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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.

Data source

Reference
Reference Type:
other: SNIF
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
not specified
GLP compliance:
yes
Type of assay:
other: in vivo mammalian bone marrow cytogenetic test

Test material

Constituent 1
Reference substance name:
A mixture of: esters of C14-C15 branched alcohols with 3,5-di-t-butyl-4-hydroxyphenyl propionic acid; C15 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate; C13 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate
EC Number:
413-750-2
EC Name:
A mixture of: esters of C14-C15 branched alcohols with 3,5-di-t-butyl-4-hydroxyphenyl propionic acid; C15 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate; C13 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate
IUPAC Name:
413-750-2
Constituent 2
Reference substance name:
reaction mass of: esters of C14-C15 branched alcohols with 3,5-di-t-butyl-4-hydroxyphenyl propionic acid; C15 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate; C13 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate
IUPAC Name:
reaction mass of: esters of C14-C15 branched alcohols with 3,5-di-t-butyl-4-hydroxyphenyl propionic acid; C15 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate; C13 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate
Test material form:
not specified

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
0.5 % methylcellulose water solution
No. of animals per sex per dose:
Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 18 hours
Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 42 hours
Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 66 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 18 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 42 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 66 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 18 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 42 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 66 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 18 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 42 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 66 hours

Results and discussion

Additional information on results:
The test substance administered to rats by oral route at the dose of 5000 mg/kg did not induce any statistically significant increase in the frequency of micronucleated cells in the bone marrow 18, 42 and 66 hours from the admnistration. The results of test are negative.

Any other information on results incl. tables

Doses producing toxicity: No lethal effects; no cytotoxicity (PCE/NCE)

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
The substance was non mutagenic under the conditions of the micronuceus test.