Registration Dossier

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation, other
Remarks:
other: many
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Principles of method if other than guideline:
Expert judgement based on data contained in this registration dossier
GLP compliance:
yes
Type of study:
other: many

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Results and discussion

In vitro / in chemico

Results
Remarks on result:
no indication of skin sensitisation
Remarks:
Based on expert judgement

Any other information on results incl. tables

See attachment in the endpoint summary.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
EAA is a water soluble, low molecular weight substance with potential to penetrate in the skin. The test substance showed no in vitro skin irritation in the EPIDERM test, and 0.02 mL test item diluted at 2%, given on the external face of the arm (semi‐occluded) was not irritating in a human skin patch test in 11 volunteers. In a repeated insult patch test, pure test item applied in 56 human subjects, of which 24 volunteers with sensitive skin, the formulation did not induce clinically
significant skin irritation nor was there any evidence of induced allergic contact dermatitis in human subjects. The test item was considered “hypoallergenic”