Registration Dossier
Registration Dossier
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EC number: 246-467-6 | CAS number: 24801-88-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (different grading system, eyes examined at 0 and 24 hours (not at 1, 24, 48, and 72 hours), not checked for reversibility (at 7, 14 and 21 days), insufficient data to further judge compliance with test guideline)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Triethoxy(3-isocyanatopropyl)silane
- EC Number:
- 246-467-6
- EC Name:
- Triethoxy(3-isocyanatopropyl)silane
- Cas Number:
- 24801-88-5
- Molecular formula:
- C10H21NO4Si
- IUPAC Name:
- triethoxy(3-isocyanatopropyl)silane
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data available
- Age at study initiation: no data available
- Weight at study initiation: no data available
- Housing: no data available
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data available
- Humidity (%): no data available
- Air changes (per hr): no data available
- Photoperiod (hrs dark / hrs light): no data available
IN-LIFE DATES: no data available
Test system
- Vehicle:
- other: propylene glycol
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.005, 0.02, 0.1 or 0.5 ml (undiluted) or 0.5 ml (diluted)
- Concentration (if solution): 1, 5, 15, 40 or 100%
VEHICLE
- Amount(s) applied (volume or weight with unit): no data available
- Concentration (if solution): no data available
- Lot/batch no. (if required): no data available
- Purity: no data available - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 24 h
- Number of animals or in vitro replicates:
- 5/dose group
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed
SCORING SYSTEM: graded from 1 to 10 (trace or no injury from 0.5 ml undiluted = grade 1)
TOOL USED TO ASSESS SCORE: unstained, and stained with fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- other: no data available
- Time point:
- other: 0 or 24 h
- Score:
- 9
- Max. score:
- 10
- Reversibility:
- other: reversibility not assessed
- Remarks on result:
- other: Severe corneal damage and iritis in response to 0.005 ml undiluted or to 0.5 ml of 5% or 15%; moderate eye injury in response to [presumably] 1%
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: individual animal scores were not given in the study report.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- other: individual animal scores were not given in the study report.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: individual animal scores were not given in the study report.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: individual animal scores were not given in the study report.
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- other: individual animal scores were not given in the study report.
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: individual animal scores were not given in the study report.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: individual animal scores were not given in the study report.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- other: individual animal scores were not given in the study report.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: individual animal scores were not given in the study report.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: individual animal scores were not given in the study report.
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- other: individual animal scores were not given in the study report.
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: individual animal scores were not given in the study report.
- Irritant / corrosive response data:
- Severe corneal damage and iritis following instillation of 0.005 ml undiluted test substance, or 0.5 ml of a 5% or 15 % solution (in propylene glycol). Application of 0.5 ml of [presumably] 1 % produced moderate eye irritation. [The summary report is ambiguous and actually states: "moderate eye injury from 1% PG solution."
- Other effects:
- No data available
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In a non-guideline study described by two summary reports, triethoxy(3-isocyanatopropyl)silane was severely irritating to the eyes of rabbits.
- Executive summary:
Two summary reports describe an eye irritation study, similar to OECD Test Guideline 405, in rabbits exposed to triethoxy(3-isocyanatopropyl)silane.
Triethoxy(3-isocyanatopropyl)silane was applied undiluted (at 0.005, 0.02, 0.1 or 0.5 ml), or in propylene glycol (0.5 ml at 1, 5, 15 or 40%) to the eyes of groups of five rabbits. Observations were made immediately after treatment (without staining) and after 24 hours (stained with fluorescein).
An undiluted administration of 0.005 ml triethoxy(3-isocyanatopropyl)silane caused severe corneal damage and iritis, as did 5% and 15% solutions. Moderate eye injury was observed following treatment with the 1% solution. An overall eye irritation grade of 9 was allocated to triethoxy(3-isocyanatopropyl)silane (on a scale of 1 (trace or no injury from 0.5 ml undiluted) to 10).
Triethoxy(3-isocyanatopropyl)silane was severely irritating to the eyes of rabbits.
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