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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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.