Registration Dossier
Registration Dossier
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EC number: 231-778-1 | CAS number: 7726-95-6
Skin sensitisation
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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