Triethoxy(vinyl)silane

Endpoint summary

Description of key information

Skin irritation (OECD 404), rabbit: not irritating
Eye irritation (OECD 405), rabbit: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 May 1998 to 23 May 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA, USA
- Age at study initiation: "young adult"
- Weight at study initiation: 3.09-4.31 kg
- Housing: 1 per suspended wire mesh cage
- Diet: standard diet, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.2-19.5
- Humidity (%): 39.8-61.5
- Photoperiod (hrs dark / hrs light): 12 /12

IN-LIFE DATES: From: 1998-05-12 To: 1998-05-23

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 ml
- Concentration: neat (100%)

Duration of treatment / exposure:

4 h

Observation period:

11 days
Reading time points: 30-60 min, and 24, 48 and 72 h following removal of patch.

Number of animals:

6 (3/sex)

Details on study design:

TEST SITE
- Area of exposure: backs and flanks
- Type of wrap if used: semi-occlusive: 2-ply gauze patch, overwrapped with gauze binder, secured with dermiform tape

REMOVAL OF TEST SUBSTANCE
- Washing: wiped with moist paper towel
- Time after start of exposure: 4h

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of 6 animals

Time point:

24/48/72 h

Score:

0.9

Max. score:

4

Reversibility:

fully reversible within: 9 days

Remarks on result:

other: desquamation observed up to Day 11

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of 6 animals

Time point:

24/48/72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

All rabbits had very slight to slight erythema. Very slight edema was noted on 5/6 rabbits. Desquamation was observed in two rabbits. There were no other dermal findings. All dermal findings were reversible and completely subsided by day 11 or earlier.

Other effects:

No deaths occurred during the study period and no effects on body weight were observed.

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	Erythema	Edema
	Max. score: 4	Max. score: 4
60 min	2/1/1/1/1/2	1/1/1/0/1/1/
24 h	2/1/2/1/1/1	1/0/1/0/0/0
48 h	1/1/1/0/1/1	0/0/0/0/0/0
72 h	1/0/1/0/1d*/1	0/0/0/0/0/0
Average 24h, 48h, 72h	0.9	0.1
Reversibility: completely reversible	erythema by day 9; desquamation by day 11	edema by 48 h

 * desquamation

 

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008

Conclusions:

In a skin irritation study conducted in accordance with OECD 404 and GLP (reliability score 1), triethoxy(vinyl)silane was concluded to be slightly irritating to the skin of rabbits. The test material would not be described as irritating if current EU criteria were applied.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

Other guidelines also mentioned.

GLP compliance:

yes

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

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.

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

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

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

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.

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

In a skin irritation study conducted in accordance with OECD 404 and GLP (WIL Research Labs Inc., 1998c), the test substance was concluded to be slightly irritating to the skin of rabbits. However, the observed irritation did not meet the criteria for classification under Regulation (EC) No. 1272/2008. 3 rabbits per sex were treated with 0.5 ml of the neat test substance for 4 h. The mean scores (over 24, 48, and 72 h) were 0.9 for erythema and 0.1 for oedema reactions. Desquamation was observed in 1/6 animals after 72 h and was fully reversible within 11 days. Erythema and oedema reactions were fully reversible within 9 days and 48 h, respectively.

 

Eye irritaion

In an eye irritation study conducted in accordance with OECD 405 and GLP (WIL Research Labs Inc., 1998d), the test substance was not irritating to the eyes of rabbits. 2 male and 4 female rabbits were treated with 0.1 ml of the neat test substance and were observed up to 72 h. No washing was performed after treatment with the test substance. Minor (grade 1) conjunctival effects were observed in 6/6 animals at 1 h, in 2/6 animals at 24 h and in 1/6 animals at 48 h, but no corneal or iridial effects were observed. The mean score over 24, 48, and 72 h was 0.1 for conjunctivae and was fully reversible within 48 h. Chemosis mean score was 0.1 with a maximum grade of 1 and was fully reversible within 72 h.

Justification for classification or non-classification

The available data on skin and eye irritation / corrosion of the test substance do not meet the criteria for classification according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.