Triethoxy(methyl)silane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 Sep 1991 - 17 Feb 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

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(methyl)silane

EC Number:

217-983-9

EC Name:

Triethoxy(methyl)silane

Cas Number:

2031-67-6

Molecular formula:

C7H18O3Si

IUPAC Name:

triethoxy(methyl)silane

Test animals

Species:

rabbit

Strain:

other: New Zealand hybrid albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bancel, St Rambert D'Albon, FRANCE
- Age at study initiation: "adult"
- Weight at study initiation: 2.5±0.2 kg
- Housing: 1/cage; polystyrene cage with perforated flooring
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 1 wk

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): no details given
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no details given

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

4 h

Observation period:

1, 24, 48, 72 h. No further observation required.

Number of animals:

Six males

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- % coverage: not stated
- Type of wrap if used: 8 layer gauze pad, covered with perforated tape on crimped gauze bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): protocol states that excess test material should be wiped away with gauze moistened with distilled water if necessary. It is not clear if this was the case.
- Time after start of exposure: 4 h

SCORING SYSTEM: according to Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0.11

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

edema 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

Irritant / corrosive response data:

See Table 1.

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	Erythema	Edema
	Max. score: 4	Max. score: 4
60 min	1/0/1/1/1/1	0/0/0/0/0/0
24 h	0/0/0/1/1/0	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	0.1	0
Reversibility*	c	-
time for reversion	48 h	-

* 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:

A skin irritation study conducted in accordance with OECD 404 and GLP (reliability score 1), found triethoxy(methyl)silane to be transiently irritating to the skin of rabbits. The report describes the material as non irritant according to EC criteria; current EC criteria would concur with this finding.