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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:
key study
Study period:
From 26 APR 1994 to 06 JUN 1994
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
yes
Remarks:
only 1000 instead of 2000 immature erythrocytes were evaluated per animal
Qualifier:
according to
Guideline:
EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
Deviations:
yes
Remarks:
only 1000 instead of 2000 immature erythrocytes were evaluated per animal
GLP compliance:
yes (incl. certificate)
Remarks:
in accordance with Directive 88/320/EEC
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
ICR
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Duration of treatment / exposure:
1250 and 2500 mg/kg group: 24 hrs
5000 mg/kg group: 24, 48 and 72 hrs
Frequency of treatment:
single
Post exposure period:
none
Doses / concentrations
Remarks:
Doses / Concentrations:
1250, 2500, 5000 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
5 males and 5 females per dose and exposure duration
Control animals:
yes, concurrent vehicle

Examinations

Tissues and cell types examined:
bone marrow cells from the femur
Evaluation criteria:
- a statistically significant increase in the number of micronucleated polychromatic erythrocytes in the treatment groups in comparison to the control group is evaluated as positive mutagenic response
- a positive response for bone marrow toxicity is demonstrated when the dose group mean polychromatic to normochromatic ratio is shown to be statistically significant from the concurrent vehicle control group
Statistics:
- Student's t-test
- one way analysis of variance

Results and discussion

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

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative