubility3.3×10-3mg/L(estimated)72.6×10-7mg/L(estimated)74.6×10-8mg/L(estimated)7<1×10-10mg/L(estimated)70.29 mg/L (measured)9;<1×10-10mg/L(estimated)7<1×10-10mg/L(estimated)7Dispersible10Log Kow8.9 (estimated)713 (estimated)714 (estimated)717 (estimated)73.15 (measured)9;17 (estimated)716 (estimated)7Not applicable111American Chemistry Council. 2003. Revised Robust Summary and Test Plan for Fatty Nitrogen-Derived Amines Category. Availableonline athttp://www.epa.gov/chemrtk/pubs/summaries/amines/c14171tc.htmas of July 15, 2010.2Estimated data provided are based on the typical representative structure; see Appendix for detailed information on the structures.3Visek, K. 2003. Amines, Fatty. Kirk-Othmer Encyclopedia ofChemical Technology. John Wiley & Sons, Inc. Article online posting date: August 15, 2003.4Aldrich Chemical Company. 2010. Handbook of Fine Chemicals and Laboratory Equipment, Catalog, p. 1539.5Beilstein search. 2010.6NOMO5. 1987. Programs to Enhance PC-Gems Estimates of Physical Properties for Organic Compounds. The Mitre Corp.7U.S. EPA. 2010. Estimation Programs Interface SuiteTM for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Washington, DC, USA.Available online athttp://www.epa.gov/opptintr/exposure/pubs/episuitedl.htmas of July 12, 2010.8SPARC Online Calculator. 2008. Version 4.2. Available online athttp://ibmlc2.chem.uga.edu/sparc/as of July 19, 2010.9The sponsor indicated that there was an apparent concentration-dependent partitioning of the test substance; the reported logKowwas based on the lowestconcentration tested.10Ash, M; Ash, I. 2000. Industrial Sufactants, Electronic Handbook 2000. Synapse Information Resources: Endicott, NY.11Due to dispersibility, log Kow cannot be reliably measured or estimated. Source: Toll, J; Sijm, D. 2000. Estimating properties of surface active chemicals. In:Handbook of Property Estimation for Chemicals. Boethling, RS; Mackay, D; eds. Chapter 17. Lewis Publishers: Boca Raton, FLpp. 419-446.U.S. Environmental Protection Agency September, 2010Hazard Characterization document19Table 6. Physical-Chemical Properties of FattyNitrogen-Derived Amines: Supporting Chemicals19-Octadecen-1-amine, (9Z)-1-Octadecanamine 1-Hexadecanamine,hydrofluorideAmines, coco alkyl2Amines, tallow alkyl21-Dodecanamine, N,Ndimethyl-3PropertyValue Value Value Value Value ValueCASRN 112-90-3 124-30-1 3151-59-5 61788-46-3 61790-33-8 112-18-5MolecularWeight267 270 262 185 (typical)2268 (typical)2213PhysicalStateLiquid3Solid3No data Liquid3Solid3Liquid4MeltingPoint21°C (measured) 52.9°C (measured) No data 16.0°C (measured)334–40°C (measured);25–30°C (measured)-15°C (measured)4BoilingPoint335°C (measured) 346.8°C (measured) >300°C (estimated)4259°C (measured,typical)5200–230°C (measured –too low, may be at reducedpressure)>300 (estimated)5260°C (measured)9VaporPressure3.0×10-4mm Hg(estimated)69.0×10-6mm Hg(measured)6.7×10-4mm Hg(estimated)48.05×10-3mm Hg(measured, typical)5<1 mm Hg (measured)3×10-4mm Hg (estimated)52.2×10-2mm Hg(estimated)7Dissociation Constant(pKa)10.4 (estimated)710.6 (measured) No data 10.6 (measured, typical)510.4 (estimated)77.5 (estimated)10Henry’sLawConstant8.2×10-4atmm3/mol(estimated)49.4×10-4atm-m3/mol(estimated)41.8×10-2atm-m3/mol(estimated)42.5×10-5atm-m3/mol(estimated)48.2×10-4atm-m3/mol(estimated)48.2×10-4atm-m3/mol(estimated)8U.S. Environmental Protection Agency September, 2010Hazard Characterization document20Table 6. Physical-Chemical Properties of FattyNitrogen-Derived Amines: Supporting Chemicals19-Octadecen-1-amine, (9Z)-1-Octadecanamine 1-Hexadecanamine,hydrofluorideAmines, coco alkyl2Amines, tallow alkyl21-Dodecanamine, N,Ndimethyl-3PropertyValue Value Value Value Value ValueWaterSolubility0.08 mg/L(estimated)42.9×10-2mg/L(estimated)4Dispersible878 mg/L (measured,typical)50.08 mg/L (estimated)49.3 mg/L (estimated)8Log Kow7.5 (estimated)47.7 (estimated)4Not applicable84.8 (estimated)47.5 (estimated)45.4 (estimated)81American Chemistry Council. 2003. Revised Robust Summary and Test Plan for Fatty Nitrogen-derived Amines Category. Availableonline athttp://www.epa.gov/chemrtk/pubs/summaries/amines/c14171tc.htmas of July 15, 2010.2Estimated data provided are based on the typical representative structure; see Appendix for detailed information on the structures.3Visek, K. 2003. Amines, Fatty. Kirk-Othmer Encyclopedia ofChemical Technology. John Wiley & Sons, Inc. Article online posting date: August 15, 2003.4U.S. EPA. 2010. EstimationPrograms Interface SuiteTM for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Washington, DC, USA.Available online athttp://www.epa.gov/opptintr/exposure/pubs/episuitedl.htmas of July 12, 2010.5SRC. 2010. The Physical Properties Database (PHYSPROP). SRC: Syracuse, NY. Available online athttp://www.srcinc.com/what-we-do/free-demos.aspxas of July 16, 2010.6NOMO5. 1987. Programs to Enhance PC-Gems Estimates of Physical Properties for Organic Compounds. The Mitre Corp.7SPARC Online Calculator. 2008. Version 4.2. Available online athttp://ibmlc2.chem.uga.edu/sparc as of July 21, 2010.8This chemical may be dispersible as a worst case scenario. Therefore, log Kowcannot be reliably measured or estimated. Source: Tolls, J; Sijm, D. 2000.Estimating properties of surface active chemicals. In: Handbook of Property Estimationfor Chemicals. Boethling, RS; Mackay,D; eds. Chapter 17. LewisPublishers: Boca Raton, FL. pp. 419–446.

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# 21 2. General Information on Exposure

2.1 Production Volume and Use Pattern

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

United States between 129.5 million pounds a nd 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 th e 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 ba sic organic chemical manufact uring, pesticide and other

agricultural chemical manuf acturing, soap and cleaning compound manufacturing, general

warehousing and storage and othe r chemical and allied products merchant wholesalers as

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

other than polymerization or vulcanization pr ocesses. Non-confid ential commercial and

consumer uses of this chemical include “other.”

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# 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 ba sic organic chemical manufact uring, pesticide and other

agricultural chemical manuf acturing, and soap and clean ing compound manufacturing as

intermediates; petroleum refineries as corrosi on inhibitors and anti-s caling 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 comm ercial 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 chem ical manufacturing and other ch emical and allied products

merchant wholesalers as intermed iates. 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 chem ical manufacturing as surface active agents,

intermediates and “other”; ot her 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 polymer ization or vulcanizati on processes; pesticide

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

and consumer uses of this chemical include wood and wood furniture.

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# 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 chemi cal manufacturing as su rface active agents and

intermediates; other petroleum and coal pr oducts manufacturing, suppor t 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 commercia l 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 chemi cal manufacturing as su rface active agents and

intermediates; asphalt paving, r oofing and saturated materials manufacturing, paper mills,

pesticide and other agricultural chemical manuf acturing, 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 chemi cal manufacturing as su rface active agents and

intermediates; asphalt paving, r oofing and saturated materials manufacturing, other petroleum

and coal products manufacturing, and support activi ties 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 chemi cal manufacturing as su rface active agents and

intermediates; asphalt paving, roof ing and saturated materials ma nufacturing, 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.

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# 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 av ailable 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), a nd 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. I nherent biodegradability results from OECD

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

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

supporting chemicals were all found to be eith er inherently biodegr adable or readily

biodegradable according to OECD guidelines.

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

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

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

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

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

4 weeks) by the modified MITI test (OECD 301C). A determina tion 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 wi th 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 availa ble 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/C EE), achieving >100% biodegradation after 28

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

(Table 10). However, data were found for th ree supporting chemicals (Tab le 11) which indicate

that these substances are not pers istent 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 al kyl derivs. (98% purity) was classified as

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

Thjs information is read-acr oss to the other sponsored chemicals in this group.

# U.S. Environmental Protection Agency September, 2010

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# 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 ca tions do not volatilize.

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

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

surfactants are generally not hydr olysable, according to the spons or. The rate of atmospheric

photooxidation is considered moderate to rapid fo r members of this categ ory; however, this is

