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EC number: 217-983-9 | CAS number: 2031-67-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- It was not compliant with GLP and lacked a detailed description of materials and methods used.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- ; limited details on housing, test animals and test substance identity reported
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Triethoxy(methyl)silane
- EC Number:
- 217-983-9
- EC Name:
- Triethoxy(methyl)silane
- Cas Number:
- 2031-67-6
- Molecular formula:
- C7H18O3Si
- IUPAC Name:
- triethoxy(methyl)silane
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet : Commerical diet was available ad libitum
- Water : Municipal water was available ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: To: No data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL (neat) - Duration of treatment / exposure:
- Single exposure, without washing. Potential duration of study 14 days - appears to have been terminated at 3 days, probably because no irritation was observed by this time point.
- Observation period (in vivo):
- Examined: 1, 6, 24, 48 and 72 h.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing : no washing reported
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein stain, no other details given
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.06
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Minor transient eye irritation. See table 1.
- Other effects:
- None reported.
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0/0/0/0 |
1/1/0/0/0/0 |
1/1/1/1/1/1 |
1/0/0/0/0/0 |
24 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/0/0/0/0/0 |
0/0/0/0/0/0 |
48 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
72 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0 |
0 |
0.06 |
0 |
Reversibility*) |
n/a |
c |
c |
c |
Average time for reversion |
n/a |
24 h |
48 h |
24 h |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Discharge was reported in 2/6 at the 1- and 6-h observations.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- In an eye irritation study that predates international guidelines and GLP (reliability score 2), only minor, transient eye irritation was observed following instillation of triethoxy(methyl)silane into the eyes of six rabbits. The Draize score of 0.06 (out of 13) would indicate that the test material would not be considered irritating to the eyes of rabbits.
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