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

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Remarks:

Well-documented journal article.

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
Refer to Section 13.2 for read-across justification document.

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 Sulfonates (LAS) in Mice and Rats

Author:

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

Year:

1976

Bibliographic source:

Ann. Rep. Tokyo Metr. Res. Lab. P.H. 27-2.

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

A group of 5 male mice was 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

Remarks:

Study pre-dates GLP

Type of assay:

mammalian germ cell chromosome aberration test

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): linear alkylbenzene sulfonate

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 (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

Dose / conc.:

1 170 mg/kg bw/day (nominal)

Remarks:

Basis: Nominal in diet

No. of animals per sex per dose:

5

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

Remarks on result:

other: No increase in chromosome aberrations was noted.

Additional information on results:

No increase in chromosome aberrations was noted.

Any other information on results incl. tables

Chromosome Aberrations

	1170 mg/kg bw/d in diet	Control
Number of cells with chromatid breaks	1	2
Number of cells with isochromatid breaks	1	0
Number of cells with chromatid gaps	4	5
Number of cells with isochromatic gaps	0	0
Number of cells with other aberrations	0	0

Applicant's summary and conclusion

Conclusions:

Interpretation of results: negative
The test substance is not clastogenic.

Executive summary:

A group of 5 male mice was 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.