Registration Dossier

Administrative data

Endpoint:
sediment toxicity: long-term
Data waiving:
exposure considerations
Justification for data waiving:
other:
Justification for type of information:
BAB is used under strictly controlled conditions. BAB is used as an intermediate under strictly controlled conditions. BAB is used as a full substance under strictly controlled conditions. In any event, BAB is used only and solely under strictly controlled conditions. The registrant does not support, and the registrant advises against all uses and life-cycle stages, which are not used under strictly controlled conditions for the REACH Regulation. The chemical safety assessment is included in the sections 9 and 10 of the Chemical Safety Report. The use and exposure characteristics of BAB mean that all relevant legal conditions are satisfied, particularly those legal conditions as set out in Section 3.2 Annex XI REACH, ensuring that: (i) there is no legal or scientific need to undertake further vertebrate animal testing particularly as regards Section 8.7.3 Annex IX/X; (ii) that testing on vertebrate animals can be avoided (Article 25 REACH) and that, given the use and exposure characteristics, undertaking further vertebrate animal testing, particularly for 8.7.3 purposes, would be to undertake vertebrate animal testing in breach of the “last resort” requirement (Article 25(1) REACH); (iii) that a requirement to require vertebrate animal testing vis-à-vis 8.7.3 would be disproportionate and not legally necessary or appropriate.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion