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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: No deviation from OECD-404 guideline, not GLP, but competent authorities agency accreditation of the lab.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Remarks:
but competent authorities agency accreditation of the lab.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hours after removing of the bandage
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
ca. 0
Max. score:
0
Reversibility:
other: not relevant as no irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
ca. 0
Max. score:
0
Reversibility:
other: not relevant as no irritation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
APP-6669 is clearly not irritating to skin according to OECD-404 test.