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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1988-02-02 until 1988-05-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study on structural analogue (free acid) according to OECD guideline 401. 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:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- (R)-2-(4-Hydroxyphenoxy)propanoic acid
- IUPAC Name:
- (R)-2-(4-Hydroxyphenoxy)propanoic acid
- 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
- 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
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Hydroxy-4 phénoxy-2 propionique acide H.P.P.A
- Physical state: fine white powder
- pH of 20% w/v suspension in 10% gum Arabic aqueous suspension: 2.7 at 21.6°C
- Storage condition of test material: minimum 19°C
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rat
- Strain:
- other: Ico rats: OFA.SD (IOPS Caw); Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Summary. Sprague-Dawley rats; however, Ico rats bred by Iffa-Credo are also reported as "Wistar/Furth/Ico strain" in the literature (Trouillas J, Girod C, Claustrat B, Cure M & Dubois MP (1982), Am J Pathology 109(1): 57 -70)
- Source: Iffa-Credo, Les Oncins, 69210 L'Arbresle, France
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 195-218 g (males), 161-179 g (females)
- Fasting period before study: 15-20 hours
- Housing: Preliminary study: 2 per cage, polycarbonate cages type FI; main study: 5 per cage, polycarbonate cages type MI
- Diet (ad libitum): Rat-mouse pelleted complete maintenance diet, U.A.R. formule "A.04 CR" (U.A.R., Villemoisson sur Orge, 91360 Epinay sur Orge, France)
- Water (ad libitum): softened and filtered drinking water
- Acclimation period: minimum 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 70 % relative humidity
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 hours
IN-LIFE DATES: From: 1988-02-02 To: 1988-02-24
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: gum Arabic, 10 % w/v aqueous dispersion
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Preliminary study: 5, 10, and 20 % w/v suspension; main study: 20 % w/v suspension
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: requested by study monitor
- Purity: no data
- pH of 20% w/v suspension in vehicle: 2.7
- pH of pure vehicle (10% w/v gum Arabic aqueous suspension): 4.4
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
DOSAGE PREPARATION (if unusual): suspension maintained on magnetic stirrer - Doses:
- Preliminary study: 500, 1000, 2000 mg/kg bw
Main study: 2000 mg/kg bw - No. of animals per sex per dose:
- Preliminary study: 2
Main study: 5 - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: days -1, 1, 8, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (15 min, 1, 2, 4 h after application, then daily), body weight, macropathology (liver, heart, kidneys, lungs) - Statistics:
- No calculation of LD50, since no mortalities were observed
Body weight: mean, standard variation, coefficient of variation; Student test to compare treated and control groups
Results and discussion
- Preliminary study:
- No mortality observed in either males or females (2 per sex) at 500, 1000, and 2000 mg/kg bw
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none at any dose
- Clinical signs:
- other: No behavioral abnormalities detected throughout the 14-day observation period
- Gross pathology:
- No macroscopic anomalies observed at terminal sacrifice
Any other information on results incl. tables
No deaths, clinical signs, or macropathological findings were observed in either sex at the limit test dose (2000 mg/kg bw) with the source substance, the free acid (R)-2-(4-hydroxyphenoxy)-propanoic acid (CAS 94050-90-5).
The acute oral toxicity of the target substance propanoic acid, 2-(4-hydroxyphenoxy)-, sodium salt (2R) (CAS 133647-88-8) is determined by read-across from the limit 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), form a pH-dependent equilibrium, and the salt is rapidly converted to the free acid under the acidic conditions in the stomach. Upon neutralization in the duodenum (with a large excess of sodium ions), source and target become fully indistinguishable in their bioavailability and metabolic fate.
The only difference, the presence of equimolar quantities of sodium ions in the target substance, is expected to have no toxicological consequences as sodium salts are typically less toxic in comparison to the free acids based on a comparison of data for sodium salts and the free acids of a number of simple organic acids and as the amount of Na+ applied in a limit test is still more than 5 times lower than the value derived from published LD50 values for NaCl.
As a conclusion, the acute oral toxicity of propanoic acid, 2-(4-hydroxyphenoxy)-, sodium salt (2R) is estimated to be > 2000 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral toxicity of sodium (2R)-2-(4-hydroxyphenoxy)propanoate is estimated to be > 2000 mg/kg bw by read across.
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