Registration Dossier

Administrative data

fish early-life stage toxicity
Data waiving:
exposure considerations
Justification for data waiving:
Justification for type of information:
The risk characterisation of 1,3-BDDMA shows that the PEC/PNECaqua ratio for the aquatic environment is <1, indicating no need for further information or testing. According to REACH regulation Annex IX, 9.1. column 2, long-term toxicity testing shall only be considered when the chemical safety assessment indicates the need for further investigations. Because there is no indication of major differences in sensitivity between trophic levels and in the absence of any significant long-term bioaccumulation potential it is not necessary to perform further chronic fish tests with the substance.
The environmental risk assessment can be performed with sufficient reliability with the available long-term ecotoxicity data based on the analogue substance 1,4-BDDMA. The analogue substances 1,3-BDDMA and 1,4-BDDMA are very similar in structure without steric differences. For more details please also refer to document “Overview phys-chem properties 1,3-BDDMA and 1,4-BDDMA” as attached in this endpoint. Thus, no long-term toxicity testing fish is required for 1,3-BDDMA.
In addition, the results of the Long-term toxicity to aquatic invertebrates study (Daphnia magna Reproduction test, 21d, OECD 211) and the Toxicity to aquatic algae and cyanobacteria study (Alga, growth inhibition test, 72h, OECD 201) are in progress. Once the pending results of 1,3-BDDMA are available, the exposure and risk assessment will be updated. We expect to have the results of the OECD 211 by 30th June 2021 and OECD 201 by 10th December 2020 in a draft report. Based on a tiered testing approach, next steps might be considered depending on the test results. For more details, please also refer to IUCLID Section 6.1.4 & 6.1.5. This approach seems justified also due to animal welfare reasons.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion