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Toxicological information

Skin irritation / corrosion

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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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Silane M1 triethoxy
- Substance type: Alkoxy-Si
- Physical state: colourless liquid
- Lot/batch No.: KNR 0505 GE
- Storage condition of test material: metallic container, at about +4°C, in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Charles River France

- Age at study initiation: adult

- Weight at study initiation: 2.5 ± 0.2 kg

- Housing: individually housed in polystyrene cages with perforated flooring

- Diet: standard rabbit diet, 150 g/animal/day

- Water: ad libitum

- Acclimation period: minimum 1 week


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 20±3

- Humidity (%): 30-70

- Photoperiod (hrs dark / hrs light): 12/12

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 hours
Observation period:
The cutaneous examinations were performed for eythema and oedema according to a numerical scale, 1, 24, 48 and 72 hours after removal of the bandage. Observation in the case of a corrosive action of the test article may be studied by observation of the animals up to 14 days.
Number of animals:
6
Details on study design:
TEST SITE

- Area of exposure: on the back or one of the flanks

- Type of wrap if used: semiocclusive patch


REMOVAL OF TEST SUBSTANCE

- Washing (if done): excess test article which has not penetrated will be wiped away with a gauze pad moistened with distilled water (or a non irritant solvent).

- Time after start of exposure: 4 hours


SCORING SYSTEM: according to Draize Scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
Not irritating.
Other effects:
None reported.

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 test conducted in accordance with OECD 404 and in compliance with GLP, trimethoxy(methyl)silane was not irritant to rabbit skin.