Registration Dossier
Registration Dossier
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EC number: 500-118-7 | CAS number: 52625-13-5 1 - 12.5 moles propoxylated
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:
- December 13, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- D-Glucitol, propoxylated
- EC Number:
- 500-118-7
- EC Name:
- D-Glucitol, propoxylated
- Cas Number:
- 52625-13-5
- Molecular formula:
- (C3 H6 O)n (C3 H6 O)n (C3 H6 O)n (C3 H6 O)n (C3 H6 O)n (C3 H6 O)n C6 H14 O6 sum of n: >1 - <12.5 mol PO
- IUPAC Name:
- D-Glucitol, propoxylated
- Details on test material:
- D-glucitol, propoxylated, (Mn = approx. 600 g/mol) (LUPRANOL 3422)
Lot number: 0328
Storage conditions: room temperature in the dark
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium
- Remarks:
- TA1535, TA1537, TA102, TA98 and TA100
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- 50, 150, 500, 1500, 5000 µg/plate
- Details on test system and experimental conditions:
- AMES test
Results and discussion
Test results
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: > 5000 µg/plate
- Remarks on result:
- other: other: Salmonella typhimurium
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
No significant increase in the frequency of revertant colonies were recorded for any of the strains of Salmonella, at any dose level either with or without metabolic activation. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative
The test material was considered to be non-mutagenic under the conditions of the test.
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