Registration Dossier
Registration Dossier
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EC number: 204-589-7 | CAS number: 122-99-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The test substance was applied under occlusive conditions.
- GLP compliance:
- no
- Remarks:
- GLP was not compulsory at the time the study was performed.
Test material
- Reference substance name:
- 2-phenoxyethanol
- EC Number:
- 204-589-7
- EC Name:
- 2-phenoxyethanol
- Cas Number:
- 122-99-6
- Molecular formula:
- C8H10O2
- IUPAC Name:
- 2-phenoxyethan-1-ol
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 2- phenoxyethanol (technical grade)
- Physical state: liquid
- Analytical purity: no data
- Lot/batch No.: substance number: 83/143
- Expiration date of the lot/batch: May 1984
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Firma Gaukler; Offenbach, Germany
- Weight at study initiation: 2.79 kg, 2.32 kg, 3.00 kg
- Housing: single in stainless-steel cages
- Diet (e.g. ad libitum): Ovator Solikanin 4mm, Muskator-Werke Düsseldorf
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 mL
- Concentration (if solution): - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3 (two males and one female)
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk (2.5 x 2.5 cm)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol/water (1:1) and water
- Time after start of exposure: 4 h
SCORING SYSTEM: according to OECD guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 30-60 min
- Score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 30-60 min as well as 24, 48 and 72 h
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
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