Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

For this endpoint, the read across between PWH/ammonium and PWH/sodium salt is valid, because this toxicological property is defined by the main component.The read across justification that takes into account the ammonium ion properties is attached on section 13 of the dossier.

Three in vitro tests have been performed to assess eye and skin irritation on Paraffin waxes and Hydrocarbon waxes C14-17, chloro, sulfochlorinated, low sulphonated, saponified.

Considering EPISKIN test, according to the established criteria (cell viability less than 50%), the test item is considered to have irritant effect on the skin under the reported experimental conditions.

Similarly, regarding HCE test for eye, a cell viability < 50% corresponding to the cut-off value for eye irritant classification has been quantified for positive control (0,6246%) and test item (0,4719%). Nevertheless a BCOP test has been performed in addition and the calculated in vitro irritancy score (IVIS) for the test item is 6.1.

According to the OECD Guideline no. 437, the test item is not to be classified as corrosive or severely irritant to the eye.

However, according to the criteria stated in the OECD Supplement to Test Guidelines nos. 437 and 438, there is indication of mild irritant effect to the eye.

As a consequence, since it is practically impossible that an eye irritant not corrosive for eye will be corrosive for skin, the skin corrosion test has not been performed and the resulting assessment and classification is reported below.

It can be assumed that the results will be the same also for Paraffin waxes and Hydrocarbon waxes, chloro, sulfochlorinated, saponified. Molecular weight will be usually higher or sulphonation degree, then hydrophylicity and/or salification proportions higher, leading to a better toxicological profile


Justification for selection of skin irritation / corrosion endpoint:
Good in vitro study, GLP with international guideline on a very similar substance

Justification for selection of eye irritation endpoint:
Two GLP in vitro studies have been performed on a very similar substance for skin irritation, a HCE study, that discriminates between irritant and non irritant substances and a BCOP, to assess the possibile corrosion behaviour of the substance. From the BCOP study the irritation property coming from HCE has been demonstrated, but the corrosion has been definitively excluded

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Only in vitro tests have been performed, all in agreement with OECD standards and in fully replacement of the in vivo tests, therefore no direct correspondence for assessing the irritation potential for eye and skin can be taken from Regulation CE 1272/2008 and their amendments until July 2012 (II and III), but clear parameters comes directly from the viability evaluations, leading to classification both for eye and for skin as irritant, with H 315 and H 319