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

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

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

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

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

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

having a high (B3) rating; with 5/6 be ing primary alkylamines/alkyldiamines.U.S. Environmental Protection Agency September, 2010Hazard Characterization document26Table 7. Environmental Fate Characteristics of Fatty Nitrogen-Derived Amines:Primary Alkylamines and Alkyldiamines1SPONSOREDCHEMICAL1-DodecanamineSPONSOREDCHEMICAL1-HexadecanamineSPONSOREDCHEMICALAmines, C14-18-alkyl2SPONSOREDCHEMICALAmines, C14-18and C16-18-unsatd. alkyl2SPONSOREDCHEMICALAmines, soyaalkyl2SPONSOREDCHEMICALAmines, C16-18and C18-unsatd.alkyl2SPONSOREDCHEMICALAmines, N-tallowalkyltrimethylenedi-2SPONSOREDCHEMICAL1,3-Propanediamine,N1-(9Z)-9-octadecen-1-ylPropertyValueValueValueValueValueValueValueValueCASRN 124-22-1 143-27-1 68037-91-2 68155-38-4 61790-18-9 68037-95-6 61791-55-7 7173-62-8PhotodegradationHalf-life2.8 hours(estimated)32.5 hours(estimated)32.6 hours(estimated)31.2 hours(estimated)30.80 hours(estimated)32.5 hours(estimated)30.4 hours(estimated)30.67 hours(estimated)3Hydrolysis HalflifeStableBiodegradation 55% in 28 days(readilybiodegradable)85% in 28 days(readilybiodegradable)4No data(RA)ReadilyBiodegradableNo data(RA)ReadilyBiodegradableNo data(RA)ReadilyBiodegradable85% in 28 days(readilybiodegradable)4Inadequate Data5(RA)ReadilyBiodegradableNo data(RA)ReadilyBiodegradableBioaccumulationFactorBAF = 900(estimated)3BAF = 2.7×104(estimated)3BAF = 2.7×103(estimated)3BAF = 3.6×104(estimated)3BAF = 3.6×105(estimated)3BAF = 2.7×104(estimated)3BAF = 1.3(estimated)3BAF = 9.6×105(estimated)3Log Koc3.7 (estimated)34.8 (estimated)34.3 (estimated)34.8 (estimated)35.3 (estimated)34.8 (estimated)310 (estimated)35.9 (estimated)3Fugacity(Level IIIModel)3Air (%)Water (%)Soil (%)Sediment (%)0.622.373.53.70.613.867.717.90.715.775.78.00.114.565.020.4<0.113.053.333.70.613.867.717.9<0.11882<0.1<0.18.139.052.8U.S. Environmental Protection Agency September, 2010Hazard Characterization document27Table 7. Environmental Fate Characteristics of Fatty Nitrogen-Derived Amines:Primary Alkylamines and Alkyldiamines1SPONSOREDCHEMICAL1-DodecanamineSPONSOREDCHEMICAL1-HexadecanamineSPONSOREDCHEMICALAmines, C14-18-alkyl2SPONSOREDCHEMICALAmines, C14-18and C16-18-unsatd. alkyl2SPONSOREDCHEMICALAmines, soyaalkyl2SPONSOREDCHEMICALAmines, C16-18and C18-unsatd.alkyl2SPONSOREDCHEMICALAmines, N-tallowalkyltrimethylenedi-2SPONSOREDCHEMICAL1,3-Propanediamine,N1-(9Z)-9-octadecen-1-ylPropertyValueValueValueValueValueValueValueValuePersistence6P1 (low) P1 (low) P1 (low) P1 (low)P1 (low) P1 (low) P1 (low) P1 (low)Bioaccumulation6B1 (low) B3 (high) B2 (moderate) B3 (high) B3 (high) B3 (high) B1 (low) B3 (high)1American Chemistry Council. 2003. Revised Robust Summary and Test Plan for Fatty Nitrogen-Derived Amines Category. Availableonline athttp://www.epa.gov/chemrtk/pubs/summaries/amines/c14171tc.htmas of July 15, 2010.2Estimated data provided are based on the typical representative structure; see Appendix for detailed information on the structures.3U.S. EPA. 2010. EstimationPrograms Interface SuiteTM for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Washington, DC, USA. Availableonline athttp://www.epa.gov/opptintr/exposure/pubs/episuitedl.htmas of July 12, 2010.4van Ginkel, CG. 1995. Biodegradability of Cationic Surfactants.In: Biodegradation of Surfactants. Karsa, DR; Porter, MR; eds. Glasgow, UK: Blackie, pp. 183-203.5Inherent biodegradability results from the OECD Guideline 302B test do not allow a prediction of the biodegradability of this chemical due to its high adsorption inactivated sludge.6Federal Register. 1999. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances.Federal Register64, Number 213 (November 4, 1999) pp.60194–60204.RA = Read Across.U.S. Environmental Protection Agency September, 2010Hazard Characterization document28Table 8. Environmental Fate Characteristics of Fatty Nitrogen-Derived Amines:Primary Alkylamines and Alkyldiamines1,2PropertySUPPORTINGCHEMICAL9-Octadecen-1-amine, (9Z)-SUPPORTINGCHEMICAL1-OctadecanamineSUPPORTINGCHEMICALAmines, hydrogenatedtallow alkyl2SUPPORTINGCHEMICALAmines, coco alkyl2SUPPORTINGCHEMICALAmines, tallow alkyl2CASRN 112-90-3 124-30-1 61788-45-2 61788-46-3 61790-33-8PhotodegradationHalf-life1.2 hours (estimated)32.4 hours (estimated)32.4 hours (estimated)32.8 hours (estimated)31.2 hours (estimated)3Hydrolysis Half-Life StableBiodegradation 66% in 28 days (notreadily biodegradable)4;>60% in 12 days(inherentlybiodegradable)70% in 28 days(readilybiodegradable);>60% in 12 days(inherentlybiodegradable)75% in 28 days (readilybiodegradable)56% in 28 days (readilybiodegradable)5;91.1% as CO2in 28 days(readily biodegradable)656% in 28 days (not readilybiodegradable); 73% in 28days (inherentlybiodegradable)BioaccumulationFactorBAF = 2.1×105(estimated)3BAF = 1.1×105(estimated)3BAF = 1.1×105(estimated)3BAF = 900(estimated)3BAF = 2.1×105(estimated)3Log Koc5.3 (estimated)35.3 (estimated)35.3 (estimated)33.7 (estimated)35.3 (estimated)3Fugacity(Level III Model)3Air (%)Water (%)Soil (%)Sediment (%)0.113.957.828.20.415.361.223.10.415.361.223.10.622.373.53.70.113.957.828.2Persistence7P1 (low) P1 (low) P1 (low) P1 (low) P1 (low)Bio-accumulation7B3 (high) B3 (high) B3 (high) B1 (low) B3 (high)1American Chemistry Council. 2003. Revised Robust Summary and TestPlan for Fatty Nitrogen-Derived Amines Category. Availableonline athttp://www.epa.gov/chemrtk/pubs/summaries/amines/c14171tc.htmas of July 15, 2010.2Supporting chemicals. Estimated data provided are based on the typical representative structure; see Appendix for detailed information on the structures.3U.S. EPA. 2010. Estimation Programs Interface SuiteTM for Microsoft® Windows, v4.00.U.S. Environmental Protection Agency, Washington, DC, USA. Available online athttp://www.epa.gov/opptintr/exposure/pubs/episuitedl.htmas of July 12, 2010.460% biodegradation needs to be achievedwithin a 10-day window following the initial 10%degradation for the substance to be considered readily biodegradable.5Sponsor stated that the test substance was readily biodegradable. However, pass/failcriteria for a Closed Bottle Test (OECD Guideline 301D) is 60% in 28 days.6Study was a variant of the OECD Closed Bottle Test using a raw sewage inoculum. The sponsor stated that the test substance wasreadily biodegradable.7Federal Register. 1999.Category for Persistent, Bioaccumulative,and Toxic New Chemical Substances.Federal Register64, Number 213 (November 4, 1999) pp. 60194–60204.U.S. Environmental Protection Agency September, 2010Hazard Characterization document29Table 9. Environmental Fate Characteristics of Fatty Nitrogen-Derived Amines: Dimethylalkylamines1SPONSOREDCHEMICAL1-Tetradecanamine, N,NdimethylSPONSOREDCHEMICAL1-Hexadecan-amine, N,N-dimethyl-SPONSOREDCHEMICAL1-Octadecan-amine, N,N-dimethyl-SPONSOREDCHEMICALAmines,(hydrogenatedtallow alkyl)dimethyl2SPONSOREDCHEMICALAmines,dimethylsoyaalkyl2SUPPORTINGCHEMICALOctadecen-1-amine, N,Ndimethyl-3SUPPORTINGCHEMICAL1-Dodecanamine,N,N-dimethyl-3SUPPORTINGCHEMICALAmines, cocoalkyldimethyl2,3PropertyValueValueValueValueValue Value Value ValueCASRN112-75-4 112-69-6 124-28-7 61788-95-2 61788-91-8 28061-69-0 112-18-5 61788-93-0PhotodegradationHalf-life41.3 hours(estimated)1.3 hours(estimated)1.3 hours(estimated)1.3 hours(estimated)0.62 hours(estimated)1.0 hours(estimated)1.4 hours(estimated)1.4 hours(estimated)Hydrolysis HalflifeStable StableBiodegradation InadequateData5(RA)ReadilyBiodegradable59% in 28 days(readilybiodegradable);100% in 28 days(readilybiodegradable)49% in 29 days(inherentlybiodegradable);72% in 4 weeks(readilybiodegradable)658% in 28 days(readilybiodegradable)98% in 28 days(readilybiodegradable)50% in 28 days and59% in 70 days(biodegradable)767% in 28 days(readilybiodegradable);72% in 29 days(readilybiodegradable)81% in 28 days(readilybiodegradable)BioaccumulationFactor4BAF = 430(estimated)BAF = 950(estimated)BAF = 1,400(estimated)BAF = 1,400(estimated)BAF = 8,600(estimated)BAF = 1,300(estimated)BAF = 280(estimated)BAF = 280(estimated)Log Koc44.3 (estimated) 4.8 (estimated) 5.3 (estimated) 5.3 (estimated) 5.3 (estimated) 5.3 (estimated) 3.8 (estimated) 3.8 (estimated)Fugacity(Level IIIModel)4Air (%)Water (%)Soil (%)Sediment (%)0.29.780.99.20.210.772.516.70.114.671.913.30.114.671.913.3<0.110.866.522.70.113.170.915.90.516.879.82.90.516.879.82.9Persistence8P1 (low) P1 (low) P1 (low) P1 (low)P1 (low) P1 (low) P1 (low) P1 (low)U.S. Environmental Protection Agency September, 2010Hazard Characterization document30Table 9. Environmental Fate Characteristics of Fatty Nitrogen-Derived Amines: Dimethylalkylamines1SPONSOREDCHEMICAL1-Tetradecanamine, N,NdimethylSPONSOREDCHEMICAL1-Hexadecan-amine, N,N-dimethyl-SPONSOREDCHEMICAL1-Octadecan-amine, N,N-dimethyl-SPONSOREDCHEMICALAmines,(hydrogenatedtallow alkyl)dimethyl2SPONSOREDCHEMICALAmines,dimethylsoyaalkyl2SUPPORTINGCHEMICALOctadecen-1-amine, N,Ndimethyl-3SUPPORTINGCHEMICAL1-Dodecanamine,N,N-dimethyl-3SUPPORTINGCHEMICALAmines, cocoalkyldimethyl2,3PropertyValueValueValueValueValue Value Value ValueBioaccumulation8B1 (low) B1 (low) B2 (moderate) B2 (moderate) B3 (high) B2 (moderate) B1 (low) B1 (low)1American Chemistry Council. 2003. Revised Robust Summary and Test Plan for Fatty Nitrogen-Derived Amines Category. Availableonline athttp://www.epa.gov/chemrtk/pubs/summaries/amines/c14171tc.htmas of July 15, 2010.2Estimated data provided are based on the typical representative structure; see Appendix for detailed information on the structures.3Supporting chemicals.4U.S. EPA. 2010. EstimationPrograms Interface SuiteTM for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Washington, DC, USA. Availableonline athttp://www.epa.gov/opptintr/exposure/pubs/episuitedl.htmas of July 12, 2010.5Although there is a guideline study (OECD 301D) that reports <2% degradation after 28 days, a determination of the biodegradability could not be reached due toresults that were inconsistent with related chemicals; it isnot considered representative of the biodegradation of this chemical.6National Institute of Technology and Evaluation. 2002. Biodegradation and Bioaccumulation of the Existing Chemical Substances under the Chemical SubstancesControl Law. Available online athttp://www.safe.nite.go.jp/english/kizon/KIZON_start_hazkizon.htmlas of August 10, 2010.7Test substance did not meet the criteria for ready biodegradability in OECD Guideline 301D (closed bottle test); however, thesponsor states that the test substanceshould be classified as biodegradable.8Federal Register. 1999. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances.Federal Register64, Number 213 November 4, 1999) pp.60194–60204.RA = read acrossU.S. Environmental Protection Agency September, 2010Hazard Characterization document31Table 10. Environmental Fate Characteristics of Fatty Nitrogen-Derived Amines :Dimethylalkylamines and Dialkylamines1SPONSOREDCHEMICAL1-Decanamine, Ndecyl-N-methylSPONSOREDCHEMICALAmines, di-C14-18-alkylmethyl2SPONSOREDCHEMICALAmines, di-C12-18-alkyl2SPONSOREDCHEMICAL1-Octadecanamine, N-methyl-N-octadecyl-SPONSOREDCHEMICALAmines,bis(hydrogenated tallowalkyl)methyl2SPONSOREDCHEMICALAmines, ditallow alkyl2PropertyValueValueValueValueValueValueCASRN 7396-58-9 67700-99-6 68153-95-7 4088-22-6 61788-63-4 68783-24-4PhotodegradationHalf-life1.2 hours (estimated)31.0 hours (estimated)31.1 hours (estimated)31.0 hours (estimated)31.0 hours (estimated)30.5 hours (estimated)3Hydrolysis HalflifeStableBiodegradation No data(RA)ReadilyBiodegradableNo data(RA)Readily BiodegradableNo data(RA)Readily BiodegradableNo data(RA)Readily Biodegradable100% in 28 days (readilybiodegradable);75% in 28 days (readilybiodegradable)No data(RA)Readily BiodegradableBioaccumulationFactorBAF = 1,500(estimated)3BAF = 3 (estimated)3BAF = 83 (estimated)3BAF = 0.95 (estimated)3BAF = 0.95 (estimated)3BAF = 1.2 (estimated)3Log Koc5.6 (estimated)38.7 (estimated)38.2 (estimated)39.8 (estimated)39.8 (estimated)39.8 (estimated)3Fugacity(Level III Model)3Air (%)Water (%)Soil (%)Sediment (%)0.222.670.56.70.117.082.9<0.10.223.776.1<0.1<0.11783<0.1<0.11783<0.1<0.11882<0.1Persistence4P1 (low) P1 (low) P1 (low)P1 (low) P1 (low) P1 (low)Bioaccumulation4B2 (moderate) B1 (low) B1 (low) B1 (low) B1 (low) B1 (low)1American Chemistry Council. 2003. RevisedRobust Summary and Test Plan for Fatty Nitrogen-Derived Amines Category. Availableonline athttp://www.epa.gov/chemrtk/pubs/summaries/amines/c14171tc.htmas of July 15, 2010.2Estimated data provided are based on the typical representative structure; see Appendix for detailed information on the structures.3U.S. EPA. 2010. Estimation Programs Interface SuiteTM for Microsoft® Windows, v4.00.U.S. Environmental Protection Agency, Washington, DC, USA. Available online athttp://www.epa.gov/opptintr/exposure/pubs/episuitedl.htmas of July 12, 2010.4Federal Register. 1999. Categoryfor Persistent, Bioaccumulative, andToxic New Chemical Substances.Federal Register64, Number 213 (November 4, 1999) pp. 60194–60204.RA = Read AcrossU.S. Environmental Protection Agency September, 2010Hazard Characterization document32Table 11. Environmental Fate Characteristics of Fatty Nitrogen-Derived Amines:Dimethylalkylamines and Dialkylamines1PropertySUPPORTING CHEMICALAmines, dicoco alkyl2SUPPORTING CHEMICALAmines, dicoco alkylmethyl2SUPPORTING CHEMICALAmines, bis(hydrogenated tallow alkyl)2CASRN 61789-76-2 61788-62-3 61789-79-5PhotodegradationHalf-life1.1 hours (estimated)31.1 hours (estimated)31.0 hours (estimated)3Hydrolysis Half-life StableBiodegradation 20% in 28 days (not readily biodegradable)482% in 28 days (readily biodegradable) 16% in 28 days (not readily biodegradable)5BioaccumulationFactorBAF = 2.2×104(estimated)3BAF = 420(estimated)3BAF = 1.0(estimated)3Log Koc6.7 (estimated)36.6 (estimated)39.8 (estimated)3Fugacity(Level III Model)3Air (%)Water (%)Soil (%)Sediment (%)0.224.174.21.50.117.880.81.30.117.082.9<0.1Persistence6P1 (low) P1 (low) P1 (low)Bioaccumulation6B3 (high) B1 (low) B1 (low)1American Chemistry Council. 2003. Revised Robust Summary and Test Plan for Fatty Nitrogen-Derived Amines Category. Availableonline athttp://www.epa.gov/chemrtk/pubs/summaries/amines/c14171tc.htmas of July 15, 2010.2Supporting chemicals. Estimated data provided are based onthe typical representative structures; see Appendix for detailed information on the structures.3U.S. EPA. 2010. EstimationPrograms Interface SuiteTM for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Washington, DC, USA. Availableonline athttp://www.epa.gov/opptintr/exposure/pubs/episuitedl.htmas of July 12, 2010.4The purity of the test substance was 87.8%.The sponsor states that this test result is inconsistent with expected results based on similar chemicals; adsorption may havehad an impact on the bioavailability of the test material since these types of substances are known to adsorb to solids.5The sponsor states that due to inconsistency with related chemicals, it is possible that the solubility of the test substance was inadequate for biodegradation using thismethod (OECD Guideline 301F, Respirometric method).6Federal Register. 1999. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances.Federal Register64, Number 213 (November 4, 1999) pp.60194–60204.U.S. Environmental Protection Agency September, 2010Hazard Characterization document33Table 12. Environmental Fate Characteristics ofFatty Nitrogen-Derived Amines: Trialkylamines1SPONSORED CHEMICALAmines, tri-C8-10-alkyl2SPONSORED CHEMICALAmines, tris(hydrogenated tallowalkyl)2SPONSORED CHEMICALEthanol, 2,2'-iminobis-, N-cocoalkyl derivs.2SPONSORED CHEMICALEthanol, 2,2'-iminobis-, N-tallowalkyl derivs.2PropertyValueValueValueValueCASRN 68814-95-9 61790-42-9 61791-31-9 61791-44-4PhotodegradationHalf-life1.0 hours (estimated)30.8 hours (estimated)31.1 hours (estimated)30.7 hours (estimated)3Hydrolysis Half-life StableBiodegradation No data(RA)Readily BiodegradableNo data(RA)Readily Biodegradable61% in 28 days (readilybiodegradable)52% in 28 days (readilybiodegradable)4BioaccumulationFactorBAF = 320 (estimated)3BAF = 0.89 (estimated)3BAF = 21 (estimated)3BAF = 97 (estimated)3Log Koc6.9 (estimated)314 (estimated)32.2 (estimated)33.8 (estimated)3Fugacity(Level III Model)3Air (%)Water (%)Soil (%)Sediment (%)0.224.474.90.6<0.11684<0.1<0.122.177.70.20.123.373.33.4Persistence5P1 (low) P1 (low) P1 (low) P1 (low)Bioaccumulation5B1 (low) B1 (low) B1 (low) B1 (low)1American Chemistry Council. 2003. Revised Robust Summary and Test Plan for Fatty Nitrogen-Derived Amines Category. Availableonline athttp://www.epa.gov/chemrtk/pubs/summaries/amines/c14171tc.htmas of July 15, 2010.2Estimated data provided are based on the typical representative structure; see Appendix for detailed information on the structures.3U.S. EPA. 2008. Estimation Programs Interface SuiteTMfor Microsoft® Windows, v3.20. United States Environmental Protection Agency, Washington, DC, USA.Available online athttp://www.epa.gov/opptintr/exposure/pubs/episuite.htmas of August 10, 2010.4The sponsor classified the test substance as readily biodegradable because biodegradation proceeded rapidly after an initial lag of 15 days.5Federal Register. 1999. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances.Federal Register64, Number 213 (November 4, 1999) pp.60194–60204.RA = Read Across

