[3-(triethoxysilyl)propyl]urea

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the appropriate OECD test guideline and in compliance with GLP. As this study was used as a read across the reliability was set to 2.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[3-(trimethoxysilyl)propyl]urea

EC Number:

245-904-8

EC Name:

[3-(trimethoxysilyl)propyl]urea

Cas Number:

23843-64-3

IUPAC Name:

1-[3-(trimethoxysilyl)propyl]urea

Details on test material:

- Name of test material (as cited in study report): Y-11542
- Physical state: clear, colourless, viscous liquid
- Lot/batch No.: 2131UG060495
- Storage condition of test material: room temperature

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 (3 males and 3 females)
- Housing: individual housing in suspended 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): 20
- Humidity (%): 35-43
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated left eye

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 ml

Duration of treatment / exposure:

single treatment without washing

Observation period (in vivo):

4 days

Number of animals or in vitro replicates:

6 (3 males and 3 females)

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-held pen light

Treatment procedure:
The test material was placed directly into the cupped lower conjunctival sac of the rabbit's right eye. The eyelid was held closed for approximately one second after instillation. The left eye was manipulated in an identical manner to simulate the dosing of the right eye.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24, 48, and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24, 48, and 72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24, 48, and 72 h

Score:

0.61

Max. score:

3

Reversibility:

fully reversible within: 4 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24, 48, and 72 h

Score:

0.06

Max. score:

4

Reversibility:

fully reversible within: 48 h

Any other information on results incl. tables

Table 1: Individual score of the eye irritation study.

Rabbit #	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	0.33		0	0
2	1	2	1	0	0
	24	1	0	0	0
	48	1	0	0	0
	72	1	0	0	0
	average	1		0	0
3	1	1	1	0	0
	24	1	0	0	0
	48	1	0	0	0
	72	1	0	0	0
	average	1		0	0
4	1	1	1	0	0
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.33		0	0
5	1	2	1	0	0
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.33		0	0
6	1	2	1	0	0
	24	1	1	0	0
	48	1	0	0	0
	72	0	0	0	0
	average	0.66		0	0
	Time [h]	conjunctivae		iris	cornea
		redness	swelling
average score	1	1.66	1	0	0
	24	1	0.17	0	0
	48	0.5	0	0	0
	72	0.33	0	0	0
	24+48+72	0.61	0.06	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a eye irritation study conducted in accordance with OECD 405 and GLP (reliability score 2), the structural analogue [3-(trimethoxysilyl)propyl]urea showed no irritating potential to the eyes of rabbits.