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Short-term studies with species of three trophic levels are available: Danio rerio, Daphnia magna and Pseudokirchnerella subcapitata (formerly known as Selenastrum capricornutum).

 

In the 96 hours fish test no mortality was observed in both the replicates with and without adjusted pH up to the loading rate of 100 mg/l.

 

The test performed to evaluate the effect of the test item on Daphnia magna, at the loading rate of 100.0 mg/l, was conducted on two replicates with and without adjusted pH. In the solution without pH adjustment (48 hours of exposure), 80 % of daphnids were found to be immobilized and were observed using the optical microscope with little white particles on the body; no disease signs were observed in daphnids exposed to the solution with pH adjusted. Thus, it can be supposed that slight changes in pH (range 5.80 - 6.54 without pH adjustment; 7.23 - 7.46 with pH adjustment) may affect the system.

 

In the full study performed on algal the No Observed Effect Concentration was established at 31.3 mg/l and the EC50 higher than 100 mg/l. As explained in the study reports, the test item is an UVCB substance, thus a Water Accommodated Fraction (WAF) method was applied to solution preparation. In deviation from GLP requirements, the analytical control of tested concentrations was not performed because it was not possible to validate an adequate analytical method that may measure the concentration of the test item. DG HF/2000 is not fully soluble in water and is characterized by opposite properties when placed in water: the piperazine phosphate, measured by ion chromatography, has quite high water solubility (about 10000 mg/l) when analyzed alone; other components practically insoluble (details in the IUCLID section 4.8) and not detectable under normal analytical conditions. Full solubility of this complex UVCB substance could not be determined as the core substance resulted as not soluble. The percentage weight soluble fraction was estimated at 20.18 %, of which the soluble fraction of phosphate in water is 2.31 % and the soluble fraction of pyperazine is 18.60 %.

 

Long-term toxicity was not tested because direct and indirect exposure is unlikely due to the risk management measures that will be applied at industrial level to avoid any release of the substance directly in the municipal waste water treatment and discussed in details within the exposure scenario. The substance is manufactured using continuous closed processes and plant is provided by internal recycle system that collects all the production residues. Taking into account the life cycle of the substance and the expected concentrations in environment a long-term toxicity test to fish is deemed as unjustified.

Furthermore, DG HF/2000 is expected to have a low bioaccumulative potential.

 

FURTHER INFORMATION: review of existing data

In order to exclude any reason of concern, literature data on the aquatic toxicity of the main components of the UVCB is reported.

PIPERAZINE

The review of available data on the environmental effects shows that piperazine is no toxic to both fish and algae: in both cases the No Observed Effect Concentration is reported as greater than 1000 mg/l, at 96 and 72 hours, respectively. The acute toxicity of piperazine to invertebrates was investigated on Daphnia magna and the determined EC50 (48 h) is 21 mg/l, based on nominal concentrations. Furthermore, a 21-day reproduction study is available for Daphnia and the NOEC is reported at 12.5 mg/l [European Chemicals Bureau, 2005].MELAMINE

Short-term tests with species of three trophic levels are available and in addition studies on chronic toxicity and reproduction toxicity with Daphnia, early life stage toxicity with fish and chronic toxicity with algae. Melamine has a low acute and also low long-term toxicity. The interspecies differences are not pronounced. The lowest short-term L(E)C50 is 940 mg/l taken from the study with algae, while the lowest long-term is reported as NOEC of 18 mg/l from the test with Daphnia. [OECD SIDS, 1998].

PHOSPHATES

Phosphates are generally considered as non toxic to fish/daphnia/algae. Phosphates are an essential nutrient for plants and stimulate the growth of water plants and/or algae if they represent the growth-limiting factor, in fact an environmental issue concerning phosphates in general is their role in the nutrient enrichment of surface waters (eutrophication). In certain circumstances, nutrient enrichment can lead to negative effects, ranging from ecosystem modifications, through algal blooms, to in extreme cases (through decomposition of plant biomass) oxygen depletion and collapse of the biocenosis in a surface water [HERA, 2003]. Nevertheless, this process involves appreciable quantities of substance available in the environment, which are not contextual in the case of the substance to be registered.

MELAMINE POLYPHOSPHATE

Melamine polyphosphate is expected to be of low hazard for acute toxicity to aquatic organisms based on experimental data for melamine polyphosphate. Short-term toxicity data are available: the LC50 (96 h) and the EC50 (48h) are reported as greater than 100 mg/l for fish and daphnia, respectively; in algae no effects are observed at the highest concentration tested (3.0 mg/l). Melamine polyphosphate is not predicted to cause eutrophication based on laboratory testing [EPA, 2014].

PIPERAZINE PYROPHOSPHATE

No experimental data are available. Nevertheless, the aquatic toxicity to fish/daphnia/algae was estimated for piperazine pyrophosphate. The estimation reported no value of concern for both short and long-term toxicity [EPA, 2014].

Reference

Environmental Protection Agency (EPA) United States. An Alternatives Assessment for the Flame Retardant Decabromodiphenyl Ether (DecaBDE). Final report. January 2014.

European Chemicals Bureau; Joint Research Centre (2005). European Union Risk Assessment Report. Piperazine CAS 110-85-0 EC: 203-808-3. 3rd Priority List Volume: 56. Office for Official Publications of the European Communities, 2005.

Human & Environmental Risk Assessment (HERA) on ingredients of European household cleaning products. Sodium Tripolyphosphate (STPP) CAS: 7758-29-4. Draft, June 2003.

OECD SIDS, 1998. Melamine CAS N°: 108-78-1. UNEP Publications.