Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.021 mg/L
Assessment factor:
10
PNEC freshwater (intermittent releases):
2.08 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.002 mg/L
Assessment factor:
100

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
84.6 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
4.67 mg/kg sediment dw
Assessment factor:
100

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.467 mg/kg sediment dw
Assessment factor:
1 000

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
2.55 mg/kg soil dw
Assessment factor:
1 000

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Perchlorate has a low potential for adsorption, does not readily biodegrade but may be rapidly removed under anaerobic conditions. The substance does not bioaccumulate in fish tissues and is not expected to biomagnify in the food chain.

Aquatic toxicity of perchlorate has been extensively reviewed. In the present dossier are presented the main studies available from registrant side. A more in depth analysis is also provided in the attached position paper which reviewed available literature and which allowed determination of a relevant PNEC aquatic for perchlorate.

·        Short-term toxicity to freshwater fish: The median lethal concentration of Ammonium Perchlorate to Oncorhynchus mykiss was found to be >200 mg/L (>169.3 mg/L as perchlorate ion) under the test conditions.

·        Long-term toxicity to freshwater fish:The NOEC-12 wk of Ammonium Perchlorate to Danio rerio was found to be 11.48 mg/L (9.7 mg/Las perchlorate ion) under the test conditions.

·        Short-term toxicity to aquatic invertebrates: The toxic effect of Ammonium Perchlorate to Daphnia magna was assessed in the static dose-response test and it was concluded that the 48 hour EC50 value was >341 mg/L (288.6 mg/L as perchlorate ion).

·        Long-term toxicity to aquatic invertebrates: The NOEC-6d of Ammonium Perchlorate to Ceriodaphnia dubia was assessed in the semi-static dose-response test and it was concluded that the NOEC-7d value was 12 mg/L (10.2 mg/L as perchlorate ion).

·        Toxicity to aquatic algae and cyanobacteria: The growth inhibition study of freshwater algae Pseudokirchneriella subcapitata found that the EC10 of Ammonium Perchlorate was 42.2 mg/L (35.7 mg/L as perchlorate ion). The EC50 of Ammonium Perchlorate was > 505 mg/L (427.4 mg/L as perchklorate ion) based on average specific growth rate and 245.6 mg/L based on yield (207.9 as perchlorate ion).

        Toxicity to amphibians: The NOEC of the perchlorate ion (geometric mean of the results of 3 laboratories for which iodide concentration data were relevant and reported) for growth and development was calculated to be 215 µg/L.

·        Toxicity to microorganisms (sludge inhibition test): At the highest concentration tested (1 g/L) ammonium perchlorate did not inhibit sludges respiration after 30 minutes of exposure. The 3-hour EC50 of the test item Perchlorate d’ammonium for activated sludge respiration inhibition was > 1000 mg/L. The highest test item concentration without significant effect on the respiration was >= 1000 mg/L 846.4 mg/L as perchlorate ion).

Terrestrial toxicity

The only available valid toxicity data for terrestrial toxicity is a 14-day acute lethality test of the earthworm (Eisenia fetida) performed in artificial soil irrigated with sodium perchlorate. The LC50 at both 7 and 14 days was 4,450 mg/kg as a wet-weight concentration in soil. No factors or other models are available to extrapolate from that LC50 to chronic effects on survival, growth, or fecundity or to extrapolate from this species to the soil invertebrate community as a whole.

Conclusion on classification

According to the CLP regulation, the basis for the identification of a hazard to the aquatic environment for a substance is the aquatic toxicity of that substance. As indiacted in the Guidance of Application of the CLP criteria (Version 4.0 - November 2013), classification for the aquatic environment is predicated on having toxicity data for fish, crustacea, and algae/aquatic plant available. The available acute toxicity information on Perchlorate indicated that the substance is not harmful for algae, daphnia and fish. In addition, long-term toxicity data obtained on these taxa gave NOEC/EC10 > 10 mg/L.

Perchlorate is considered as a non bioaccumulative species regarding results obtained in the frame of experiments equivalent to OECD 305 which is also supported by its intrinsic properties (high water solubility and non complexing agent). As it is an inorganic substance, no data is required for characterizing readily biodegradation potential of Perchlorate.

As a conclusion, Perchlorate is not classified according to classification criteria edicted under CLP regulation.