Registration Dossier

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: well documented non guideline study, no GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: as prescribed by 1.1 - 1.4

Test animals

Species:
rabbit
Strain:
Vienna White

Test system

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Observation period:
up to 8 days
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, and 72 hrs
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, and 72 hrs
Score:
1.8
Max. score:
3
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Based on the available data, the test substance showed irritative effects after application to the skin of rabbits.
Executive summary:

The undiluted test substance was droped at a test patch (2.5 x 2.5 cm). After adsorption the patch was placed on the upper third of the back or flanks. The untreated skin sites served as the negative control. The reading of the parameter was conducted 24, 48, 72 hours, and 8 days after removal of the test patches. Based on the results of the available data, the test substance showed irritative effects after application to the skin of rabbits.