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# 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.

LD 50 

# > 2000 mg/kg

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

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

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

LD 50 

# > 5000 mg/kg

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

(1) CD strain rats (5/sex/dose) were admini stered 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 LD 50 

# was calculated based on the slope of the dose-response

curve.

LD 50 

# = 2116 mg/kg

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

tetradecanamine (“Genamin 14R 302D”) in sesa me 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.

LD 50 

# = 1320 mg/kg

(3) Wistar rats (10 males/dose) were admini stered N,N-dimethyl-1-t etradecanamine (“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 CA SRN at the following link: http://www.srcinc.com/what-wedo/databaseforms.aspx?id=384

. LD 50 

# = 720 mg/kg

N,N-Dimethyl-1-hexadecan amine (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 LD 50 

# value was

0.80 mL/kg.

LD 50 

# = 641 mg/kg [calculated using a density of 0.801 g/mL]

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# 35 (2) Sprague-Dawley rats (5/sex/dose) were ad ministered 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).

LD 50 

# > 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 a nd observed for 14 days. No animals died at

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

LD 50 

# = 1015 mg/kg (combined)

(4) Wistar rats (10 males/dose) were admini stered 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 (1/1 0), 600 (4/10) and all an imals (10/10) at the

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

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

. LD 50 

# = 620 mg/kg (males)

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

(1) Albino rats (5/sex/dose) were administered N,N-dimet hyl-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 we re 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 LD 50 

# value was 0.78 mL/kg.

LD 50 

# = 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 LD 50 

# value was

calculated using Probit analysis.

LD 50 

# = 2116 mg/kg (combined)

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

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

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

LD 50 

# > 2000 mg/kg

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

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

gum arabic (except for two highest dose groups, whic h 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, re spectively and 100% at 2, 4 and 8 mL/kg.

The LD 50 

# was 0.835 mL/kg.

LD 50 

# = 835 mg/kg [based on the density of chemical ~ 1 g/mL]

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Hazard Characterization document



# 36 1-Octadecanamine, N-methyl-N -octadecyl (CASRN 4088-22-6)

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

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

mortalities occurred.

LD 50 

# > 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 fo r 14 days. No mortalities

occurred.

LD 50 

# > 5000 mg/kg

Dihydrogenated tallow meth ylamine (CASRN 61788-63-4)

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

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

mortalities occurred.

LD 50 

# > 5000 mg/kg

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

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

mortalities occurred.

LD 50 

# > 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.

LD 50 

# > 2000 mg/kg

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

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

gavage at doses ranging from 0.5 to 2.0 g/kg a nd 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.

LD 50 

# = 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.

LD 50 

# = 2040 – > 6000 mg/kg

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

(1) Wistar rats (5/sex/dose) were administer ed 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.

