Registration Dossier

Administrative data

Description of key information

Concerning the skin irritation/corrosion toxicity of 3,4'-dichlorodiphenyl ether two in vivo studies were performed. Both can be assessed as reliable without restriction. However the results of the studies differ and lead to different classification.
According to the precautionary principle 3,4'-dichlorodiphenyl ether should be classified and labelled.

Key value for chemical safety assessment

Additional information

Based on the data obtained under the conditions of the 2006 study the test substance 3,4'-dichlorodiphenyl ether should not be classified according to Directive 67/548/EEC (substances) and also not classified according toRegulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures(CLP).

 

Based on the data obtained under the conditions of the 1994 study, the test substance 3,4'-dichlorodiphenyl ether should be classified as Xi, R38 (irritating to skin) according toDirective 67/548/EEC (substances)and as Skin irritation 2, H 315 (causes skin irritation) according toRegulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures(CLP).

There is no obvious reason explaining the different test results in the two studies. Both studies are in accordance with guidelines in force at time of study conduction. Further on both studies are quality checked and in compliance with the Principles of Good Laboratory Practice. Therefore they should be assessed as reliable without restriction (Klimisch 1, GLP guideline study). The purity of both test items was high but nevertheless there may be different contaminants or side products in the test item which have not been reported. Therefore it may be possible that unknown components or influences had an impact on the study results. This can not finally be assessed.


Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

According to the precautionary principle 3,4'-dichlorodiphenyl ether

should be classified as Xi, R38 (irritating to skin) according to Directive 67/548/EEC (substances) and as Skin Irrit. 2, H315 (causes skin irritation) according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures(CLP).