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EC number: 280-084-5 | CAS number: 82985-35-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP. No information is given on the test material purity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- use of 6 animals; dosage with 0.005 ml test substance
- GLP compliance:
- no
Test material
- Reference substance name:
- Bis(trimethoxysilylpropyl)amine
- EC Number:
- 280-084-5
- EC Name:
- Bis(trimethoxysilylpropyl)amine
- Cas Number:
- 82985-35-1
- Molecular formula:
- C12H31NO6Si2
- IUPAC Name:
- 3,3,11,11-tetramethoxy-2,12-dioxa-7-aza-3,11-disilatridecane
- Details on test material:
- - Name of test material (as cited in study report): Organofunctional Silane Y-9492
- Physical state: clear, non-viscous liquid
- Lot/batch No.: 09989
- Identification: NB 2225-99
- BRRC Sample No.: 44-365
- Date of Receipt: 15 December 1981
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Fasting period before study: none
- Diet: appropriate commercial diet, ad libitum
- Water: municipal water, ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.005 ml - Duration of treatment / exposure:
- single treatment without washing
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein (2%)
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:
- 1.22
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 2.61
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritant / corrosive response data:
- At 24, 48, and 72 h several eyes were encrusted with dry pus. Some necrosis of the conjunctivae was observed at 1 (3/6 animals) and 4 h (5/6 animals).
Any other information on results incl. tables
Table 1: Results of the eye irritation study.
Rabbit # |
Time |
conjunctivae |
iris |
cornea |
|
redness |
swelling |
||||
1 |
1 h |
3 |
3 |
1 |
0 |
24 h |
3 |
4 |
1 |
1 |
|
48 h |
1 |
4 |
1 |
1 |
|
72 h |
2 |
2 |
1 |
1 |
|
7 d |
2 |
1 |
1 |
1 |
|
|
14 d |
0 |
0 |
0 |
0 |
|
21 d |
0 |
0 |
0 |
0 |
2 |
1 h |
3 |
4 |
1 |
0 |
|
24 h |
2 |
4 |
1 |
1 |
|
48 h |
2 |
3 |
1 |
1 |
|
72 h |
3 |
3 |
1 |
1 |
|
7 d |
2 |
1 |
0 |
0 |
|
14 d |
0 |
0 |
0 |
0 |
|
21 d |
0 |
0 |
0 |
0 |
3 |
1 h |
3 |
3 |
1 |
0 |
|
24 h |
3 |
4 |
1 |
1 |
|
48 h |
2 |
3 |
1 |
1 |
|
72 h |
3 |
4 |
1 |
2 |
|
7 d |
2 |
2 |
1 |
2 |
|
14 d |
0 |
0 |
0 |
0 |
|
21 d |
0 |
0 |
0 |
0 |
4 |
1 h |
3 |
2 |
0 |
0 |
|
24 h |
3 |
4 |
1 |
1 |
|
48 h |
3 |
4 |
1 |
1 |
|
72 h |
3 |
4 |
1 |
2 |
|
7 d |
3 |
3 |
1 |
2 |
|
14 d |
0 |
0 |
0 |
0 |
|
21 d |
0 |
0 |
0 |
0 |
5 |
1 h |
3 |
2 |
1 |
0 |
|
24 h |
3 |
4 |
1 |
1 |
|
48 h |
3 |
4 |
1 |
1 |
|
72 h |
2 |
4 |
1 |
1 |
|
7 d |
1 |
3 |
1 |
2 |
|
14 d |
3 |
2 |
1 |
1 |
|
21 d |
1 |
2 |
1 |
2 |
6 |
1 h |
2 |
3 |
1 |
0 |
|
24 h |
3 |
4 |
1 |
1 |
|
48 h |
3 |
3 |
1 |
1 |
|
72 h |
3 |
4 |
- (opacity too great) |
3 |
|
7 d |
3 |
4 |
- (opacity too great) |
3 |
|
14 d |
3 |
3 |
2 |
3 |
|
21 d |
1 |
0 |
1 |
3 |
|
|
|
|
|
|
average |
1 h |
2.83 |
2.83 |
0.83 |
0.0 |
|
24 h |
2.83 |
4.0 |
1.0 |
1.0 |
|
48 h |
2.33 |
3.5 |
1.0 |
1.0 |
72 h |
2.66 |
3.5 |
1.0 (out of 5 animals) |
1.66 |
|
24+48+72 |
2.61 |
3.67 |
1.0 |
1.22 |
|
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 1 (irreversible effects on the eye) based on CLP criteria (EU criteria according to Regulation (EC) No. 1272/2008)
- Conclusions:
- A generally reliable study, conducted similar to OECD 405 (not in compliance with GLP), reported that the neat test material caused significant irreversible effects and necrosis to the conjunctiva, iris and cornea of rabbits.
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