Registration Dossier
Registration Dossier
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EC number: 220-011-6 | CAS number: 2602-34-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17.06.2002 to 06.09.2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- [3-(2,3-epoxypropoxy)propyl]triethoxysilane
- EC Number:
- 220-011-6
- EC Name:
- [3-(2,3-epoxypropoxy)propyl]triethoxysilane
- Cas Number:
- 2602-34-8
- Molecular formula:
- C12-H26-O5-Si
- IUPAC Name:
- triethoxy[3-(oxiran-2-ylmethoxy)propyl]silane
- Details on test material:
- - Name of test material (as cited in study report): Silan GF 82
- Substance type: Alkoxysilane
- Physical state: Colourless liquid
- Stability under test conditions: > one year
- Storage condition of test material: At room temperature, dark, dry, tightly closed
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology KG, Wankendorf
- Age at study initiation: 3.5 months
- Weight at study initiation: 2.1 - 2.3 kg
- Housing: Individually in cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3
- Humidity (%): 55 ±15
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 17.06.2002 To: 13.07. 2002
Test system
- Type of coverage:
- semiocclusive
- 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): 0.5 ml - Duration of treatment / exposure:
- Four hours
- Observation period:
- 72 hours
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal area of trunk
- % coverage: No data
- Type of wrap if used: Non-irritating semi-occlusive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not required as there was no residual test substance
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No skin reactions were observed in any of the animals at any timepoint.
- Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- In a skin irritation study conducted to OECD 404 and in compliance with GLP (reliability score 1) [3-(2,3-epoxypropoxy)propyl]triethoxysilane was not irritating to the skin of rabbits.
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