Registration Dossier
Registration Dossier
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EC number: 946-764-7 | 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:
- From January 24, 1996
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- D-Glucopyranose, oligomeric, C10-14-alkyl glycosides tartaric esters, sodium salt
- EC Number:
- 946-764-7
- Molecular formula:
- -
- IUPAC Name:
- D-Glucopyranose, oligomeric, C10-14-alkyl glycosides tartaric esters, sodium salt
- Test material form:
- liquid: viscous
Constituent 1
Method
- Target gene:
- histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA1535, TA1537, TA1538, TA98, TA100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Mix
- Test concentrations with justification for top dose:
- 0 (as positive control)-10-100-1000-10000-100000 g/plate were tested for 3 times
- Vehicle / solvent:
- water for injection
Controls
- Untreated negative controls:
- yes
- Remarks:
- solvent
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 9-aminoacridine, sodium azide, 2-nitrofluorene, 2-aminoanthracene
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: ta 1535, 1537, 1538, 98, 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- at 10 mg/plate with and without metabolic activation
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- -
Any other information on results incl. tables
The sterility checks with the compound proved negative for bacterial growth.
As regards mutagenicity, no appreciable increase in the number of reversions in comparison with the negative control was evident in either experiment at any of the doses for any strain, with or without metabolic activation.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative
In the concentration range investigated, the test substance did not show any mutagenic activity with or without the addition of S9 mix.
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