Registration Dossier

Administrative data

Description of key information

Eye irritation, Eye Irritection assay, H318: Causes serious eye damage
Skin irritation, Dermal Irritection assay, slight irritant

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study following in-vitro guideline performed on a similar substance
Principles of method if other than guideline:
Dermal Irritection Assay System (refinement of the former Skintex method).It is an in-vitro irritation prediction method that uses non-human substrates as a biomembrane barrier macromolecular matrix system. In particular former Skintex (TM) used a two-compartment physico-chemical model incorporating a keratine/collagen membrane barrier and an ordered macromolecular matrix. When irritating agents are applied to the matrix of the test, they produce effects as they produce nucleation of particles that make the matrix cloudy proportionally with the aggressiveness of the substance. This phenomenon can be quantified with an optical density spectrophotometer measurement, that according to the protocol, is revelead at 450 nm. Due to the fact that the exposure time is a critical point, a semi-permeable membrane with tailored porosity is used which allows to clearly detect the maximum opacification point. A direct correlation between the Patch test and the scale determined with Dermal Irritection protocol was also determined and used for quantification of the results.
GLP compliance:
no
Irritation / corrosion parameter:
other: opacity
Remarks on result:
other: results are reported in the relevant section
Interpretation of results:
slightly irritating
Conclusions:
The substance was tested for skin irritation by means of Dermal Irritection Assay. Under the experimental conditions the substance showed slight skin irritation properties.
Executive summary:

The substance was tested for skin irritation by means of Dermal Irritection Assay. Under the experimental conditions the substance showed slight skin irritation properties.

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study following in-vitro guideline under validation
Principles of method if other than guideline:
Ocular Irritection Assay System (refinement of the former Eyetex method)The system evalutes the ocular hazard effects of test chemicals based on the premise that eye irritation and corneal opacity after exposure to rirritating substances are the result of perturbation or denaturation of corneal proteins. The test method makes use of a macromolecular reagent composed of a mixture of proteins and glycoproteins, carbohydrates, lipids and low molecular weight components, which when rehydrated, form an ordered molecular matrix mimicking the structure of the transparent cornea. Irritating substances produce a turbidity of the reagent by changing both protein conformation and degree of hydration. Changes in the turbidity of the reagent solution caused by the tested material can be quantified by measuring an increase in the light scattering detected at a wavelenght of 405 nm with the help of a spectrometer. The increase in optical density produced by the test material is compared with that produced by a set of calibration substances each of which having previously estimated in vivo irritancy potential.
GLP compliance:
no
Details on test animals or tissues and environmental conditions:
Reagent pH before activation: 8.19Reagent pH after activation: 5.98Reagent temperature: 25°CKit Lot Number: 110700
Amount / concentration applied:
1, 5, 10 and 25%
Duration of treatment / exposure:
5h
Irritation parameter:
other: opacity
Remarks on result:
other: results are reported in the relevant section

 Dose irritation score   
16.1   
 5  30.5  
 10  15.9  
 25  16.1  
Interpretation of results:
other: classified under Regulation 1272/2008
Conclusions:
The substance was tested for eye irritation potential by means of Ocular Irritection Assay. Under the experimental conditions the substance showed eye irritation properties.
Executive summary:

The substance was tested for eye irritation potential by means of Ocular Irritection Assay. Doses of 1, 5, 10 and 25 % of the test item were applied to the matrix mimicking the ordered structure of the cornea for 5h. Irritection score were all,except one, in the mild range. Under the experimental conditions the substance showed an increase in turbidity and therefore eye irritation properties classified as H318, Category 1.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Additional information

In vitro Irritection tests are available for both eye and skin irritation properties (Ricci; 2002) on the substance and on a group of substances that differ from the target substance only for the lenght of the fatty acid in the final structure.

Eye irritation was determined by Ocular Irritection Assay and the result is that the substance is a mild/modearte eye irritant in the Draize score system.

Skin irritation was determined on a similar substance by Dermal Irritection Assay, which resulted as mild skin irritant. However, based on the considerations reported in the attached document and on the read across considerations no skin irritation potential is considered for the substance while eye irritation potential is classified as H318.


Justification for classification or non-classification

The irritative scores determined by the Irritection Assay (dermal and Ocular) classify the substance as H318 and do not classify the substance for skin irritation under Regulation 1272/2008 ( refer to the attached document).