Registration Dossier
Registration Dossier
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EC number: 262-061-1 | CAS number: 60111-54-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 August 2011 - 29 August 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING: The study was not conducted for REACH purposes, but according to Article No 25 of Regulation EC No 1272/2008, it has been used to fulfil data gap for eye irritation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane
- EC Number:
- 262-061-1
- EC Name:
- 3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane
- Cas Number:
- 60111-54-8
- Molecular formula:
- C16H36O4Si5
- IUPAC Name:
- tetraethenyldimethylsilyl silicate
- Reference substance name:
- 3,3-bis[(dimethyvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane
- IUPAC Name:
- 3,3-bis[(dimethyvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River France
- Age at study initiation: minimum 10 weeks
- Weight at study initiation: minimum 2 kg
- Housing: individually housed in cages with perforated floors and shelters
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.2-20.1
- Humidity (%): 43-88
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light /12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.23
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- within 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis 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:
- Instillation of the test material into one eye of each animal resulted in irritation of the conjunctivae, which consisted of redness and discharge in two animals. The irritation had completely resolved within 24 hours in one animal and within 48 hours in the other animal. The mean Draize score at 1 hour post instillation was 2.7; at 24 hours post instillation it was 0.7 and at 48 and 72 hours post instillation it was 0.
- Other effects:
- No staining of ocular or peri-ocular tissues by the test substance was observed and no test substance remnants were seen. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was found not irritating to the eye of rabbits, as determined in a reliable study conducted according to current OECD Test Guideline 405 and in compliance with GLP.
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