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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 germ cell study: gene mutation
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
not specified
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Type of assay:
in vitro mammalian cell transformation assay

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.58 (Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays)
Deviations:
no
GLP compliance:
yes
Type of assay:
rodent dominant lethal assay

Test material

Constituent 1
Reference substance name:
958872-63-4
Cas Number:
958872-63-4
IUPAC Name:
958872-63-4

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
not specified
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
not determinable

Applicant's summary and conclusion