Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
additional toxicological information
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted in accordance with the intent and purpose of Good Clinical Practice regulations described in CFR Title 21, Parts 50, 56 and 312 and/or the Declaration of Helsinki, as appropriate.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Type of study / information:
REPEATED INSULT PATCH TEST
Test guideline
Qualifier:
according to guideline
Guideline:
other: Good Clinical Practice regulations described in CFR Title 21, Parts 50, 56 and 312 and/or the Declaration of Helsinki
Deviations:
not applicable
GLP compliance:
no

Test material

Constituent 1
Test material form:
other: creamy solid

Results and discussion

Any other information on results incl. tables

Forty-six (46/55) subjects satisfactorily completed the test procedure on Test Article: YOFCO MAS Lot# 50224. Nine (9/55) subjects discontinued for personal reasons unrelated to the conduct of the study. Discontinued panelist data are shown up to the point of discontinuation, but are not used in the Conclusions section of this final report.

Scattered, transient, barely perceptible (+) patch test responses were observed on two (2/46) test panelists (Subject Nos. 39 and 43) during the Induction phase of the study. These responses are judged to be non-specific in nature and are not indicative of clinically significant irritation.

There were no responses on any subject during the Challenge phase.

Applicant's summary and conclusion

Conclusions:
Under the conditions of a repeated insult (occlusive) patch test procedure conducted in 46 subjects, Test Article: YOFCO MAS Lot# 50224 was "Dermatologist-Tested" and did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis in human subjects.
Executive summary:

Forty-six (46/55) subjects satisfactorily completed the test procedure on Test Article: YOFCO MAS Lot# 50224. Nine (9/55) subjects discontinued for personal reasons unrelated to the conduct of the study. Discontinued panelist data are shown up to the point of discontinuation, but are not used in the Conclusions section of this final report.

Scattered, transient, barely perceptible (+) patch test responses were observed on two (2/46) test panelists (Subject Nos. 39 and 43) during the Induction phase of the study. These responses are judged to be non-specific in nature and are not indicative of clinically significant irritation.

There were no responses on any subject during the Challenge phase.

Under the conditions of a repeated insult (occlusive) patch test procedure conducted in 46 subjects, Test Article: YOFCO MAS Lot# 50224 was "Dermatologist-Tested" and did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis in human subjects.