Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
1 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
10 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/).

Long-term toxicity to aquatic invertebrates- OECD Guidelines for Testing of Chemicals No 211 (1998) "Daphnia magna, Reproduction Test", referenced as Method C.20 of Commission Regulation (EC) No. 440/2008.

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 LL*50based 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 freshly prepared test media at 0 and 72 hours showed measured test concentrations to range from 0.0054 to 0.192 mg/l. Analysis of the old or expired test media at 24 and 96 hours showed measured concentrations to range from less than the limit of quantitation (LOQ) of the analytical method, (which was determined to be 0.00044 mg/l) to 0.00981 mg/l. 

Given that the toxicity cannot be attributed to a single component or a mixture of components but to the test item as a whole, the results were based on nominal loading rates only.


*LL = Lethal Loading rate

Short-term toxicity to aquatic invertebrates

The 48-Hour EL*50 for the test material to Daphnia magna based on nominal loading rates was greater than 100 mg/l loading rate WAF and the No Observed Effect Loading rate was 56 mg/l loading rate WAF.

Chemical analysis of the control and 1.0, 3.2, 10, 32 and 100 mg/l loading rate WAFs at 0 and 48 hours showed measured samples ranging from less than the Limit of Quantitation (LOQ) of the analytical method (which was determined to be 0.0024 mg/l) to 0.421 mg/l.

Samples of the control and 1.0, 3.2, 10, 32 and 100 mg/l loading rate WAFs were taken at 0 (fresh media) and 48 hours (old media) for Total Organic Carbon (TOC). Given the background level of carbon in the control vessels and also the low level of carbon in the test vessels, it was considered that all the results were around the limit of quantitation of the analytical method.

Therefore, given that 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 around 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 0.78 mg/l with 95% confidence limits of 0.68 – 0.88 mg/l. The No Observed Effect Concentration was 0.32 mg/l.


*EL = Effective Loading rate

Long-term toxicity to aquatic invertebrates

The 21-Day EL*50 (immobilisation) value, based on nominal loading rates, for the parentalDaphniageneration (P1) was estimated to be greater than 100 mg/l loading rate WAF.

The 21-Day EL*50 (reproduction) value based on nominal loading rates was estimated to be greater than 100 mg/l loading rate WAF.

The "Lowest Observed Effect Loading rate" was considered to be greater than 100 mg/l loading rate WAF on the basis that at this loading rate no significant mortalities (immobilisation) were observed in the parental generation (P1) and that there were no significant differences (P>=0.05) between the control and the 100 mg/l loading rate WAF test group in terms of numbers of live young produced per adult by Day 21.

The "No Observed Effect Loading rate" was considered to be 100 mg/l loading rate WAF on the basis that at this loading rate there were no significant mortalities (immobilisation) observed in the parental generation (P1) and that there were no significant differences (P>=0.05) between the control and the 100 mg/l loading rate WAF test group in terms of numbers of live young produced per adult by Day 21.

Analysis of the freshly prepared test concentrations on Days 0, 5, 9 and 19 showed measured concentrations to range from less than the limit of quantitation (assessed as 0.00044 mg/l) to 0.0258 mg/l. Analysis of the old or expired media on Days 2, 7, 12 and 21 showed measured concentrations to range from less than the limit of quantitation to 0.0254 mg/l. The dissolved test item may have been one or several components of the test item. Given that toxicity cannot be attributed to a single component or mixture of components but to the test item as a whole, the results were based on nominal loading rates only.

Short-term toxicity to aquatic algae and cyanobacteria

Exposure of Desmodesmus subspicatus to the test material gave EL*50 values 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 hours showed measured test concentrations to range from 0.13 to 0.15 mg/l. A slight decline in measured test concentrations was observed at 72 hours in the range of 0.067 to 0.12 mg/l. This decline was in line with the preliminary stability analyses conducted which indicated that the test material was unstable in culture medium over the test period at a concentration of 0.10 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, the results were based on nominal loading rates only.


*EL = Effective Loading Rate

Short-term toxicity to microorganisms

The effect of the test material on the respiration of activated sewage sludge gave a 3-Hour EC50 of greater than 320 mg/l. The No Observed Effect Concentration (NOEC) after 3 hours exposure was320mg/l.

The reference material gave a 3-Hour EC50value of 7.9 mg/l, 95% confidence limits
6.1 - 10 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 acute toxicity studies conducted to OECD guidelines.

The substance is not classified according to the CLP. It is not acutely toxic, and a Daphnia reproduction study has demonstrated that there are no long-term adverse effects in the aquatic environment.

The substance is not classified according to the Dangerous Substances Directive as there is an absence of chronic effects at the solubililty limit e.g. the no-observed effect concentration (>100 mg/l) is greater than the solubility limit determined in a prolonged toxicity sudy with Daphnia.