Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
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 VIII Standard Information Requirements for REACH, .an acute toxicity test by the dermal route is required. A specific rule for adaptation (Col. 2) for the acute dermal test states that the study (ies) do not need to be conducted if inhalation of the substance is unlikely, skin contact during production is likely, and the physicochemical and toxicological properties suggest a potential for a significant rate of absorption through the skin.

Also in Annex VII, a specific rule for adaptation (Col. 2) for acute oral toxicity in the 8.5 series states that the 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.

In case of a spill of liquid bromine, exposure by inhalation is likely as the material would volatilize. Skin contact during production is not likely because of production in closed systems. Toxicological studies have shown that 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). Conducting this test would present a risk to laboratory personel as bromine would be released from application of the liquid to mammalian skin. As sufficient acute toxicity data is available for classification, it is not scientifically justified to conduct this test by the dermal route.

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