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EC number: 241-698-9 | CAS number: 17696-62-7
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018-02-20 to 2018-02-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted: 28th July 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Phenyl 4-hydroxybenzoate
- EC Number:
- 241-698-9
- EC Name:
- Phenyl 4-hydroxybenzoate
- Cas Number:
- 17696-62-7
- Molecular formula:
- C13H10O3
- IUPAC Name:
- phenyl 4-hydroxybenzoate
Constituent 1
- Specific details on test material used for the study:
- - Sponsor’s identification: PHENYL 4-HYDROXYBENZOATE
- Batch No.: 018964K19K
- CAS No.:17696-62-7
- Storage: room temperature
- Form: powder
- Colour: white
- Expiry date: 2018-10-01
- Purity: 99.1%
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: The 0.6 cm² reconstituted epidermis (epiCS, Cell Systems – Batch No. 100-AH0252-1) were received on 20 February 2018. The insert (filter + epidermis) was gently removed from the agarose while avoiding leaving agarose on the polycarbonate filter. The insert was placed in a 6 wells culture plate which had been previously filled with 1 mL of culture medium (Cell Systems Batch No. 305-AH-0432). The culture dishes were incubated at 37 ± 2 °C, 5% CO2 during 21 hours and 23 minutes before treatment. Just before the treatment, the culture medium was replaced by a new culture medium (Cell Systems, Batch No. 305-AH-0432).
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature (3 min), 37 °C ± 1 °C, 5% ± 1% CO2 (1 hour)
- Temperature of post-treatment incubation (MTT incubation): 37 ± 1 °C (for 3 h, 5.0% CO2)
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: 3 minutes and 1 hour after the test item application the human epidermis were washed 20 times with 1 mL of DPBS (DPBS – Dutscher, Batch No. 5691217).
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h (at 37 ± 1 °C)
- Spectrophotometer: plate spectrophotometer
- Wavelength: 570 nm
- Filter: not specified
- Filter bandwidth: max. ± 30 nm
PREDICTION MODEL / DECISION CRITERIA:
See Table 1 in box ‘Any other information on materials and methods incl. tables’ - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL KOH
- Concentration (if solution): 8N
Negative CONTROL
- Amount(s) applied (volume or weight): 50 µL distilled water
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test item was applied as supplied at the dose of 25 mg to the epidermal surface of the 2 living human skin models previously moistened with 25 μL of distilled water, during 3 minutes at room temperature and during 1 hour at 37°C ± 1°C, 5% ± 1% CO2.
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
- Concentration (if solution): 8N - Duration of treatment / exposure:
- 3 minutes and 1 hour
- Duration of post-treatment incubation (if applicable):
- 3 h
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 min exposure
- Run / experiment:
- Mean of two replicates
- Value:
- 100.51
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60 min exposure
- Run / experiment:
- Mean of two replicates
- Value:
- 99.87
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: not specified
- Direct-MTT reduction: no
- Colour interference with MTT: no
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
For individual results see Table 2 in box "Any other information on results incl. tables".
Any other information on results incl. tables
Table 2: Results of main experiment
|
Mean viability (%) |
||
3 min exposure |
1 hour exposure |
Conclusion |
|
Positive control |
6.08 |
0.39 |
Category 1A |
Test item |
100.51 |
99.87 |
Non Corrosive |
Applicant's summary and conclusion
- Interpretation of results:
- other: non-corrosive
- Conclusions:
- In this study under the given conditions the test item showed no corrosive effects. The test item is therefore not classified as “non-corrosive“ in accordance with UN GHS Criteria "Category 1".
- Executive summary:
In a primary skin corrosion study conducted according to guideline OECD 431, two EpiDerm tissues per dose group were exposed to 25 mg of Phenyl 4-hydroxybenzoate, chloride (99.1 % purity) for 60 min and 3 min each and cytotoxicity was measured in comparison to the concurrent negative controls. Irritation was scored by the method of mean relative tissue viability. No corrosive effects were observed after treatment with the test item. The mean relative tissue viability (% negative control) of the epidermis skins treated with the test item were 100.51% (considered as 100%) and 99.87%. In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item does not have to be classified for Category 1 “Corrosive”. The hazard statement “H314: Causes severe skin burns and eye damage” with the signal word “Danger” are not required.
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