Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier

Data source

Reference
Reference Type:
other: body responsible for the test
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Vehicle:
other: solution at 0.9% NaCl
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0.3
Max. score:
2
Reversibility:
fully reversible
Remarks:
3 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0.7
Max. score:
2
Reversibility:
fully reversible within: 3 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0.7
Max. score:
2
Reversibility:
fully reversible within: 3 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Max. score:
1
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Max. score:
1
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Max. score:
1

Any other information on results incl. tables

Form of application: To the intact, shorn skin in the dorsal region of the trunk (area 25 cm2). Type and duration of the signs of irritation: One hour after the removal of the plaster the skin of the animals revealed hardly perceptible to clearly outlined erythema. Very slight oedema was observed in two animals. 24 to 48 hours after the removal of the plaster the skin still exhibited hardly perceptible erythema. 72 hours after the removal of the plaster, all of the animals were free from signs of irritation.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information under Regulation 1272/2008 Criteria used for interpretation of results: EU
Conclusions:
The substance was tested following OECD 404. Under the experimental conditions the substance did not show any skin irritation properties.
Executive summary:

The substance was tested following OECD 404. Under the experimental conditions the substance did not show any skin irritation properties.