Registration Dossier
Registration Dossier
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EC number: 270-096-9 | CAS number: 68411-04-1
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- non GLP; content not given
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[3-(dimethylamino)propyl]amino]sulfonyl derivs.
- EC Number:
- 270-096-9
- EC Name:
- Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[3-(dimethylamino)propyl]amino]sulfonyl derivs.
- Cas Number:
- 68411-04-1
- Molecular formula:
- [C32H16CuN8][O3S]n[C5H12N2O2S]m
- IUPAC Name:
- Copper, [29H,31H-phthalocyaninato(2-)-.kappa.N29,.kappa.N30,.kappa.N31,.kappa.N32]-, [[3-(dimethylamino)propyl]amino]sulfonyl derivs.
- Test material form:
- not specified
Constituent 1
Method
- Target gene:
- Histidine biosynthesis
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Negative control
C.I. Direct Blue 264: 5000, 1581, 500, 158, 50, 16 µg/plate
Positive controls:
Na-azide: 10 µg/plate (TA1535)
Nitrofurantoin: 0.2 µg{plate (TA100)
4-nitro-1,2-phenylene diamine: 10 µg/plate (TA1537); 0.5 µg/plate (TA98)
Cumene: 50 µg/plate (TA102)
2-Aminoanthracene: 3 µg/plate
Due to precipitation of the substance, doses ranging from 100 to 3200µg/tube were chosen for the repeat tests.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- cumene hydroperoxide
- other: nitrofurantoin, 4-nitro-1,2-phenylene diamine, 2-aminoantracene
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
No bacteriotoxic effects up to 158 µg/plate; total bacterial count remained unchanged an no growth inhibition was seen.
At doses above 158 µg/plate strain-specific cytotoxicity.
Compound precipitation started at 500 µg/plate; and 5000 µg/plate could not be used for evaluation.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
- Executive summary:
No evidence of mutagenic activity in plate incorporation test and preincubation test in the presence and absence of S9 mix.
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