Potassium 4-acetoacetylaminobenzenesulphonate

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

This reverse mutation assay was performed GLP-study in accordance with OECD-guidelines. Five Salm. typh. strains (TA1535, TA1537, TA98, TA100 and TA 102) were tested with and without metabolic activation. Test concentrations ranged from 313 ug/plate up to 5000 ug/plate. The test item was found to be not mutagenic in a bacterial reversion mutation assay using the Ames plate incorporation 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:

November - December 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliant guideline study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Metabolic activation system:

S9-liver fractions of rats treated with phenobarbital & beta-naphthoflavone

Test concentrations with justification for top dose:

- Pretest: 50-5000 ug/plate (with and without metabolic acivation) & solvent control
- Main test: 313-5000 ug/plate (with and without metabolic acivation) & solvent control

Vehicle / solvent:

water

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

other: 2-aminoanthracene & cumene hydroperoxide

Details on test system and experimental conditions:

METHOD OF APPLICATION:
- in agar (plate incorporation)

DURATION:
- Preincubation period: 24 h

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

It is concluded that the test item is not mutagenic when tested against 5 strains in the Ames plate incorporation assay.

Executive summary:

This reverse mutation assay was performed GLP-study in accordance with OECD-guidelines. Five Salm. typh. strains (TA1535, TA1537, TA98, TA100 and TA 102) were tested with and without metabolic activation. Test concentrations ranged from 313 ug/plate up to 5000 ug/plate. The test item was found to be not mutagenic in a bacterial reversion mutation assay using the Ames plate incorporation assay.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Source: GLP-report

Justification for selection of genetic toxicity endpoint
GLP Klimisch 1 study

Justification for classification or non-classification

Based on the data available the substance is not classified or labeled according to Directive 67/548/EEC (DSD) or Regulation 1272/2008/EC (CLP).