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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
2128-55-0
IUPAC Name:
2128-55-0
Test material form:
other: colourless liquid

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system 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