Disodium 2-[[5-carbamoyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl]azo]-4-[[4-[(2-chloro-5-sulphonatophenyl)amino]-6-fluoro-1,3,5-triazin-2-yl]amino]benzenesulphonate

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Reactive Yellow 143 is considered as non mutagenic from the results of the available bacterial reverse mutation assays.

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:

29 January 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Principles of method if other than guideline:

None

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Specific details on test material used for the study:

FAT 40138/B

Target gene:

Histidine-auxotrophic strains of Salmonella typhimurium and on a tryptophan-auxotrophic strain of E. coli.

Species / strain / cell type:

other: TA 98, TA 100, TA 1535, TA 1537 and TA 1538, strains of Salmonella typhimurium and strain E. coli WP2 uvrA

Metabolic activation:

with and without

Metabolic activation system:

S9 liver microsomal fraction from rats

Test concentrations with justification for top dose:

5, 10, 50, 100, 500, 1000 and 5000 µg/0.1 ml.

Vehicle / solvent:

Sodiumphosphate buffer

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

Without S9: TA 98 and TA 1538

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

N-ethyl-N-nitro-N-nitrosoguanidine

Remarks:

Without S9: TA 100 and TA 1535

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: aminoacridine hydrochloride monohydrate

Remarks:

Without S9: TA 1537

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

N-ethyl-N-nitro-N-nitrosoguanidine

Remarks:

Without S9: E. coli WP2 uvrA

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

With S9: TA 98 TA 1538 TA 100 TA 1535 TA 1537 and E. coli WP2 uvrA

Details on test system and experimental conditions:

TEST SYSTEM:
The bacteria on which the tests were performed were the histidine-auxotrophic TA 98, TA 100, TA 1535, TA 1537 and TA 1538, strains of Salmonella typhimurium and the tryptophan-auxotrophic strain E. coli WP2 uvrA.

Evaluation criteria:

The test substance is generally considered to be non-mutagenic if the colony count in relation to the negative control is not doubled at any concentration.

Statistics:

When the colonies had been counted, the arithmetic mean was calculated.

Key result

Species / strain:

other: Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98, TA 100 and E. coli WP2 uvrA

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

other: All strains were used

In the experiments performed without and with microsomal activation, comparison of the number of histidine- or tryptophan-prototrophic mutants in the controls and after treatment with FAT 40138/B revealed no marked differences.

Conclusions:

FAT 40138/B is considered to be non-mutagenic in the bacterial reverse mutation assay.

Executive summary:

A study was performed to investigate the potential of FAT 40138/B to induce gene mutations according to the bacterial reverse mutation assay using the Salmonella typhimurium strains TA 1535, TA 1537, TA1538, TA 98, TA 100 and E. coli WP2 uvrA. The study was carried out equivalent or similar to OECD guideline 471. The test article was tested at 5, 10, 50, 100, 500, 1000 and 5000 µg/0.1 ml concentrations with and witout metabolic activation. Comparison of the number of histidine- or tryptophan-prototrophic mutants in the controls and after treatment with FAT 40 138/B revealed no marked differences in both experiments performed with and without metabolic activation. Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies. In conclusion, under the experimental conditions reported, the test article did not induce gene mutations. Therefore, FAT 40138/B is considered to be non-mutagenic in this bacterial reverse mutation assay.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Three studies to assess the mutagenic potential of FAT 40138 are available. A key study was performed to investigate the potential of FAT 40138/B to induce gene mutations according to the bacterial reverse mutation assay using the Salmonella typhimurium strains TA 1535, TA 1537, TA1538, TA 98, TA 100 and E. coli WP2 uvrA. The study was carried out equivalent or similar to OECD guideline 471. The test article was tested at5, 10, 50, 100, 500, 1000 and 5000µg/0.1 ml concentrations with and without metabolic activation.

Comparison of the number of histidine- or tryptophan-prototrophic mutants in the controls and after treatment with FAT 40138/B revealed no marked differences in both experiments performed with and without metabolic activation. Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies. In conclusion, under the experimental conditions reported, the test article did not induce gene mutations. Therefore, FAT 40138/B is considered to be non-mutagenic in this bacterial reverse mutation assay. Two supporting bacterial reverse mutation assays also support the conclusion that FAT 40138 is devoid of mutagenic potential. Based on the above information, FAT 40138 can be considered to be not mutagenic.

Justification for classification or non-classification

Based on the findings of the genetic toxicity studies, the test substance does not considered to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.