Registration Dossier
Registration Dossier
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EC number: 203-404-7 | CAS number: 106-50-3
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
The 21-d NOEC for reproduction in aquatic invertebrates is 0.0051 mg/L.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- NOEC
- Effect concentration:
- 0.005 mg/L
Additional information
Three chronic toxicity studies with aquatic invertebrates are available for evaluation. All were conducted in accordance with generally accepted test guidelines and in compliance with GLP criteria. Two older studies with Daphnia were already included in the REACH dossier submitted in 2010. The first one is a 21-d reproduction study with a semi-static study design (Japan Food Research Laboratories, 2002), the second a 21-d reproduction study with a flow-through design (Haskell laboratory, 1994). From an experimental design point of view, in the semi-static study concentrations were reasonably well maintained with a 24 hours renewal rate. However, as this study had some limitations with regard to reporting, for the dossier registration in 2010 the flow-through study was preferred for assessment.
Since the registration of the substance in 2010, based on the fact that the substance is not stable in aquatic environments, some of the available aquatic toxicity data were considered to be not fully reliable (communicated to ECHA in 2011). At the time it was proposed that the long-term toxicity test on invertebrates (among others) would be repeated taking extra care to ensure proper development and validation of the analytical method for PPD in aquatic medium. In addition, trial studies were conducted to take the best decision on the exposure regime for the chronic invertebrate test. Based on different trials with different exposure regimes it was decided that a semi-static study design allowed for an overall best study performance. The results of these trial studies are described in the relevant sections in IUCLID. The newly generated chronic Daphnia study, which was conducted in accordance with OECD guideline and in compliance with GLP criteria, was finalized in 2013 (Dr. Noack, 2013b). Based on the reported time weighted mean concentrations, recoveries of 40-66% were calculated to be achieved throughout the test. The study was assigned Klimisch 1 and the 21-d NOEC of 0.0051 mg/L is considered for assessment.
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