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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

OECD 471, plate incorportation, with and without metabolic activation, negative

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
other: S.Typhimurium TA98, TA100, TA1535, Ta1538, E. Coli WP2 uvrA
Metabolic activation:
with and without
Metabolic activation system:
S9 mix rat and hamster liver
Test concentrations with justification for top dose:
Concentration range in the first test (with and without metabolic activation): 4, 20, 100, 500, 2500 and 5000 µg/plate
Concentration range in the second test (with and without metabolic activation): 4, 20, 100, 500, 2500 and 5000 µg/plate
Vehicle / solvent:
none
Details on test system and experimental conditions:
method of application: in agar, plate incorporation
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
> 10000 ug/plate
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
> 10000 ug/plate
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Conclusions:
The substance was tested for genetic toxicity in vitro following OECD 471 (Ames test). Under the experimental conditions the substance did not show any mutagenic properties with and without metabolic activation
Executive summary:

The substance was tested for mutagenicity with the strains TA100, TA1535, TA1537, TA1538, TA98 of salmonella typhimurium and Escherichia coli WP2uvrA.

The mutagenicity studies were conducted in the absence and in the presence of a metabolizing system derived from rat liver homogenate. A dose range of 6 different dosees from 4 µg/plate to 5000 µg/plate was used.

Control plates without mutagen showed that the number of spontaneous revertant colonies was similar to that described in the literature. All the positive control compounds gave the expected increase in the number of revertant colonies.

Toxicity: the test compound proved to be not toxic o f the bacterial strains. On the basis of the preliminary test results the top dose level did no exceed 5000 µg/plate.

Mutagenicity: In the absence of the metabolic activation system the test compound did not show a dose dependent increase in the number of revertants in any of the bacterial strains. Also in the presence of a metabolic activation system, treatment of the cells with the test item did no result in relevant increases in the number of revertant colonies.

Sumarizing, it can be stated that Reaktiv-Rot F-52 167 is not mutagenic in these bacterial test systems niether with or without exogenous metabolic activation at the dose levels investigated.

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

Additional information

The analogue substance was tested for gene mutation following OECD 471 (NONS dossier, 1988). Different strains at concentrations ranging from 10 to 5000 ug/plate were tested with and without S9 mix showing no potential for gene mutation.

Based on the read across considerations same results apply to the test item


Justification for classification or non-classification

Classification for mutagenicity under Regulation 1272/2008 is warranted for substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans. The classification in Category 2 is based on:

— positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from:

— somatic cell mutagenicity tests in vivo, in mammals; or

— other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.

Based on the results from genetic toxicity tests the substance is not classified as mutagen.