Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 221-916-9 | CAS number: 3279-27-4
- 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 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Japanese Ministry of Health study. Well documented study performed to the principles of OECD guideline 471. No GLP status.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-tert.-butylphenol
- IUPAC Name:
- 2-tert.-butylphenol
- Reference substance name:
- 2-tert-butylphenol
- EC Number:
- 201-807-2
- EC Name:
- 2-tert-butylphenol
- Cas Number:
- 88-18-6
- Molecular formula:
- C10H14O
- IUPAC Name:
- 2-tert-butylphenol
- Reference substance name:
- o.-tert.-butylphenol
- IUPAC Name:
- o.-tert.-butylphenol
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 2-tert.-butylphenol
- Physical state: liquid
- Analytical purity: 99.97%
- Purity test date: 2014-05-07
- Lot/batch No.: 1419
- Expiration date of the lot/batch: 05/2015
- Stability under test conditions: stable
- Storage condition of test material: under N2 in tightly closed container at a cool, well ventilated place
- Colour: clear
Constituent 1
Constituent 2
Constituent 3
Method
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:
- phenobarbital and 5,6-benzoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- The test solutions were prepared at the time of use.
Dose-finding test - 50 to 5000 μg/plate.
Main test - 200 μg/plate at maximum and 100, 50, 25, 12.5 and 6.25 μg/plate using a common ratio of 2. - Vehicle / solvent:
- DMSO
Test material not soluble in water
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- furylfuramide
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- The study was conducted by the pre-incubation method.
To a test tube, 0.1 mL of the solvent, test article solution or positive control article solution, 0.5 mL of 0.1 M sodium phosphate buffer (pH 7.4) for the direct method or 0.5 mL of S9 mix for the metabolic activation method, and then 0.1 mL of bacterial suspension were added and cultured with
shaking for 20 minutes at 37°C. Then, the mixture to which 2 mL of top agar was added and warmed to 45°C was overlaid on the plate. After the end of cultivation for 48 hours at 37°C, the number of revertant colonies was counted and the presence or absence of growth inhibition of the indicator bacterial strains was observed simultaneously using a stereomicroscope. The number of plates used was one for each dose concentration in the
dose selection test and three for each dose concentration in the main test. The main test was conducted twice using the same dose concentrations. - Evaluation criteria:
- If the number of revertant colonies (mean value) in the test article-treated plate was at least twice that of the vehicle control plate and dose dependency and reproducibility of the results were observed, the test article was judged to be positive.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: Growth inhibition of bacteria was observed at the dose levels of 200 μg/plate and above for all bacterial
strains irrespective of the presence or absence of metabolic activation, and slight growth inhibition was observed at 100 μg/plate in the direct
method for TA100, TA1535 and TA1537. - Remarks on result:
- other: all strains/cell types tested
Applicant's summary and conclusion
- Conclusions:
- Based on the results described above, it was judged that o-tert-butylphenol was negative for gene mutation inducibility under the conditions of this experiment
- Executive summary:
In a study reported by the Japanese Ministry of Health, o-tert butyl phenol in DMSO (concentrations 6.25 to 200 μg/plate) was tested using the pre-incubation method in the absence (direct method) or presence (metabolic activation method) of S9 mix usingSalmonella typhimuriumTA100, TA1535, TA98, TA1537 andEscherichia coliWP2uvrAas index bacterial strains.
Under the conditions of this experiment, o-tert butyl phenol was not mutagenic.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.