Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987
Reference Type:
secondary source
Title:
SIDS Category of Alkyl sulfates, Alkane sulfonates and Alpha-olefin sulfonates
Author:
OECD
Year:
2007
Bibliographic source:
UNEP Publications

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
yes
Remarks:
lack of details on test substance
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Triethanolaminlaurylsulfat
- Physical state: No data
- Analytical purity: 40.9 - 42% a.i.
- Lot/batch No.: No data
- Storage condition of test material: No data

Test animals

Species:
mouse
Strain:
other: CFW 1
Sex:
male/female
Details on test animals and environmental conditions:
According to guideline.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
Aqua bidest.
Duration of treatment / exposure:
24 h (all doses)
48, 72 h (4000 mg/kg bw)
Frequency of treatment:
single
Post exposure period:
n.a.
Doses / concentrations
Remarks:
Doses / Concentrations:
400, 2000, 4000 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
7
Control animals:
yes, concurrent vehicle
Positive control(s):
Yes

Examinations

Details of tissue and slide preparation:
TREATMENT AND SAMPLING TIMES:
400 and 2000 mg/kg bw: after 24 hours
4000 mg/kg bw group: after 24, 48 and 72 hours
control groups: after 24 hours

Evaluation criteria:
According to guideline.
Statistics:
Yes.

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
The test item was not considered to be clastogenic.
Executive summary:

No increase in micronucleated polychromatic erythrocytes was observed in this micronucleus test. Therefore, the test substance was not considered to be clastogenic.