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EC number: 618-855-9 | CAS number: 925430-39-3
- 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 gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-[(1R)-2-chloro-1-hydroxyethyl]phenol
- EC Number:
- 618-855-9
- Cas Number:
- 925430-39-3
- Molecular formula:
- C8 H9 Cl O2
- IUPAC Name:
- 3-[(1R)-2-chloro-1-hydroxyethyl]phenol
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): HCPE and Impurities
- Physical state: solid
- Expiration date of the lot/batch: 24 Jun 2015
- Storage condition of test material: room temperature
Constituent 1
Method
- Target gene:
- - S. typhimurium: his-locus
- E. coli: trp-locus
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital and β-naphthoflavone-induced rat liver S9 mix
- Test concentrations with justification for top dose:
- 1st experiment: 0; 33; 100; 333; 1 000; 2 500 and 5 000 μg/plate
2nd experiment: 0; 500; 1 000; 2 000; 3 000; 4 000 and 5 000 μg/plate - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 2.5 μg/plate, dissolved in DMSO for TA 1535, TA 100, TA 1537, TA 98; 60 μg/plate, dissolved in DMSO for E. coli WP2 uvrA
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 5 μg/plate, dissolved in DMSO for TA 1535, TA 100
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine
- Remarks:
- without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 10 μg/plate, dissolved in DMSO - strain: TA 98
- Positive control substance:
- other: 4-nitro-o-phenylenediamine
- Remarks:
- without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 100 μg/plate, dissolved in DMSO - strain: TA 1537
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 5 μg/plate, dissolved in DMSO - strain: E. coli WP2 uvrA
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- other: demonstration of the efficacy of the S9 mix
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- To demonstrate the efficacy of the S9 mix in this assay, the S9 batch was characterized with benzo(a)pyrene.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48-72h
SELECTION AGENT (mutation assays): agar with minimal amino acid solution for the determination of mutants: 0.5 mM histidine + 0.5 mM biotin for Salmonella typhimurium strains and 0.5 mM tryptophan for E. Coli
DETERMINATION OF CYTOTOXICITY
- Method: his- or trp- background growth, number of his+ or trp+ revertants - Evaluation criteria:
- Acceptance criteria
Generally, the experiment was considered valid if the following criteria were met:
The number of revertant colonies in the negative controls was within the range of the
historical negative control data for each tester strain.
The sterility controls revealed no indication of bacterial contamination.
The positive control substances both with and without S9 mix induced a distinct increase in
the number of revertant colonies within the range of the historical positive control data or
above.
Fresh bacterial culture containing approximately 109 cells per mL were used.
Assessment criteria
The test substance was considered positive in this assay if the following criteria were met:
A dose-related and reproducible increase in the number of revertant colonies, i.e. at least
doubling (bacteria strains with high spontaneous mutation rate, like TA 98, TA 100 and
E.coli WP2 uvrA) or tripling (bacteria strains with low spontaneous mutation rate, like TA
1535 and TA 1537) of the spontaneous mutation rate in at least one tester strain either
without S9 mix or after adding a metabolizing system.
A test substance was generally considered non-mutagenic in this test if:
The number of revertants for all tester strains were within the historical negative control
data range under all experimental conditions in at least two experiments carried out
independently of each other.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- not valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- ambiguous
- Remarks:
- slight increases in the number of his+ or trp+ revertants
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- other: slight increases in the number of his+ or trp+ revertants
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- other: slight increases in the number of his+ or trp+ revertants
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- A biologically relevant increase in the number of his+ revertants was not observed using the
tester strain TA 1537 and TA 98 in the standard plate test either without S9 mix or after the
addition of a metabolizing system.
A reproducible and partly dose-dependent increase in the number of his+ revertants
exceeding a factor of 3 compared to the concurrent vehicle control was observed in tester
strain TA 1535 without S9 mix: Increase at a concentration of 5 000 μg/plate (1st Exp.) and at
concentrations of 3 000; 4 000 and 5 000 μg/plate (2nd Exp.).
Furthermore, slight increases in the number of his+ or trp+ revertants were observed in tester
strain TA 1535, TA 100 and E.coli WP2 uvrA with and/or without S9 mix. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The positive findings were not confirmed by the preincubation test.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
Thus, under the experimental conditions of this study, the test substance HCPE and
Impurities is mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation
assay in the absence and the presence of metabolic activation. - Executive summary:
The substance was tested for its mutagenic potential, in an OECD 471 guideline study (in compliance with GLP), based on the ability to induce point mutation in selected loci of several bacterial strains, i.e. Salmonella typhimurium (TA 1535, TA 100, TA 1537, TA98) and Escherichia coli (WP2 uvrA) in a reverse mutation assay. Bacteria were exposed to 33 -5000 µg substance/plate in a standard plate test in the presence and absence of a metabolizing system (rat liver S-9 mix). No precipitation of the test substance and no bacteriotoxic effect was found with and without S9 mix. A dose-dependent increase in the number of his+ revertants in the tester strain TA 1535 was observed in the standard plate test in the absence of a metabolizing system. Furthermore, slight increases in the number of his+ or trp+ revertants were observed in tester strain TA 1535, TA 100 and E.coli WP2 uvrA with and/or without S9 mix.Thus, under the experimental conditions of this study, the test substance HCPE and Impurities is mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and presence of metabolic activation.
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