Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test performed under GLP but no access to full documentation.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
Type of assay:
micronucleus assay

Test animals

Species:
other: Chinese Hamster (random outbred strain)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
0.5% aqueous sodium carboxymethyl cellulose
No. of animals per sex per dose:
Male: 5000 mg/kg; No. of animals: 8; Sacrifice time: hours
Female: 5000 mg/kg; No. of animals: 8; Sacrifice times: hours

Results and discussion

Test results
Toxicity:
yes
Remarks:
Doses producing toxicity: P/N ratio. There was a small decrease at 48 hours only No other signs of toxicity

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative