Registration Dossier
Registration Dossier
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EC number: 294-955-2 | CAS number: 91771-62-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Cyperus scariosus, Cyperaceae.
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source
Data source
Reference
- Reference Type:
- secondary source
- Title:
- In-vitro gene toxicity study of Cyperus scariosus, ext
- Author:
- EPA
- Year:
- 2 018
- Bibliographic source:
- United States Environmental Protection Agency, 2018
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- AMES salmonella/microsome mutagenesis assay
- Principles of method if other than guideline:
- In – vitro Bacterial reverse mutation assay of test chemical in S. typhimurium
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Camphene
- EC Number:
- 201-234-8
- EC Name:
- Camphene
- Cas Number:
- 79-92-5
- Molecular formula:
- C10H16
- IUPAC Name:
- Camphene
- Details on test material:
- - IUPAC Name: Camphene- InChI: 1S/C10H16/c1-7-8-4-5-9(6-8)10(7,2)3/h8-9H,1,4-6H2,2-3H3- Smiles:C1([C@@H]2C[C@@H](C1=C)CC2)(C)C- Molecular formula :C10H16- Molecular weight :136.236 g/mole- Substance type:Organic
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- not specified
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- not specified
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium, other: UTH8414 and UTH8413
- Details on mammalian cell type (if applicable):
- UTH8414 and UTH8413
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver microsome fraction S9 from Aroclor induced male
- Test concentrations with justification for top dose:
- 10-1000 ug/plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: cisplatin (10 ug/plate) was the positive control for UTH8414 and UTH 8413 without S9. 2-Aminoanthracene (10 ug/plate) was the positive control for TA98 with S9.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)DURATION- Preincubation period:- Exposure duration: 48 hours NUMBER OF REPLICATIONS: duplicate
- Evaluation criteria:
- Number of colonies per plate were counted.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: UTH8414 and UTH8413
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: not mutagenic
Applicant's summary and conclusion
- Conclusions:
- Test chemical did not induce mutation in Salmonella Typhimurium TA 98 and 100, UTH8414 and UTH8413 and hence it is not likely to classify as a gene mutant in vitro.
- Executive summary:
Gene toxicity test was performed to determine the mutagenic nature oftest chemical. The study was performed usingSalmonella TyphimuriumTA 98 and 100, UTH8414 and UTH8413 both in the presence and absence of mammalian S-9 microsomal fraction. The test material did not induce reverse mutations. Therefore,Test chemical did not induce mutation inSalmonella TyphimuriumTA 98 and 100, UTH8414 and UTH8413 with and withoutmammalian S-9 microsomal fraction.Hence it is not likely to classify as a gene mutant in vitro.
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