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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliance, not OECD guideline

Data source

Reference
Reference Type:
other: inquiry result from ECHA
Title:
Unnamed
Year:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Non-Annex V (Cytogenetics, see comments)
GLP compliance:
yes
Type of assay:
other: in vivo mammalian bone marrow cytogenetic test

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
400-820-2
EC Name:
-
Cas Number:
84268-33-7
Molecular formula:
C20H23N3O3
IUPAC Name:
methyl 3-[3-(2H-1,2,3-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl]propanoate

Test animals

Species:
other: Chinese hamster

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
0.5% aqueous sodium carboxymethylcellulose plus 0.1% Tween 80.
No. of animals per sex per dose:
Male: 0 mg/kg; No. of animals: 3; Sacrifice time: 48 hours
Male: 560 mg/kg; No. of animals: 3; Sacrifice time: 48 hours
Male: 1120 mg/kg; No. of animals: 3; Sacrifice time: 48 hours
Male: 2240 mg/kg; No. of animals: 3; Sacrifice time: 48 hours
Female: 0 mg/kg; No. of animals: 3; Sacrifice times: 48 hours
Female: 560 mg/kg; No. of animals: 3; Sacrifice times: 48 hours
Female: 1120 mg/kg; No. of animals: 3; Sacrifice times: 48 hours
Female: 2240 mg/kg; No. of animals: 3; Sacrifice times: 48 hours

Results and discussion

Test results
Genotoxicity:
negative
Toxicity:
yes
Remarks:
(Doses producing toxicity: In a preliminary test 1 out of 4 animals died after a single application of 2800 mg/kg. No effects evident in bone marrow.)
Additional information on results:
Observations:
Positive control gave a satisfactory response.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative