Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
2.37 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.237 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
2.84 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
0.833 mg/kg food
Assessment factor:
300

Additional information

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, "Daphnia sp, Acute Immobilisation Test" referenced as Method C.2 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

Short-term toxicity to aquatic algae and cyanobacteria- OECD Guidelines for Testing of Chemicals (1984) No 201, "Alga, 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", EEC Commission Directive 87/302/EEC and US EPA Draft Ecological Effects Test Guidelines OPPTS 850.6800.

Long-term toxicity to aquatic invertebrates- OECD Guideline 211 (Daphnia magna Reproduction Test)

The results of these studies are detailed below:

Short-term toxicity to fish

Analysis of the fresh and old test media preparations over the 96 hour study duration showed the measured test concentrations to be within the range of 80% to 101% of nominal for the unfiltered test media (a single exception was noted) and within a range of 1% to 16% of nominal for the filtered test samples.

The measured concentrations of the unfiltered media indicate both the amount of dispersed and dissolved test material in the test system, whereas the measured values from the filtered media show the amount of test material which was in solution and hence bioavailable to the test fish. It was therefore considered appropriate to base the results on the time-weighted mean measured test concentrations of the unfiltered media in order to give a worst case analysis of the data.

The 96 -Hour LC50 based on the time-weighted mean measured test concentrations of the filtered media was greater than 0.027 mg/l and correspondingly the No Observed Effect Concentration (NOEC) was 0.027 mg/l.

Short-term toxicity to aquatic invertebrates

Analysis of the unfiltered media showed measured values of 72% and 67% of nominal at 0 hours and 82% and 8 0% at 48 hours. The low results shown for the 0 hour test samples were considered to be due to the problems associated with sampling and analysis of dispersions at low test concentrations in a complex biological system. Analysis of frozen duplicate samples showed lowered measured values from those originally obtained. This was considered to be due to losses during storage and thawing prior to analysis. Analysis of the filtered test media showed measured test concentrations of 3% of nominal at 0 hours and 6% of nominal at 48 hours.

The results shown from analysis of the unfiltered media indicate both the amount of dispersed and dissolved test material in the test system, whereas the measured values from the filtered media indicate the amount of dissolved test material which was bioavailable to the test organisms. It was therefore considered appropriate to base the results on the time-weighted mean measured test concentrations of the filtered test media in order to give a "worst case" analysis of the data.

The 48 -hour EC50 based on the time-weighted mean measured test concentration of the filtered test media was greater than 0.032 mg/l and correspondingly the NOEC was 0.032 mg/l.

Short-term toxicity to aquatic algae and cyanobacteria

Analysis of the test solutions at 0 hours showed measured values of 104% and 87% of nominal for the unfiltered samples abd 3% and 4% of nominal for the filtered samples.

Analysis of the test solutions at 72 hours showed measured values of 65% and 87% of nominal for the unfiltered samples abd 4% and 6% of nominal for the filtered samples.

The measured concentrations of the unfiltered samples indicate the amount of test material which is both dispersed abd dissolved in the test system. The filtered samples indicate the amount of test material in solution and ths bioavailable to the algae. It was therefore considered justifiable to base the results on the time-weighted mean measured test concentration of the filtered test material in order to give a "worst case" analysis of the data.

The EC50 values based on the time-weighted mean measured test concentrations were greater than 0.031 mg/l and correspondingly the NOEC was 0.031 mg/l.

Short-term toxicity to microorganisms

In the single test vessel prepared using a preliminary solution in auxillary solvent to give a test concentration of 0.80 mg/l (the limit of visual solubility) no significant inhibition of the respiration rate of activated sewage sludge was observed and hence the 3 hour EC50 value was determined to be greater than 0.80 mg/l. Correspondingly the NOEC determined from this vessel was 0.80 mg/l. These results show that at the limit of visual solubility of the test material, the test material has no effect on the respiration rate of activated sewage sludge.

The effect of the test material on the respiration rate of activated sewage sludge at concentrations in excess of the visual solubility of the test material was also assessed using a single test concentration of 1000 mg/l prepared by direct dispersion of the test material in water with the aid of ultrasonication. At a test concentration in excess of the visual solubility level of the test material inhibition of the activated sewage sludge did not occur and the 3 -hour EC50 value was determined to be greater than 1000 mg/l. correspndingly, the NOEC was determined to be 1000 mg/l. These results show that at a concentration in excess of the visual solubility level of the test material, the test material does not have an effect on the respiration rate of activated sewage sludge.

Long-term toxicity to aquatic invertebrates

The test concentration in the following is shown in the time-weighted mean (0.00077 mg/L) of the test item concentrations measured during the exposure.

Observation of daphnid

Mortality of parent animal

No mortality of it was obtained in the control, and the mortality was 0% which met the criterion for the validity of the test (i.e. not exceed 20%).

In the test concentration level, no mortality of it was obtained and it was no difference in comparison with the control.

Time to production of first brood

The mean time to it in the control was 8.1 days. It in the test concentration level was 8.1 days which showed no significant difference compared to that in the control.

Mean cumulative number of live offspring

The mean cumulative number of live offspring per parent animal for 21 days in the control was 201, which met the criterion for the validity of the test, i.e. >60.

It in the test concentration level was 200which showed no significant compared to that in the control.

General condition of parent animal

During the exposure, growth inhibition, abnormal behavior, and abnormal appearance were observed in the control and test concentration level.

Appearance of ephippium etc.

In the control and test concentration level during the exposure, no aborted eggs but a few aborticide eggs, and a dead offspring were observed.

Observation and measurement of test solution

Appearance of test solution

At the start of the exposure, the test solution was colourless and clear. The appearance before the renewal was light green by feeding chlorella

Condition of test solutions

The measured value of temperature of test solutions ranged from 20.1 to 20.39C, which were within the range of 20±1°C. Dissolved oxygen concentration ranged from 8.7 to 9.0 mg/L, which exceeded 3 mg/L. The pH ranged from 8.1 to 8.5, which were within the range of 6 to 9 and within the variation of 1.5. Total hardness ranged from 167.1 to 169.5 mg/L, which exceeded 140 mg/LCaC03/L light intensity was 15 /μE m-2 s-1, which was below the range of 15 to 20 μE m-2 s-1. These values of water temperature, dissolved oxygen concentration, pH, total hardness, and light intensity were within the appropriate range as environmental condition.

Test item concentration in test solution

The measured concentrations of the test item (dissolved concentration of the test item) in the test solutions ranged from 0.000088 to 0.00074 mg/L at the preparation, and ranged from 0.00047 to 0.0030 mg/L at before the renewal or the end of the exposure.

On the other hand, the test solution used in the study included insoluble test item, which measured concentration ranged from 0.0066 to 0.045 mg/L at the preparation and ranged from 0.0043 to 0.037 mg/L at before the renewal or the end of the exposure.

LC50 for parent animal

Both the 14-day and 21-day LC50S were >0.00077 mg/L

EC50 for reproduction

Both the 14-day and 21-day EC50S were >0.00077 mg/L.

LOEC and NOEC for reproduction

For 21-day daphnid reproduction, the LOEC was not obtained and the NOEC was >0.00077 mg/L

Reliability.

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

Conclusion on classification

The submission substance cannot be classified as toxic to aquatic organisms or activated sludge, as the EC50 values obtained in the short term studies and the NOEC in the long term test are all limit, which are meaningless as regards classification.

The PNEC data available for the substance are all based on the lowest attainable exposure solutions in the relevent studies. As the substance is water insoluble, however, and no evidence of toxicity observed at the limit of solubility the true PNEC values will exist at undeterminable concentrations higher than the values stated above.