Registration Dossier
Registration Dossier
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EC number: 233-113-0 | CAS number: 10035-10-6
Eye irritation
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
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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