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EC number: 447-830-3 | CAS number: -
- 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:
- 30 March 2004 and 13 April 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 447-830-3
- EC Name:
- -
- Molecular formula:
- Not applicable to this UVCB substance.
- IUPAC Name:
- 2-ethylphenol; 3,5-dimethylphenol; formaldehyde; phenol
- Test material form:
- other: solid resin
- Details on test material:
- Date received: 30 January 2004
Storage conditions: room temperature in the dark under nitrogen
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 - 20 weeks old
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): free access to certified rabbit diet
- Water (e.g. ad libitum): free access to mains drinking water
- Acclimation period: at least five days
- Other: The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06:00 to 18:00) and twelve hours darkness
IN-LIFE DATES: From: 30 March 2004 To: 13 April 2004
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- Distilled
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 3 minutes, 1 hour and 4 hours
- Observation period:
- Observations made at 1 hour, 24 hours, 48 hours, 72 hours and 7 days after removal of the patch.
- Number of animals:
- 3
- Details on study design:
- TEST MATERIAL APPLICATION
One rabbit was initially treated. Three suitable sites were selected on the back of the rabbit. At each test site a quantity of 0.5 g of the test material, moistened with 0.5 mL of distilled water, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. Each patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset and the animal was returned to its cage for the duration of the exposure period.
After consideration of the skin reactions produced in the first animal, two additional animals were treated with 0.5 g of test material moistened with 0.5 mL of distilled water. One patch was applied to the back of each rabbit, and was allowed to remain in contact with the skin for a period of four hours.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours after application.
SCORING SYSTEM: Draize J H (1959) "Dermal Toxicity" In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food and Drug Officials of the United States, Austin, Texas, p.47:
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean of time points 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean of time points 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean of time points 24, 48 and 72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean of time points 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema observed
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean of time points 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean of time points 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritant / corrosive response data:
- 4 hour exposure:
Very slight erythema was noted at two treated skin sites one hour after patch removal. Very slight to well-defined erythema was noted at all treated skin sites at the 24 and 48-hour observations with very slight erythema at two treated skin sites at the 72-hour observation.
Very slight oedema was noted at one treated skin site one hour after patch removal with very slight to slight oedema at two treated skin sites at the 24-hour observation and very slight oedema at one treated skin site at the 48-hour observation.
One treated skin site appeared normal at the 72-hour observation and the remaining two treated skin sites appeared normal at the 7-day observation.
1 hour exposure:
Very slight erythema was noted at the treated skin site at the 24 and 48-hour observations.
The treated skin site appeared normal at the 72-hour observation.
3 minutes exposure:
No evidence of skin irritation was noted during the study. - Other effects:
- None
Any other information on results incl. tables
Table 1: Individual Skin Reactions Following 4-Hour Exposure
Skin Reaction |
Observation Time |
Individual Scores – Rabbit Number and Sex |
Total |
||
Rabbit #1 |
Rabbit #2 |
Rabbit #3 |
|||
Erythema/Eschar Formation |
1 hour |
0 |
1 |
1 |
2 |
24 hours |
1 |
1 |
2 |
4 |
|
48 hours |
1 |
1 |
2 |
4 |
|
72 hours |
1 |
0 |
1 |
2 |
|
7 days |
0 |
0 |
0 |
0 |
|
Oedema Formation |
1 hour |
0 |
0 |
1 |
1 |
24 hours |
0 |
1 |
2 |
3 |
|
48 hours |
0 |
0 |
1 |
1 |
|
72 hours |
0 |
0 |
0 |
0 |
|
7 days |
0 |
0 |
0 |
0 |
Sum of 24 and 72-hour Readings (S): 9
Primary Irritation Index (S/6): 9/6 = 1.5
Transcutaneous Electrical Resistance Assay
After a test material contact time of 24 hours, the mean electrical resistance was determined as 17.6 (± 7.3) kΩ. The test material was considered not to be corrosive to the skin in vivo.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is not considered to be irritating to the skin of rabbits.
- Executive summary:
A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. Three female rabbits were used. The test material was moisted with distilled water prior to application to the clipped flank of the rabbits.
Irritation was scored according to the method of Draize (1977). A semi-occlusive dressing was used. The study was performed in accordance with the OECD 404 and EU Method B.4 guidelines.
A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight to well-defined erythema and very slight to slight oedema. One treated skin site appeared normal at the 72-hour observation and the remaining two treated skin sites appeared normal at the 7-day observation. 3-minute and 1-hour semi-occluded applications of the test material to the intact skin of one rabbit produced no corrosive effects.
The test material is therefore not considered to be irritating to the skin of rabbits.
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