Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in chemico
Remarks:
Sample was sent to Bioneeds India Private Limited, Devarahosahally, Sompura Hobli, Nelamangala Taluk, Bangalore-562111
Type of information:
experimental study
Adequacy of study:
key study
Study period:
90 Days
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
Deviations:
no
GLP compliance:
yes
Type of study:
direct peptide binding assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Results and discussion

In vitro / in chemico

Results
Key result
Parameter:
other: Direct Peptie Reactivity Assay
Value:
>= 38.7 - <= 38.7
Vehicle controls validity:
not valid
Negative controls validity:
not valid
Positive controls validity:
not valid
Remarks on result:
other: Moderately Reactivity Sensitizer

Applicant's summary and conclusion

Interpretation of results:
other: The Skin sensitisation evaluation by "In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA)" for Thioctamidoethyl Dimethylamine Maleate confirms it is classified as “Moderately Reactiity Sensitizer" or “Moderately Reactivity Sensitizer".
Conclusions:
The Skin sensitisation evaluation by "In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA)" for Thioctamidoethyl Dimethylamine Maleate confirms it is classified as "Moderate Reactivity Sensitizer" or predicts as "Positive". The study is performed in compliance with guidelines OECD TG 442C.