Registration Dossier
Registration Dossier
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EC number: 270-128-1 | CAS number: 68411-46-1
Endpoint summary
Administrative data
Description of key information
Additional information
No inhibitory or toxic effects of the UVCB substance and similar substances were determined by acute tests on fish and activated sludge, respectively. However, slight toxicity was observed in acute test with Daphnia. Thus, the UVCB substance is considered to be slightly acutely toxic to Daphnia.
However, there is evidence that the substituted diphenylamines as C8 mono- and C8 di-alkylated diphenylamines are not acutely toxic to Daphnia. Furthermore, dose response relationship was observed in the Daphnia test but the effects did not correspond to the measured concentrations of the main constituents.
A study on the effects of the UVCB substance on Daphnia reproduction is available. Adverse effects were observed, however, the EC10 (reproduction) was determined to be 1.69mg/L.
Toxicity data on algae show that the EC50 growth rate is > 100mg/l and the NOEC is > 10mg/L for UVCB substance EC 270 -128 -1
No effects in fish was observed in acute studies. Furthermore, in a BCF study with a substance similar to one constituent of the UVCB substance (CAS 27177-41-9) no adverse effects in fish were observed throughout the exposure period of 42 days and the elimination period of 42 days. No long-term adverse effects to fish are expected. Therefore, and for reasons of animal welfare, a long-term toxicity study in fish is not proposed.
No toxicity in the solubility range of the substituted diphenylamines was observed in the available acute and chronic aquatic toxicity data.
Furthermore, it could be shown that the observed effects in the Daphnia studies with the UVCB Substance CAS68411-46-1 were concentration dependent. The representative components of the uvcb substance with the highest bioaccumulation potential are poorly water soluble. It is doubtful that these constituents have caused these effects because there were tested at saturation concentration also at different loading rates.
Toxic effects to sediment organisms were observed in test according to OECD 225. The EC10-values for biomass and reproduction were determined to be 81.0 and 44.6 mg/kg sediment dry weight, respectively.
The lead dossier contains two boundary compositions: boundary composition 1 requires no PNEC derivation and consequently no risk assessment since the substance is not classified.
Boundary composition 2, however, requires a PNEC derivation and consequently a risk assessment since the substance is classified.
Due to the classification of boundary composition 2 a risk assessment is provided taking into account the PNEC data for the impurity Diphenylamine (DPA) by using the mixture mode of EasyTra. The relevant PNEC data for DPA are derived from the European Union Risk assessment report for Diphenylamine (2008). The following values of DPA were used for the risk assessment:
PNEC aqua: 1.2 µg/l
PNEC marine: 0.12 µ/l
PNEC sediment: 0.0246 mg/kg(w/w)
PNEC marine sediment: 0.00246 mg/kg(w/w)
PNEC soil: 62.8 µg/kg (w/w)
PNEC wwtp: 0.187 mg/l
Inherently degradable not fulfilling specific criteria
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