Registration Dossier

Administrative data

Description of key information

The test substance was predicted not to be an irritant to either skin or eyes, on the basis of results from relevant in-vitro tests.

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)

Additional information

An EPISKIN skin irritation test was conducted by Huntingdon Life Sciences, UK, to assess the potential of the test substance to cause skin irritation, by means of anin-vitrotest. The EPISKIN test has been accepted as a replacement to thein vivotest (Draize Skin Irritation Test), by the European Centre for the Validation of Alternative Methods (ECVAM), and an OECD Guideline 439 (2010) was followed; the study was also conducted in accordance with GLP. The test substance was applied to EPISKIN human epidermis skin constructs which consisted of normal, human-derived epidermal keratinocytes, which had been cultured to form a multilayered, highly differentiated model of the human epidermis with a functional multilayered stratum corneum. The cell viability of the multi layers was determined by mitochondrial dehydrogenase activity. The prediction model uses the percentage viability values (compared to negative control viability) to identify irritant and non-irritant substances. The test substance elicited a mean tissue viability of 116.4% and it was concluded that the test substance is predicted as a non irritant to the skin.

An In-vitro eye irritation / corrosion test was conducted by Huntingdon Life Sciences, UK, to assess the potential for eye irritation of the test substance. The study was conducted according to the OECD Test Guideline 437, and in compliance with GLP. The corneas from freshly excised Bovine eyes were exposed to a 20% (w/w) solution of the test substance in saline solution (sodium chloride 0.9% (w/v) solution) for four hours prior to washing, recording of the opacity, then determination of the permeability. The test substance elicited an in vitroIrritancy Score of 23.8 ± 0.4 and was predicted to be a non corrosive / non severe eye irritant.

Justification for classification or non-classification

The irritant properties to skin and eyes of the substance were assessed using relevant in-vitro tests. The tests indicated that the test substance would not be expected to cause irritation either to skin or eyes. The test substance does not require classification according to EC Directive 67/548/EEC on the basis of these results.