1,2-Bis(stearoylamino)ethane

1,2-ビス(ステアロイルアミノ)エタン

[CAS No. 110-30-5]

N,N'-1,2-Ethylenebis(octadecanamide)

N,N'-1,2-エチレンビス(オクタデカンアミド)

Molecular formula: C₃₈H₇₆N₂O₂　Molecular weight: 593.02

ABSTRACT

1,2-Bis(stearoylamino)ethane was studied for oral toxicity in rats in a 28-day repeat dose toxicity test at doses of 0, 100, 300 and 1000 mg/kg. No deaths in either sex were observed in any of the treatment groups. There were no changes in general appearance, body weight, food consumption, hematological findings, blood chemical findings, urinalysis findings, absolute and relative organ weights, gross findings or histopathological findings in any of the treatment groups, in either sex.

The NOEL for repeat dose toxicity is considered to be 1000 mg/kg/day for both sexes.

1,2-Bis(stearoylamino)ethane was not mutagenic in Salmonella typhimurium TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA, with or without an exogenous metabolic activation system.

1,2-Bis(stearoylamino)ethane did not induce structural chromosomal aberrations or polyploidy in CHL/IU cells, with or without exogenous metabolic activation.

SUMMARIZED DATA FROM THE STUDIES

1. Single Dose Oral Toxicity ¹⁾

Purity	:	99.7 wt%
Test species/strain	:	Rat/Crj:CD(SD)
Test method	:	OECD Test Guideline 401
Route	:	Oral(gavage)
Doses	:	0, 2000 mg/kg
Number of animals/group	:	Males, 5; females, 5
Vehicle	:	Corn oil
GLP	:	Yes

　Test results:

No deaths occurred in either sex during the observation period. No abnormal clinical signs were observed in any males or females during the observation period.

The LD₅₀ values were estimated to be more than 2000 mg/kg for both sexes.

2. Repeat Dose Toxicity ¹⁾

Purity	:	99.7 wt%
Test species/strain	:	Rat/Crj:CD(SD)IGS
Test method	:	Guideline for 28-Day Repeated Dose Toxicity Test in Mammalian Species (Chemical Substances Control Law of Japan)
Route	:	Oral
Doses	:	0(vehicle), 100, 300, 1000 mg/kg/day
Number of animals	:	Males, 5; females, 5
Vehicle	:	Corn oil
Administration period	:	Males and females, 28 days
Terminal kill	:	Males and females, days 29 and 43
GLP	:	Yes

　Test results:

No deaths were observed in either sex in any of the treatment groups. There were no changes in general appearance, body weight, food consumption, hematological findings, blood chemical findings, urinalysis findings, absolute and relative organ weights, gross findings or histopathological findings in any of the treatment groups, in either sex.

The NOEL is considered to be 1000 mg/kg/day for both sexes.

3. Genetic Toxicity

3-1. Bacterial test ²⁾

Purity	:	99.7 %
Test species/strain	:	Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA
Test method	:	Guidelines for Screening Mutagenicity Testing of Chemicals(Chemical Substances Control Law of Japan) and OECD Test Guideline 471
Procedures	:	Pre-incubation method
Solvent	:	DMSO
Positive controls	:	-S9 mix; 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (TA100, TA98), Sodium azide (TA1535), 9-Aminoacridine (TA1537) and N-Ethyl-N'-nitro-N-nitrosoguanidine (WP2 uvrA) +S9 mix; 2-Aminoanthracene (all strains)
Doses	:	-S9 mix; 313, 625, 1250, 2500 and 5000 μg/plate (all strains) +S9 mix; 313, 625, 1250, 2500 and 5000 μg/plate (all strains)
S9	:	Rat liver, induced with phenobarbital and 5,6-benzoflavone
Plates/test	:	3
Number of replicates	:	2
GLP	:	Yes

　Test results:

This chemical did not induce gene mutations in the Salmonella typhimurium and Escherichia coli strains. Toxicity was not observed at 5000 μg/plate in any of the tester strains, with or without metabolic activation.

Genetic effects:
Salmonella typhimurium TA100, TA1535, TA98 and TA1537

	+	?	-
Without metabolic activation:	[ ]	[ ]	[*]
With metabolic activation:	[ ]	[ ]	[*]

Escherichia coli WP2 uvrA

	+	?	-
Without metabolic activation:	[ ]	[ ]	[*]
With metabolic activation:	[ ]	[ ]	[*]

3-2. Non-bacterial in vitro test (chromosomal aberration test) ²⁾

Purity	:	99.7 %
Type of cell used	:	Chinese hamster CHL/IU cells
Test method	:	Guidelines for Screening Mutagenicity Testing of Chemicals(Chemical Substances Control Law of Japan) and OECD Test Guideline 473
Solvent	:	Dimethylsulfoxide
Positive controls	:	-S9 mix; Mitomycin C +S9 mix; Benzo[a]pyrene
Doses	:	-S9 mix(6 hr short-term treatment); 0, 125, 250, 500 μg/mL +S9 mix(6 hr short-term treatment); 0, 125, 250, 500 μg/mL -S9 mix(24 hr continuous treatment); 0, 125, 250, 500 μg/mL
S9	:	Rat liver, induced with phenobarbital and 5,6-benzoflavone
Plates/test	:	2
GLP	:	Yes

　Test results:

This chemical did not induce structural chromosomal aberrations or polyploidy under the conditions of this experiment.

Genotoxic effects:

	clastogenicity			polyploidy
	+	?	-	+	?	-
Without metabolic activation:	[ ]	[ ]	[*]	[ ]	[ ]	[*]
With metabolic activation:	[ ]	[ ]	[*]	[ ]	[ ]	[*]

1)	The tests were performed by the Biosafety Research Center, Foods, Drugs and Pesticides (An-pyo Center), 582-2 Arahama, Shioshinden, Fukude-cho, Iwata-gun, Shizuoka, 437-1213, Japan. Tel +81-538-58-1266 Fax +81-538-58-1393
2)	The tests were performed by the Mitsubishi Chemical Safety Institute Ltd., 14 Sunayama, Hasaki-machi, Kashima-gun, Ibaraki, 314-0255, Japan. Tel +81-479-46-2871 Fax +81-479-46-2874