Sodium [3-hydroxy-4-[(1-hydroxy-5-sulpho-2-naphthyl)azo]naphthalene-1-sulphonato(4-)]chromate(1-)

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

An in vitro study was performed to investigate the potential of the test substance to induce gene mutations according to method equivalent to OECD Guideline 471.

The substance was tested for mutagenic effects with Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100 without and with metabolic activation at doses from 0.2 to 2000 µg active ingredient/plate. The lack of evidence for mutagenicity existed both in the absence and presence of metabolic activation.

Under the experimental conditions followed in the protocol and employing a doubling of the spontaneous reversion rate and dose-effect relationship as criteria of mutagenicity, the product FAT 20290/A was not mutagenic for S. typhimurium strains TA 1535, TA 1537, TA 98 and TA 100. Therefore, FAT 20290/A was non-mutagenic in the Salmonella typhimurium reverse mutation assay.

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:

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:

yes

Remarks:

only 4 tester strains tested; no tester strain to detect cross-linking mutagens was included (TA 102 or E.coli WP2 uvra); maximum concentration tested 2000 mg/plate and not 5000 g/plate as recommended by the guideline as of today;

Principles of method if other than guideline:

None

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Target gene:

Histidine gene

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

Mutagenicity tests: 0.2, 2, 20, 200 and 2000 µg (or nl) per Petri dish

Vehicle / solvent:

No data

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

other: 2-anthramine; N-methyl-N'-nitro-N-nitrosoguanidine (MNNG), Daunomycine:

Details on test system and experimental conditions:

No data

Evaluation criteria:

The criteria of mutagenicity used in this test are a doubling of the spontaneous reversion rate and a dose-effect relationship.

Statistics:

No data.

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

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

Additional information on results:

The substance FAT 20290/A was tested with the Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 at concentrations from 0.2 to 2000 M9 (or nl) per Petri dish both in the presence and absence of metabolic activation.

No mutagenic effect was observed.

Conclusions:

FAT 20290/A was considered to be non-mutagenic in the Salmonella typhimurium reverse mutation assay.

Executive summary:

An in vitro study was performed to investigate the potential of the test substance to induce gene mutations according to method equivalent to OECD Guideline 471.

The substance was tested for mutagenic effects with Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100 without and with metabolic activation at doses from 0.2 to 2000 µg active ingredient/plate. The lack of evidence for mutagenicity existed both in the absence and presence of metabolic activation.

Under the experimental conditions followed in the protocol, and employing a doubling of the spontaneous reversion rate and dose-effect relationship as criteria of mutagenicity, the product FAT 20290/A was not mutagenic for S. typhimurium strains TA 1535, TA 1537, TA 98 and TA 100.

Therefore, FAT 20290/A was considered to be non-mutagenic in the Salmonella typhimurium reverse mutation assay.

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available genotoxicity study, the test substance does not need to be classified for genotoxicity according to Directive 67/548/EEC and according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.