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EC number: 212-611-1 | CAS number: 831-82-3
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-phenoxyphenol
- EC Number:
- 212-611-1
- EC Name:
- 4-phenoxyphenol
- Cas Number:
- 831-82-3
- Molecular formula:
- C12H10O2
- IUPAC Name:
- 4-phenoxyphenol
- Reference substance name:
- Phenol
- EC Number:
- 203-632-7
- EC Name:
- Phenol
- Cas Number:
- 108-95-2
- Molecular formula:
- C6H6O
- IUPAC Name:
- Phenol
- Test material form:
- solid: particulate/powder
- Details on test material:
- Batch : 20180328 (28 March 2018)
Constituent 1
impurity 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch No.of test material: n°batch 20180328
- Expiration date of the lot/batch: March 2019
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Reactivity of the test substance with MTT : Yes (no direct interaction and there is no need to add non-specific coloration controls to the study)
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: SkinEthic RHE® model
- Details on test system:
- Test model :
- Source: EPISKIN - reconstructed human epidermis - supplied by SkinEthic Laboratories, Nice, France
- batch: 18-RHE-060
- Received : 05 June 2018
- Maintenance medium : Episkin SA, batch No. 18 SMM 021
- Quality control : histological observation, cell viability and barrier fucton integrity test - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- 3 replicates
NEGATIVE CONTROL
- 3 replicates
POSITIVE CONTROL
- 3 replicates
REMOVAL OF TEST SUBSTANCE
- Washing: Yes with 25 x 1 mL of DPBS (Dutscher - Batch No. 9120318).
- Time after start of exposure: 42 minutes
OBSERVATION
The cell viability was quantified by measurement of the cell succinate dehydrogenase activity
The measured Optical Density (OD), after extraction from tissues, are proportional to the number of living cells.
SCORING SYSTEM:
For each tissue, OD values and calculated percentage cell viability data for the test item, positive and negative controls, - Duration of treatment / exposure:
- 42 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hoours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 2.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 1.7%
- Remarks on result:
- positive indication of irritation
- Remarks:
- mean score from three replicates
Any other information on results incl. tables
Assessment of the skin irritation – individual and average values of OD after 42 minutes exposure
Application: 16 mg of the test item on 0.50 cm² human skin model
|
N° |
OD |
Mean OD/ disc |
Mean OD/ product |
Viability % |
Mean Viability % |
SD viability |
Conclusion |
Negative control |
1 |
0.646 |
0.598 |
108.0 |
100 |
7.0 |
7.0 |
- |
2 |
0.573 |
95.8 |
||||||
3 |
0.575 |
96.2 |
||||||
Positive control |
1 |
0.010 |
0.010 |
1.7 |
1.7 |
0.1 |
0.1 |
Irritant |
2 |
0.011 |
1.8 |
||||||
3 |
0.010 |
1.7 |
||||||
Test item |
1 |
0.010 |
0.012 |
1.7 |
2.1 |
0.4 |
0.4 |
Irritant or corrosive |
2 |
0.015 |
2.5 |
||||||
3 |
0.012 |
2.0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Irritant or corrosive
- Conclusions:
- The mean percent viability of the treated tissues was 2.1%, versus 1.7% in the positive control (5% Sodium Dodecyl Sulfate).
In accordance with the Regulation EC No. 1272/2008 and in absence of information on skin corrosion, the test item Paraphenoxyphenol has to be classified in Category 2 “Irritating to skin” or in Category 1 “Corrosive”. - Executive summary:
In accordance with the OECD guideline n°439, the test item Paraphenoxyphenol was applied as supplied, during 42 minutes, at the dose of 16 mg, to 3 living Reconstructed Human epidermis (SkinEthic RHE® model) previously moistened with 10 μL of distilled water. The application was followed by a rinse with 25 mL of DPBS and a 42 hours post-incubation period at 37°C, 5% CO2. Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues.
The mean percent viability of the treated tissues was 2.1%, versus 1.7% in the positive control (5% Sodium Dodecyl Sulfate).
In accordance with the Regulation EC No. 1272/2008 and in absence of information on skin corrosion, the test item Paraphenoxyphenol has to be classified in Category 2 “Irritating to skin” or in Category 1 “Corrosive”.
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