LD 50 

# > 2000 mg/kg

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization document



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

1.5, 2.5, 3.5 and 5.0 mL/kg and observed for 14 days. Mo rtalities 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 LD 50 

# was 2.4 mL/kg.

LD 50 

# = 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.

LD 50 

# = 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-dime thyl-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.

LD 50 

# = 1220 mg/kg

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

in either Mazola oil or no vehicle via gava ge 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.

LD 50 

# = 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 deriva tives of 2,2’-iminobis ethanol via

gavage at 5.0, 6.3, 7.01, 7.94 or 10.0 g/kg and observed fo r 14 days. Mortali ties 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.

LD 50 

# ~ 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 th at 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.

LD 50 

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

(2) Sprague-Dawley rats (5/sex/dose) were ad ministered 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.

LD 50 

# > 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 ga vage at doses ranging from 0.547 to 1.071 g/kg

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization document



# 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.

LD 50 

# = 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 ga vage 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.

LD 50 

# = 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 gava ge 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.

LD 50 

# = 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 dis tilled 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).

LD 50 

# > 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 expos ed 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.

LC 50 

# > 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 deri vatives 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.

LC 50 

# > 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 obs erved for 14 days. Skin abrasions were

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

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization document



# 39 (2/4) and all animals (4/4) at the hi ghest two dose levels. (TSCATS:

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

LD 50 

# = 4400 mg/kg

N,N-Dimethyl-1-hexadecan amine (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. Mortalit ies occurred at all

doses; 50, 75 and 100% at 4, 6 a nd 8 mL/kg, respectively. The LD 50 

# value was 4.29 mL/kg.

LD 50 

# ~ 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 administ ered N,N-dimethyl-1-

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

occluded conditions for 24 hours and observed for 14 da ys. Mortalities occurr ed at all doses; 50,

75 and 100% at 4, 6 and 8 mL/kg, respectively. The LD 50 

# value was 4.29 mL/kg.

LD 50 

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

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

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

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

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

LD 50 

# = 8000 mg/kg

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

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

alkyl (“Armeen DMSD”, undiluted) via the derm al 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 LD 50 

# value was 3.0 mL/kg.

LD 50 

# ~ 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. Th e skin on half of the animals was abraded.

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

LD 50 

# > 2000 mg/kg

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

(1) In two rabbit studies, New Zealand White rabb its (3/sex/dose) were ad ministered 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 st udy (the latter was cons idered not treatmentrelated).

LD 50 

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

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization document



# 40 (2) Sprague-Dawley rats (2/sex/dose) were admini stered coco alkyl amines (“Amine KK”) via

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

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

LD 50 

# > 2000 mg/kg

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

New Zealand White rabbits (4/dose) (females and males; number pe r 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 occurr ed at all dose levels; 50, 25, 100 and 100% at 2.68,

5.20, 10.2 and 20.0 g/kg, respectively.

LD 50 

# ~ 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/d ose) were administered N-tallow

alkyl derivatives of 2,2’-iminobi s ethanol via the dermal rout e 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 studie s; one of which had half the animals exposed

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

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

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

between intact and abraded skin ). For the purposes of this hazard characterization, the LD 50 

# will

be conservatively estimated to be the only dose level tested.

LD 50 

# ~ 1600 mg/kg [one study only; calculated usi ng 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 vi a 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 (f emales). 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 speci fic information provided) were de creased in the high (males and

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

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

leukocyte counts and reductions in hemoglobin co ncentration 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 cytoplas m was found in all dose groups in the lamina

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

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

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization document



# 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 change s, accumulation of histiocytes with foamy

cytoplasm in jejunum and lymph nodes and foamy interstitial ce lls 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 – po lyethylene glycol) were

applied to non-abraded skin with a syringe and le ft 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 irritati on 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 ep ithelioid cells in the mesenteric

lymph node.

LOAEL (systemic) = 50 mg/kg/day (based on decreased body we ight, 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 irrita tion, 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% hexadecylami ne) 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 signifi cant 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 (“He taflur”) 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 provide d 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

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization document



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

glutamic pyruvic transaminase (females), alka line phosphatase (females, also females in middose group), total protein (females), calcium (m ales and females), cholesterol (males) and

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

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

such effects were reported for th e low and mid dose groups. The de scription of histopathological

damage was extensive, but the dose levels were no t 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 obs erved, with incidence dependent on dose (but no

details were presented on numb ers 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 chan ges in the small intestine and lymph nodes)

NOAEL ~ 6 mg/kg/day

(2) Beagle dogs (six/sex/dose) were administered the test substance (“He taflur”) 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 excessi ve salivation before a nd after dosing, diarrhea

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

other effects observed at a ny dose on body weight, food consum ption, hematology, clinical

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

(including the reproductive organs) for th e 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 admini stered 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 (a ll 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 (unle ss noted): mean corpuscular

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

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

also seen in one or both sexe s at the mid and high doses (unl ess 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 onl y hematology/clinical chemistry findings

observed in the low dose group were decrease d 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 orga ns: brain, adrenals and liver

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

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization document



# 43 absolute liver and kidney weights were decrease d in males and the relative kidney weight was

increased in females. Histol ogical 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 change s 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 hematol ogy 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 dos e rats were sacrificed at in tervals 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 observati ons were noted in rats at any other dietary

level. Body weight gain was i nhibited at 450 mg/kg/day and part ly inhibited at 150 mg/kg/day.

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

hematological abnormalities were detected at a ny 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 finding s observed in high and mid-dose animals were

engorgement of the villi and lamina propria of the small intestin e with swollen foamy

macrophages. Similar macrophages were presen t 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 admi nistered N-tallow alkyl derivatives of 2,2’-

iminobis ethanol (“E1095.01”) daily for 13 weeks via the diet at con centrations 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 group s were not considered treatment related. Body

weight gain was slightly reduced at the mid (mal es only) and high (males and females) levels.

There were no effects on food consumption or bi ologically significant diffe rences in hematology

or organ weights between treatment and contro l groups. Histiocytosi s 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 ga in and histopathologic effects on

the small intestine and lymph nodes)

NOAEL ~ 12 mg/kg/day

(3) Beagle dogs (4/dose, dist ribution by sex not indicated) were administered N-tallow alkyl

derivatives of 2,2’-iminobis etha nol (“Ethomeen T/12”) via the di et at doses of 0, 13, 40 or 120

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization document



# 44 mg/kg/day for 90 days. No deaths occurred. Vo miting of the meal was seen in dogs at 40 and

120 mg/kg/day, but not at 13 mg/kg/day. Tr eatment of the 120 mg/kg/day group was

discontinued after 5 – 6 weeks due to poor hea lth 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 [m ales] 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-2 20D”) dermally at doses of 0 or 2% w/v (40 mg/kg/day) 5

days/week for 4 weeks. Distilled water was us ed as the vehicle and skin was prepared by

clipping and abrasion before each application (whi ch was done with a syringe and gentle rubbing

with a glass rod and left for se ven hours). Abrasion was discontinued if skin became fissured. In

addition to body weight and hematology, only liv er and kidney weights were obtained.

Reproductive organs and skin were examined hist ologically; it is not cl ear which other organs

were examined microscopically. Dermal irritati on 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 rela tive to the control rabbits were observed.

No treatment-related changes in hematological va lues were observed. Histologically, mild to

moderate hyperplasia of the epid ermis 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 abrade d, once the concentration dropped,

abrading the skin discontinued. In addition to body weight and hematology, liver and kidney

were weighed. Several tissues, in cluding skin, were examined hist ologically. The test substance

produced severe irritation (ery thema to edema, atonia, de squamation) 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 th e end of week 1, after which steady weight gain

was noted. Anorexia was noted in three animal s. Those same three animals, along with two

others, displayed signs of rales (histopathology s howed signs of focal inflammatory respiratory

tract disease). No biological ly significant, treatment-rela ted effects on hematology were

observed in the treated animals. Additionally, necropsy confirmed treatment-related cutaneous

morphological alterations. Females e xhibited decreased kidney weight.

LOAEL (local) ~ 40 mg/kg/day (only dose tested))

NOAEL (systemic) ~ 40 mg/kg/day ( only dose tested))

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization document



# 45 (6) There were four dermal toxicity studies presented in the HPV submission. The two

summarized above are 28-day studies. A 90-day st udy 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 et hanol) 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 decisi on to stop the study was based on

moderate/marked skin irritation th at precluded an assessment of sy stemic toxicity because of the

likely effect the irritation would have on absorp tion. In addition to the terminated 90-day study,

one 28-day study is not presented because it resu lted in excessive numbers of deaths that

precluded evaluation of tr eatment-related effects.

Reproductive Toxicity

Subcategory I: Non-Hydroxylated FND Amines

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

In a reproductive/developmental screeni ng test, Sprague-Dawley Crl:CD(SD)BR rats

(10/sex/dose) were administered tallow alkyl amines (“Genami n TA 100”) in sesame oil via

gavage at doses of 0, 12.5, 50 or 150 mg/kg/da y for a 14 day premating period and throughout

mating, gestation and up to day 3 of lactati on 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 we re observed at high (sal ivation, hunched posture,

incidental soft stools an d piloerection) and mid (salivation) doses. A dose-related decrease in

premating body weight gains was ob served in the 50 and 150 mg/kg/ day groups (all animals) and

it was also seen in all doses in females during gest ation. A decrease in ge stational 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 decr eased 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 provide d). Males at 150 mg/kg/day showed increased

relative weights of epididymis and testes (and decreased absolu te weight of epididymis) and

tubular degeneration with decrea sed spermatogenesis in the test es 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 toxi city) = 150 mg/kg/day (based on implantation loss, decreased

mating and fertility indices, increased pr ecoital time, atrophy of corpora lutea)

NOAEL (reproductive toxi city) = 50 mg/kg/day

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization document



# 46 9-Octadecen-1-amine, hydrofluoride ( CASRN 3151-59-5, supporting chemical) and 9-

octadecen-1-amine, hydrofluoride (CASRN 365 05-83-6, supporting chemical), 1:1 mixture

In a one-generation study, Long-Ev ans rats (10 males and 20 female s/group) were administered a

1:1 mixture of 9-octadecen-1-amine, hydrofl uoride 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, gestat ion 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 gr oup. 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 gro ss pathology results.

NOAEL (parental toxicity) = 30 mg/kg/day (highest dose tested)

NOAEL (reproductive toxi city) = 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-o ctadecyl- (CASRN 4088-22-6)

Pregnant New Zealand White rabb its (16/dose) were administered1-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, matern al body weight gain wa s significantly lower

during days 12 through 18 of gestation. No tr eatment-related effects were found on pregnancy

rate, mortality, abortions or gestation length. Th ere was a high post-implantation loss seen in the

high dose group, but it was not significant given th e unusually high loss observed in controls.

