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EC number: 222-746-8 | CAS number: 3598-16-1
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A study according to the EU and OECD methods, including GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- yes
- Remarks:
- Only 2 tissues could be used for the test substance; without affecting the validity of the test.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- Only the draft of the guideline 431 was available in 2009.
- Deviations:
- yes
- Remarks:
- Only 2 tissues could be used for the test substance; without affecting the validity of the test.
- Principles of method if other than guideline:
- The test consists of topical exposure of the neat test substance to a human reconstituted epidermis model followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of MTT, present in cell mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The reduction of viability of tissue exposed to chemicals in comparison to negative controls is used to predict skin irritation potential.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium phenoxyacetate hemihydrate
- EC Number:
- 222-746-8
- EC Name:
- Sodium phenoxyacetate hemihydrate
- Cas Number:
- 3598-16-1
- Molecular formula:
- C8H8O3.Na
- IUPAC Name:
- sodium phenoxyacetate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Common name: sodium phenoxyacetate
CAS No: 3598-16-1
Purity (dry basis): 99.83 %
Appearance: off white powder
Conditions of storage: Room temperature, no light protection
Stability at conditions of storage: Stable
Batch No: 30031722 or WE 30031722
Date of expiry: 13 January 2011
Supplier: Sandoz GmbH
Constituent 1
Test animals
- Species:
- other: In vitro test using human reconstituted epidermis.
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: none
- Vehicle:
- other: Phosphate buffered saline (PBS)
- Amount / concentration applied:
- The application spoon was filled with 25 mg finely grounded test substance. The "spoonful" was levelled by gently scratching the excess material away, avoiding compression. 25 µL PBS were added for wetting of the tissue.
30 µL of each reference substance. - Duration of treatment / exposure:
- 1 hour.
- Observation period:
- MTT-test after a post-exposure period of 42 hours.
- Number of animals:
- 3 tissue replicates were used.
- Details on study design:
- MatTek's EpiDerm System consists of normal, human-derived epidermal keratinocytes which have been cultured form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm™ tissues (surface 0.6 cm2) are cultured on specially prepared cell culture inserts (MILLICELLs®, 10 mm Ø) and shipped as kits, containing 24 tissues on shipping agarose.
Negative control: distilled water.
Positive control: 5 % sodium dodecylsulfate (SDS).
MTT-test:
After incubation with the test substance, post-incubation and washing with PBS, the tissues were incubated with MTT medium at 37 °C and 5 % CO2. After 3 hours, the MTT medium was aspirated from all wells and the tissues were gently rinsed with PBS (2 times). For extraction, the tissues were incubated with extractant solution (isopropanol) for 2 hours with shaking.
After the extraction period, the tissues were pierced with an injection needle and the extract (now a blue formazan solution) was allowed to run into the well from which the tissue was taken. The 24-well plates were placed on a shaker for 15 minutes until the solutions were homogeneous in colour.
Cell viability measurement:
Per each tissue 2 x 200 µL aliquots of the blue formazan solution were transferred into a 96- well flat bottom microliter plate and the optical density (OD) was measured using the extractant solution as blank in a plate spectrophotometer at 570 nm, without reference filter.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 69
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 87.7
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The tissue viabilities of 69.0 and 87.7 % (mean: 78.4 %) for the test substance indicate "no irritation".
Any other information on results incl. tables
Assay acceptance criteria:
• The mean OD 570 of the negative control tissues is≥1.0 and≤2.5. Actually obtained for water: 1.569.
• The mean tissue viability of the positive control is≤20 %. Actually obtained for 5 %-SDS: 10.5 %.
• The standard deviation calculated from individual percentual tissue viabilities of the 3 identically treated replicates is <18. Actually obtained for the test substance treated tissues: 13.2.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Under the experimental conditions of this study, the test substance is considered to be 'non-irritant' to skin.
- Executive summary:
The EpiDerm Skin Irritation Test (Model EPI-200) was performed to reveal possible irreversible tissue damages of the skin following the application of sodium phenoxyacetate. The test substance was topically applied for 60 minutes to the epidermal surfaces of three dimensional human epidermis models. After a post-incubation of 42 hours, a cell viability test was performed.
Investigations performed were in conformance with the EC-method B.46 "In vitro skin irritation: Reconstructed Human Epidermis Model Test" and the draft OECD Guideline "In vitro Skin irritation: Reconstructed Human Epidermis (RhE) Test Method".
The mean percentage viability of the treated skin discs was 78.4 % which is above the threshold of 50 % for classification. According to the results of this study and the Directive 2001/59/EC, sodium phenoxyacetate is considered to be non-irritant to skin.
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