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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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

Constituent 1
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.