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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

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
Study period:
Not specified
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP (taken from SNIF file). Registrant referring to studies >12 years old at the permission of ECHA.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Report date:
1991

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:
-
EC Number:
406-040-9
EC Name:
-
Cas Number:
125643-61-0
Molecular formula:
C17 H25 O3 R, Where R = (C7 H15) or (C8 H17) or (C9 H19)
IUPAC Name:
Reaction mass of C7-9-alkyl 3-(3,5-di-trans-butyl-4-hydroxyphenyl)propionate
Details on test material:
No data

Test animals

Species:
hamster, Chinese
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
Klucel hydroxypropylcellulose (HPC), 0.5%
Details on exposure:
No data
Duration of treatment / 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 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
Frequency of treatment:
Single dose
Post exposure period:
No data
Doses / concentrations
Remarks:
Doses / Concentrations:
5000 mg/kg
Basis:
actual ingested
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

Tissues and cell types examined:
No data
Details of tissue and slide preparation:
No data
Evaluation criteria:
No data
Statistics:
No data

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
not specified
Negative controls validity:
not examined
Positive controls validity:
not specified
Additional information on results:
No data

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
The substance was negative with and without metabolic activation.
Executive summary:

The substance was negative with and without metabolic activation.

No classification is required.