Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Body responsible for the test

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD GUIDELINE 404 (1981) EEC Directive 84/449 (1984) - Annex V - method B4 EPA n° 798.4470 (1990) MAFF n° 4200 (1985)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Body responsible for the test
IUPAC Name:
Body responsible for the test
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
other: New Zealand hydbrid albino rabbit

Test system

Type of coverage:
semiocclusive
Vehicle:
other: Sterile Codex liquid paraffin
Duration of treatment / exposure:
4 h
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Score:
0.3
Max. score:
2
Remarks on result:
other: Max. duration: 48 d; Max. value at end of observation period: 0
Irritation parameter:
edema score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0

Any other information on results incl. tables

Reversibility of any observed effect: Changes fully reversible within 3 days

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was found to be not irritating to skin under the condition of the test.