Undecane

ウンデカン

[CAS No. 1120-21-4]

n-Undecane

n-ウンデカン

Molecular formula: C11H24 Molecular weight: 156.31

ABSTRACT

The single dose toxicity test revealed an LD50 value of above 2000 mg/kg for both sexes.

In the repeat dose toxicity test, salivation was observed in males and females given 300 or 1000 mg/kg. Body weight gain was suppressed in males given 1000 mg/kg, and body weights was increased in females given 1000 mg/kg during the lactation period. Food consumption was decreased in males given 300 and 1000 mg/kg in the first half of the administration period, increased in males given 1000 mg/kg in the second half of administration period, and increased in females given 1000 mg/kg in the second half of pregnancy and during the lactation period. Hemoglobin concentration was decreased in males given 1000 mg/kg. Undecane caused liver changes such as increased relative organ weights in males and females given 1000 mg/kg, and a decrease in serum albumin and increases in serum α2-globulin, GPT, cholinesterase and total cholesterol in males given 1000 mg/kg. The NOEL for repeat dose toxicity is considered to be 100 mg/kg/day for both sexes. Body weight gain was decreased in male and female offspring of the 1000 mg/kg group. No effects were observed on reproductive performance in either sex. The NOEL for reproductive and developmental performances is considered to be 300 mg/kg/day.

Undecane was not mutagenic to Salmonella typhimurium TA100, TA98, TA1535, TA1537 and Escherichia coli WP2 uvrA, with or without metabolic activation.

Undecane did not induce structural chromosomal aberrations or polyploidy in CHL/IU cells up to the limit concentration of 10 mM, in the absence or presence of an exogenous metabolic activation system.

SUMMARIZED DATA FROM THE STUDIES

1. Single Dose Oral Toxicity 1)

Purity	:	≧ 99%
Test species/strain	:	Rat/Crj:CD (SD)
Test method	:	OECD Guidelines 401
Doses	:	0, 500, 1000, 2000 mg/kg
Number of animals/group	:	Males, 5 ; females, 5
GLP	:	Yes

　 Test results:

No deaths occurred in either males or females of any of the treated groups. No effects were detected in terms of general condition, body weight changes, autopsy or histopathology findings.

LD50: Male, > 2000 mg/kg; female, > 2000 mg/kg

2. Repeat Dose and Reproductive/Developmental Toxicity 1)

Purity	:	≧ 99%
Test species/strain	:	Rat/Crj:CD (SD)
Test method	:	OECD Combined Repeat Dose and Reproductive/Developmental Toxicity Screening Test
Route	:	Oral (gavage)
Doses	:	0 (vehicle), 100, 300, 1000 mg/kg/day
Number of animals/group	:	Males, 12 ; females, 12
Vehicle	:	Olive oil
Administration period	:	Males, 46 days Females, from 14 days before mating to day 3 of lactation
Terminal kill	:	Males, day 47 Females, day 4 of lactation
GLP	:	Yes

　 Test results:

<Repeat dose toxicity>

In the repeat dose toxicity test, salivation was observed in males and females given 300 and 1000 mg/kg. Body weight gain was suppressed in males given 1000 mg/kg, and body weights were increased in females given 1000 mg/kg during the lactation period. Food consumption was decreased in males given 300 and 1000 mg/kg in the first half of the administration period, increased in males given 1000 mg/kg in the second half of the administration period, and increased in females given 1000 mg/kg in the second half of pregnancy and during the lactation period. Hematological and blood chemical examinations revealed a decrease in hemoglobin concentration, an increase in the white blood cell count, a decrease in albumin, and increases in a2-globulin, GPT, cholinesterase and total cholesterol in males given 1000 mg/kg. Relative liver weights and absolute and relative thymes weights were increased in males given 1000 mg/kg, and absolute and relative liver weights were elevated in females given 1000 mg/kg. No effects were detected in the autopsy or histopathology findings. The NOEL for repeat dose toxicity is considered to be 100 mg/kg/day for both sexes.

<Reproductive and developmental toxicity>

No effects were detected with regard to reproductive ability, reproductive organ weights, or autopsy or histopathology findings in either sex, and there was no apparent influence on delivery or maternal behavior of dams. Body weight gain was decreased in male and female offspring of the 1000 mg/kg group. No effects were noted in terms of viability, general condition or autopsy findings of offspring. The NOELs for reproductive and developmental performance are considered to be both 300 mg/kg/day.

3. Genetic Toxicity

3-1. Bacterial test 2)

Purity	:	99%
Test species/strains	:	S.typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA
Test methods	:	Guidelines for Screening Mutagenicity Testing of Chemicals (Japan) and OECD (471 and 472)
Procedures	:	Plate incorporation method
Solvent	:	Acetone
Positive controls	:	-S9 mix, 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (TA100, WP2, TA98), Sodium azide (TA1535) and 9-Aminoacridine (TA1537), +S9 mix, 2-Aminoanthracene (five strains)
Dosage	:	0, 313, 625, 1250, 2500 and 5000 μg/plate in five strains, -S9 mix and +S9 mix
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 S. typhimurium and E. coli strains. Toxicity was not observed at 5000 μg/plate in the five strains with either the -S9 mix or the +S9 mix.

Genetic effects:

Salmonella typhimurium TA100, TA1535, TA98, 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%
Type of cell used	:	Chinese hamster lung (CHL/IU) cells
Test method	:	Guidelines for Screening Mutagenicity Testing of Chemicals (Japan)
Solvent	:	Acetone
Positive controls	:	-S9 mix, Mitomycin C +S9 mix, Cyclophosphamide
Doses	:	-S9 mix (continuous treatment): 0, 0.40, 0.80, 1.6 mg/ml -S9 mix (short-term treatment): 0, 0.40, 0.80, 1.6 mg/ml +S9 mix (short-term treatment): 0, 0.40, 0.80, 1.6 mg/ml
S-9	:	Rat liver, induced with phenobarbital and 5,6-benzoflavone
Plates/test	:	2
GLP	:	Yes

　 Test results:

Cytogenetic effects were not seen under the conditions of this experiment.

Genotoxic effects:

	clastogenicity			polyploidy
	+	?	-	+	?	-
without metabolic activation:	[ ]	[ ]	[*]	[ ]	[ ]	[*]
with metabolic activation:	[ ]	[ ]	[*]	[ ]	[ ]	[*]

1)	The tests were performed by the Safety Research Institute for Chemical Compounds Co., Ltd., 363-24, Shin-ei, Toyohira-ku, Sapporo, Hokkaido, 004, Japan. Tel +81-11-885-5031 Fax +81-11-885-5313
2)	The tests were performed by the Hatano Research Institute, Food and Drug Safety Center, 729-5 Ochiai, Hadano-shi, Kanagawa, 257, Japan. Tel +81-463-82-4751 Fax +81-463-82-9627