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:
guideline study without detailed documentation

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD [C(99) 186 (Final)]
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Nature of substance: ESACURE 1001

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
500 mg
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
Max. score:
0
Remarks on result:
other: Max. duration: 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: d; Max. value at end of observation period: 0
Other effects:
No clinical signs, either general or local (at the application sites), were noted in any animal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met