Triethoxy(vinyl)silane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 May 1998 to 25 May 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

Other guidelines also mentioned.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Triethoxy(vinyl)silane

EC Number:

201-081-7

EC Name:

Triethoxy(vinyl)silane

Cas Number:

78-08-0

Molecular formula:

C8H18O3Si

IUPAC Name:

triethoxy(vinyl)silane

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, USA
- Age at study initiation: young adults - not further specfied
- Weight at study initiation: 3.0-3.2 g (males); 3.7-4.8 g (females)
- Housing: individual suspended mesh-bottomed cages
- Diet: standard diet, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.2-19.4
- Humidity (%): 39.8-64.3
- Photoperiod: 12 h/12 h

IN-LIFE DATES: 18.05.1998 to 25.05.1998

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 ml
- Concentration: n/a - neat

Duration of treatment / exposure:

Single application without washing

Observation period (in vivo):

72 h
Reading time points: 1, 24, 48 and 72 h after application

Number of animals or in vitro replicates:

2 males, 4 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: unwashed

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-held pen light at all time points; use of sodium fluorescein at 72 h.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 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:

24/48/72 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:

24/48/72 h

Score:

0.1

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

Minor (grade 1) conjunctival effects in 6/6 at 1 h, in 2/6 at 24 h and in 1/6 at 48 h, but no corneal or iridial effects were noted (see table 1). The maximum average score (MAS), for all time points 1-72 h, was given as 4 (at 1 h) (see also table 1).

Other effects:

There were no deaths observed during the study. One animal lost 6% of its body weight during the test. Slight losses were considered in the report to be common among this weight range and strain.

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
	Opacity - Max. score 4 (a)	Area - Max. score 4 (b)	Max. - score 2 (c)	Redness - Max score 3 (d)	Chemosis - Max. score 4 (e)	Discharge -Max. score 3 (f)
60 min	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	1/1/1/1/1/1	1/1/1/1/1/1	0/0/0/0/0/0
24 h	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/1/1/0/0	0/0/1/0/0/0	0/0/0/0/0/0
48 h	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/1/0/0/0	0/0/0/0/0/0
72 h	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0
Average 24h, 48h, 72h	0	0	0	0.1	0.1	0
Maximum total scores** for each time point (max 110), described in the report as maximum average score (MAS)	MAS: 4 (I h); 1 (24 hr); 0.3 (48 h); 0 (72 h) [in each case the score is the average for 6 animals]
Reversibility***	n/a	n/a	n/a	c	c	n/a
Time for reversion (h)	-	-	-	48	72	-

*Each entry shows values for each of the 6 animals

**Maximum total score (average of 6 animals in each case) = [axbx5] + [cx5] + [(d+e+f)x2] =110

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

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 conducted in accordance with OECD 405 and to GLP (reliability score 1) triethoxy(vinyl)silane was not irritating to the eyes of rabbits.