Registration Dossier
Registration Dossier
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EC number: 429-630-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Test material form:
- liquid
- Details on test material:
- Name of test material (as cited in study report): Eldew PS-203
Physical state: pale yellow, oily liquid
Analytical purity: 100%
Purity test date: not reported
Lot/batch No.: 808010
Expiration date of the lot/batch: 31.03.2000
Storage condition of test material: test material was stored at room temperature (ca. 20°C), away from direct sunlight
Constituent 1
- Specific details on test material used for the study:
- Identification: ELDEW PS-203
Description: pale yellow liquid
Batch: 808010
Expiry date: 31.03.2000
Purity: 100 %
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 15 weeks
- Weight at study initiation: 2682 - 2768 g
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 40 – 70 %
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 1 m / 2 f
- Details on study design:
- The test item was applied to 6 cm2 intact dorsal skin.
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A study with NZW rabbits performed according to EU Method B.4 gave no indication for dermal irritation or corrosion.
- Executive summary:
A study with NZW rabbits performed according to EU Method B.4 gave no indications for dermal irritation or corrosion.
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