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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given
Remarks:
(no details on study design and results provided)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
To evaluate irritating properties towards the skin, the test substance was topically applied to the skin of six rabbits for 4 and 24 h. Local reactions were scored at 4, 24, 48, 72 und 168 h.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: KL 1003

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:
4 and 24 h
Observation period:
21 days
Reading time points: 4, 24, 48, 72 and 168 h and daily afterwards until day 21
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: erythema
Basis:
animal: 1 - 6
Time point:
other: 4 h
Reversibility:
not reversible
Remarks on result:
other: severe erythema were observed (no scores given).
Irritation parameter:
other: edema
Basis:
animal: 1-6
Time point:
other: 4 h
Reversibility:
not reversible
Remarks on result:
other: severe edema were observed.
Irritant / corrosive response data:
Topical application for 4 h resulted in severe erythema and edema. When the test substance was applied for 24 h, eschar formation was observed. Loosening about edges of scab after 17 - 21 days showed injury in depth.

Applicant's summary and conclusion

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