No treatment-related effects were found on fetal si ze, 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 t oxicity) = 1000 mg/kg/day (based on possible embryolethality)

NOAEL (developmental t oxicity) = 250 mg/kg/day

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

In a reproductive/developmenta l screening test describe a bove, Sprague-Dawley Crl:CD(SD)BR

rats (10/sex/group) were admini stered 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 a nd reproductive effects

described previously). There were no litte rs in the high dose group. Pup body weights were

decreased in the mid-dose group. There were no treatment-related e ffects on the sex ratio,

viability index, survival or visible ab normalities for the 12.5 and 50 mg/kg/day groups.

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization document



# 47 LOAEL (maternal toxicity) = 12.5 mg/kg/day (based on decreased body weight during

gestation)

NOAEL (maternal toxicity) = Not established

LOAEL (developmental t oxicity) = 50 mg/kg/day (decreased pup body weight)

NOAEL (developmental t oxicity) = 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 dos es of 0, 10, 40 or 80 mg/kg/day for days 6 through

15 of gestation. Clinical signs (rales, saliva tion, soft stools, diarrhea, few/abnormal colored

feces, fecal/urine staining and unkempt appearance) of toxicity were obs erved in the 40 and 80

mg/kg/day dose groups. High dose animals also presente d emaciation, rough coat, and dark red

material around the eyes/nose/mouth. Dose-dep endent body weight losses or reduced weight

gain, and reduction in food cons umption, occurred during the trea tment period in the 40 and 80

mg/kg/day dose groups. No other maternal e ffects 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 t oxicity) = 80 mg/kg/day (highest dose tested)

(2) New Zealand White rabbits (22 artificially-i nseminated 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 th e lips and chin, labored breathing and rales) of toxicity were

observed at 10 and 30 mg/kg/day. Dose-depende nt body weight losses or reduced gains and

reduced food consumption occurred at the 10 an d 30 mg/kg/day groups (si gnificant only in the

high dose group). There were no effects on the gastro intestinal 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 t oxicity) = 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 365 05-83-6, 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 mixtur e (“Hetaflur”) in met hylcellulose 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 treat ment-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 t oxicity) = 30 mg/kg/day (based on unspecified malformations)

NOAEL (developmental t oxicity) = 6 mg/kg/day

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization document



# 48 (2) To clarify the resu lts of the study described above in which sporadic fetal malformations

were observed, the same test substance was admi nistered under identical conditions as those

described above. In this study, th ere was a significant decrease in the mean weight gains of the

high-dose group dams. No other adverse eff ects were found on pregnancy rate, mortality,

gestation length, implantation efficiency or reso rptions. No treatment-related effects were found

on fetal size, fetal sex, incidence of ossification, incidence of ma lformations 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 t oxicity) = 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 mixtur e (“Hetaflur”) in methylcellulose via gavage

at doses of 0, 1.2, 6.0 and 30.0 mg/kg/day from ge station 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 mate rnal body weight (there was a slight reduction

in body weight gain in high dose does only during l actation), pregnancy rate , mortality, gestation

length, implantation efficiency or resorptions, live-birth index, postn atal viability, sex ratios or

soft-tissue malformations. No significant treat ment-related effects were found on fetal size

(there was reduced mean fetal weights in all treated groups on l actation day 0, but not

statistically significant compared with controls), fetal sex, incide nce of ossification, incidence of

malformations or mortalities. EPA considers th is 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 t oxicity) = 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 th ree sponsored chemicals (CASRNs 112-

75-4, 112-69-6 and 124-28-7), however in each case only two bacterial strain s 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.

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization document



# 49 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 a nd without metabolic

activation. Both positive and nega tive controls were used. Cytot oxicity 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 posit ive and negative controls were used. Cytotoxicity was not

observed at any concentration. C ontrol responses were not provided.

CASRN 4088-22-6 was not mutagenic in these assays.

Dihydrogenated tallow methyl amine (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 ac tivation. Both positive and negative controls

were used. Cytotoxicity was obs erved at concentrations greater than or equal to 10 μg/plate.

Precipitate was observed at al l concentrations. Control re sponses were not provided.

CASRN 61788-63-4 was not mutagenic in this assay.

(2) Dihydrogenated tallow methylamine (“Adog en 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 positiv e and negative controls were us ed. 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 ne gative controls were used. Ev idence of cytotoxicity was not

noted; but precipitate was observed at 333 and 1000 ug/plate (no menti on 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/p late (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 we re used in each study. Cytotoxicity occurred

at 100 μg/plate and there was a visible precipitat e at concentrations of 500 ug/plate and higher.

Control responses were not provided.

CASRN 124-30-1 was not mutagenic in this assay.

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization document



# 50 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 meta bolic activation. Both positive and negative

controls were used in each study. Cytot oxicity 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). Cont rol responses were not provided.

CASRN 112-90-3 was not mutagenic in these assays.

(2) Cis-9-octadecenylamine was tested in Chin ese hamster ovary cells in an HGPRT mutation

assay at concentrations of 0.1 – 2 nL/mL (without metabolic activat ion, 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 stra in. Cytotoxicity was observed at 2.5 nL/mL

in the absence of activation a nd at 10.0 nL/mL in the presence of activation. In these three

assays, an increase in mutant frequency was obs erved on two occasions, but were not reproduced

in the other two assays (i.e., at the highest dos e of 2 nL/mL without activation and 9 nL/mL with

activation in the first assay, but not in the other two; and in on e assay at a concentration not

stated, but apparently not repr oduced 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 activ ation] or 1.2 – 13 nL/mL [with activation]

(first assay); of 0.13 – 1.8 nL/mL [without ac tivation] or 1.3 – 13 nL /mL [with activation]

(second assay); and 0.2 - 1 nL/mL [without activa tion] or 1.5 – 11.0 nL/mL [with activation]

(third [confirmatory] assay). Both positive a nd negative controls were used in each study.

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization document



# 51 Cytotoxicity was observed in each assay at concen trations greater than or equal to the highest

concentration tested. Contro l 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 deriva tives 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. S light 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 deriva tives 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 wit hout metabolic activation. Both positive and

negative controls were used. S light 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 derivativ es 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 a nd 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 (“Varoni c T-220”) was tested in L5178Y

TK+/- mouse lymphoma cells at concentratio ns of 0.33, 1.0, 3.3, 10, 33 and 100 μg/plate with

and without metabolic activation. Both positive and ne gative controls were used. Complete

cytotoxicity was observed at 0.1 μL/mL (equi valent to 100 ug/mL) without and 10 μL/mL

(equivalent to 10000 ug/mL) with metabolic acti vation. Control respons es 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 Chines e 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 ne gative controls were used in each study.

Cytotoxicity was observed at 5.0 nL/mL wit hout 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.

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization document



# 52 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 etha nol (“Varonic T-220”) wa s 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 fo r the without and with metabolic activation

assays, respectively. Contro ls responded appropriately.

CASRN 61791-44-4 induced chromosomal aberration s with metabolic activation, and did

not induce chromosomal aberrations withou t 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:N MRI 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 do ses). Both positive and negative controls were

used. The robust summary states that 6/10 mi ce died prematurely in the high dose group, but

they were replaced and the new animals surv ived. 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 administer ed to Sprague-Dawley rats (5/sex/group) in a

single dose of 2000 mg/kg by gavage in a rat mi cronucleus test in bone marrow cells. Both

positive and negative controls were used. One ma le died at 48 hours. Genotoxic effects were

not observed in the test group. Cont rol 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 admi nistered 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/g roup) were administered N-ta llow 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 chromoso me aberrations in this assay.

(2) In an erythrocyte micronucle us test, CD1 mice (15/sex/group) were administer ed N-tallow

alkyl derivatives of 2,2’-iminobis etha nol (“15% TAMET solution with 5% H 3 

# PO 4 

# 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 us ed. One treated male died. Although there

# U.S. Environmental Protection Agency September, 2010

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# 53 were no biologically significant increases in the number of micronuc leated polychromatic

erythrocytes, there was apparent t oxicity to the bone marrow. B ecause of this toxicity in the

bone marrow, three dose levels should have been employed – in accordance with OECD/OCSPP

guidelines for this assay. C ontrols 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 methyl amine (CASRN 61788-63-4)

In an unscheduled DNA synthesis test, dihydrog enated tallow methylamine (“Adogen 343”) was

tested in Sprague-Dawley hepa tocyte 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 unschedul ed 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 te sts, N-tallow alkyl deri vatives 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 experime nt, 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-hexadecan amine (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.

# U.S. Environmental Protection Agency September, 2010

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

New Zealand White rabbits (6/dose) were ad ministered 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 an d 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 ad ministered 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-hexadecan amine (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 su bmission 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 ad ministered 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 su bmission 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

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

New Zealand White rabbits (6/dose) were ad ministered 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 su bmission 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 memb ers 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 chemi cals in rabbits. Oral repeateddose toxicity studies are availa ble 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 chemi cal (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, or gan weight changes, hematol ogical changes and pathological

changes in the intestine, lymph nodes and ova ries. 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 th e 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 obser ved at 50 mg/kg/day: decreased body weight,

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

nodes.

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

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

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

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

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

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

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

parameters assessed; the NOAEL for reproductiv e 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

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# 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. Embryol ethality at 1000 mg/kg/day could not be

discounted; the NOAEL for developmental toxi city 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, on e with rats and one with rabb its, using the supporting chemical

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

signs and a decrease in body we ight); 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 th e rabbit study, dams exhibited cl inical signs and decreased body

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

developmental toxicity; the NOAEL for developmen tal 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 toxi city was observed at 30 mg/kg/da y (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; th e NOAEL for developmental toxicity was of 6 mg/kg/day.

