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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:
03.10.1989 to 17.01.1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

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

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: 2.4 to 2.6 kg
- Housing: Individually in polystyrene cages
- Diet (e.g. ad libitum): 150 g/animal/day
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 8 days before treatment

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

IN-LIFE DATES: From: 03.10.1989 To: 17.10.1989

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 (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
Four hours
Observation period:
14 days
Number of animals:
Three
Details on study design:
TEST SITE
- Area of exposure: Flanks
- % coverage: No data
- Type of wrap if used: Semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No done

SCORING SYSTEM: Equivalent to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Grade 4 erythema was observed on Day 14 for animal No. 1. Burns developed by 72 hours and remained on Day 14.
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Grade 2 edema was observed for animal No 1, which was fully reversible within 14 days.
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Burns developed immediately, and were replaced by eschar by Day 14 for animal No 2.
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Grade 1 edema was observed for animal No 2, which was fully reversible within 72 hours.
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Burns developed immediately, and were replaced by eschar by Day 14 for animal No 3.
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Grade 2.33 edema was observed for animal No 3, which was fully reversible within 14 days.
Irritant / corrosive response data:
Severe erythema (Grade 4) still apparent at 14 day observation, with necrosis. Max Grade 3 oedema, resolved by Day 14.

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
In a skin irritation/corrosion study conducted according to OECD TG 404 and in compliance with GLP (reliability score 1) methylsilanetriyl triacetate was corrosive to the skin of rabbits. Severe erythema (Grade 4) was still apparent at the 14 day observation point, with necrosis. Maximum Grade 3 oedema was resolved by Day 14 in all animals.