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EC number: 457-670-6 | CAS number: 157859-20-6
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 November 2004 to 5 January 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Triisopropylsilyl acrylate
- Cas Number:
- 157859-20-6
- Molecular formula:
- C12H24O2Si
- IUPAC Name:
- Triisopropylsilyl acrylate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dornbes, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: 14 weeks (males), 13-14 weeks (females)
- Weight at study initiation: No data
- Housing: Individually in stainless steel cages
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet, ad libitum
- Water: Community tap water, ad libitum
- Acclimation period: 5-6 days under laboratory conditions after health examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 23-Nov-2004 To: 30-Nov-2004
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated right eye served as reference control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 1 male, 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing : Not done
SCORING SYSTEM: Numercial scoring system listed in Commission Directive 2004/73/EC; classification according to Commission Directive 2001/59/EC and Kay JH and Calandra JC (1962). Interpretation of eye irritation tests. J. Soc. Cosmet Chem. 13, 281.
TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- Calculated across 3 readings for all 3 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Very slight corneal opacity (1) affecting the whole area (4) in 1 animal at 1 hour
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- Calculated across 3 reading for all 3 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 10
- Remarks on result:
- other: No abnormal findings in the iris of any animal at any reading
- Irritation parameter:
- conjunctivae score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- Calculated across 3 readings for all 3 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 20
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Slight (1) to moderate (2) reddening of the conjunctivae in all 3 animals at 1 hour, slight reddening (1) persisted in 1 animal at 24 hours; slight (1) swelling (chemosis) in 2 animals at 1 hour
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Calculated across 3 readings for all 3 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Slight swelling (chemosis) (1) of the conjunctivae 2 animals at 1 hour
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- animal #1
- Remarks:
- Mean score calculated across 3 readings
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Slight reddening (1) of the conjunctiva at 1 hour
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- animal #2
- Remarks:
- Mean score calculated across 3 readings
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Moderate reddening (2) of the conjunctiva at 1 hour
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- animal #3
- Remarks:
- Mean score calculated across 3 readings
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Moderate reddening (2) of the conjunctiva at 1 hour, slight reddening (1) persisted to 24 hours.
- Irritation parameter:
- other: sclera
- Basis:
- other: Individual mean score calculated across 3 scoring times for each animal
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Slight to moderate reddening of the sclera present in all animals at the 1-hour reading.
- 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
- Max. score:
- 3
- 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:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- 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:
- No corrosion of the cornea at any of the reading times. Mild, early-onset and transient ocular changes (e.g. corneal opacity, reddening of the conjunctivae and sclerae and chemosis) were seen but these effects were reversible and were no longer evident 48 hours after treatment.
- Other effects:
- No clinical signs of systemic toxicity, no mortality, no staining of the eye, and body weights considered to be within normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an eye irritation study in rabbits, conducted according to OECD Test Guideline 405 and in compliance with GLP, tri(isopropyl)silyl acrylate, tested at 100%, was not irritating.
- Executive summary:
Tri(isopropyl)silyl acrylate was tested in an eye irritation test, conducted to OECD test guideline 405 and in compliance with GLP.
Undiluted test material (0.1ml) was applied to the left eyes of 3 rabbits, with the right eyes serving as controls. Eyes were examined 1, 24, 48 and 72 hours after application.
Some signs of irritation were seen at the 1- and 24-hour time points, but these had disappeared by the 48-hour time point.
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