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

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

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

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

chromosomal effects in one sponsored and th ree supporting chemicals also showed negative

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

The available data in three sponsored chemical s 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 a nd 61791-44-4) in this subcategory for human

health endpoints. With the ex ception of acute oral toxicity da ta, data were available for

CASRN 61791-44-4. Acute oral toxicity of CASR Ns 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 re sults 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, th e NOAEL was 12 mg/kg/da y based on decreases

in body weight gain and histopathological e ffects 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 in testine and lymph nodes at

# U.S. Environmental Protection Agency September, 2010

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# 57 40 mg/kg/day. There were three 28-day dermal toxicity studies in ra bbits. Local effects

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

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

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

There were no reproductive/develop mental 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 re sults 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, 2010Hazard Characterization document58Table 13. Summary Table of the Screening Information DataSet as Submitted under the U.S. HPV Challenge Program –Human Health DataSubcategory 1: Non-Hydroxylated FND AminesEndpointsDodecylamine(124-22-1)Hexadecylamine(143-27-1)N-(9Z)-octadecenyl1,3-propanediamine(7173-62-8)C14 –18-alkylamines(68037-91-2)C16 – 18and C18-unsaturatedalkyl amines(68037-95-6)C14 – 18and C16 –18-unsaturatedalkyl amines(68155-38-4)Soya alkylamines(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)N-Tallowalkyltrimethylenediamines(61791-55-7)Dimethylsoya alkylamines(61788-91-8)(Hydrogenated tallowalkyl)dimethylamines(61788-95-2)SPONSORED CHEMICALSAcute OralToxicityLD50(mg/kg)> 2000No Data620(RA)No Data620(RA)No Data620(RA)No Data620(RA)No Data620(RA)No Data620(RA)620 - >20001720 - 21161624 - 21161> 5000835> 2000Acute DermalToxicityLD50(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)343244003432-80001No Data> 2000(RA)2400No Data> 2000(RA)Repeated-DoseToxicity Oral(mg/kg/day)NOAEL/LOAEL(systemic)No DataNOAEL =NotEstablishedLOAEL =12.5(RA)No DataNOAEL =NotEstablishedLOAEL =12.5(RA)No DataNOAEL =NotEstablishedLOAEL =12.5(RA)No DataNOAEL =NotEstablishedLOAEL =12.5(RA)No DataNOAEL =NotEstablishedLOAEL =12.5(RA)No DataNOAEL =NotEstablishedLOAEL =12.5(RA)No DataNOAEL =NotEstablishedLOAEL =12.5(RA)No DataNOAEL =NotEstablishedLOAEL =12.5(RA)No DataNOAEL =NotEstablishedLOAEL =12.5(RA)No DataNOAEL =NotEstablishedLOAEL =12.5(RA)No DataNOAEL =NotEstablishedLOAEL =12.5(RA)No DataNOAEL =NotEstablishedLOAEL =12.5(RA)No DataNOAEL =NotEstablishedLOAEL =12.5(RA)Repeated-DoseToxicity Dermal(mg/kg/day)NOAEL/LOAEL(systemic)No DataNOAEL = 5LOAEL = 50(RA)No DataNOAEL = 5LOAEL = 50(RA)No DataNOAEL = 5LOAEL = 50(RA)No DataNOAEL = 5LOAEL = 50(RA)No DataNOAEL = 5LOAEL = 50(RA)No DataNOAEL = 5LOAEL = 50(RA)No DataNOAEL = 5LOAEL = 50(RA)No DataNOAEL = 5LOAEL = 50(RA)No DataNOAEL = 5LOAEL = 50(RA)No DataNOAEL = 5LOAEL = 50(RA)No DataNOAEL = 5LOAEL = 50(RA)No DataNOAEL = 5LOAEL = 50(RA)No DataNOAEL = 5LOAEL = 50(RA)ReproductiveToxicityOral(mg/kg/day)NOAEL/LOAELReproductiveToxicityNo DataNOAEL =50LOAEL =150(RA)No DataNOAEL =50LOAEL =150(RA)No DataNOAEL =50LOAEL =150(RA)No DataNOAEL =50LOAEL =150(RA)No DataNOAEL =50LOAEL =150(RA)No DataNOAEL =50LOAEL =150(RA)No DataNOAEL =50LOAEL =150(RA)No DataNOAEL =50LOAEL =150(RA)No DataNOAEL =50LOAEL =150(RA)No DataNOAEL =50LOAEL =150(RA)No DataNOAEL =50LOAEL =150(RA)No DataNOAEL =50LOAEL =150(RA)No DataNOAEL =50LOAEL =150(RA)U.S. Environmental Protection Agency September, 2010Hazard Characterization document59Table 13. Summary Table of the Screening Information DataSet as Submitted under the U.S. HPV Challenge Program –Human Health DataSubcategory 1: Non-Hydroxylated FND AminesEndpointsDodecylamine(124-22-1)Hexadecylamine(143-27-1)N-(9Z)-octadecenyl1,3-propanediamine(7173-62-8)C14 –18-alkylamines(68037-91-2)C16 – 18and C18-unsaturatedalkyl amines(68037-95-6)C14 – 18and C16 –18-unsaturatedalkyl amines(68155-38-4)Soya alkylamines(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)N-Tallowalkyltrimethylenediamines(61791-55-7)Dimethylsoya alkylamines(61788-91-8)(Hydrogenated tallowalkyl)dimethylamines(61788-95-2)DevelopmentalToxicityOral(mg/kg/day)NOAEL/LOAELMaternalToxicityDevelopmentalToxicityNo Data(rat)NOAEL = 6LOAEL = 30NOAEL = 6LOAEL = 30(RA)No Data(rat)NOAEL = 6LOAEL = 30NOAEL = 6LOAEL = 30(RA)No Data(rat)NOAEL = 6LOAEL = 30NOAEL = 6LOAEL = 30(RA)No Data(rat)NOAEL = 6LOAEL = 30NOAEL = 6LOAEL = 30(RA)No Data(rat)NOAEL = 6LOAEL = 30NOAEL = 6LOAEL = 30(RA)No Data(rat)NOAEL = 6LOAEL = 30NOAEL = 6LOAEL = 30(RA)No Data(rat)NOAEL = 6LOAEL = 30NOAEL = 6LOAEL = 30(RA)No Data(rat)NOAEL = 6LOAEL = 30NOAEL = 6LOAEL = 30(RA)No Data(rat)NOAEL = 6LOAEL = 30NOAEL = 6LOAEL = 30(RA)No Data(rat)NOAEL = 6LOAEL = 30NOAEL = 6LOAEL = 30(RA)No Data(rat)NOAEL = 6LOAEL = 30NOAEL = 6LOAEL = 30(RA)No Data(rat)NOAEL = 6LOAEL = 30NOAEL = 6LOAEL = 30(RA)No Data(rat)NOAEL = 6LOAEL = 30NOAEL = 6LOAEL = 30(RA)Genetic Toxicity–Gene MutationIn vitroNo DataNegative(RA)NegativeNo DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)Genetic Toxicity–ChromosomalAberrationsIn vitro_____________Genetic Toxicity–ChromosomalAberrationsIn vivoNo DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)Genetic Toxicity–OtherUnscheduledDNA synthesisIn vitroNo DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)U.S. Environmental Protection Agency September, 2010Hazard Characterization document60Table 13. Summary Table of the Screening Information DataSet as Submitted under the U.S. HPV Challenge Program –Human Health DataSubcategory 1: Non-Hydroxylated FND AminesEndpointsDodecylamine(124-22-1)Hexadecylamine(143-27-1)N-(9Z)-octadecenyl1,3-propanediamine(7173-62-8)C14 –18-alkylamines(68037-91-2)C16 – 18and C18-unsaturatedalkyl amines(68037-95-6)C14 – 18and C16 –18-unsaturatedalkyl amines(68155-38-4)Soya alkylamines(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)N-Tallowalkyltrimethylenediamines(61791-55-7)Dimethylsoya alkylamines(61788-91-8)(Hydrogenated tallowalkyl)dimethylamines(61788-95-2)AdditionalInformationSkin irritationEye irritation——————————————PositivePositiveNegativePositivePositivePositive——————Measured data in bold text; (RA) = Read Across; — indicates that endpoint was not addressed for this substance1A range is presented due to different responses depending on the formulation used. Please seeappropriate text for individualvalues.U.S. Environmental Protection Agency September, 2010Hazard Characterization document61Table 14. Summary Table of the Screening Information DataSet as Submitted under the U.S.HPV Challenge Program –Human Health DataSubcategory 1: Non-Hydroxylated FND AminesEndpointsN-MethylN-octadecyl1-octadecanamine(4088-22-6)Dihydrogenatedtallow methylamine(61788-63-4)Di-C14 – 18-alkylmethylamines(67700-99-6)Di-C12 –18-alkyl amines(68153-95-7)Ditallow alkylamines(68783-24-4)N-DecylN-methyl1-decanamine(7396-58-9)Tri-C8 – 10-alkylamines(68814-95-9)Tris(hydrogenatedtallow alkyl)amines(61790-42-9)SPONSORED CHEMICALSAcute OralToxicityLD50(mg/kg)> 2000, >50001> 5000, >15,0001No Data620(RA)No Data620(RA)No Data620(RA)No Data620(RA)No Data620(RA)No Data620(RA)Acute DermalToxicityLD50(mg/kg)> 2000No 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)Repeated-DoseToxicity Oral(mg/kg/day)NOAEL/LOAEL(rat)NOAEL = NotestablishedLOAEL = 117No DataNOAEL = NotEstablishedLOAEL = 12.5(RA)No DataNOAEL = NotEstablishedLOAEL = 12.5(RA)No DataNOAEL = NotEstablishedLOAEL = 12.5(RA)No DataNOAEL = NotEstablishedLOAEL = 12.5(RA)No DataNOAEL = NotEstablishedLOAEL = 12.5(RA)No DataNOAEL = NotEstablishedLOAEL = 12.5(RA)No DataNOAEL = NotEstablishedLOAEL = 12.5(RA)Repeated-DoseToxicity Dermal(mg/kg/day)NOAEL/LOAEL(rabbit)NOAEL = 5LOAEL = 50No DataNOAEL = 5LOAEL = 50(RA)No DataNOAEL = 5LOAEL = 50(RA)No DataNOAEL = 5LOAEL = 50(RA)No DataNOAEL = 5LOAEL = 50(RA)No DataNOAEL = 5LOAEL = 50(RA)No DataNOAEL = 5LOAEL = 50(RA)No DataNOAEL = 5LOAEL = 50(RA)ReproductiveToxicity Oral(mg/kg/day)NOAEL/LOAELReproductiveToxicityNo DataNOAEL = 50LOAEL = 150(RA)No DataNOAEL = 50LOAEL = 150(RA)No DataNOAEL = 50LOAEL = 150(RA)No DataNOAEL = 50LOAEL = 150(RA)No DataNOAEL = 50LOAEL = 150(RA)No DataNOAEL = 50LOAEL = 150(RA)No DataNOAEL = 50LOAEL = 150(RA)No DataNOAEL = 50LOAEL = 150(RA)U.S. Environmental Protection Agency September, 2010Hazard Characterization document62Table 14. Summary Table of the Screening Information DataSet as Submitted under the U.S.HPV Challenge Program –Human Health DataSubcategory 1: Non-Hydroxylated FND AminesEndpointsN-MethylN-octadecyl1-octadecanamine(4088-22-6)Dihydrogenatedtallow methylamine(61788-63-4)Di-C14 – 18-alkylmethylamines(67700-99-6)Di-C12 –18-alkyl amines(68153-95-7)Ditallow alkylamines(68783-24-4)N-DecylN-methyl1-decanamine(7396-58-9)Tri-C8 – 10-alkylamines(68814-95-9)Tris(hydrogenatedtallow alkyl)amines(61790-42-9)DevelopmentalToxicity Oral(mg/kg/day)NOAEL/LOAELMaternal ToxicityDevelopmentalToxicity(rabbit)NOAEL = 50LOAEL = 250NOAEL = 250LOAEL = 1000No Data(rat)NOAEL = 6LOAEL = 30NOAEL = 6LOAEL = 30(RA)No Data(rat)NOAEL = 6LOAEL = 30NOAEL = 6LOAEL = 30(RA)No Data(rat)NOAEL = 6LOAEL = 30NOAEL = 6LOAEL = 30(RA)No Data(rat)NOAEL = 6LOAEL = 30NOAEL = 6LOAEL = 30(RA)No Data(rat)NOAEL = 6LOAEL = 30NOAEL = 6LOAEL = 30(RA)No Data(rat)NOAEL = 6LOAEL = 30NOAEL = 6LOAEL = 30(RA)No Data(rat)NOAEL = 6LOAEL = 30NOAEL = 6LOAEL = 30(RA)Genetic Toxicity –Gene MutationIn vitroNegativeNegativeNo DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)Genetic Toxicity –ChromosomalAberrationsIn vitro________Genetic Toxicity –ChromosomalAberrationsIn vivoNo DataNegative(RA)NegativeNo DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)Genetic Toxicity –OtherUnscheduledDNA synthesisInvitroNo DataNegative(RA)NegativeNo DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)No DataNegative(RA)Measured data in bold text; (RA) = Read Across; — indicates that endpoint was not addressed for this substance1A range is presented due to different responses depending on the formulation used. Please seeappropriate text for individualvalues.U.S. Environmental Protection Agency September, 2010Hazard Characterization document63Table 15. Summary Table of the Screening Information DataSet as Submitted under the U.S.HPV Challenge Program –Human Health DataSubcategory I: Non-Hydroxylated FND AminesSubcategory II:Hydroxylated FND AminesEndpoints SUPPORTINGCHEMICALCis-9-octadecylamine(112-90-3)SUPPORTINGCHEMICALOctadecylamine(124-30-1)SUPPORTINGCHEMICALHexadecylaminehydrofluoride(3151-59-5) and9-Octadecen-1-aminehydrofluoride(36505-83-6), 1:1mixtureSUPPORTINGCHEMICALCoco alkylamines(61788-46-3)SUPPORTINGCHEMICALTallow alkylamines(61790-33-8)SUPPORTINGCHEMICALN,N-Dimethyl1-dodecanamine(112-18-5)SPONSOREDCHEMICALN-Coco alkylderivatives of2,2’-iminobisethanol(61791-31-9)SPONSOREDCHEMICALN-Tallow alkylderivatives of2,2’-iminobisethanol(61791-44-4)Acute Oral ToxicityLD50(mg/kg)1689> 2000_1300 - >600011944790 - 12201> 5000 630 - >15,0001Acute Dermal ToxicityLD50(mg/kg)___> 2000_5000No Data~ 1600(RA)~ 1600Repeated-DoseToxicity Oral(mg/kg/day)NOAEL/LOAEL(systemic)_(dog)NOAEL = 3LOAEL = 15(rat)NOAEL = 6LOAEL = 30(dog)NOAEL = 12(highest dosetested)_NOAEL = NotEstablishedLOAEL = 12.5_ No Data(rat)NOAEL = 50LOAEL = 150(dog)NOAEL = 13LOAEL = 40(RA)(rat)NOAEL = 50LOAEL = 150(dog)NOAEL = 13LOAEL = 40Repeated-DoseToxicity Dermal(mg/kg/day)NOAEL/LOAEL(systemic)_ _ _ __ _No DataNOAEL = 40(RA)(rabbit)NOAEL = 40(only dose tested)U.S. Environmental Protection Agency September, 2010Hazard Characterization document64Table 15. Summary Table of the Screening Information DataSet as Submitted under the U.S.HPV Challenge Program –Human Health DataSubcategory I: Non-Hydroxylated FND AminesSubcategory II:Hydroxylated FND AminesEndpoints SUPPORTINGCHEMICALCis-9-octadecylamine(112-90-3)SUPPORTINGCHEMICALOctadecylamine(124-30-1)SUPPORTINGCHEMICALHexadecylaminehydrofluoride(3151-59-5) and9-Octadecen-1-aminehydrofluoride(36505-83-6), 1:1mixtureSUPPORTINGCHEMICALCoco alkylamines(61788-46-3)SUPPORTINGCHEMICALTallow alkylamines(61790-33-8)SUPPORTINGCHEMICALN,N-Dimethyl1-dodecanamine(112-18-5)SPONSOREDCHEMICALN-Coco alkylderivatives of2,2’-iminobisethanol(61791-31-9)SPONSOREDCHEMICALN-Tallow alkylderivatives of2,2’-iminobisethanol(61791-44-4)Reproductive ToxicityOral (mg/kg/day)NOAEL/LOAELReproductive Toxicity__(rat)NOAEL = 30(highest dosetested)_(rat)NOAEL = 50LOAEL = 150_No dataNo dataDevelopmentalToxicity Oral(mg/kg/day)NOAEL/LOAELMaternal ToxicityDevelopmentalToxicityMaternal ToxicityDevelopmentalToxicity(rat)NOAEL = 10LOAEL = 40NOAEL = 80(highest dosetested)(rabbit)NOAEL = 3LOAEL = 10NOAEL = 30(highest dosetested)_(rat)NOAEL = 6LOAEL = 30NOAEL = 6LOAEL = 30_(rat)NOAEL = NotEstablishedLOAEL = 12.5NOAEL = 12.5LOAEL = 50_No DataNo DataU.S. Environmental Protection Agency September, 2010Hazard Characterization document65Table 15. Summary Table of the Screening Information DataSet as Submitted under the U.S.HPV Challenge Program –Human Health DataSubcategory I: Non-Hydroxylated FND AminesSubcategory II:Hydroxylated FND AminesEndpoints SUPPORTINGCHEMICALCis-9-octadecylamine(112-90-3)SUPPORTINGCHEMICALOctadecylamine(124-30-1)SUPPORTINGCHEMICALHexadecylaminehydrofluoride(3151-59-5) and9-Octadecen-1-aminehydrofluoride(36505-83-6), 1:1mixtureSUPPORTINGCHEMICALCoco alkylamines(61788-46-3)SUPPORTINGCHEMICALTallow alkylamines(61790-33-8)SUPPORTINGCHEMICALN,N-Dimethyl1-dodecanamine(112-18-5)SPONSOREDCHEMICALN-Coco alkylderivatives of2,2’-iminobisethanol(61791-31-9)SPONSOREDCHEMICALN-Tallow alkylderivatives of2,2’-iminobisethanol(61791-44-4)Genetic Toxicity –Gene MutationIn vitroNegativeNegative_NegativeNegative_ No DataNegative(RA)NegativeGenetic Toxicity –ChromosomalAberrationsIn vitroNegative_ _ _ _ _ No DataPositive(RA)Positive (w/)Negative (w/o)Genetic Toxicity –ChromosomalAberrationsIn vivoNegative_ _ _NegativeNegativeNo DataInconclusive(RA)InconclusiveGenetic Toxicity –OtherUDSIn vitro__ _ __ _No DataNegative(RA)NegativeMeasured data in bold; (RA) = Read Across; – endpoint not evaluated for this substance; w= withactivation; w/o =without activation1A range is presented due to different responses depending on the formulation used. Please seeappropriate text for individualvalues.

