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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 904-653-0 | CAS number: -
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study is comparable to OECD guideline study with accepatable restrictions (details of results not documented due to publication inherent shortening; positive control not concurrent and no positive control for TA98; partly limited documentation, e.g. no data about purity of test substance)
Data source
Reference
- Reference Type:
- publication
- Title:
- Multiple activation pathways of benzene leading to products with varying genotoxic characteristics
- Author:
- Glatt H, Padykula R, Berchtold GA, Ludewig G, Platt KL, Klein J, Oesch F
- Year:
- 1 989
- Bibliographic source:
- Environ Health Perspect 82: 81-89
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Study according to Glatt HR, Seidel A, Bochnitschek W, Marquardt H, Marquardt H, Hodgson RM, Grover PL, Oesch F (1986) Mutagenic and cell-transforming activities of triol-epoxides as compared to other chrysese metabolites. Cancer Res. 46: 4556-4565
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
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:
- No details given
Constituent 1
Method
- Target gene:
- His-
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA97, TA98, TA100, TA102, TA104, TA1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- NADPH-fortified postmitochondral fraction from liver homogenate of Aroclor 1254 treated rats
- Test concentrations with justification for top dose:
- 100-5000 µg/plate (without S-9 mix); 20-5000 µg/plate (with S-9 mix)
- Vehicle / solvent:
- no details but presumably buffer
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- other: concurrent positive controls were not tested but in parallel experiments benzene metabolites were tested and positive results were obtained with exception of TA98
- Details on test system and experimental conditions:
- Test substance, bacteria, and S9-mix (or buffer) were preincubated for 20 minutes at 37°C and then added to minimal agar plates; colonies counted after incubation for 3 days.
The toxicity was determined (LD50 value in µg/plate) using his+ mutants as an internal standard.
No further details were documented on methods. - Evaluation criteria:
- At least 2-fold increase in TA98 and TA1535 or at least 1.5-fold increase of revertants in other strains.
- Statistics:
- No data but minor restriction in this study
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- other: no historical controls but valid compared to parallel experiments
- Positive controls validity:
- other: positive results obtained in parallel experiments (except for TA98)
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- other: no historical controls but valid compared to parallel experiments
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- other: no historical controls but valid compared to parallel experiments
- Positive controls validity:
- other: positive results obtained in parallel experiments (except for TA98)
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- other: no historical controls but valid compared to parallel experiments
- Positive controls validity:
- other: ^positive results obtained in parallel experiments (except for TA98)
- Species / strain:
- S. typhimurium, other: TA104
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- other: no historical controls but valid compared to parallel experiments
- Positive controls validity:
- other: positive results obtained in parallel experiments (except for TA98)
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- other: no historical controls but valid compared to parallel experiments
- Positive controls validity:
- other: positive results obtained in parallel experiments (except for TA98)
- Additional information on results:
- No further details presented on results (not documented due to publication inherent shortening).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
No induction of gene mutation in the bacterial reverse mutation assay at concentrations up to 5 mg/plate (max. recommended dose level in OECD 471). - Executive summary:
The study is comparable to OECD guideline study with acceptable restrictions (details of results not documented due to publication inherent shortening; positive control not concurrent and no positive control for TA98; partly limited documentation, e.g. no data about purity of test substance).
S. typhimurium strains TA97, TA98, TA100, TA102, TA104, and TA1535 were exposed with and without metabolic activation to varying concentrations of phenol (100 -5000 µg/plate without S-9 mix and 20 -5000 µg/plate with S-9 mix). Cytotoxic effects (LD50 measured in his+ mutants as internal standards) were detected at 3000 µg/plate without S9 -mix and at 1800 µg/plate with S9 -mix. No genotoxic effects were recorded in any strain (increase in revertants less than 1.5 -2 -fold).
Conclusion: No induction of gene mutation in the bacterial reverse mutation assay at concentrations up to 5 mg/plate (max. recommended dose level in OECD 471).
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.