Registration Dossier

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:
1966
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data are given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report Date:
1966

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
Method: BASF-test
- Exposure period was 1, 5, and 15 minutes.
- Occlusive instead of semi-occlusive dressing
- No scoring at 60 minutes, and at 48 and 72 hours is reported
- No observation up to 14 days after dosing is indicated (with respect to reversibility, etc).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Vienna White

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
Not indicated.
Duration of treatment / exposure:
1, 5, 15 min
Observation period:
24h, 8 days
Number of animals:
2 per duration of exposure
Details on study design:
TEST SITE
- Area of exposure: 2.5 * 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes (water, sometimes with mild detergent)
SCORING SYSTEM:
Recorded scores:
N++ or N+++: Full thickness necrosis

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: necrosis
Basis:
mean
Time point:
other: 24h
Remarks on result:
other: Strong necrosis in all test groups
Irritation parameter:
other: necrosis
Basis:
mean
Time point:
other: 8 days
Remarks on result:
other: Strong necrosis in 1 and 5 min exposure groups and very strong necrosis in 15 min exposure group

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria