Registration Dossier
Registration Dossier
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EC number: 402-810-3 | CAS number: 17980-47-1 DYNASILAN BH N; DYNASILAN BSM 100 N; DYNASILAN NH 42
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17.03.1987 to 27.03.1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline and EU test guideline, and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Some details on test substance missing
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Triethoxyisobutylsilane
- EC Number:
- 402-810-3
- EC Name:
- Triethoxyisobutylsilane
- Cas Number:
- 17980-47-1
- Molecular formula:
- Hill formula: C10H24O3Si CAS formula: C10H24O3Si
- IUPAC Name:
- triethoxy(2-methylpropyl)silane
- Details on test material:
- - Name of test material (as cited in study report): Isobutyltriethoxysilane (Dynasylan IBTEO)
- Substance type: Alkoxysilane
- Physical state: Liquid
- Stability under test conditions: Not determined
- Storage condition of test material: Tightly closed original container under ambient conditions
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Buckmasters, Henham, UK
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 2.2-2.5 kg
- Housing: Individually in metal cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Period not given
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Approximately 19
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 17.03.1987 to 27.03.1987
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:
- Skin examinations were made on Day 1 (approximately 30 minutes after removal) and on Days 2, 3 and 4. Additional observations were made on Days 5 to 11.
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: Dorso-lumbar region
- % coverage: No data
- Type of wrap if used: Semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: four hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: Desquamation on Day 10
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: Desquamation on Day 10
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 11 days
- Remarks on result:
- other: Desquamation on Days 9 and 10
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritant / corrosive response data:
- Very slight or well-defined erythema with and without very slight to moderate oedema was observed in all three animals. Desquamation of the stratum corneum was observed in all three animals on Day 9 and one animal on Day 10. The skin was normal by Day 10 (two animals) or Day 11 (one animal).
- Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a skin irritating study conducted using a protocol comparable to OECD 404 and to GLP (reliability score 1) triethoxyisobutylsilane was mildly irritaing to the skin of rabbits, but this irritation did not meet the criteria for classification.
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