Dimethoxymethylvinylsilane

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:

weight of evidence

Study period:

1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP and considered reliability 1. Read-across is considered scientifically valid and reliability 2.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

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:

Trimethoxyvinylsilane

EC Number:

220-449-8

EC Name:

Trimethoxyvinylsilane

Cas Number:

2768-02-7

IUPAC Name:

trimethoxy(vinyl)silane

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS

- Source: Hoechst AG, Kastengrund

- Age at study initiation: 3-5 months

- Weight at study initiation: 2.2-3.9 kg

- Housing: Individually caged

- Diet: Altromin 2123 rabbit feed (GmbH), ad libitum

- Water: ad libitum



ENVIRONMENTAL CONDITIONS

- Temperature (°C): 18 (± 3)

- Humidity (%): 55 (±20)

- Air changes (per hr): The report states that the room was air-conditioned.

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

Test system

Vehicle:

other: none

Controls:

other: The untreated eye served as a control

Amount / concentration applied:

TEST MATERIAL

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

- Concentration (if solution): undiluted

Duration of treatment / exposure:

24 hour(s)

Observation period (in vivo):

1, 24, 48, 72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE

- Washing (if done): Yes, with a saline solution at 37C.

- Time after start of exposure: 24 h


SCORING SYSTEM: The Draize scale


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: mean of 24,48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

other: no effects

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: mean of 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

other: no effects

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: mean of 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 24 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: mean of 24, 48 and 72 hours

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Irritant / corrosive response data:

The conjunctiva of the animals showed marked hyperaemia and redness. Slight conjunctival swelling was evident. Irritation was only observed 30 - 60 minutes post application; all effects were reversible within 1 day.

Other effects:

None reported.

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	2/1/2	1/1/0
24 h	0/0/0	0/0/0	0/0/0	0/0/0
48 h	0/0/0	0/0/0	0/0/0	0/0/0
72 h	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0	0	0	0
Reversibility*)	-	-	c	c
Average time (unit) for reversion			24h	24h

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

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material was determined not to be irritating to eyes in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.