Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Remarks:
Sample sent to sa-FORD, Plot V -10, MIDC Industrial Area, Taloja, Dist Raigad, Navi Mumbai, PIN: 410208, Maharashtra, India
Type of information:
experimental study
Adequacy of study:
key study
Study period:
51 days
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Sample sent to sa-FORD, Plot V -10, MIDC Industrial Area, Taloja, Dist Raigad, Navi Mumbai, PIN: 410208, Maharashtra, India for analysis.
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
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

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 - < 5 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Acute Oral Toxicity study for Emblica officinalis extract was performed on wistar Rat (female) and is classified as 'Category 5 or unclassified' in Compliance with the OECD guidelines No. 423.

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