Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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, an acute oral toxicity test in the rat or other verterbrate species is required. A specific rule for adaptation (Col. 2) for acute toxicity in the 8.5 series is that the study (ies) do not need to be conducted if – the substance is classified as corrosive to the skin and does not need to be conducted if a study on acute toxicity by the inhalation route (8.5.2) is available.  According to the Annex VIII Standard Information Requirements for REACH, an acute oral toxicity test in the rat or other verterbrate species is required. A specific rule for adaptation (Col. 2) for acute oral toxicity in the 8.5 series is that the study (ies) do not need to be conducted if –the substance is classified as corrosive to the skin.  Need for a second study by another route is based on potential route of human exposure. If there is only one route of exposure, information for only that route need be provided.

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 liquid to animals. Thus, it is not scientifically justified to conduct this test.

Thus, exposure of mammalian species to bromine by the oral route would not generate meaningful data, and it is not necessary to conduct the acute oral toxicity test.