Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 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 491 (Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
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

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
physiological saline
Controls:
yes, concurrent vehicle
yes, concurrent positive control

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Vehicle controls validity:
valid
Negative controls validity:
not valid
Positive controls validity:
valid
Remarks on result:
other: Amla Extract is Classified as No Category, No prediction can be made and Category 1, as defined by the United Nations (UN) and GHS

Applicant's summary and conclusion

Interpretation of results:
other: No prediction can be made as per UN GHS for classification of chemicals
Conclusions:
Short term Exposure In-Vitro Study Using SIRC Cell Line for Identification of Eye Irritation or Serious Eye Damage for Emblica officinalis extract is in compliance with OECD Guideline No. 491. It is concluded that Emblica officinalis extract is classified into ' No prediction can be made' category as per UN GHS for classification of chemicals.

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