Triethoxy(vinyl)silane

Skin irritation / corrosion

Administrative data

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.

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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

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

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

Test system

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

Results and discussion

In vivo

Results

Results 1

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

Results 2

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.

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	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

 

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 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.