Registration Dossier

Administrative data

Description of key information

Not a skin irritant

Not an eye irritant

Key value for chemical safety assessment

Skin irritation / corrosion

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

Eye irritation

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation/Corrosion: The potential of the test item to induce skin irritation was investigated through an in vitro skin irritation study using a commercial reconstructed human epidermis (RhE) model named EpiSkin™ according to the OECD Guideline 439 (2015). The test item did not induce cell death in any replicate. The mean cell viability after subtraction of the blank solution was 95% compared to the negative control. Based on these results, the test item is not considered irritating to the skin.

 

Eye Irritation/Serious Eye Damage: In order to assess the corneal damaging potential of the test item, an in vitro study was performed by quantitative measurement of the change in bovine corneal opacity and permeability (Bovine Corneal Opacity and Permeability (BCOP) test), according to the OECD Guideline 437 (2017) and the EU Method B.47 (2017). The test item showed no effects on the cornea of the bovine eye, and the calculated IVIS of the test item was 0.31. As the IVIS was ≤ 3, the test item requires no classification for eye irritation or serious eye damage.

Justification for classification or non-classification

SKIN CORROSION/ IRRITATION

According to the CLP Regulation (EC 1272/2008), Skin Irritation means the production of reversible damage to the skin following the application of a substance for up to 4 hours. In vitro alternatives that have been validated and accepted may also be used to help make classification decisions. Table R.7.2-2 of the Guidance on IR & CSA lists the status of validation and regulatory acceptance for in vitro test methods for skin corrosion and skin irritation. The OECD has adopted an in vitro skin irritation test guideline (i.e. OECD TG 439 (TM B. 46)) which currently contains four test methods including the EpiSkinTM test. This test method allows distinction between irritants (CLP Category 1 / Category 2) and substances not classified. Depending on the regulatory framework in member countries, a substance may be considered as a non-irritant to skin in accordance with UN GHS No Category if the tissue viability value after exposure and post-treatment incubation is greater than 50 %.

Based on the results obtained in the study performed on the test item, the mean cell viability after subtration of the blank was found to be 95 % when compared to the negative control. Thus, no classification for skin irritation is warranted according to the CLP Regulation (EC) No. 1272/2008.

SERIOUS EYE DAMAGE/EYE IRRITATION

According to the CLP Regulation (EC 1272/2008), Serious Eye Damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a substance to the anterior surface of the eye, which is not fully reversible within 21 days of application. The classification system for substances involves a tiered testing and evaluation scheme, combining pre-existing information on serious ocular tissue damage and on eye irritation as well as considerations on (Q)SAR and the output of validated in vitro tests in order to avoid unnecessary animal testing.

The OECD has at present adopted five in vitro test guidelines for assessing eye hazard potential. These tests are recommended for use as part of a tiered-testing strategy for regulatory classification and labelling.

The Bovine Corneal Opacity and Permeability (BCOP) test method (as detailed in EU Method B.47 / OECD Guideline 437) is an in vitro assay that may be used to identify chemicals (substances or mixtures) as either i) causing “serious eye damage” (Category 1 of CLP), or ii) not requiring classification for eye irritation or serious eye damage according to the CLP Regulation (1272/2008). The IVIS cut-off values for identifying substances as inducing Serious Eye Damage (UN GHS Category 1) and substances not requiring classification for eye irritation or serious eye damage (UN GHS No Category) are: IVIS UN GHS values of 3 or less determine No Category; values greater than 3 and up to 55 denote that no prediction can be made; and values greater than 55 classify the substance in Category 1.

Based on the results obtained in the BCOP test performed on the test item, the calculated IVIS (in vitro irritancy score) was found to be 0.31. Therefore, no classification for eye irritation is warranted according to the CLP Regulation (EC) No. 1272/2008.