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Registration Dossier
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EC number: 245-904-8 | CAS number: 23843-64-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 Feb - 28 June 1996
- 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:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no data on purity available
- GLP compliance:
- yes
Test material
- Reference substance name:
- [3-(trimethoxysilyl)propyl]urea
- EC Number:
- 245-904-8
- EC Name:
- [3-(trimethoxysilyl)propyl]urea
- Cas Number:
- 23843-64-3
- Molecular formula:
- C7H18N2O4Si
- IUPAC Name:
- [3-(trimethoxysilyl)propyl]urea
- Details on test material:
- - Name of test material (as cited in study report): Y-11542
- Physical state: clear, colourless, slightly viscous liquid
- Analytical purity: no data available
- Lot/batch No.: 2131UG060495
- 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, PA, USA
- Age at study initiation: young adult
- Weight at study initiation: 2425 - 3073 g
- Fasting period before study: no
- Housing: individually housed in mesh-bottom cages
- Diet: Purina Certified Rabbit Chow No. 5322, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.8-20.2
- Humidity (%): 35.0-42.6
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml - Duration of treatment / exposure:
- single instillation without washing
- Observation period (in vivo):
- 4 days
Reading time points: 1, 24, 48 and 72 h and 4 days - Number of animals or in vitro replicates:
- 6 (3 males, 3 females)
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: hand-held penlight / fluorescein (UV light)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean of all 6 animals
- 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:
- other: mean of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- other: mean of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.61
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- other: mean of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.06
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No effects on cornea or iris were observed in any animal at any time point. Slight conjuntivae redness (grade 1-2) was observed in every animal 1 h after instillation of test item and were fully reversible within 4 days. Chemosis (grade 1) was observed in every animal 1 h after instillation of test substance and was fully reversible within 48 h. Clear discharge was observed in 1 animal 1 h after instillation of test substance but was fully reversible within 24 h.
- Other effects:
- No signs of systemic toxicity or effects on body weight gain were observed.
Any other information on results incl. tables
Table 1: Individual scores from eye irritation study in male rabbits.
Rabbit # (males) |
Time [h]
|
conjunctivae
|
iris
|
cornea
|
|
redness |
swelling |
||||
1
|
1 |
2 |
1 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average (over 24, 48, 72 h) |
0.33 |
0 |
0 |
0 |
|
2
|
1 |
2 |
1 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
|
96 |
0 |
0 |
0 |
0 |
|
average (over 24, 48, 72 h) |
1.00 |
0 |
0 |
0 |
|
3
|
1 |
1 |
1 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
|
96 |
0 |
0 |
0 |
0 |
|
average (over 24, 48, 72 h) |
1.00 |
0 |
0 |
0 |
|
|
|||||
Table 2: Individual scores from eye irritation study in female
rabbits.
Rabbit # (females) |
Time [h]
|
conjunctivae
|
iris
|
cornea
|
|
redness |
swelling |
||||
1
|
1 |
1 |
1 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average (over 24, 48, 72 h) |
0.33 |
0 |
0 |
0 |
|
2
|
1 |
2 |
1 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
96 |
0 |
0 |
0 |
0 |
|
average (over 24, 48, 72 h) |
0.33 |
0 |
0 |
0 |
|
3
|
1 |
2 |
1 |
0 |
0 |
24 |
1 |
1 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
96 |
0 |
0 |
0 |
0 |
|
average (over 24, 48, 72 h) |
0.66 |
0.33 |
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 according to OECD 405 the substance was found to be not irritating to eyes. Treatment of 3 female and 3 male New Zealand White rabbits with 0.1 ml undiluted test substance resulted in no effects on cornea and iris in any animal at any time point. Slight conjuntivae redness (grade 1-2) was observed in every animal 1 h after instillation of test item and were fully reversible within 4 days. Chemosis (grade 1) was observed in every animal 1 h after instillation of test substance and was fully reversible within 48 h. Clear discharge was observed in 1 animal 1 h after instillation of test substance but was fully reversible within 24 h.
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