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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A study summary was made available by ECHA under Article 25, Para 3., of EC Regulation 1907/2006

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline 404 (1981); EEC Directive 84/449 (1984) Annex V-Method B4, EPA No.798 4470 (1990), MAFF No.4200 (1985)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
other: Sterile codex liquid paraffin
Amount / concentration applied:

46 mg

Duration of treatment / exposure:
4h
Observation period:
Presumed to be 72 hrs
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Score:
0.3
Max. score:
2
Reversibility:
fully reversible
Remarks:
within 3 days
Remarks on result:
other: Maximum duration 48h; Maximum value at end of observation period 0
Irritation parameter:
edema score
Basis:
mean
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks:
within 3 days
Remarks on result:
other: Maximum duration 0 days; Maximum value at end of observation period 0.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is slightly irritating to the skin and is not classified according to EU CLP criteria.