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Toxicological information

Genetic toxicity: in vitro

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ASC PLUS, dried
- Physical state: white powder, odourless
- Analytical purity: 99.24%
- Lot/batch No.: 110526S
- Expiration date of the lot/batch: 26-05-2016
- Storage condition of test material: ambient temperature (15-25°C)
- Other: soluble in DMSO

Method

Target gene:
TA100: his G46
TA98: his D3052
TA97: his D6610
TA102: his G428 (pAQ1)
TA1535: his G46
Species / strainopen allclose all
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
Controls
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

Results and discussion

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.