Registration Dossier
Registration Dossier
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EC number: 700-475-0 | CAS number: 145783-14-8
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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V B.13/14
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Harmoniced Tripartite Guidelines S2A
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: USEPA Health Effects Test Guideline OPPTS870.5100 (1998)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4,6-dichloro-5-nitro-2-(propylsulfanyl)pyrimidine
- EC Number:
- 700-475-0
- Cas Number:
- 145783-14-8
- Molecular formula:
- C7H7Cl2N3O2S
- IUPAC Name:
- 4,6-dichloro-5-nitro-2-(propylsulfanyl)pyrimidine
Constituent 1
Method
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:
- rat liver-derived, S9-mix
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 100 - 5000 µg/plate
Concentration range in the main test (without metabolic activation): 100 - 5000 µg/plate - Vehicle / solvent:
- Solvent: DMSO
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: Acridine Mutagen ICR 191
- Positive controls:
- yes
- Positive control substance:
- other: Sodium Azide
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Positive controls:
- yes
- Positive control substance:
- other: Daunomycin HCl
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- 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 with metabolic activation
negative without metabolic activation
Under the conditions of this assay, UL111 gave a negative, i.e. non-mutagenic response in S.typhimurium strains TA1535, TA1537, TA98 and TA100 and E.coli strains WP2P and WP2Puvr A in both the presence and absence of S9-mix.
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