Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.1 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1 mg/L

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Additional information

Assessment of the aquatic environment only has been conducted. Assessment of other environmental compartments is not required at this level of supply.

Testing was carried out on the following endpoints using the following guidelines:

Short-term toxicity to fish-OECD Guidelines for Testing of Chemicals (1992) No 203, "Fish, Acute Toxicity Test" referenced as Method C.1 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

Short-term toxicity to aquatic invertebrates- OECD Guidelines for Testing of Chemicals (April 2004) No 202, "Daphniasp, Acute Immobilisation Test" referenced as Method C.2 of Commission Directive 92/69/(which constitutes Annex V of Council Directive 67/548/).

Short-term toxicity to aquatic algae and cyanobacteria -OECD Guidelines for Testing of Chemicals (2006) No 201, "Freshwater Alga and Cyanobacteria, Growth Inhibition Test" referenced as Method C.3 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

Short-term toxicity to microorganisms -OECD Guidelines for Testing of Chemicals (1984) No 209 "Activated Sludge, Respiration Inhibition Test", Method C.11 of EEC Commission Directive 88/302/EEC and US EPA Draft Ecological Effects Test Guidelines OPPTS 850.6800.

The results of the studies are detailed below:

Short-term toxicity to fish

The 96-Hour LL50*based on nominal loading rates was greater than 100 mg/l loading rate WAF and correspondingly the No Observed Effect Loading rate was 100 mg/l loading rate WAF.

It was considered unnecessary and unrealistic to test at loading rates in excess of 100 mg/l.

Analysis of the test preparations at 0 (fresh media), 24 (old media), 72 (fresh media) and 96 hours (old media) showed the measured concentrations to be less than the limit of quantitation (LOQ) of the analytical method with the exception of a measured concentration of 0.864 mg/l at 96 hours for replicate R2.

This does not infer that no test material was in solution but that the dissolved concentration (i.e. bioavailable to the test organisms) was generally below the limit of quantitation which was assessed down to 0.414 mg/l.

The dissolved test material may have been one or several components of the test material. Given that toxicity cannot be attributed to a single component or mixture of components but to the test material as a whole and the dissolved test material was generally below the quantifiable limit of the analytical method, the results were based on nominal loading rates only.


*LL = Lethal Loading rate

Short-term toxicity to aquatic invertebrates

The 48-Hour EL*50for the test material to Daphnia magna based on nominal loading rates was greater than 100 mg/l loading rate WAF and correspondingly the No Observed Effect Loading rate was 100 mg/l loading rate WAF.

It was considered unnecessary and unrealistic to test at loading rates in excess of 100 mg/l.

Analysis of the test preparations at 0 and 48 hours showed measured test concentrations to be less than the limit of quantitation (LOQ) of the analytical method employed which was assessed down to 0.41 mg/l.

Given that the toxicity cannot be attributed to a single component or a mixture of components but to the test material as a whole, and the dissolved test material was below the quantifiable limit of the analytical method, the results were based on nominal loading rates only.

The 48-Hour EC50for the reference material to Daphnia magna based on nominal concentrations was 0.70 mg/l with 95% confidence limits of 0.62 – 0.80 mg/l. The No Observed Effect Concentration was 0.32 mg/l.


*EL = Effective Loading Rate

Short-term toxicity to aquatic algae and cyanobacteria

Exposure of Desmodesmus subspicatus to the test material gave EL*50values of greater than 100 mg/l loading rate WAF and correspondingly the No Observed Effect Loading Rate was 100 mg/l loading rate WAF.

It was considered unnecessary and unrealistic to test at loading rates in excess of 100 mg/l.

Analysis of the test preparations at 0 and 72 hours showed measured test concentrations to be less than the limit of quantitation (LOQ) of the analytical method employed which was assessed down to 0.69 mg/l.

Given that the toxicity cannot be attributed to a single component or a mixture of components but to the test material as a whole, and the dissolved test material was below the quantifiable limit of the analytical method, the results were based on nominal loading rates only.

Exposure of Desmodesmus subspicatus to the reference material, potassium dichromate, gave an ErC50(0 - 72 h) of 0.64 mg/l*, an EyC50 (0 - 72 h) of 0.36 mg/l; 95% confidence limits 0.30 ‑ 0.43 mg/l, and an EbC50(0 - 72 h) of 0.32 mg/l; 95% confidence limits 0.29 - 0.35 mg/l. The Lowest Observed Effect Concentration based on inhibition of growth rate, yield and biomass integral was 0.25 mg/l and the No Observed Effect Concentration was 0.125 mg/l. 


*EL = Effective Loading Rate

*It was not possible to calculate 95% confidence limits for the ErC50value as the data generated did not fit the models available for the calculation of confidence limits.

Short-term toxicity to microorganisms

The effect of the test material on the respiration of activated sewage sludge gave a 3‑Hour EC50of greater than 1000 mg/l. The No Observed Effect Concentration (NOEC) after 3 hours exposure was1000mg/l. It was considered unnecessary and unrealistic to test at concentrations in excess of 1000 mg/l.

The reference material gave a 3-Hour EC50value of 8.5 mg/l, 95% confidence limits 6.8 - 11 mg/l.

Reliability

The above studies have all been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP and were in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Conclusion on classification

The substance is not classified as regards ecotoxicological endpoints. It was found to be non-toxic to fish, aquatic invertebrates and algae and also activated sludge in studies conducted to OECD guidelines.

The substance has a low water solubility, is readily biodegradable (when classified according to the Dangerous Preparations Directive 99/45/EEC)and has a Pow of >6.5, is should not be classified as regards it's possible long-term effects on the aquatic environment.