Registration Dossier

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

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 publication.

Data source

Reference
Reference Type:
publication
Title:
In Vivo Chromosome Tests of Synthetic Detergents in Mice
Author:
Inoue, K., Shibata, T., Hamano, Y., Oda, Y., Kuwano, A., Yamamoto, H., Mitsuda, B. and Kunita, N.
Year:
1976
Bibliographic source:
Ann. Res. Osaka Prefect Inst. Public Health. 8:17-24.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Groups of male mice were given doses of 200, 400, or 800 mg/kg of Benzenesulfonic acid, C10-14-alkyl derivs., sodium salts. At 6, 24, and 48 hrs, 3 of the mice from each dosage group were sacrificed. The bone marrow cells from the femurs were collected and examined for chromosome aberrations. In addition, one group of mice was exposed daily for 5 consecutive days. Additional groups of mice were exposed to commerical detergents containing 19% or 17.1% of the test substance. Mitomycin C was used as a positive control.
GLP compliance:
no
Type of assay:
chromosome aberration assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Benzenesulfonic acid, C10-14-alkyl derivs., sodium salts (CAS #69669-44-9)
average alkyl chain length (based on LAS SIDS Consortium Survey, 2000) = 11.7
Besides the pure test substance, commercial preparations containing 19% and 17.1% test substance were tested.

Test animals

Species:
mouse
Strain:
other: ICR/JCL
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CLEA Japan Inc.
- Age at study initiation: 9-11 weeks
- Housing: individually in plastic cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 2
- Humidity (%): 55 +/- 5
- Photoperiod (hrs dark / hrs light): 12/12 hrs

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
- Vehicle(s)/solvent(s) used: distilled water
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: Samples were diluted to make a 5 ml/kg dose volume

Duration of treatment / exposure:
Single treatment, except for one group which was given 5 consecutive daily exposures to the test substance
Frequency of treatment:
once daily
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
200, 400, 800 mg/kg
Basis:
nominal conc.
test substance
Remarks:
Doses / Concentrations:
800, 1600, 3200 mg/kg
Basis:
nominal conc.
commercial detergent containing 19% test substance
Remarks:
Doses / Concentrations:
1000, 2000, 4000 mg/kg
Basis:
nominal conc.
commercial detergent containing 17.1% test substance
No. of animals per sex per dose:
9
Control animals:
yes, concurrent vehicle
Positive control(s):
mitomycin C1

- Route of administration: intraperitoneally
- Doses / concentrations: 5 mg/kg

Examinations

Tissues and cell types examined:
bone marrow cells from femurs
Details of tissue and slide preparation:
CRITERIA FOR DOSE SELECTION:

TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): 3 animals were sacrificed at 6, 24, and 48 hrs after treatment. One group was exposed daily for 5 days prior to sacrifice.

DETAILS OF SLIDE PREPARATION: Cells were placed in Hank's solution, then centrifuged at 1000 rpm for 5 min. Supernatant was discarded, and 5 ml of 0.075 M KCl was added. The mixture then stood for 5 min., then was stirred and centrifuged again. This was repeated several times, before finally placing one or two drops on the slides, and staining with 2% Giemsa solution.

Evaluation criteria:
number of cells with chromatid and chromosome gaps, number of cells with aberrations
50 metaphases per animal (150 total) were imaged at each time point.

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
not examined
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
No significant differences in the incidence of chromosomal aberrations were observed in any test substance treatment group relative to the controls.

Any other information on results incl. tables

Chromosome Aberrations

 

Total number of cells having aberrations and occurrence (%)

 

6 hrs

24 hrs

48 hrs

5 days

200 mg/kg

0 (0)

0 (0)

0 (0)

1 (0.7)

400 mg/kg

1 (0.7)

0 (0)

0 (0)

0 (0)

800 mg/kg

0 (0)

0 (0)

0 (0)

0 (0)

800 mg/kg of 17.1% detergent

0 (0)

0 (0)

0 (0)

-

1600 mg/kg of 17.1% detergent

0 (0)

1 (0.7)

0 (0)

-

3200 mg/kg of 17.1% detergent

2 (1.3)

2 (1.3)

0 (0)

-

1000 mg/kg of 19% detergent

-

0 (0)

-

-

2000 mg/kg of 19% detergent

-

0 (0)

-

-

4000 mg/kg of 19% detergent

-

0 (0)

-

-

Mitomycin C

16 (10.7)

53 (353)

13 (8.7)

112 (74.7)

Distilled water

0 (0)

0 (0)

0 (0)

0 (0)

untreated

0 (0)

0 (0)

1 (0.7)

0 (0)

Applicant's summary and conclusion

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

Groups of male mice were given doses of 200, 400, or 800 mg/kg of Benzenesulfonic acid, C10-14-alkyl derivs., sodium salts. At 6, 24, and 48 hrs, 3 of the mice from each dosage group were sacrificed. The bone marrow cells from the femurs were collected and examined for chromosome aberrations. In addition, one group of mice was exposed daily for 5 consecutive days. Additional groups of mice were exposed to commerical detergents containing 19% or 17.1% of the test substance. Mitomycin C was used as a positive control. None of the treatment groups showed any significant increase in chromosome aberrations as compared to negative controls. The test substance in not clastogenic.