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Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Remarks:
Ocular Irretection Assay system
Adequacy of study:
key study
Study period:
2011
Reliability:
2 (reliable with restrictions)
Qualifier:
according to guideline
Guideline:
other: Ocular Irritection® assay system
Principles of method if other than guideline:
The Ocular Irretection (OI) assay system is a quantitative in vitro test method that mimics acute ocular irritation test. This method is able to evaluate the potential of a test substance to cause eye irritation and corneal opacity by measuring the optical density produced by the interaction of the test substance with a mixture of proteins and glycoproteins. The basis is that the interaction of an irritating agent with cornea causes denaturation and/or disruption of local proteins. So, during the test, the induced alterations in the proteins structures are measured with the differences in turbidity of the reagents matrix at 405 nm using a spettrometer. The interpretation of results is performed by a software that compares the optical density produced by the test substance with a standard curve obtained by a set of calibration well known substances. This standard curve of calibration relates to the ocular potential in the in vivo Draize rabbits eye test. The irritancy potential of a test substance is expressed as an Irritatition Draize Equivalent (IDE) score (0-50), that is obtained by comparison of results of calibration standards with correspondent in vivo studies.
GLP compliance:
not specified
Specific details on test material used for the study:
lot/batch: ESTER B/1 FU 150211
Species:
other: Ocular Irritation Assay measures the optical density produced by the interaction of the test substance with a mixture of proteins and glycoproteins
Details on test animals or tissues and environmental conditions:
mixture of proteins and glycoproteins
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50, 75, 100, 125 micrograms.
Duration of treatment / exposure:
24h
Irritation parameter:
other: Irritection Draize Equivalent
Value:
9.1
Vehicle controls validity:
not applicable
Negative controls validity:
not applicable
Positive controls validity:
not applicable
Remarks on result:
no indication of irritation
Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
IDE score = 9.1
ESTER B is evaluated as minimal irritant by the OI assay system.
Executive summary:

ESTER B is evaluated as minimal irritant by the OI assay system.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

ESTER B is evaluated as minimal irritant by the OI assay system.

Human patch test do not show evidence of skin irritation (see human studies).

Justification for classification or non-classification

The substance is not classified accordig CLP EU Regulation for eye irritation cause the outcome OI assay perfomed on Ester B.

Human patch test do not show evidence of skin irritation.

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