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EC number: 204-442-7 | CAS number: 121-00-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: gene mutation
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- The sex-linked recessive lethal test for mutagenesis in Drosophila melanogaster
- Author:
- W.R. Lee (Leader), S. Abrahamson, R. Valencia, E.S. von Halle, F.E. Wurgler and S. Zimmering
- Year:
- 1 983
- Bibliographic source:
- Mutation Research, 123 (1983) 183-279 REVIEW
- Reference Type:
- publication
- Title:
- Gene mutation in vivo toxicity study of the test chemical
- Author:
- Lee et al
- Year:
- 1 983
- Bibliographic source:
- Mutation Research
Materials and methods
- Principles of method if other than guideline:
- The test for sex-linked recessive lethals (SLRL) in Drosophila melanogaster is used to detect induced mutations. The advantage of the test for both screening and hazard evaluation is its objectivity in testing for transmissible mutations in various chemicals. One of the chemicals studied include the test chemical of interest.
- GLP compliance:
- not specified
- Type of assay:
- Drosophila SLRL assay
Test material
- Reference substance name:
- 2-tert-butyl-4-methoxyphenol
- EC Number:
- 204-442-7
- EC Name:
- 2-tert-butyl-4-methoxyphenol
- Cas Number:
- 121-00-6
- Molecular formula:
- C11H16O2
- IUPAC Name:
- 2-tert-butyl-4-methoxyphenol
- Test material form:
- solid: bulk
- Details on test material:
- - Name of test material: tert-butyl-4-methoxyphenol
- Common name: Phenol, (1,1-dimethylethyl)-4-methoxy-
- Molecular formula: C11H16O2
- Molecular weight: 180.2454 g/mol
- Smiles notation: COc1ccc(O)c(c1)C(C)(C)C
- InChI=1S/C11H16O2/c1-11(2,3)9-7-8(13-4)5-6-10(9)12/h5-7,12H,1-4H3
- Substance type: Organic
Constituent 1
Test animals
- Species:
- Drosophila melanogaster
- Strain:
- other: Balancer strains: Suitably marked inverted X chromosomes Tester strains: Males from wild type strains Oregon-K, Oregon-R, Canton-S, and Berlin-K.
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- Vehicles
- Vehicle(s)/solvent(s) used: Test chemical is dissolved in either DMSO or ethanol
- Justification for choice of solvent/vehicle: DMSO is a commonly used solvent, while ethanol has an advantage since the flies have large quantities of the alcohol dehydrogenase (ADH) enzyme and can readily metabolize ethanol.
- Concentration of test material in vehicle: No data available
- Amount of vehicle (if gavage or dermal): No data available
- Type and concentration of dispersant aid (if powder): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available
OTHER INFORMATION: In a test to screen for mutagenicity of a chemical, a single concentration of the chemical may be used to test for SLRLs. The selection of the final test concentration should be preceded by one or more exposure range-finding experiments in which two points are studied:
1. Toxicity to the males during treatment and during the breeding for the mating pattern analysis; and
2. Sterilizing effect due to lethal damage to one or several germ cell stages.
Based on the results obtained in such studies, a convenient exposure may be selected, usually at the LD50 level for treated males, provided sterility does not create problems. If sterility is induced, a lower exposure may have to be used. If no adverse effects are detected, the highest technically feasible exposure at which the flies will feed should be used. - Details on exposure:
- For oral route
PREPARATION OF DOSING SOLUTIONS: No data available
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available - Duration of treatment / exposure:
- No data
- Frequency of treatment:
- No data
- Post exposure period:
- No data
Doses / concentrations
- Remarks:
- No data
- No. of animals per sex per dose:
- No data
- Control animals:
- yes, historical
- Positive control(s):
- Yes, nonconcurrent positive control with ethylmethanesulphonate (EMS) or diethylnitrosamine (DEN)
Justification for choice of positive control(s): Nonconcurrent positive control are satisfactory for routine recessive lethal tests
- Route of administration: No data available
- Doses / concentrations: No data available
Examinations
- Tissues and cell types examined:
- Eye shape and eye color
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: No data available
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): No data available
DETAILS OF SLIDE PREPARATION: No data available
METHOD OF ANALYSIS:
Hazard evaluation has been made using dose to the germ cells of ionizing radiation, and similar use of this test system with chemical mutagens is possible with the development of dosimetry of chemical mutagens (Comment: I don’t think this statement is correct, however, I am not sure what to state here since there is no real directions on methods of analysis in the report text.)
OTHER: No data available - Evaluation criteria:
- Statistical evaluation
- Statistics:
- 1. Comparison of control and treated frequencies
The most common problem is a comparison of the mutation frequencies obtained in a control and in a treated group. As long as the total number of mutations recovered (control and treated) is below 100, the Kastenbaum-Bowman test should be used. If more than 100 mutations are obtained, the chi square test is appropriate.
2. Analysis of the pattern of successive matings
The pooling of data from submatings is one by adding the number of chromosomes tested and the number of mutations found. In this way a weighted mean is obtained. For each of the samples, the statistical significance of a difference between the mutation frequency found in the control and in the treated groups should be checked as described above.
In a second step, the same procedure is repeated to obtain the analysis of the data pooled from the two samples.
3. Dose-response data
Dose-response data can be analyzed using standard regression techniques when germ cell dosimetry is available.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- not specified
- Negative controls validity:
- other: Yes, solvent (If used) without the test chemical (administered in the same way as the treatment) is used for the negative control.
- Positive controls validity:
- other: Nonconcurrent positive control
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: No data available
- Solubility: No data available
- Clinical signs of toxicity in test animals: No data available
- Evidence of cytotoxicity in tissue analyzed: No data available
- Rationale for exposure: No data available
- Harvest times: No data available
- High dose with and without activation: No data available
- Other: No data available
RESULTS OF DEFINITIVE STUDY
- Types of structural aberrations for significant dose levels (for Cytogenetic or SCE assay): No data available
- Induction of micronuclei (for Micronucleus assay): No data available
- Ratio of PCE/NCE (for Micronucleus assay): No data available
- Appropriateness of dose levels and route: No data available
- Statistical evaluation: No data available
Applicant's summary and conclusion
- Conclusions:
- The test chemical is regarded to be negative for any mutagenic response when a SLRL test carried out on male Drosophila melanogaster.
- Executive summary:
Drosophila melanogaster was tested in a test for sex-linked recessive lethals (SLRL) to detect induced mutations. Ten day germ cell-staged adult male flies were fed with a solvent containing the test chemical to detect if it induced any mutagenic responses. No mutagenic responses were detected when a SLRL test was carried out on Drosophila melanogaster.
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