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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Supporting study:

The Ames test was carried out with the test item using Salmonella typhimurium strains TA 98, TA 100. The test was performed with and without matabolic activation. The concentrations were 0-10000 (0, 50, 100, 500, 1000, 5000, 10000) µg/plate.

Supporting study:

The substance did not show any mutagenic effect under test conditions.

The test item was tested with S. typhimurum TA1535, TA1537, TA1538, TA98, or TA100 with and without male rat Aroclor S9 mix.

The test item was non  mutagenic in plate incorporation test at 5000 mcg, and liquid preincubation test at 1000 mcg.

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
(Only 2 strains were tested)
Principles of method if other than guideline:
Method: preincubaton
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
S. typhimurium, other: TA 98, TA 100.
Metabolic activation:
with and without
Metabolic activation system:
-S9 and +S9 were tested.
Test concentrations with justification for top dose:
0-10000 (0, 50, 100, 500, 1000, 5000, 10000) ug/plate were tested
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Key result
Species / strain:
S. typhimurium, other: TA 98, TA 100,
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

The test item did not show any mutagenic effect under test conditions, with and without metabolic activation.

Conclusions:
The test item did not show any mutagenic effect under test conditions, with and without metabolic activation.
Executive summary:

The Ames test was carried out with the test item using Salmonella typhimurium strains TA 98, TA 100. The test was performed with and without matabolic activation. The concentrations were 0-10000 (0, 50, 100, 500, 1000, 5000, 10000) µg/plate.

The substance did not show any mutagenic effect under test conditions.

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Justification for type of information:
Information form a scientific publication.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Tested only: Salmonella typhimurium TA1535, TA1537, TA1538, TA98, or TA100
Principles of method if other than guideline:
The Salmonella typhimurium tester strains TA1535, TA1537, TA1538, TA98, and TA100 were grown in nutrient broth shaken for 14 h at 370C. The plate incorporation assays were performed as described by Ames et al. with the modifications of Andrews et al.


GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Specific details on test material used for the study:
Provided by Adrian B. Leatherman of the Food and Drug Administration, Washington DC.
Key result
Species / strain:
S. typhimurium, other: TA1535, TA1537, TA1538, TA98, or TA100 with and without male rat Aroclor S9 mix
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks:
Maximum non toxic dose that was nonmutagenic: Plate incorporation test: 5000 mcg, and liquid preincubation test 1000 mcg.
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
Maximum non toxic dose that was nonmutagenic: Plate incorporation test: 5000 mcg, and liquid preincubation test 1000 mcg.
Conclusions:
The test item was non mutagenic in plate incorporation test at 5000 mcg, and liquid preincubation test at 1000 mcg.
Executive summary:

The test item was tested with S. typhimurum TA1535, TA1537, TA1538, TA98, or TA100 with and without male rat Aroclor S9 mix.

The test item was non  mutagenic in plate incorporation test at 5000 mcg, and liquid preincubation test at 1000 mcg.

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

Additional information

Justification for classification or non-classification