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 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.