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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
other: All information in this endpoint has been provided by the ECHA using the 12 year rule, this data is not owned by the registrant . The reliability is estimated to be at level 2 at a minimum.
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
All information in this endpoint has been provided by the ECHA using the 12 year rule, data are not owned by the registrant. The reliability is estimated to be at level 2 at a minimum. Therefore the reliability statement below can be used: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
not specified
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
424-240-4
EC Name:
-
Cas Number:
96478-09-0
Molecular formula:
C18 H17 N3 O3
IUPAC Name:
2-[3-(2H-1,2,3-benzotriazol-2-yl)-4-hydroxyphenyl]ethyl 2-methylprop-2-enoate

Method

Target gene:
This information was not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
Concentration range in the main test is between 8 and 5000 µg/plate (for both with and without metabolic activation).
Vehicle / solvent:
The solvent used was DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
not specified
Details on test system and experimental conditions:
This information was not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Evaluation criteria:
This information was not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Statistics:
This information was not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

Results and discussion

Test resultsopen allclose all
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
Remarks:
> 5000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
> 5000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
The test material showed signs of precipitation at a dose level of greater than 40 µg/plate.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Under the conditions of this study, the test material has produced no signs of genetic toxicity both with and without metabolic activation.
Executive summary:

The study has been conducted using Method B14 of Directive 92/69 EEC. Under the conditions of this study, the test material has produced no signs of genetic toxicity both with and without metabolic activation.