Registration Dossier
Registration Dossier
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EC number: 500-047-1 | CAS number: 26316-40-5 1 - 4.8 moles ethoxylated and 1 - 8.5 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:
- July 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 1a Guideline study under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Details on test material:
- Voranol RA 800, Supplier: Dow Europe GmbH.
EO: 10-30%; PO 70-90%
Molecular Weight: (average Mn = 280 g/mol)
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10% S9 liver homogenate in standard cofactors
- Test concentrations with justification for top dose:
- 0, 0.15, 0.5, 1.5, 5.0, 15, 50, 150, 500, 1500, 5000 µg/plate.
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Migrated to IUCLID6: 9-Aminoacridin; Mitomycin C; 4-Nitroquinoline-1-oxide.
- Details on test system and experimental conditions:
- Strains were obtained from the University of California at Berkley in 1995 and stroed under liquid nitorgen at the testing laboratory.
- Evaluation criteria:
- reproducable, dose related and statistically significant increase in the revertatn count in at least one strain.
- Statistics:
- Dunnett's linear regression. s
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No test material preciptation observed. No cytotoxicity observed.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Teh test material was considered to be non-mutagenic in the bacterial reverse mutation assay.
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