Registration Dossier
Registration Dossier
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EC number: 412-960-1 | CAS number: 148878-21-1 PROCION BRILLIANT ORANGE H-EXL; S156745
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From July 30, 1993 to September 20, 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- 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:
- S9 mix
- Test concentrations with justification for top dose:
- 200, 500, 1000, 2500, 5000 and 7500 µg/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water and DMSO
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- N-ethyl-N-nitro-N-nitrosoguanidine
- mitomycin C
- other: Acridine mutagen, 2-amino anthacene, Daunomycine,
- Details on test system and experimental conditions:
- Batch number: 3507/15
- Key result
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Under the study conditions, the substance was not mutagenic in the Salmonella typhimurium and Escherichia coli reverse mutation assay.
- Executive summary:
A study was conducted to determine the mutagenic potential of the substance according to OECD Guideline 471, in compliance with GLP. The bacterial strains Salmonella typhimurium TA 1535, TA 1537, TA 98,TA 100 and E. coli strains WP2P and WP2PuvrA were tested with following test substance concentrations: 0, 200, 500, 1000, 2500, 5000 and 7500 µg/plate with and without metabolic activation. In two separate assays, the compound did not induce any significant reproducible increase in the observed number of revertant colonies in strains TA 1535, TA 1537, TA 98, TA 100 and E. coli strains either in the presence or absence of a metabolising system (S9). Although some increases in colony numbers were observed with the strains TA1535 and WP2P without S9, this did not exceed twice the background level in any instance and were not dose -related. In each experiment the positive controls responded as expected indicating that the assay performed satisfactorily. Under the study conditions, the substance was not mutagenic in the Salmonella typhimurium and Escherichia coli reverse mutation assay (Callander, 1993).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In vitro:
A study was conducted to determine the mutagenic potential of the substance according to OECD Guideline 471, in compliance with GLP. The bacterial strains Salmonella typhimurium TA 1535, TA 1537, TA 98,TA 100 and E. coli strains WP2P and WP2PuvrA were tested with following test substance concentrations: 0, 200, 500, 1000, 2500, 5000 and 7500 µg/plate with and without metabolic activation. In two separate assays, the compound did not induce any significant reproducible increase in the observed number of revertant colonies in strains TA 1535, TA 1537, TA 98, TA 100 and E. coli strains either in the presence or absence of a metabolising system (S9). Although some increases in colony numbers were observed with the strains TA1535 and WP2P without S9, this did not exceed twice the background level in any instance and were not dose -related. In each experiment the positive controls responded as expected indicating that the assay performed satisfactorily. Under the study conditions, the substance was not mutagenic in the Salmonella typhimurium and Escherichia coli reverse mutation assay (Callander, 1993).
Justification for classification or non-classification
Based on the results of in vitro gene mutation study in bacteria, no conclusion could be reached on classification for mutagenicity according to EU CLP (EC 1272/2008) criteria.
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