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EC number: 221-328-2 | CAS number: 3068-76-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 Sep - 08 Dec 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-[3-(trimethoxysilyl)propyl]aniline
- EC Number:
- 221-328-2
- EC Name:
- N-[3-(trimethoxysilyl)propyl]aniline
- Cas Number:
- 3068-76-6
- Molecular formula:
- C12H21NO3Si
- IUPAC Name:
- N-[3-(trimethoxysilyl)propyl]aniline
- Details on test material:
- - Name of test material (as cited in study report): SILQUEST Y-9669 Silane
- Physical state: clear colourless liquid
- Analytical purity: 99.4%
- Lot/batch No.: 16166-67
- Storage condition of test material: original container at room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc., Denver, USA
- Age at study initiation: young adult
- Weight at study initiation: 2317 - 3832 g
- Housing: individual housing in mesh-bottom cages
- Diet: Purina Certified Rabbit Chow #5322, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7-20.2
- Humidity (%): 41.2-47.5
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single treatment without washing
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3 per sex
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: hand-held penlight / fluorescein
MORTALITY:
The rabbits were observed twice daily (morning and afternoon) for mortality for the duration of the study.
OCULAR OBSERVATIONS:
Both eyes of each rabbit were examined for ocular abnormalities prior to initiation of dosing. The pre-initiation examination included the use of sodium fluorescein and ultraviolet light for detection of corneal abnormalities. The rabbits assigned to study had no pre-existing ocular abnormalities. Both eyes of each rabbit were examined macroscopically for ocular irritation using a handheld penlight in accordance with the method of Draize at approximately one, 24,48 and 72 hours after dosing. In addition, both eyes were further examined at 72 hours with sodium fluorescein and ultraviolet light.
BODY WEIGHTS:
The body weights were obtained and recorded on study day 0 (initiation) and on day 3 (termination).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.05
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- After 1 h redness and chemosis (grade 1) were observed in 5/6 and 4/6 animals, respectively. These effects were reversible within 24 h. At 48 h one animal had a redness score of 1, which again was fully reversible upon the next reading time point (72 h). No effects on cornea and iris were observed in any anmal at any time point.
- Other effects:
- There were no deaths during the study. The rabbits did not vocalize upon instillation of the test material. There were no remarkable changes or differences observed in body weight during the study period.
Any other information on results incl. tables
Table 1: Scores of eye reactions observed in the eye irritation study in rabbits.
Rabbit No. |
Time [h]
|
conjunctivae
|
iris
|
cornea
|
|
|
redness |
swelling |
|||
1 |
1 |
1 |
1 |
0 |
0 |
|
24 |
0 |
0 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.33 |
0 |
0 |
0 |
2 |
1 |
0 |
1 |
0 |
0 |
|
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0 |
0 |
0 |
0 |
3 |
1 |
1 |
1 |
0 |
0 |
|
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0 |
0 |
0 |
0 |
4 |
1 |
1 |
1 |
0 |
0 |
|
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0 |
0 |
0 |
0 |
5 |
1 |
1 |
0 |
0 |
0 |
|
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0 |
0 |
0 |
0 |
6 |
1 |
1 |
0 |
0 |
0 |
|
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0 |
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
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