Triethoxysilane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11-02-1994 to 22-03-1995

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:

1995

Report date:

1995

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:

Triethoxysilane

EC Number:

213-650-7

EC Name:

Triethoxysilane

Cas Number:

998-30-1

Molecular formula:

C6H16O3Si

IUPAC Name:

triethoxysilane

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Not reported.
- Age at study initiation: Young adult.
- Weight at study initiation: 3235 - 3389 g
- Housing: Individual suspended wire-mesh cages.
- Diet: Purina® Certified Rodent Chow® #5322 provided ad libitum
- Water: Municipal water were provided ad libitum
- Acclimation period: The animals were acclimated to laboratory conditions for a minimum of six days prior to initiation of dosing.

ENVIRONMENTAL CONDITIONS
- Temperature : 66-70°F
- Humidity (%): 32-70
- Photoperiod (hrs dark / hrs light): 12/ 12.

IN-LIFE DATES: From: 08-04-1994 To: 22-04-1994.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

4 h

Observation period:

14 days
Reading time points: 30-60 min, 24, 48, 72 h and daily to day 14.

Number of animals:

1 male and 2 females

Details on study design:

TEST SITE
- Area of exposure: One inch square patch on the back of the rabbit.
- % coverage: 20-25 %
- Type of wrap if used: Each 0.5 ml dose was applied under a 2-ply, one inch square gauze patch secured in place with surgical porous tape, that was overwrapped with a gauze binder and secured with Dermiform® tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The site was wiped with disposable paper towels moistened with deionised water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 14 d

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 d.

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 14 d. Although very slight erythema persisted through study termination for a single animal this irritation was considered to be reversible.

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 d.

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h.

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 d

Other effects:

The test material induced moderate to slight erythema on two and one rabbits, respectively. All rabbits had very slight edema. Desquamation was noted for all rabbits by Day 5. Dermal irritation subsided by Day 14 for one animal. Desquamation persisted through Day 14 for two rabbits. Very slight erythema was present on Day 14 for one animal. There were no other dermal findings.

Any other information on results incl. tables

Table 1. Results of skin irritation study

Observation time	Rabbit no.
	1		2		3
	E*	O*	E	O	E	O
1 h	2	1	2	1	2	1
24 h	2	1	2	1	2	1
48 h	3	1	3	0	2	1
72 h	3	1	3	0	2	1
Mean value 24 +48 + 72 h	2.67	1.00	2.67	0.33	2.00	1.00
Mean value 24 +48 + 72 h, all animals	2.44	0.77

* E: erythema, O: oedema (according to Draize Score)

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute dermal irritation/corrosion study conducted according to OECD 404 and GLP, the primary irritation index was calculated to be 3.1. The test material, triethoxysilane produced moderate, reversible dermal irritation under the conditions of this study and therefore classified as a Category II skin irritant (EU).