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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05.08.1988 to 14.12.1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Three minute exposure, but this is acceptable in light of the severity of the findings. No test substance purity.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

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: 2.4-2.7 kg
- Housing: Individual in polystyrene cages
- Diet (e.g. ad libitum): 150 g per animal per day
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-23
- Humidity (%): 38-75
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 07.09.1989 To: 21.09.1989

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:
3 minutes
Observation period:
14 days
Number of animals:
Six males
Details on study design:
TEST SITE
- Area of exposure: Back and flanks
- % coverage: No data
- Type of wrap if used: Semi-occlusive dressing

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

SCORING SYSTEM: Equivalent to Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.6
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Some burning noticed from 24 hours. Grade 4 erythema by Day 7 and still apparent on Day 14. Burning and dryness on Day 14.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: By Day 14 there was no erythema, but there was dryness and desquamation. Burns observed.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: By Day 14 there was still grade 4 erythema, burns, dryness and desquamation. Burns observed.
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: On Day 14 there was desquamation and dryness.
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: On Day 14 there was Grade 1 erythema, burns, desquamation and dryness. Burns observed.
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: On Day 14 there was Grade 1 erythema, dryness and desquamation. Burns observed.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: Edema reversible within 14 days.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.6
Max. score:
4
Reversibility:
fully reversible within: Edema reversible within 14 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3.6
Max. score:
4
Reversibility:
fully reversible within: Edema fully reversible within 14 days.
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: Edema reversible within72 hours.
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: Edema reversible within 7 days.
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: Edema reversible within 7 days.
Irritant / corrosive response data:
Grade 2 erythema and edema were observed in all animals within the first hour after dressing removal. The overall reactions peaked between 24 and 48 hours after dressing removal. By 72 hours the edema began to reverse in all of the animals. However, erythema persisted for longer, such that two of the animals still had Grade 4 erythema on Day 14. Burns of varying sizes (as a proportion of the initial test area) were observed in five of the six exposed animals.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
In a non-guideline study that was comparable to OECD 405 and to GLP, triacetoxyethylsilane was corrosive to the skin of rabbits. In this study the skin was exposed under semi-occlusive conditions for three minutes. Although this exposure period does not comply with current guidelines, it was long enough to show the corrosive nature of the test substance and the study is therefore considered to be reliable (reliability score 1). Grade 2 erythema and edema were observed in all animals within the first hour after dressing removal. The overall reactions peaked between 24 and 48 hours after dressing removal. By 72 hours the edema began to reverse in all of the animals. However, erythema persisted for longer, such that two of the animals still had Grade 4 erythema on Day 14. Burns of varying sizes (as a proportion of the test site) were observed in five of the six exposed animals.