Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according 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:
- Tricyclo[8.2.2.24,7]hexadeca-4,6,10,12,13,15-hexaene, 5,11,13,15-tetramethyl-
- Cas Number:
- 205825-52-1
- Molecular formula:
- C20H24
- IUPAC Name:
- Tricyclo[8.2.2.24,7]hexadeca-4,6,10,12,13,15-hexaene, 5,11,13,15-tetramethyl-
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Batch no. 350321
Method
- Target gene:
- histidine
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:
- S9-mix
- Test concentrations with justification for top dose:
- 31.6, 100, 316, 1000, 2500 and 5000 µg/plate
- Vehicle / solvent:
- The test item was dissolved in DMSO, processed by ultrasound for 25 min at 37 °C and diluted prior
to treatment. The solvent was compatible with the survival of the bacteria and the S9 activity.
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Negative controls (A. dest., Eurofins Munich, Lot No. 210320, 210520, 210616) and solvent controls (DMSO, AppliChem Lot No. 0001926479, 0001886811) were treated in the same way as all dose groups.
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- sodium azide
- other:
Results and discussion
Test results
- Key result
- Species / strain:
- other: all tester strains
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
Applicant's summary and conclusion
- Conclusions:
- It can be stated that during the described mutagenicity test and under the experimental
conditions reported, PARYFREE® DIMER did not cause gene mutations by base pair changes or
frameshifts in the genome of the tester strains used.
Therefore, PARYFREE® DIMER is considered to be non-mutagenic in this bacterial reverse mutation assay.
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