Registration Dossier
Registration Dossier
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EC number: 201-250-5 | CAS number: 80-09-1
Toxicity to birds
Administrative data
Link to relevant study record(s)
Description of key information
Waiver:
In accordance with column 2 of REACH Annex X, reproductive toxicity tests to birds (required in section 9.6.1) do not need to be conducted as a large mammalian dataset is available (see toxicological studies). In addition direct and indirect exposure of soil compartment and consequently birds is unlikely.
According to the available information about production and use of 4,4-sulphonyldiphenol, direct and indirect releases of 4,4-sulphonyldiphenol to the terrestrial compartment and for the environment can practically be excluded. Thus, it can be concluded, that the exposure of the terrestrial compartment is negligible.
Secondary exposure to birds either by direct contact (e.g. drinking water) or via the food chain is considered to be negligible as well. Thus, no further information and/or testing are needed. The assessment of the secondary poisoning risks will be done using the large mammalian dataset available or proposed. The calculation of the PNEC oral will be done based on the NOAEL for repeated dose exposure in rats.
In conclusion, the exposure of the terrestrial compartment is negligible during the production and based on the use descriptions. Secondary exposure to birds either by direct contact (e.g. drinking water) or via the food chain is considered as negligible. Thus, no further information and/or testing are needed. The assessment of the secondary poisoning risks will be done using the large mammalian dataset available or proposed. The calculation of the PNEC oral will be done based on the NOAEL for repeated dose exposure in rats.
Key value for chemical safety assessment
Additional information
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