Registration Dossier
Registration Dossier
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EC number: 245-605-2 | CAS number: 23356-96-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- L-(pyrrolidin-1-yl)methanol
- EC Number:
- 245-605-2
- EC Name:
- L-(pyrrolidin-1-yl)methanol
- Cas Number:
- 23356-96-9
- Molecular formula:
- C5H11NO
- IUPAC Name:
- L-(pyrrolidin-1-yl)methanol
Constituent 1
Method
- Target gene:
- Not specified
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Obtained from liver of rat
- Test concentrations with justification for top dose:
- 156, 313, 625, 1250, 2500, 5000 µg/plate
- Vehicle / solvent:
- Distilled water
Controls
- Untreated negative controls:
- yes
- Remarks:
- distilled water
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 2-aminoanthracene, 6-chloro-9-[3-(2-chloroethyl amine)-propylamino]-2-methoxyacridine dihydrochloride, 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA1535, 1537, 98, 100, WP2uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at doses 2500 and 5000 µg/plate
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Based on the results, mutagenicity of PROL was judged negative under the condition of the present study.
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