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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
march 1993
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Sophoroses lipides
IUPAC Name:
Sophoroses lipides

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml of undiluted product per semi-occlusive patch
Duration of treatment / exposure:
4h
Observation period:
1h, 24h, 48h, 72h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 H
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible within: 24H
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 H
Score:
ca. 1
Max. score:
2
Reversibility:
fully reversible within: 24 H
Irritant / corrosive response data:
no reaction observed after 24h

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
This substance is not skin irritating

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