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# 66 4. Hazard to the Environment

A summary of aquatic toxicity data submitted fo r 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 te st 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 LC 50 

# = 0.42 mg/L

N,N-Dimethyl-1-tetradeca namine (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 dete rmined. Mortality was 100% at concentrations

≥ 1.0 mg/L.

96-h LC 50 

# = 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 LC 50 

# > 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 concentratio ns were not determined. Mortalities were

observed at concentrations ≥ 0.58 mg/L.

96-h LC 50 

# = 0.35 mg/L

N,N-Dimethyl-1-hexadecan amine (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 LC 50 

# = 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 unde r static conditions fo r 96 hours. Measured

concentrations were not provided. Mortalities were observed at ≥ 1.0 mg/L

96-h LC 50 

# > 0.1 and < 1 mg/L

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# 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 LC 50 

# = 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 provi ded. Mortalities were observe d at both dose levels.

96-h LC 50 

# > 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-octade canamine (CASRN 4088-22-6)

The study submitted was inadequate.

Dihydrogenated tallow methyl amine (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 LC 50 

# = 0.11 mg/L

Chronic Toxicity to Fish

N-Coco alkyl derivatives of 2,2’-i minobis 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 surviv al was the only indicator of an e ffect. Survival of larvae at

0.11 and 0.15 mg/L was less than controls.

30-d LC 50 

# = 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. Mort alities occurred at ≥ 0.052 mg/L.

96-h LC 50 

# = 0.074 mg/L

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# 68 Dihydrogenated tallow methyl amine (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 subs tance (CASRN 112-90-3) at nominal

concentrations of 0.006, 0.011, 0.023, 0.045 and 0.090 mg/L under static conditi ons for 48 hours.

Measured concentrations for the nomina l 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 EC 50 

# = 0.011 mg/L

N-Coco alkyl derivatives of 2,2’-i minobis 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 con centrations were not determined.

48-h LC 50 

# = 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 da ys. 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 lo wer in the 0.18 and 0.32 mg/L groups.

21-d LC 50 

# = 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 F 0 

# survivors in the

0.101 and 0.195 mg/L groups were lower than controls.

21-d LC 50 

# = 0.14 mg/L

Toxicity to Aquatic Plants

Dihydrogenated tallow methyl amine (CASRN 61788-63-4)

Green algae ( Pseudokirchnerie lla 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 EC 50 

# = 0.05 mg/L (biomass)

72-h EC 50 

# = 0.12 mg/L (growth rate)

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# 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 ( Pseudokirchnerie lla subcapitata ) were exposed to the te st 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 c ontrol, 0.01, 0.04 and 0.15 mg/L were 0, ND, 0.016,

0.011 and ND mg/L.

