Registration Dossier
Registration Dossier
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EC number: 233-113-0 | CAS number: 10035-10-6
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 vivotesting
in the rat or other vertebrate species are required. A specific rule for
adaptation for the skin sensitisation test states that thein vivostudy
(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.
The pH of hydrobromic acid (the strong mineral acid formed by HBr in water) is known to be acidic – the pH of a 62 % solution is 1. Toxicological studies have shown that HBr gas and hydrobromic acid are well known to cause burns to skin and eyes. This fact is reflected in the EU classification and labelling of HBr and hydrobromic acid as they are classified/labelled with the symbols “C” and “Xi” and the risk phrases “R35” “R37”. Thus, it is not scientifically justified to conduct this test.
Thus, exposure of the skin of mammalian species to HBr or hydrobromic acid would not generate meaningful data as to sensitization potential, and noin vivoskin 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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