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EC number: 603-758-6 | CAS number: 133647-88-8
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1995-08-10 until 1995-10-04
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study on structural analogue (free acid) according to OECD guideline 471. The fact that the study is used for read-across purposes triggers reliability rating 2.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
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:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (R)-2-(4-Hydroxyphenoxy)propanoic acid
- IUPAC Name:
- (R)-2-(4-Hydroxyphenoxy)propanoic acid
- Reference substance name:
- (R)-2-(4-hydroxyphenoxy)propanoic acid
- EC Number:
- 407-960-3
- EC Name:
- (R)-2-(4-hydroxyphenoxy)propanoic acid
- IUPAC Name:
- 407-960-3
- Reference substance name:
- Propanoic acid, 2-(4-hydroxyphenoxy)-, (2R)-
- IUPAC Name:
- Propanoic acid, 2-(4-hydroxyphenoxy)-, (2R)-
- Reference substance name:
- 94050-90-5
- Cas Number:
- 94050-90-5
- IUPAC Name:
- 94050-90-5
- Test material form:
- not specified
- Details on test material:
- - Substance type: Pure test substance
- Physical state: Solid
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Method
- Target gene:
- hisD, hisG, hisC, trpE
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9 fraction, induced with Aroclor 1254
- Test concentrations with justification for top dose:
- Range finding test: 20.6, 61.7, 185, 556, 1667, 5000 microgram/plate (with S. typhimurium TA100 and E. coli WP2 uvrA only)
Main experiment: 312.5, 625, 1250, 2500, 5000 microgram/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: solubility of test substance without precipitation
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without metabolic activation
Migrated to IUCLID6: 4-nitroquinoline, mitomycin-C, 2-nitrofluorene, 9-aminoacridine
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation
Migrated to IUCLID6: for TA1535, 2-aminoanthracene for all other strains
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Incubation period: 48 hours at 37 +/- 1.5°C
NUMBER OF REPLICATIONS: 3
- Two identical replicate experiments with identical concentrations: original and confirmatory
DETERMINATION OF CYTOTOXICITY
- Method: inspection of the bacterial background lawn, reduction of revertant colony numbers - Evaluation criteria:
- Criteria for positive response:
- Reproducible doubling of mean number of revertants above solvent control (at any concentration): for S. typhimurium TA98, TA1535, TA1537, E. coli WP2 uvrA
- Reproducible increase of mean number of revertants by at least a factor 1.5 above solvent control (at any concentration): for S. typhimurium TA100, TA102
- Concentration-related effect should be demonstrable
Assay acceptance criteria:
- Mean colony counts of negative control of all strains within acceptable range (historical controls documented)
- Results for positive controls meet criteria for positive response (historical controls documented) - Statistics:
- None
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- precipitation: none
- no reduction of the background lawn
RANGE-FINDING/SCREENING STUDIES:
- no increase in colony counts
- no signs of strong cytotoxicity (no reduction of the background lawn)
- slight reduction of revertant colony numbers at highest concentration, E. coli with S) only
ANALYTICAL DETERMINATION OF TEST SUBSTANCE
- HPLC with UV detection
- lowest serial dilution of stock solution in DMSO analyzed (in duplicate)
- recoveries 97.2 % and 100.8%
- test substance stable in the vehicle - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
No increase in the incidence of either histidine- or tryptophan-prototrophic mutants was elicited by the source substance, the free acid (R)-2-(4-hydroxyphenoxy)-propanoic acid (CAS 94050-90-5), in strains S. typhimurium TA 98, TA 100, TA 102, TA1535, TA1537 and E. coli WP2 uvrA, with and without metabolic activation, i.e. the source substance and its metabolites did not induce gene mutations.
The bacterial mutagenicity of the target substance propanoic acid, 2-(4-hydroxyphenoxy)-, sodium salt (2R) (CAS 133647-88-8) is determined by read-across from the Ames test with the free acid. The analogue approach is based on the facts that source and target contain the identical molecular structure and the same functional groups (except the Na+ counterion), and that they form a pH-dependent equilibrium. In the assay mixture (top agar), the free acid is neutralized to the Na+ salt (by the buffer, with a possible pH decrease to 6.4), which makes the two forms indistinguishable. The additional sodium introduced via the sodium salt is in fact negligible compared to the overall sodium content in the assay.
No mutagenic effect was observed with the free acid. As a conclusion, the target substance propanoic acid, 2-(4-hydroxyphenoxy)-, sodium salt (2R) is also unlikely to be a bacterial mutagen in the Ames test.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Sodium (2R)-2-(4-hydroxyphenoxy)propanoate is unlikely to be a bacterial mutagen in the Ames test based on read-across.
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