96-h EC 50 

# = 0.03 mg/L (biomass)

96-h EC 50 

# = 0.04 mg/L (growth rate)

Conclusion: The typical 96-h LC 50 

# for fish with the supporting chemical, CASRN 112-90-3, is

0.11 mg/L and the typical 48-h EC 50 

# for aquatic invertebrates is 0.011 mg/L. The 96/72-h EC 50 

# 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, 2010Hazard Characterization document70Table 16. Summary Table of the Screening Information DataSet as Submitted under the U.S. HPV Challenge Program –Aquatic Toxicity DataEndpointsDodecylamine(124-22-1)Hexadecylamine(143-27-1)N-(9Z)-octadecenyl1,3-propanediamine(7173-62-8)C14 –18-alkylamines(68037-91-2)C16 – 18andC18-unsaturatedalkyl amines(68037-95-6)C14 – 18andC16 – 18-unsaturatedalkyl amines(68155-38-4)Soya alkylamines(61790-18-9)N,N-Dimethyl-1-hexadecanamine(112-69-6)N,N-Dimethyl1-tetradecanamine(112-75-4)N,N-Dimethyl1-octadecanamine(124-28-7)N-Tallowalkyltrimethylenediamines(61791-55-7)Dimethylsoya alkylamines(61788-91-8)(Hydrogenated tallowalkyl)-dimethylamines(61788-95-2)SPONSORED CHEMICALSFish96-h LC50(mg/L)0.42 (m)No Data0.11(RA)No Data0.11(RA)No Data0.11(RA)No Data0.11(RA)No Data0.11(RA)No Data0.11(RA)0.180.18 (m)0.18No Data0.11(RA)No adequatedata0.11(RA)No Data0.11(RA)AquaticInvertebrates48-h EC50(mg/L)No Data0.011(RA)No Data0.011(RA)No Data0.011(RA)No Data0.011(RA)No Data0.011(RA)No Data0.011(RA)No Data0.011(RA)No Data0.011(RA)No Data0.011(RA)0.074No Data0.011(RA)No Data0.011(RA)No Data0.011(RA)Aquatic Plants72/96-h EC50(mg/L)BiomassGrowth rateNo Data0.030.04(RA)No Data0.030.04(RA)No Data0.030.04(RA)No Data0.030.04(RA)No Data0.030.04(RA)No Data0.030.04(RA)No Data0.030.04(RA)No Data0.030.04(RA)No Data0.030.04(RA)No adequatedata0.030.04(RA)No Data0.030.04(RA)No Data0.030.04(RA)No Data0.030.04(RA)Chronic Toxicityto Fish21-d EC50(mg/L)No Data0.0179(RA)No Data0.0179(RA)No Data0.0179(RA)No Data0.0179(RA)No Data0.0179(RA)No Data0.0179(RA)No Data0.0179(RA)No Data0.0179(RA)No Data0.0179(RA)No Data0.0179(RA)No Data0.0179(RA)No Data0.0179(RA)No Data0.0179(RA)Chronic Toxicityto Invertebrates21-d EC50(mg/L)No Data0.14(RA)No Data0.14(RA)No Data0.14(RA)No Data0.14(RA)No Data0.14(RA)No Data0.14(RA)No Data0.14(RA)No Data0.14(RA)No Data0.14(RA)No Data0.14(RA)No Data0.14(RA)No Data0.14(RA)No Data0.14(RA)bold = measured data(i.e., derived from testing); (RA) = Read Across; – indicates that endpoint was not evaluated for this substanceU.S. Environmental Protection Agency September, 2010Hazard Characterization document71Table 16. Summary Table of the Screening Information DataSet as Submitted under the U.S. HPV Challenge Program –Aquatic Toxicity DataEndpointsN-MethylN-octadecyl1-octadecanamine(4088-22-6)Dihydrogenated tallowmethylamine(61788-63-4)Di-C14 –18-alkylmethyl amines(67700-99-6)Di-C12 –18-alkylamines(68153-95-7)Ditallow alkylamines(68783-24-4)N-decylN-methyl1-decanamine(7396-58-9)Tri-C8 –10-alkylamines(68814-95-9)Tris-(hydrogenatedtallow alkyl)amines(61790-42-9)Cis-9-octadecylamine(112-90-3,supportingchemical)N-Coco alkylderivatives of2,2’-iminobisethanol(61791-31-9)N-Tallowalkylderivatives of2,2’-iminobisethanol(61791-44-4)SPONSORED CHEMICALSSUPPORTINGCHEMICALSPONSORED CHEMICALSFish96-h LC50(mg/L)No adequatedata0.11(RA)No adequatedata0.11(RA)No Data0.11(RA)No Data0.11(RA)No Data0.11(RA)No Data0.11(RA)No Data0.11(RA)No Data0.11(RA)0.11No Data0.11(RA)No Data0.11(RA)AquaticInvertebrates48-h EC50(mg/L)No Data0.011(RA)No adequatedata0.011(RA)No Data0.011(RA)No Data0.11(RA)No Data0.11(RA)No Data0.11(RA)No Data0.11(RA)No Data0.11(RA)0.0110.38No Data0.011(RA)Aquatic Plants72/96-h EC50(mg/L)BiomassGrowth rateNo Data0.030.04(RA)0.050.12(72-h)No Data0.030.04(RA)No Data0.030.04(RA)No Data0.030.04(RA)No Data0.030.04(RA)No Data0.030.04(RA)No Data0.030.04(RA)0.030.04(96-h)No Data0.030.04(RA)No Data0.030.04(RA)ChronicToxicity to Fish21-d EC50(mg/L)No Data0.0179(RA)No Data0.0179(RA)No Data0.0179(RA)No Data0.0179(RA)No Data0.0179(RA)No Data0.0179(RA)No Data0.0179(RA)No Data0.0179(RA)_0.0179No Data0.0179(RA)ChronicToxicity toInvertebrates21-d EC50(mg/L)No Data0.14(RA)No Data0.14(RA)No Data0.14(RA)No Data0.14(RA)No Data0.14(RA)No Data0.14(RA)No Data0.14(RA)No Data0.14(RA)_0.14No Data0.14(RA)bold = measured data(i.e., derived from testing); (RA) = Read Across; – indicates that endpoint was not evaluated for this substance

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# 72 APPENDIX 1: Structures for FND Amines Category

SPONSORED CHEMICALS



# Name CASRN Structure

Subcategory I: Hydroxylated FND Amines (21)

1-Dodecanamine 124-22-1 

# CH

3 

# N H

2



# 1-Hexadecanamine 143-27-1



# N H

2 

# CH

3



# Amines, C14-18-

alkyl 68037-

91-2 

# N H

2 

# CH

3



# Representative structure 1 

# (1-tetradecanamine, CASRN 2016-42-4)

Amines, C14-18

and C16-18-

unsatd. alkyl 68155-

38-4 

# N H

2 

# CH

3



# Representative structure 1



# Amines, soya

alkyl 61790-

18-9



# N H

2 

# CH

3



# Representative structure 2



# Amines, C16-18

and C18-unsatd.

Alkyl 68037-

95-6 

# N H

2 

# CH

3



# Representative structure 3 

# (1-hexadecanamine, CASRN 143-27-1)

Amines, Ntallow

alkyltrimethylene

di61791-

55-7 

# N H CH

3



# NH

2



# Representative structure 4



# 1,3-Propanediamine, N1-(9Z)-

9-octadecen-1-

yl7173-62-

8 

# N

H N H

2 

# CH

3



# 1-Tetradecanamine, N,Ndimethyl112-75-4



# N

CH

3 

# C H

3 

# CH

3



# 1-Hexadecanamine, N,Ndimethyl112-69-6



# N CH

3



# CH

3 

# C H

3

# U.S. Environmental Protection Agency September, 2010

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# 73 SPONSORED CHEMICALS



# Name CASRN Structure

1-Octadecanamine, N,Ndimethyl124-28-7



# N CH

3



# CH

3 

# C H

3



# Amines,

(hydrogenated

tallow

alkyl)dimethyl 61788-

95-2 

# N CH

3



# CH

3 

# C H

3



# Representative structure 5 

# (1-Octadecanamine, N,N-di methyl-, CASRN 124-28-7)

Amines,

dimethylsoya

alkyl 61788-

91-8 

# N CH

3 

# C H

3



# CH

3



# Representative structure 2



# 1-Decanamine,

N-decyl-Nmethyl7396-58-

9



# N CH

3



# CH

3 

# C H

3



# Amines, di-C14-

18-alkylmethyl 67700-

99-6 

# N CH

3



# CH

3 

# C H

3



# Representative structure 1



# Amines, di-C12-

18-alkyl 68153-

95-7 

# N H CH

3



# CH

3



# Representative structure 1



# 1-Octadecanamine, Nmethyl-Noctadecyl4088-22-

6 

# N CH

3



# CH

3 

# C H

3



# Amines,

b is(hydrogenated

tallow

alkyl)methyl 61788-

63-4 

# N CH

3



# CH

3 

# C H

3



# Representative structure 5 

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

Amines, ditallow

alkyl 68783-

24-4 

# N H CH

3



# CH

3



# Representative structure 4

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization document



# 74 SPONSORED CHEMICALS



# Name CASRN Structure

Amines, tri-C8-

10-alkyl 68814-

95-9 

# N CH

3 

# C H

3



# CH

3



# Representative structure 1



# Amines,

tris(hydrogenated

tallow alkyl) 61790-

42-9



# N C H

3



# CH

3 

# CH

3



# Representative structure 5



# Subcategory II: Hydroxylated FND Amines (2)

Ethanol, 2,2'-

iminobis-, Ncoco alkyl

derivs. 61791-

31-9 

# CH

3 

# N

OH OH

Representative structure 6



# Ethanol, 2,2'-

iminobis-, Ntallow alkyl

derivs. 61791-

44-4 

# N

OH OH CH

3



# Representative structure 4

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization document



# 75 Supporting Chemicals (All for Subcategor y I – Nonhydroxylated FND Amines)

Name CASRN Structure

9-Octadecen-1-

amine, (9Z)- 112-90-3



# N H

2 

# CH

3



# 1-

Octadecanamin

e 124-30-1



# N H

2 

# CH

3



# 1-

Hexadecanami

ne,

hydrofluoride 3151-59-5



# N + 

# CH

3 

# H

H H F

Amines,

hydrogenated

tallow alkyl 61788-45-2



# N H

2 

# CH

3



# Representative structure 5 

# (1-Octadecanamine, CASRN 124-30-1)

Amines, coco

alkyl 61788-46-3 

# CH

3 

# N H

2



# Representative structure 6 

# (1-Dodecanamine, CASRN 124-22-1)

Amines, tallow

alkyl 61790-33-8



# N H

2 

# CH

3



# Representative structure 4 

# (9-Octadecen-1-amine, (9 Z)-, CASRN 112-90-3)

Octadecen-1-

amine, N,Ndimethyl28061-69-0



# C H

2 

# N CH

3



# CH

3



# Representative structure, position of double bond unspecified

1-

Dodecanamine,

N,N-dimethyl112-18-5



# CH

3 

# N

CH

3 

# C H

3



# Amines, coco

alkyldimethyl 61788-93-0



# CH

3 

# N

CH

3 

# C H

3



# Representative structure 6 

# (1-Dodecanamine, N,N-dimethyl-, CASRN 112-18-5)

Amines, dicoco

alkyl 61789-76-2 

# CH

3 

# N H

CH

3



# Representative structure 6

# U.S. Environmental Protection Agency September, 2010

Hazard Characterization document



# 76 Supporting Chemicals (All for Subcategor y I – Nonhydroxylated FND Amines)

Name CASRN Structure

Amines, dicoco

alkylmethyl 61788-62-3 

# CH

3 

# N

CH

3 

# C H

3



# Representative structure 6



# Amines,

bis(hydrogenat

ed tallow alkyl) 61789-79-5



# N H CH

3



# CH

3



# Representative structure 5

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 amin e; 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 struct ure shown is for the 16 carb on 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 amin e. 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 le ngth, 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.