Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
Sample sent to INTOX PVT. LTD. , 375, Urawade, Tal. Mulshi, Dist. Pune, Maharashtra, 412115, India for analysis.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
39 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 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))
Deviations:
no
GLP compliance:
yes

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 vitro test system

Test system:
isolated skin discs
Source species:
rat
Cell type:
other:
Cell source:
other: Epidermal surface of skin disc
Source strain:
Wistar
Vehicle:
water
Control samples:
yes, concurrent negative control
yes, concurrent positive control

Test animals

Species:
rat
Strain:
Wistar

Test system

Type of coverage:
not specified
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
transcutaneous electrical resistance (in kΩ)
Value:
> 10.78 - < 10.78
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
Category 3 (mild irritant) based on GHS criteria
Conclusions:
The In-Vitro Skin Corrosion Study by TER ( Transcutaneous Electrical Resistance Test Method) for Emblica officinalis Extract concludes that Emblica officinalis Extract is Non-corrosive as per the United Nations (UN) Gloally Harmonised System (GHS) for classification of Chemicals. The Study is performed as per OECD Guideline for testing of Chemicals Guideline No. 430.

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