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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 1987
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
449-160-7
EC Name:
-
Cas Number:
116912-64-2
Molecular formula:
C7H18N2O4Si C8H20N2O4Si C9H22N2O4Si C10H24N2O4Si
IUPAC Name:
[3-(ethoxydimethoxysilyl)propyl]urea; [3-(trimethoxysilyl)propyl]urea; {3-[diethoxy(methoxy)silyl]propyl}urea

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Nederlands, The Netherlands
- Age at study initiation: at least 6 weeks
- Weight at study initiation: less than 3.5 kg
- Housing: single housing
- Diet: Standard laboratory rabbit diet (LKK-20), Hope Farms, Woerden, The Netherlands (approximately 100 g per day). In addition, hay (BMI, Helmond, The Netherlands) was provided once a week.
- Water (e.g. ad libitum): Tap water diluted with decalcified water.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 (Fluctuations were observed, but were not considered to be relevant)
- Humidity (%): 50 (Fluctuations were observed, but were not considered to be relevant)
- Air changes (per hr): 15
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 ml
- Concentration: undiluted
Duration of treatment / exposure:
Single application without washing.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:
Draize scoring system
TOOL USED TO ASSESS SCORE:
24 hours after treatment fluorescein (2%) was instilled into both eyes of the animals to quantitatively assess the corneal epithelial damage.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
No effects on cornea or iris have been observed in any animal and at any time point. Conjunctival redness was observed in all 3 animals 1 hour after treatment up to 72 hours after treatment, and was fully reversibly within 7 days. The scores for redness were the same in all animals, being 2 at the time points 1, 24, and 48 hours. After 72 hours the scores decreased to 1 in all 3 animals. In 2 out of 3 animals a chemosis score of 3 was observed 1 hours after treatment, decreased to 1 at the time points 24 and 48 h, and was fully reversible within 72 hours. In the third animal the chemosis score was 3 after 1 hour, 2 after 24 hours, and 1 after 48 and 72 hours. It was fully reversible within 7 days.
Other effects:
Remnants of the test substance were observed on the outside of the eyelids.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
In an eye irritation study according to OECD TG 405 and GLP (reliability score 1), only minor, transient eye irritation was observed following instillation of ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters in 3 rabbits. The scores of 0 for cornea and iris and the mean scores of 1.7 for conjunctivae and 0.9 for chemosis indicate that the test material would not be considered irritating to the eyes of rabbits.