N-bromosuccinimide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because skin contact in production and/or use is not likely

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
For N-Bromosuccinimide information on acute oral toxicity is available, which resulted in no requirements for classification and labelling for acute oral toxicity. According to point 8.5 of Annex VIII, information on acute toxicity for at least one other route of exposure needs to be provided. As for N-Bromosuccinimide skin contact in production and/or use is likely, and the physicochemical and toxicological properties of the substance suggest potential for absorption through the skin, testing by the dermal route is considered appropriate for this endpoint. However, as N-Bromosuccinimide has skin irritating properties, eye corrosive properties and skin sensitizing properties, dermal exposure needs to be prevented by using adequate protective equipment. From the available data on N-Bromosuccinimide it can already be concluded that dermal toxicity may pose a risk, due to the irritating and skin sensitizing properties. This is also confirmed by the available data from a short-term oral repeated dose toxicity study with the reproduction/developmental toxicity screening test in rats. In this study, the NOAEL is set based on both local effects (adverse changes in the esophagus, stomach, trachea and lung (ulceration/erosion of protective epithelial layers and associated inflammation) as well as systemic effects (moribundity/mortality, likely related to the local effects) at the same dose level. Additional acute dermal toxicity testing will not provide relevant and essential toxicological information for N-Bromosuccinimide. , but will only be informative for classification and labelling purposes. Therefore, as sufficient toxicological information is already available and exposure needs to be prevented due to the already known properties of the substance, performing a study with animals for classification purposes only is considered ethically not acceptable.