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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other information
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP (taken from SNIF file). Registrant refering to studies >12 years old at the permission of ECHA.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
Deviations:
not specified
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
4,6-bis(octylthiomethyl)-o-cresol
EC Number:
402-860-6
EC Name:
4,6-bis(octylthiomethyl)-o-cresol
Cas Number:
110553-27-0
Molecular formula:
C25H44OS2
IUPAC Name:
4,6-bis(octylthiomethyl)-o-cresol

Test animals

Species:
hamster
Strain:
other: Chinese Hamster (cricetulus griseus) random outbred strain
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on exposure:
Male: 5000 mg/kg; No. of animals: 8; Sacrifice time: 16 hours
Male: 5000 mg/kg; No. of animals: 8; Sacrifice time: 24 hours
Male: 5000 mg/kg; No. of animals: 8; Sacrifice time: 48 hours

Female: 5000 mg/kg; No. of animals: 8; Sacrifice times: 16 hours
Female: 5000 mg/kg; No. of animals: 8; Sacrifice times: 24 hours
Female: 5000 mg/kg; No. of animals: 8; Sacrifice times: 48 hours
Duration of treatment / exposure:
As above
Frequency of treatment:
Single dose
Post exposure period:
Not specified.
Doses / concentrations
Remarks:
Doses / Concentrations:
5000 mg/kg
Basis:
actual ingested
Positive control(s):
Not specified.

Examinations

Details of tissue and slide preparation:
Not specified.
Evaluation criteria:
Not specified.
Statistics:
Not specified.

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Remarks:
Doses producing toxicity: >5000 mg/Kg
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
No evidence of mutagenic effects in the Chinese Hamster under the conditions of the experiment were noted.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
No evidence of mutagenic effects in the Chinese Hamster under the conditions of the experiment were noted.
Executive summary:

No evidence of mutagenic effects in the Chinese Hamster under the conditions of the experiment were noted.