Registration Dossier

Toxicological information

Genetic toxicity: in vivo

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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
restriction: only one sampling time

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity of cosmetics ingredients licensed by the European Community.
Author:
Gocke, E. et al.
Year:
1981
Bibliographic source:
Mutat Res 90: 91-109

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
yes
Remarks:
- limited documentation, only one sampling time
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Duration of treatment / exposure:
one single injection
Frequency of treatment:
only one sampling time
Post exposure period:
30 h
Doses / concentrations
Remarks:
Doses / Concentrations:
1920; 3200; 4480 mg/kg
Basis:
nominal conc.
No. of animals per sex per dose:
2
Control animals:
yes

Examinations

Tissues and cell types examined:
bone-marrow cells

Results and discussion

Test results
Key result
Sex:
male/female
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not applicable
Negative controls validity:
not examined
Positive controls validity:
not examined

Any other information on results incl. tables

There was no significant effect on the frequency of micronuclei in treated as compared to control animals: 1.3/1000 (control and low dose), 2.0/1000 (2nd dose), and 3.7/1000 (top dose).

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative