Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation, other
Remarks:
Skin sensitization Maximization Study in Guinea Pigs
Type of information:
experimental study
Remarks:
Skin Sensitiation Maximization Study performed at sa-FORD, Plot V -10, MIDC Industrial Area, Taloja, Dist Raigad, Navi Mumbai, PIN: 410208, Maharashtra, India
Adequacy of study:
key study
Study period:
49 days
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
In-Vivo test was done
Deviations:
no
GLP compliance:
yes
Type of study:
Draize test

Test material

Constituent 1
Reference substance name:
Emblic, ext.
EC Number:
289-817-3
EC Name:
Emblic, ext.
Cas Number:
90028-28-7
IUPAC Name:
Beta-Glucogallin and Gallic acid are the main constituents of Emblica officinalis extract.
Test material form:
solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
other: Control and treatment Group
Dose level:
100mg
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
No sensitization
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Substance is not a Sensitizer as per GHS classification.
Conclusions:
The study "In-vivo Skin Sensitization Maximization in Guinea Pigs" confirms that Emblica officinalis Extract is considered as a Non-Sensitizer as per the GHS classification of Chemicals. And the study is in complience with OECD guideline No. 406.

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