Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
November 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 2c The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline. It was not compliant with GLP.

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:
Six 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

Results
Irritation parameter:
other: corrosion
Time point:
other: all time points
Reversibility:
not reversible
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

This corrosion was reported rather than scores being given.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
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.