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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ames: The test substance is non mutagenic in the bacterial reverse mutation test, both in the presence and absence of a metabolizing system (S9-mix).

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:
1983-03-10 to 1983-04-11
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP mentioned. Basic data are given in the study report summary.
Qualifier:
equivalent or similar to guideline
Guideline:
other: Standard Japanese test methods (in according with the Industrial Safety and Health Act)
Deviations:
not specified
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
S. typhimurium, other: TA 98, TA100, TA 1535, TA 1537; TA1538 and E. Coli WP2uvrA
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
Six doses: 1 - 500 µg/plate or 0.5 - 100 µg/plate
The tests of TA 98 without S9-mix in Salmonella typhimurium were conducted in a concentration of 0.1 - 50 µg/plate.
Vehicle / solvent:
No data
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Details on test system and experimental conditions:
No data
Evaluation criteria:
No data
Statistics:
No data
Species / strain:
S. typhimurium, other: TA 98, TA100, TA 1535, TA 1537; TA1538 and E. Coli WP2uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
Regarding the above concentration, the growth inhibition of Salmonella typhimurium was confirmed.
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: all strains/cell types tested
Conclusions:
Interpretation of results (migrated information):
negative

The test substance is non mutagenic in the bacterial reverse mutation test, both in the presence and absence of a metabolizing system (S9-mix).
Executive summary:

The test substance had been tested for reverse mutation in Salmonella typhimurium TA 98, TA100, TA 1535, TA 1537; TA1538 and Escherichia coli WP2uvrA with and without exogenous metabolic activation at six doses: 1 – 500 µg/plate or 0.5 – 100 µg/plate. In addition, the tests of TA 98 without S9-mix in Salmonella typhimurium were conducted in a concentration of 0.1 – 50 µg/plate. The tests were negative, both in the presence and absence of a metabolizing system (S9-mix).


 

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

Additional information

Bacterial reverse mutation test


 


The test substance has been tested for reverse mutation in Salmonella typhimurium TA 98, TA100, TA 1535, TA 1537; TA1538 and Escherichia coli WP2uvrA with and without exogenous metabolic activation at six doses: 1 - 500 µg/plate or 0.5-100µg/plate. In addition, the tests of TA 98 without S9-mix in Salmonella typhimurium were conducted in a concentration of 0.1 – 50 µg/plate. The tests were negative, both in the presence and absence of a metabolizing system (S9-mix).


 


Justification for selection of genetic toxicity endpoint


Available study report summary.

Justification for classification or non-classification

Based on the result of the bacterial reverse mutation test to the test substance, classification is not warranted according to the criteria of Regulation (EC) No 1272/2008 (CLP).