Registration Dossier
Registration Dossier
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EC number: 425-400-6 | CAS number: 179986-09-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD, GLP, QAU)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted July 17, 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 425-400-6
- EC Name:
- -
- Cas Number:
- 179986-09-5
- Molecular formula:
- UVCB substance
- IUPAC Name:
- methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate; propane-1,2,3-triol; tetradecanoic acid
- Details on test material:
- - Analytical purity: 95%
- Physical state: colourless liquid
- Storage condition of test material: at room temperature, away from light.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH
- Age at study initiation: 15 weeks
- Weight at study initiation: male: 3.0 kg, females: 2.9 kg
- Housing: individually in stainless steel cages with an automatic cleaning system, equipped with feed hoppers, drinking water bowls, and wood for gnawing.
- Diet (ad libitum): pelleted standard Kliba 341 rabbit maintenance diet
- Water (ad libitum): tap water
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated skin of each animal served for control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: left side
- % coverage: 6 cm2
- Type of wrap if used: patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was flushed with lukewarm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-48-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-48-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Neither erythema nor edema was seen.
The test article did not cause staining of the treated skin.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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