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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23.03.1987 to 30.03.1987
- 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 method, 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 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye 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
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield Rabbits, Hampshire, England
- Age at study initiation: 11-14 weeks
- Weight at study initiation: 2.5-3.2 kg
- Housing: Individually in metal cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Period not specified in report
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: 23.03.1987 to 30.03.1987
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- Unspecified
- Observation period (in vivo):
- Examination of the eyes was made 1 hour, and 1, 2, 3, 4 and 7 days after instillation.
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: handheld torch
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: all
- Score:
- 0
- Remarks on result:
- other: No response in any animal at any time point
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: all
- Score:
- 0
- Remarks on result:
- other: No response in any animal at any time point
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No chemosis observed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No chemosis observed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No corneal or iridial inflammation was observed in any of the animals. Obvious swelling with partial eversion of the eyelids was observed in two animals, accompanied by a diffuse, crimson colouration of the conjunctivae in one animal after one hour. The eyes were normal by 48 hours after instillation.
- 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 an eye irritation study conducted using a protocol comparable to OECD 405 and to GLP (reliability score 1) triethoxyisobutylsilane was not irritating to the eyes of rabbits.
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