Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

Executive summary:

According to the Annex VII Standard Information Requirements for REACH, as step 2 of the assessment of the skin sensitisation endpoint, in vivo testing in the rat or other verterbrate species are required. A specific rule for adaptation for the skin sensitisation test states that the in vivo study (ies) do not need to be conducted if – the available information indicates that the substance should be classified for skin sensitisation or corrosivity or - the substance is flammable in air at room temperature.   

Bromine is a highly reactive substance which is well known to cause burns to skin and eyes. This fact is reflected in the EU classification and Labelling of bromine as it is classified/labelled with symbol C, R35 (causes severe burns). It is also very toxic by inhalation (T +, R26), presenting risk to workers conducting this test as bromine would be released from application of the compressed liquid to mammalian skin. Thus, it is not scientifically justified to conduct this test.

Thus, exposure of mammalian species to bromine would not generate meaningful data, and no in vivo skin sensitisation studies are required for this substance.