Registration Dossier

Diss Factsheets

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:
supporting study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: test data from ELINCS-notification obtained from ECHA on 10-June-2010 (EC-no. 405-740-1 / notification-no. 91-06-0255-00); performed under GLP and according to EU-testing methods
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
Deviations:
no
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
no data

Test animals

Species:
mouse
Strain:
ICR
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
Corn oil
Duration of treatment / exposure:
- 24, 48, 72 hours (+ controls only at 24 hours)
- Vehicle: corn oil
Frequency of treatment:
Once
Post exposure period:
no data
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
37.5 mg/kg
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
75 mg/kg
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
150 mg/kg
Basis:
nominal conc.
No. of animals per sex per dose:
5 males and 5 females
Control animals:
yes, concurrent vehicle

Examinations

Tissues and cell types examined:
bone marrow cells

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

- Doses producing toxicity: yes

- Toxic Signs: One death (replaced with another animal) at 150 rng/kg. Mild trerrors and clonic convulsions also seen at 150 rng/kg.

- P/N Ratio: No clear effect was seen

No clear change in the P/N ratio. However, the toxic signs noted, and the liver damage seen in the earlier sub-acute study, suggest that the substance does enter the blood system and hence the bone marrow is likely to be exposed to the substance and/or metabolites.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
The test item was found to be non-mutagenic in this test system
Executive summary:

Submitted as supporting information. The micronucleus test assay was performed according to EU-test method B.12 with mice (5 males & 5 females per dose group). Tested concentrations ranged from 37 -150 mg/kg, vehicle was corn oil. The following effects observed: One death (replaced with another animal) at 150 rng/kg. Mild trerrors and clonic convulsions also seen at 150 rng/kg.). No clear change in the PiN ratio. However, the toxic signs noted, and the liver damage seen in the earlier sub-acute study, suggest that the substance does enter the blood system and hence the bone marrow is likely to be exposed to the substance and/or metabolites.

The test item was found to be non-mutagenic in this study.