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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.

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