Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data provided by ECHA - information from migrated NONS file as per inquiry 06-0000021296-70-0000.

Data source

Reference
Reference Type:
other: body responsible for the test
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: (Micronucleus test) Annex V, B12
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, Chinese
Strain:
other: random outbred strain
Sex:
male/female
Details on test animals or test system and environmental conditions:
no data

Administration / exposure

Duration of treatment / exposure:
16, 24, 48 h
Frequency of treatment:
no data
Post exposure period:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
5000 mg/kg
Basis:
no data
No. of animals per sex per dose:
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 time: 16 hours
Female: 5000 mg/kg; no of animals: 8; sacrifice time: 24 hours
Female: 5000 mg/kg; no of animals: 8; sacrifice time: 48 hours
Control animals:
not specified
Positive control(s):
no data

Examinations

Details of tissue and slide preparation:
no data
Statistics:
no data

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 Chinese hamster under the conditions of this experiment.

Any other information on results incl. tables

no data

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
The test substance is not mutagenic in the in vivo micronucleus test under the applied experimental conditions.