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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
The test substance was found not to be genotoxic in an Ames test with and without metabolic activation
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:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions: Incomplete documentation, TA 102 or E.coli WP2 were not tested
Qualifier:
according to
Guideline:
other: see Principles of method if other than guideline
Principles of method if other than guideline:
Ames BN et al. (1975). Mutat. Res. 31, 347-364
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
other: Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100
Metabolic activation:
with and without
Test concentrations with justification for top dose:
10; 50; 250; 1000; 2000; 5000 µg/plate
Vehicle / solvent:
Dimethyl sulfoxide (CAS: 67-68-5)
Details on test system and experimental conditions:
Type: Ames test
Species / strain:
other: Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: >= 1000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: other: Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100
Remarks:
Migrated from field 'Test system'.

GENOTOXIC EFFECTS: 
- With metabolic activation: None
- Without metabolic activation: None
  The positive controls were functional.
PRECIPITATION CONCENTRATION: No precipitation was observed.
CYTOTOXIC CONCENTRATION: 
  TA 98: 5000 µg/plate (+/- S9)
  TA 100: 5000 µg/plate (+/- S9)
  TA 1535: 5000 µg/plate (+ S9), 250/1000 µg/plate (- S9)
  TA 1537: 5000 µg/plate (+ S9), 1000 µg/plate (- S9)
  TA 1538: 5000 µg/plate (+/- S9)

Conclusions:
Interpretation of results (migrated information):
negative +/- S9

The test substance was found not to be genotoxic in an Ames test with and without metabolic activation
Executive summary:

The test substance was found not to be genotoxic in an Ames test with and without metabolic activation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

An Ames test was conducted with the substance. The test substance was found not to be genotoxic in the Ames test with and without metabolic activation.

Justification for classification or non-classification

Based on the results of the available study there is no need for classification regarding to this endpoint.