(1,1,3,3-tetramethyldisiloxane-1,3-diyl)dipropane-1,3-diyl dimethacrylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000/10/02-2000/10/12

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-trimethoxysilylpropyl methacrylate

EC Number:

219-785-8

EC Name:

3-trimethoxysilylpropyl methacrylate

Cas Number:

2530-85-0

Molecular formula:

C10H20O5Si

IUPAC Name:

3-(Trimethoxysilyl)propyl 2-methylprop-2-enoate

Test material form:

other: liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS

- Source: Covance Research Products Inc., Denver, PA

- Age at study initiation: Young adults

- Weight at study initiation: 2501 to 2936 g

- Housing: Individual suspended wire mesh cages. The animals were maintained by the animals husbandry staff of WIL Research laboratories, Inc. in accordance with standard operating procedures.

- Diet: PMI Nutrition International, Inc. Certified Rabbit LabDiet 5322 was offered at approximately 150 g per day.

- Water: Municipal water, ad libitum

- Acclimation period: minimum of 7 days


ENVIRONMENTAL CONDITIONS

- Temperature (°F): 67-69 (19.4-20.6 °C)

- Humidity (%): 40-61

- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated eye.

Amount / concentration applied:

TEST MATERIAL

- Amount(s) applied (volume or weight with unit):0.1ml

- Concentration (if solution): undiluted

Duration of treatment / exposure:

Single instillation, not rinsed.

Observation period (in vivo):

The eyes were examined for ocular reactions as approximately 24, 48 and 72 hours after dosing.

Number of animals or in vitro replicates:

3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE

- Washing (if done): not rinsed

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein and UV lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.66

Max. score:

3

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Minor conjunctival irritation (grade 1) was observed in the treated eye of all animals, which completely subsided by 72 hours. There were no corneal or iridial findings.

Other effects:

There were no deaths or test article - related body weight changes during the study period.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	0/0/0	0/0/0	1/1/1	1/0/1
24 h	0/0/0	0/0/0	1/1/1	0/0/0
48 h	0/0/0	0/0/0	1/0/1	0/0/0
72 h	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0	0	0.55	0
Reversibility*)	-	-	c	-
Average time (unit) for reversion	-	-	By 72 hours	-

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the eye irritation study, condicted according to OECD TG 405, and in compliance with GLP, the test substance, 3-trimethoxysilylpropyl methacrylate, was reported to be not irritating to eyes.