Registration Dossier

Administrative data

Endpoint:
eye irritation
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 3 of the assessment of the eye irritation endpoint,in vitro testing for eye irritation is required. A specific rule for adaptation for the in vitro eye irritation test states that the in vitro study (ies) do not need to be conducted if – the available information indicates that the criteria for classification as corrosive to the skin or irritation to the eyes.   

According to the Annex VIII Standard Information Requirements for REACH, for the assessment of the eye irritation endpoint,in vivotesting for eye irritation is required. A specific rule for adaptation (Column 2) for the eye irritation test states that thein vivostudy (ies) do not need to be conducted if the substance is classified as irritating to the eyes with risk of serious damage to the eyes or if the substance is classified as corrosive to the skin; or the substance is a strong acid (pH equal or less than 2).

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” and “R37”. Thus, it is not scientifically justified to conduct this test.Thus, exposure of eye tissue in mammalian species to HBr or hydrobromic acid would not generate meaningful data, and no in vivo eye irritation studies are required for this substance