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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Information from migrated NONS file, as per inquiry number 06-2120030080-80-0000 permission to refer granted by ECHA.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Version / remarks:
Reported as "Annex V (Ames)"
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

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

Method

Target gene:
Not reported
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat liver S9
Test concentrations with justification for top dose:
20 to 5120 µg/plate (with and without metabolic activation)

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

The test substance precipitated at 320 micrograms/plate and above.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The test material was determined to be non-mutagenic under the conditions of this test in both the absence and presence of a metabolic activation system.
Executive summary:
In an Ames test study conducted in accordance with the standard EU Annex V method (B13/14) under conditions of GLP, the substance was considered to be non-mutagenic in both the absence and presence of a metabolic activation system. The positive controls produced a satisfactory response whilst the substance was seem to precipitate at concentrations of 320 µg/plate and above. Cytotoxicty was observed both with and without S9 mix at concentrations above 5000 µg/plate.