Methyl 3-[3-(2H-benzotriazol-2-yl)-4-hydroxy-5-(2-methyl-2-propanyl)phenyl]propanoate

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Information from migrated NONS file, as per inquiry number 06-2120030080-80-0000 permission to refer granted by ECHA.

Link to relevant study records

Reference

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.

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

Target gene:

Not reported

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)

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'.

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

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.

Justification for selection of genetic toxicity endpoint
Only available data source

Justification for classification or non-classification

The substance did not show indications of genotoxicty in the only study available and as such it is not considered justified to assign a classification to the substance.