EU 2016/1688

EU regulation amending Annex VII to Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards skin sensitisation.

8.3. Skin sensitisation

Information allowing:

—	a conclusion whether the substance is a skin sensitiser and whether it can be presumed to have the potential to produce significant sensitisation in humans (Cat. 1A), and

—	risk assessment, where required.

The study(ies) under point 8.3.1 and 8.3.2 do not need to be conducted if:

—	the substance is classified as skin corrosion (Category 1), or

—	the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5), or

—	the substance is spontaneously flammable in air or in contact with water or moisture at room temperature.

8.3.1. Skin sensitisation, in vitro/in chemico

Information from in vitro/in chemico test method(s) recognised according to Article 13(3), addressing each of the following key events of skin sensitisation:

(a)	molecular interaction with skin proteins;

(b)	inflammatory response in keratinocytes;

(c)	activation of dendritic cells.

The(se) test(s) do not need to be conducted if

—	an in vivo study according to point 8.3.2 is available, or

—	the available in vitro/in chemico test methods are not applicable for the substance or are not adequate for classification and risk assessment according to point 8.3.

If information from test method(s) addressing one or two of the key events in column 1 already allows classification and risk assessment according to point 8.3, studies addressing the other key event(s) need not be conducted.

8.3.2. Skin sensitisation, in vivo

An in vivo study shall be conducted only if in vitro/in chemico test methods described under point 8.3.1 are not applicable, or the results obtained from those studies are not adequate for classification and risk assessment according to point 8.3.

The murine local lymph node assay (LLNA) is the first-choice method for in vivo testing. Only in exceptional circumstances should another test be used. Justification for the use of another in vivo test shall be provided.

In vivo skin sensitisation studies that were carried out or initiated before 11 October 2016, and that meet the requirements set out in Article 13(3), first subparagraph, and Article 13(4) shall be considered appropriate to address this standard information requirement

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EU 2016/1688

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