Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1964-07-06 to 1964-08-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP. Equivalent or similar to OECD 404

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964
Report Date:
1964

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
Test material form:
other: colourless liquid

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
No data

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
No data
Duration of treatment / exposure:
The test item was applied to the dorsal skin and the ear of the test animals.
Times of exposure were as follows:
Dorsal skin: 1 min, 5 min, 15 min, 20 h;
Ear: 20 h;
Observation period:
8 days
Number of animals:
2 animals
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap: occlusive wrap

REMOVAL OF TEST SUBSTANCE
- Washing : No


SCORING SYSTEM:
ER = erythema
ED = edema
e = extending beyond the area of exposure
SC = scaling
+ = slight
++ = severe
+++ = very severe

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
3
Max. score:
4
Reversibility:
other: reversible within 8 d
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
2.33
Max. score:
4
Reversibility:
other: reversible within 8 d
Irritant / corrosive response data:
The test substance caused slight to severe erythema and edema which were extending beyond the area of exposure after 24 hours observation. After the 8 days observation, the animals showed slight erythema and severe scaling on the dorsal exposure sites.
Other effects:
Severe erythema and skin hemorrhages were detected on the ears of the test animals after 24 hours. After 8 days observation, severe scaling was detetctable on the ears of the test animals.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU