Registration Dossier
Registration Dossier
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EC number: 700-786-1 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- 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:
- 2003
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sophorolipids: fermentation products of glucose and rapeseed-oil fatty acids methyl esters with yeast Candida Bombicola
- EC Number:
- 700-786-1
- Cas Number:
- 1194682-64-8
- IUPAC Name:
- Sophorolipids: fermentation products of glucose and rapeseed-oil fatty acids methyl esters with yeast Candida Bombicola
Constituent 1
Method
- Target gene:
- Salmonella thiphymurium TA1535 --> His G 46 --> additional mutations: rfa uvrB
Salmonella thiphymurium TA100 --> His G 46 --> additional mutations: rfa uvrB pKM 101
Salmonella thiphymurium TA102 --> His G 428 (pAQ1) --> additional mutations: rfa pKM 101
Salmonella thiphymurium TA1537 --> His C 3076 --> additional mutations: rfa uvrB
Salmonella thiphymurium TA98 --> His D 3052 --> additional mutations: rfa uvrB pKM 101
Species / strain
- 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 mix - liver microsomal fraction (S9) of rats
- Test concentrations with justification for top dose:
- Based on the toxicity showed in the preliminary studies the doses were chosen as follows:
1st experiment with and without S9 mix: from 312.5 to 5000µg/plate, idem for TA102 in the 2nd one
2nd experiment: from 156.25 to 2500µg/plate - Vehicle / solvent:
- The tested substance sopholiance was dissolved in DMSO (dimethylsulfoxide).
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Remarks:
- 5 known mutagens tested to check sensitivity
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2-anthramine
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The tested substance sopholiance does not show any mutagenic activity in the bacterial reverse mutation test with Salmonella Typhimurium
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