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EC number: 239-415-9 | CAS number: 15396-00-6
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:
- 28.06.1994 to 13.09.1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
- Reference Type:
- other: Summary of toxicological data
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
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-(trimethoxysilyl)propyl isocyanate
- EC Number:
- 239-415-9
- EC Name:
- 3-(trimethoxysilyl)propyl isocyanate
- Cas Number:
- 15396-00-6
- Molecular formula:
- C7H15NO4Si
- IUPAC Name:
- (3-isocyanatopropyl)trimethoxysilane
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: HRP, Inc (Denver, PA)
- Age at study initiation: 13-18 weeks
- Weight at study initiation: 2-2.3 kg
- Fasting period before study: No
- Housing: Individually in cages with wire floors
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22
- Humidity (%): 40-60
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 28.06.1994 To: 13.09.1994
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 or 0.01 ml - Duration of treatment / exposure:
- N/A
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- The dose was first instilled into the lower conjunctival sac of a total of only 2 rabbits (both males) because of the potential of the test substance to produce severe ocular injury. The undosed eye of each animal served as the control. Severe ocular injury was produced; therefore, a total of 6 rabbits (3 males, 3 females) were administered 0.01 ml of Y-5187 (applied directly to the cornea).
- 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:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Grade 2 on Day 21.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Grade 2 on day 21
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Grade 1 on Day 21.
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Grade 1 on Day 21
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Grade 1 on Day 21.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 Days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Grade 1 on Day 21.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Grade 3 on Day 21.
- Irritant / corrosive response data:
- Severe corneal injury was produced in 2 of 2 rabbits following the instillation of 0.1 ml of Y-5187 into rabbit eyes. Iritis and severe conjunctival irritation were also observed in both eyes. Within 48 hours, both rabbits developed haemorrhages of the nictitating membrane. Necrosis of the conjunctivae, necrosis of the nictitating membrane and a pus-like ocular discharge developed in both dosed rabbit eyes at 48 to 72 hours. At 72 hours, corneal vascularization was evident in each dosed eye. Both rabbits had alopecia or desquamation of the periocular area by 10 or 14 days, respectively. Two rabbits had an abnormal corneal shape (characterized by surface bulging) at 14 and/or 21 days. Haemorrhages of the conjunctivae and periocular encrustation were also observed on 1 at 17 days. Within 21 days, scabs were present on the periocular area of 1 animal. Both rabbits had severe ocular irritation through 21 days.
Following the instillation of 0.01 ml of the test substance, minor to moderate corneal injury, iritis and severe conjunctival irritation were apparent in 6 of 6 rabbit eyes. A pus-like ocular discharge was evident in all 6 dosed eyes within 24 to 48 hours. By 48 to 72 hours, necrosis of the nictitating membrane was observed in 5. Three rabbits had necrosis of the conjunctivae at 48 to 72 hours. Haemorrhages of the nictitating membrane were observed in all 6 dosed eyes within 48 hours to 7 days. By 7 days, corneal vascularization was evident in 2 rabbits. Each rabbit had periocular alopecia (around the dosed eye) within 7 to 14 days. Apparent ulceration was observed on the inside of the lower conjunctivae area of 1 rabbit at 14 days and persisted through 21 days. One eye was healed by 14 days; however, periocular alopecia was evident for this rabbit at 17 days. Three additional rabbits had a normal ocular appearance within 21 days. Severe ocular irritation was evident in 2 of 6 rabbits through 21 days.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In an eye irritation/corrosion study conducted to OECD 405 and to GLP (reliability score 1) 3-(trimethoxysilyl)propyl isocyanate caused irreversible effects on the eyes of rabbits.
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