Registration Dossier
Registration Dossier
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EC number: 205-031-5 | CAS number: 131-57-7
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:
- 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to the OECD TG 471 (draft).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: draft OECD TG 471
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Oxybenzone
- EC Number:
- 205-031-5
- EC Name:
- Oxybenzone
- Cas Number:
- 131-57-7
- Molecular formula:
- C14H12O3
- IUPAC Name:
- 2-benzoyl-5-methoxyphenol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Method
- Target gene:
- HIS operon (S. thyphimurium)
TRY operon (E. coli)
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium TA 100, TA 98, TA 1535, TA 1537, TA 1538, and Escherichia coli WP2 and WP2 uvrA
- Additional strain / cell type characteristics:
- other: mutations in HIS or TRY operon
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver homogenate (S9 mix) with standard co-factors with metabolic activation (Aroclor)
- Test concentrations with justification for top dose:
- 100, 250, 500, 750, 1000 and 1250 µg/plate.
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 9-Aminoacridine, 2-Aminoanthracene, Daunomycin, 1-Ethyl-2-nitro-3-nitrosoguanidine, Methyl methanesulfonate, N-Methyl-N-nitro-N-nitrosoguanidine , 2-Nitrofluorene, l,2-phenylene diamine
- Details on test system and experimental conditions:
- plate incorpoaration protocol
Bacteria suspension for test 0.1 ml
Tested sample (or solvent) 0.1 ml
Na-phosphate buffer (in trials without metabolic activation) 0.5 ml
S-9 mix (in trials with metabolic activation) 0.5 ml
Soft agar solution 2.0 ml
Incubation of plates
Temperature 37 °C
Hours 48 - Statistics:
- no statistics performed
Results and discussion
Test results
- Species / strain:
- other: all strains tested
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >1250 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- 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 and without metabolic activation
The test material is considered to be not mutagenic in this bacterial mutagenicity assay. - Executive summary:
Study Design
The test material was tested for its potential to induce reverse mutation in bacteria using Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 and TA 1538 and Escherichia coli WP2 and WP2 uvrA as tester strains. The test item was investigated at concentrations between 100 and 1250 µg/plate in the presence and absence of a metabolic activation system (S9 mix derived from male rats pre-treated with Aroclor 1254) using the plate incorporation technique. Two experiments were performed. Negative solvent control and appropriate positive controls were carried along. The design of the study meets the requirements of test guideline OECD 471.
Results
In a preliminary test using concentrations between 5 and 10000 µg/plate, toxicity was observed at concentrations >1250 µg/plate.
The test material was dissolved in DMSO and tested at concentrations ranging from 100 to 1250 µg/plate.
The test material did not show any mutagenic activity up to the highest concentration tested in the presence and absence of metabolic activation where the substances used as positive controls led to a clear increase in revertant colonies in the expected range.
Conclusion
Based on the results of this study, the test material is considered to be not mutagenic in this bacterial mutagenicity assay.
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