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Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well-documented journal article.

Data source

Referenceopen allclose all

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, Switzerland.
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:
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
Type of assay:
mammalian germ cell cytogenetic assay

Test material

Constituent 1
Reference substance name:
Linear Alkylbenzene sulphonate (LABS Na)
IUPAC Name:
Linear Alkylbenzene sulphonate (LABS Na)
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
Remarks:
Doses / Concentrations:
0.9%, 1170 mg/kg bw d
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
Additional information on results:
No increase in chromosome aberrations was noted.

Any other information on results incl. tables

Chromosome Aberrations

 

0.9% in Diet

Control

No. of cells with chromatid breaks

1

2

No. of cells with isochromatid breaks

1

0

No. of cells with chromatid gaps

4

5

No. of cells with isochromatid gaps

0

0

No. of cells with other aberrations

0

0

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): 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.