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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:
November 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): dimethyldichlorsilan
- Physical state: liquid
No further details available

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Hacking and Churchill Ltd, UK
- Age at study initiation: No data (needs translation)
- Weight at study initiation: 3.7 kg
- Housing: No data
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: No data (needs translation)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-60
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: November 1984

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:
3 males
Details on study design:
TEST SITE
- Area of exposure: Flanks
- % coverage: No data (6 x 6cm)
- Type of wrap if used: Semiocclusive


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: four hours


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: skin induration and pale yellow or light-red bordered skin at the application site was observed at 24 and 48 hours; at 72 hours necrosis of the whole application site was observed.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: skin induration and pale yellow or light-red bordered skin at the application site was observed at 24 and 48 hours; at 72 hours necrosis of the whole application site was observed.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: skin induration and pale yellow or light-red bordered skin at the application site was observed at 24, 48 and 72 hours; day 4 necrosis of the whole application site was observed.
Irritant / corrosive response data:
Eschar formation observed.
Other effects:
Signs of corrosion were observed from 1 hour to 14 days.

Any other information on results incl. tables

Corrosion was reported rather than scores being given.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
In a well conducted skin irritation study (reliability score 2) comparable to OECD 404, but not to GLP, dichlorodimethylsilane was corrosive to rabbit skin.
Executive summary:

In a well conducted skin irritation study (reliability score 2) comparable to OECD 404, but not to GLP, 0.5 ml undiluted dichlorodimethylsilane was applied to the shaved flanks of six New Zealand white rabbits under a semi-occlusive dressing for four hours. The application site was then washed with water, and the site assessed for signs of irritation for 14 days. Eschar formation was noted, as a result of the corrosive activity of the test substance.