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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
No adverse effects observed (negative) from studies according to OECD 471, 476 and 487.
Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: genome mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, detailed documentation
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay
Target gene:
TA100: his G46
TA98: his D3052
TA97: his D6610
TA102: his G428 (pAQ1)
TA1535: his G46
Species / strain / cell type:
S. typhimurium TA 100
Additional strain / cell type characteristics:
other: Strain is histidine-dependent
Species / strain / cell type:
S. typhimurium TA 98
Additional strain / cell type characteristics:
other: Strain is histidine-dependent
Species / strain / cell type:
S. typhimurium TA 97
Additional strain / cell type characteristics:
other: Strain is histidine-dependent
Species / strain / cell type:
S. typhimurium TA 1535
Additional strain / cell type characteristics:
other: Strain is histidine-dependent
Species / strain / cell type:
S. typhimurium TA 102
Additional strain / cell type characteristics:
other: Strain is histidine-dependent
Metabolic activation:
with and without
Metabolic activation system:
Mammalian liver post-mitochondrial fraction (S9), prepared from Sprague Dawley male rats.
Test concentrations with justification for top dose:
Range-Finding: 7 concentrations in the range of 0.01-5.0 mg/plate
Definitive assay: 8 concentrations in the range of 0.000001-1 mg/plate
Confirmatory assay with preincubation: 0.000000-0.5 mg/plate
Appropriate amount of test item was weighted and diluted in DMSO not earlier than 30 min prior to test start. For dilution of final doses, sterile DMSO was used.
Vehicle / solvent:
- Vehicle/solvent used: DMSO
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48-72 hr

NUMBER OF REPLICATIONS: 3
Evaluation criteria:
- concentration-related increase over the tested range and reproducible increase at one or more concentrations in the number of revertant colonies per plate in at least one strain with or without metabolic activation
- mutation factor >2
Statistics:
Student's t-test was used

No significant increase in the mutant frequency was observed for the 5 tested strains, neither in the standard plate incorporation nor in the preincubation assays with or without metabolic activation.

Conclusions:
Interpretation of results (migrated information):
negative

ASC PLUS, dried is considered to be non-mutagenic in the bacterial gene mutation test system.
Executive summary:

According to OECD 471 ASC PLUS, dried was dissolved in DMSO and tested with the 5 strains of Salmonella typhimurium: TA100, TA98, TA97, TA102 and TA1535.

Neither with nor without metabolic activation with S-9 mix an induction of mutagenic activity was seen. Adequate positive and negative control substances were included in the test system.

Up to and including concentrations of 5000 µg/plate ASC PLUS, dried did not increase the mutation frequency of the 5 tested strains and is therefore considered to be non-.mutagenic.

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

Additional information

Additional information from genetic toxicity in vitro:

6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid (ASC plus) is regarded as not genotoxic.

No further in vivo mutagenicity studies need to be considered because of negative results in all of the available genotoxicity studies that are required according to REACH Annex VII or VIII (c.f. REACH Annex VIII 8.4)

Justification for selection of genetic toxicity endpoint
The studies according to OECD 471, 476 and 487 were selected as key studies (Guideline studies under GLP).

Justification for classification or non-classification

All test systems gave no positive reaction to ASC plus. ASC plus is classed as not genotoxic according to the classification and labelling criteria of regulation (EC) 1272/2008 and EEC Directive 67/548.

Therefore, it can be concluded that ASC plus does not need to be classified and labelled.