Benzenesulfonic acid, 4-C20-24 (even numbered) sec-alkyl derivs., sodium salts

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian germ cell study: cytogenicity / chromosome aberration

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well-documented journal article.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

The Cytogenetic Studies and Dominant Lethal Tests of Long Term Administration with Butylated Hydroxytoluene (BHT) and Linear Alkylbenzene Sulfonates (LAS) in Mice and Rats

Author:

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

Year:

1976

Bibliographic source:

Ann. Rep. Tokyo Metrop. Res. Lab. Public Health. 27:100-104 (in Japanese); cited in: IPCS (1996); Environmental Health Criteria 169: Linear Alkylbenzene Sulfonates (LAS) and Related Compounds. WHO, Geneva, Sw

Reference 2

Reference Type:

publication

Title:

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

Author:

European Commission

Year:

2000

Bibliographic source:

Year 2000 CD-ROM edition

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Groups of 5 male rats were fed a diet containing 0.9% test substance for 9 months. At the end of this period, the animals were sacrificed, and the bone marrow cells examined for chromosome aberrations.

GLP compliance:

no

Type of assay:

mammalian germ cell cytogenetic 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

IUPAC Name:

sodium 4-undecylbenzenesulfonate

Test material form:

solid

Test animals

Species:

rat

Strain:

other: Wistar and SD

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
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:

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 (Type of food): feed powder CE-2

Duration of treatment / exposure:

9 months

Frequency of treatment:

daily

Doses / concentrations

Remarks:

Doses / Concentrations:
0.9%, 450 mg/kg bw d
Basis:
nominal in diet

No. of animals per sex per dose:

10

Control animals:

yes

Examinations

Tissues and cell types examined:

femur bone marrow cells

Details of tissue and slide preparation:

Animals were sacrificed by administration of 1 ml/kg of 1% colchine solution. Femurs were then removed, and bone marrow cells washed into centrifuge tubes. The cells were then treated with 0.075 M KCl solution at 37 degree C for 15 min, and then fixed with an acetic acid 1: ethanol 3 solution. Samples were then flame dried and treated with Giemsa.

Evaluation criteria:

Presence and absence of chromosomal aberrations. 50 metaphases per individual.

Statistics:

Rohrborn's method.

Results and discussion

Test results

Sex:

male

Genotoxicity:

negative

Negative controls validity:

valid

Additional information on results:

No increase in chromosome aberrations was noted.

Any other information on results incl. tables

Chromosome Aberrations

	0.9% in Diet ¿ Wister Rats	0.9% in Diet ¿ SD Rats	Control	Control
No. of cells with chromatid breaks	0	0	1	0
No. of cells with isochromatid breaks	0	0	0	0
No. of cells with chromatid gaps	3	4	3	4
No. of cells with isochromatid gaps	0	0	0	0
No. of cells with other aberrations	0	0	0	0

Applicant's summary and conclusion

Conclusions:

The test substance is not clastogenic.

Executive summary:

Groups of 5 male rats were fed a diet containing 0.9% test substance for 9 months. At the end of this period, the animals were sacrificed, and the bone marrow cells examined for chromosome aberrations. No increase in chromosome aberrations was seen as compared to controls. The test substance is not clastogenic.