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skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)

Data source

Referenceopen allclose all

Reference Type:
study report
Report date:
Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
other: Human Repeat Insult Patch Test
Principles of method if other than guideline:
Reference: Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics published by The Association of Food and Drug Officials of The United States.
GLP compliance:
not specified
Type of study:
patch test

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
Cas Number:
Molecular formula:
Specific details on test material used for the study:
0.2ml of 2% Synoxyl HSS in corn oil.
0.2ml of 5% Synoxyl HSS in Synovea DOI.

In vitro test system

Details on the study design:
0.2ml/0.5ml of the diluted test material was dispensed onto the occlusive, hypoallergenic patch.
The patch was then applied directly to the skin of the infrascapular regions of the back, to the right or left of the midline and the subject was dismissed with instructions not to wet or expose the test area to direct sunlight.
After 24 hours the patch was removed by the panelist at home.
This procedure was repeated until a series of nine consecutive 24 hour exposures have been made for every Monday, Wednesday and Friday for three consecutive weeks.
In the event of an adverse reaction, the area of erythema and edema is measured. The edema is estimated by the evaluation of the skin with respect to the contour of the unaffected normal skin. Reactions are scored just before applications two through nine and the next test date following application nine. Clients are notified immediately in the case of adverse reaction and determination is made as to treatment program if necessary.
Subject were then given a 10 - 14 day rest period after which a challenge or retest dose was applied once to a previously unexposed test site. The retest dose is equivalent to any one of the original nine exposures. Reactions arc scored 24 and 48 hours after application.
Comparison was made between the nine inductive responses and the retest dose.

Results and discussion

In vitro / in chemico

Key result
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
not sensitising
The test material when tested under occlusive conditions at 2% dilution in corn oil and 5% dilution in Synovea DOI may be considered as a NON-PRIMARY IRRITANT to the skin according to the reference.