Registration Dossier
Registration Dossier
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EC number: 700-932-4 | CAS number: -
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
waiving: exposure considerations
Key value for chemical safety assessment
Additional information
According to the REACH Regulation EC 1907/2006, Annex IX, Column 2 (specific rules for adaptation from Column 1), long-term toxicity testing shall be proposed by the registrant if the Chemical Safety Assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms.
Direct and indirect exposure is unlikely due to the risk management measures that will be applied at industrial level and discussed in details within the exposure scenario to avoid any release of the substance directly in the municipal waste water treatment.The monitoring data and the field studies showed that the substance can be effectively removed from the waste waters. Therefore it is expected that the discharge in environment will be very low.
Based both on the available tests, a PNEC of 0.1 mg/l in freshwater is calculated, while the maximum exposure calculated by EUSES based on the actual exposure scenarios and condition of use are of 0.05 mg/l and the maximum monitored quantity referred to 1997 of a monitored substance belonging to the Stilbene Fluorescent Optical Brightener group of substances is 0.0011 mg/l. The local RCR in surface water is then 0.5 and 0.0052 based on estimated and monitored quantities, respectively.
Taking into account the expected concentrations in environment, a long term toxicity test on fish is deemed as unjustified.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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