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EC number: 221-339-2 | CAS number: 3069-42-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 Nov - 24 Nov 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- No data for analytical purity is reported.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Trimethoxyoctadecylsilane
- EC Number:
- 221-339-2
- EC Name:
- Trimethoxyoctadecylsilane
- Cas Number:
- 3069-42-9
- Molecular formula:
- C21H46O3Si
- IUPAC Name:
- trimethoxyoctadecylsilane
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Si 118 (Degussa-Silan Si 118)
- Physical state: colourless liquid
- Stability under test conditions: stable
- Storage condition of test material: at room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: White Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Asta-Werke AG, Bielefeld, Germany
- Age at study initiation: 6 months
- Weight at study initiation: 2400 – 2700 g
- Housing: animals were caged individually in stainless-steel cages
- Diet: maintenance diet for rabbits (ssniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 45 - 60
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated contralateral eye served as control
- Amount / concentration applied:
- TEST MATERIAL
Amount applied: 0.1 ml - Duration of treatment / exposure:
- single application without rinsing
- Observation period (in vivo):
- 7 days
Reading time points: 1, 24, 48 and 72 h and daily up to 7 days - Number of animals or in vitro replicates:
- 2 males and 1 female
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: Cliptrix fluorescent marker
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- One hour post exposure, effects on conjunctivae redness (grade 3, 3/3 animals) were observed. Mean values over 24, 48 and 72 h for conjunctivae redness were 1.33, 1.67 and 1, respectively. Any effects observed were fully reversed at the end of the observation period.
Any other information on results incl. tables
Table 1: Summary of eye irritation parameters
Rabbit #
|
Time [h]
|
conjunctivae
|
iris
|
cornea
|
|
redness |
swelling |
||||
1
|
1 |
3 |
0 |
0 |
0 |
24 |
2 |
0 |
0 |
0 |
|
48 |
2 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
1.33 |
0 |
0 |
0 |
|
2
|
1 |
3 |
0 |
0 |
0 |
24 |
2 |
0 |
0 |
0 |
|
48 |
2 |
0 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
|
average |
1.67 |
0 |
0 |
0 |
|
3
|
1 |
3 |
0 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
|
average |
1 |
0 |
0 |
0 |
|
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 performed according to OECD 405 the substance was found to be not irritating to eyes. Treatment of 3 White Russian rabbits with 0.1 ml test substance resulted in no effects on cornea and iris in any animal at any time point. No chemosis was observed in any animal. One hour post exposure, effects on conjunctivae redness (grade 3, 3/3 animals) were observed. Mean values over 24, 48 and 72 h for conjunctivae redness were 1.33, 1.67 and 1, respectively. Any effects observed were fully reversed at the end of the observation period. Based on the results of the study the test item is considered as non-irritant.
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