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: The study was performed following GLP standards and EU method B.4 guidelines. However, full study report is not available as the data is > 12 year old and summaries have been prepared using data provided by ECHA.

Data source

Reference
Reference Type:
other:
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: NZW SPF

Test system

Type of coverage:
semiocclusive
Vehicle:
other: Moisten solid
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 hours
Number of animals:
Three (3)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
Other effects:
No abnormalities were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information
Conclusions:
In a study carried out in accordance with GLP and EEC guideline B.4, test substance (EC No. 413-920-6) was evaluated for its skin irritation potential by applying 500 mg under semi-occlusive coverage on skin surface of NZW SPF rabbit. Test substance was not found to be skin irritant at the applied concentration.
The test substance was not classified as skin irritant/corrosive under the test conditions.