Registration Dossier

Administrative data

Endpoint:
skin sensitisation, other
Remarks:
HRIPT
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: modified Draize method of Jordan and King (1977)
GLP compliance:
not specified
Remarks:
ICH Guidelines on Good Clinical Practice, 1996
Type of study:
patch test

Test material

Reference
Name:
Unnamed

In vivo test system

Test animals

Species:
other: human

Results and discussion

In vivo (LLNA)

Results
Remarks on result:
other: it was not an in vivo test on animals, but on hunman volunteer

Any other information on results incl. tables

No adverse events or reactions were reported. 5 subjects withdrew for personal reasons.

From the data, the test article elicited faint, mild erythematous reactions during the Induction phase of the study. There

were no questionable reactions during the Challenge Phase (Days 38 and 40) by any of the subjects to the test article.

Applicant's summary and conclusion

Interpretation of results:
other: not sensitising