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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Key study Examination of Gyrane ST. 2 for mutagenic activity in the Ames test dated on December 1985 and perfomed at Division for nutrition and food research TNO according to the OECD guideline 471 (1983 version).

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
.
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
no TA102 strains used
Principles of method if other than guideline:
As OECD 471 (1983) required to test Salmonella typhimurium TA1535, TA1537, TA98 and TA100 only, there is no deviation from the guideline.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Specific details on test material used for the study:
Material Identification (as stated in the report) : Gyrane St. 2
Sample received on 2nd, December 1985
Dilutions of the test substance were made with ethanol just prior to use.
Target gene:
- Salmonella typhimurium TA1535, TA1537, TA98 and TA100
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
Rat liver S9-mix induced by Aroclor 1254
Test concentrations with justification for top dose:
Preliminary test with TA98, without S9-mix: 8.5, 85, 850, 8500 and 85000 µg/plate

Main study: TA1535, TA1537, TA1538, TA98 and TA100:
Without and with S9-mix: 10.49, 31.48, 94.44, 283.33 and 850 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: Dilutions of the test substance were made with ethanol just prior to use.
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
ethanol
Positive controls:
yes
Positive control substance:
other: 2-nitrofluorene 1.0 µg/plate in DMSO for TA98 and TA1538
Remarks:
without S9
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
ethanol
Positive controls:
yes
Positive control substance:
other: Sodium azide 1.0 µg/plate in water for TA1535 and TA100
Remarks:
without S9
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
ethanol
Positive controls:
yes
Positive control substance:
other: 9-aminoacridine 80 µg/plate in DMSO for TA1537
Remarks:
without S9
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
ethanol
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene 2.0 µg/plate in DMSO for all tester strains
Remarks:
with S9
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at the highest dose level µg/plate without S9 only
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium, other: TA1537, TA 1538, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
At 850 µg/plate
Vehicle controls validity:
valid
Positive controls validity:
valid
Conclusions:
From the above findings it is concluded that Gyrane St 2. did not show any mutagenic activity in the Salmonella/mammalian microsome mutagenicity test under the conditions employed in this evaluation.
Executive summary:

The genetic toxicity of Gyrane was assessed at toxic concentrations of ≤ 850 µg/plate using S. typhimurium TA100, TA1535, TA98, TA1537 and TA1538 strains, in accordance with OECD 471 guideline and according to GLP principles. All strains showed cytotoxicity at the highest tested concentrations.

All bacterial strains showed negative responses with and without metabolic activation. Based on the results of this study, the substance Gyrane is not mutagenic in the Salmonella typhimurium reverse mutation assay.

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

Additional information

Justification for classification or non-classification

The genetic toxicity of Gyrane was assessed at toxic concentrations of ≤ 850 µg/plate using S. typhimurium TA100, TA1535, TA98, TA1537 and TA1538 strains, in accordance with OECD 471 guideline and according to GLP principles. All strains showed cytotoxicity at the highest tested concentrations.

All bacterial strains showed negative responses with and without metabolic activation. Based on the results of this study, the substance Gyrane is not mutagenic in the Salmonella typhimurium reverse mutation assay.