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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 309-849-4 | CAS number: 101316-44-3
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to OECD Guideline 473 with acceptable restrictions (limited documentation on cytotoxicity; unusual harvest time after addition of colcemid; no data about osmolarity at high dose levels; no data about historical control values of this lab)
Data source
Reference
- Reference Type:
- publication
- Title:
- Chromosomal aberrations and sister chromatid exchange tests in Chinese hamster ovary cells in vitro. IV. Results with 15 chemicals
- Author:
- Ivett JL, Brown BM, Rodgers C, Anderson BE, Resnick MA, Zeiger E
- Year:
- 1 989
- Bibliographic source:
- Environ Mol Mutagen 14: 165-187
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Phenol
- EC Number:
- 203-632-7
- EC Name:
- Phenol
- Cas Number:
- 108-95-2
- Molecular formula:
- C6H6O
- IUPAC Name:
- phenol
- Details on test material:
- - Analytical purity: 99.9%
- Impurities (identity and concentrations): no data
- Purity test date: no data, but analysis performed by Radian Corp., Austin, TX.
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data, but stability in aqueous solutions have been shown in other studies
- Storage condition of test material: no data
- Source: Fluka
Constituent 1
Method
- Target gene:
- Target: chromosome
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- CHO-WBL
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 obtained from livers of Aroclor 1254-treated male Sprague-Dawley rats
- Test concentrations with justification for top dose:
- The top dose (TD) was based on toxicity; doses used were generally the TD, 0.75 TD, 0.50 TD, 0.25 TD, 0.1 TD, 0.075 TD, 0.05 TD, 0.025 TD.
The highest three doses with sufficient number of cells analyzed for chromosomal aberrations.
Without metabolic activation (MA): 600, 700, 800 µg/ml
With MA: 2000, 2500, 3000 µg/ml - Vehicle / solvent:
- dimethyl sulfoxide (DMSO)
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Remarks:
- Mitomycin C without MA and cyclophosphamide with MA
- Remarks:
- concurrent controls
- Details on test system and experimental conditions:
- The pH of the test chemical solution diluted in culture media was in the range of 7.0-7.5. Positive results verified with additional testing in repeat trials; the dose with the positive response was bracketed with a higher and lower dose.
Without MA cells exposed to phenol for 8 hr, chemical washed off, and cells treated with 0.1 ug/ml Colcemid for 2-2.5 hr, followed by further incubation (see below). With MA cells were exposed to phenol plus the metabolic activation mixture for 2 hr, washed, incubated for 8 h, and then treated with Colcemid for 2-2.5 h. A delayed harvest was used (cell cycle delay): cell growth period extended to about 20 hr. After cells were harvested air-dried slides were coded and stained with Giemsa. 100-200 cells from each of the three highest scorable doses analyzed. All aberrations individually classified (e.g., chromatid breaks, chromosome breaks, triradials) combined as the percent of cells with simple (deletions), complex (exchanges), and total (simple, complex and other) aberrations. Only total percent cells with aberrations considered in the statistical evaluation. Gaps and endoreduplications recorded but not included. - Evaluation criteria:
- Trials with two or more significant doses considered positive, and trials with one significant dose and a significant trend judged as weak positive (+ W). Trials with a significant response at one dose and no significant trend, and trials with no significant responses but having a significant trend were considered equivocal.
- Statistics:
- A significant increase in aberration based on a binomial sampling assumption; the P values were adjusted according to Dunnett's method to take into account multiple dose comparisons. The trend test for both assays used a linear regression analysis: the percentage of cells with aberrations vs . the log dose.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- slight reduction in cell confluency at the two top doses with and without S-9 mix; no further data
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- slight reduction in cell confluency at the two top doses with and without S-9 mix; no further data
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Significant increases in chromosomal aberrations were observed with MA and delayed harvest time.
Any other information on results incl. tables
Aberrations in CHO cells after exposure to phenol without metabolic activation
Dose level in µg/ml | % aberrations |
0 | 2 |
600 | 4 |
700 | 6 |
800 | 7 |
positive control | 48 |
In parallel experiments the range for aberration of negative controls was 1 - 4%
Aberrations in CHO cells after exposure to phenol with metabolic activation
Dose level in µg/ml | % aberrations |
0 | 2 |
2000 | 18 |
2500 | 14 |
3000 | 17 |
positive control | 34 |
In parallel experiments the range for aberration of negative controls was 1 - 4%
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
negative without metabolic activation
In CHO cells phenol was mutagenic in the chromosome aberration assay with metabolic activation. - Executive summary:
The study is comparable to OECD Guideline 473 with acceptable restrictions (limited data on cytotoxicity; unusual harvest time after addition of colcemid; no data about osmolarity at high dose levels; no data about historical control values of this lab).
Chinese hamster ovary cells were exposed without metabolic activation (MA) to 600, 700, 800 µg/ml (exposure duration 8 hours) and with MA to 2000, 2500, 3000 µg/ml (exposure duration 2 hours) (solvent DMSO). 100-200 cells from each of the three highest scorable doses were analyzed and cytotoxicity evaluated by cell confluency. No increase in aberrations were recorded without MA. However, increased incidence of chromosome aberration were found with MA. A slight reduction in cell confluency at the two top doses were found with and without MA.
Conclusion: Phenol was mutagenic in the chromosome aberration assay in CHO cells with metabolic activation.
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.