Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian germ cell study: cytogenicity / chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

The cytogenetic studies and dominant lethal tests of long term administration with butylated hydroxytoluene (BHT) and linear alkylbenzene sulfonate (LAS) in mice and rats.

Author:

Masubuchi, M, Takahashi, A, Takahashi, O and Hiraga, K

Year:

1976

Bibliographic source:

Masubuchi et. al.,1976. The cytogenetic studies and dominant lethal tests of long term administration with butylated hydroxytoluene (BHT) and linear alkylbenzene sulfonate (LAS) in mice and rats. Ann. Rep. Tokyo Metrop. Res. Lab. Public Health, 27, 100-4.

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

A group of 7 male mice was fed a diet containing 0.6% test substance for 9 months. At the end of this period, the animals were each mated with two untreated females. On day 13 of pregnancy, the females were sacrificed, and the ovaries and uteri were examined.

GLP compliance:

no

Type of assay:

rodent dominant lethal assay

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts

EC Number:

270-115-0

EC Name:

Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts

Cas Number:

68411-30-3

Molecular formula:

Not applicable for UVCB

IUPAC Name:

sodium 4-undecylbenzenesulfonate

Test animals

Species:

mouse

Strain:

other: JCL-ICR

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CLEA Japan, Inc.
- Age at study initiation: 4 weeks
- Housing: individually, except during breeding
- Diet: ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: feed

Details on exposure:

DIET PREPARATION
- Mixing appropriate amounts with: feed powder CE-2

Duration of treatment / exposure:

9 months

Frequency of treatment:

daily

Doses / concentrations

Dose / conc.:

300 mg/kg bw/day (nominal)

Remarks:

0.6% in diet

No. of animals per sex per dose:

7

Control animals:

yes

Examinations

Statistics:

Rohrborn's method.

Results and discussion

Test results

Key result

Sex:

male

Genotoxicity:

negative

Toxicity:

not specified

Negative controls validity:

valid

Additional information on results:

There were no significant differences in fertility, the mortality of ova and embryos, the number of surviving fetuses, or the index of dominant lethal induction between the experimental groups and the control group.

Any other information on results incl. tables

Dominant Lethal Assay Results

	0.6% in Diet	Control
Number of mating females	14	18
Number pregnant	11	12
No. with dead embryos	6	10
Dead embryos per pregnant female	54.6%	83.3%
No. of corpora lutea	156	161
Corpora lutea per pregnant female	14.2	13.4
No. of implants	148	156
Implants per pregnant female	13.5	13.0
Implants per corpora lutea	94.9	96.9
No. of live fetuses	142	143
Live fetuses per pregnant female	12.9	11.9
Live fetuses per corpora lutea	91.0	88.8
Live fetuses per total implants	96.0	91.7
No. of early dead fetuses	4	12
No. of late dead fetuses	2	1
% of dominant lethals	-4.67	-
% of dominant lethals	-8.33	-

Applicant's summary and conclusion

Conclusions:

The test substance did not cause genetic disorders in mice.

Executive summary:

A group of 7 male mice was fed a diet containing 0.6% test substance for 9 months. At the end of this period, the animals were each mated with two untreated females. On day 13 of pregnancy, the females were sacrificed, and the ovaries and uteri were examined. No increase in dominant lethal induction was seen as compared to controls. The test substance does not cause genetic disorders.