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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:
13.07.1987 to 27.07.1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Degussa-Silane Si 108
- Substance type: Alkoxysilane
- Physical state: Colourless liquid
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature

Test animals

Species:
rabbit
Strain:
other: white Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: ASTA Pharma AG, D-4800 Bielefeld 14
- Age at study initiation: 9-11 months
- Weight at study initiation: 2.2-2.45 kg
- Housing: Stainless steel cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least one day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±2
- Humidity (%): 55 ±15
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 13.07.1987 to 27.07.1987

Test system

Type of coverage:
occlusive
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 (observation times: 1, 24, 48 and 72 hours, then once daily
Number of animals:
Three
Details on study design:
TEST SITE
- Area of exposure: Dorsal skin
- % coverage: No data
- Type of wrap if used: Occlusive (linen cloth which adhered to a synthetic film glue, bandage wrapped several times around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not mentioned, so assumed no washing

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
4.9
Max. score:
8
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Erythema occurred in all three animals immediately after removal of the patches. The erythema was moderate to severe, but had disappeared by day 10 of observation. Edema also occurred immediately after the end of exposure; slight in one animal and moderate in two animals. The findings had disappeared by day 9. From the middle of the first observation week all animals showed eschar formation, which had not competely peeled off in two animals until the end of the observation period.
Other effects:
The general condition of the animals was not affected by the treatment.

Any other information on results incl. tables

Table 1 summary of skin irritation results

Skin reaction  Hours after end of exposure         Draize score
     Animal 1  Animal 2  Animal 3
 Erythema and eschar formation  1  1  2
   24  3  2  3
   48  3  2  3
   72  3  3 3
 Edema Formation  1  2  2  2
   24  3  2  3
   48  3  2  3
   72  3  2  3

Mean value fotr erythema/eschar: 2.42

Mean value for edema: 2.5

Irritation index: 4.9

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
In a skin irritation study conducted to OECD 404 but not to GLP (reliability score 2) trimethoxyoctylsilane was irritating to the skin of rabbits. There were no systemic effects.