Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Acute toxicity

Fish

The key study was performed to OECD Guideline No. 203 and EC Method C1.Preliminary solubility work conducted indicated that it was not possible to obtain a testable solution of the test item using traditional methods of preparation e.g. ultrasonication and high shear mixing. A pre-study media preparation trial indicated that a dissolved test item concentration of approximately 3.8 mL (calculated from analysis of dissolved zinc determined as 0.54 mg/L) was obtained from a saturated solution method of preparation indicating this to be the limit of water solubility of this item under test conditions.

Following a preliminary range-finding test, seven fish were exposed to an aqueous solution of test item, at a single concentration of 1.6 mg/L (calculated from analysis of dissolved zinc determined as 0.23 mg/L) for a period of 96 hours at a temperature of approximately 15°C under semi-static test conditions. The test item solution was prepared by stirring an excess (50 mg/L) of test item in test water using a propeller stirrer at approximately 1500 rpm for 24 hours. After the stirring period any undissolved test item was removed by filtration (0.2µm Sartorius Sartpore filter, first approximate 2 litres discarded in order to pre-condition the filter) to produce a saturated solution of the test item. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 3 and 6 hours after the start of exposure and then daily throughout the test until termination after 96 hours.

There were no mortalities in 7 fish exposed to test concentrations of 1.6 mg/L for a period of 96 hours.

There were no sub-lethal effects of exposure observed in the test.

The test concentration of 1.6 mg/L was the highest attainable test concentration that could be prepared due to the limited solubility of the test item in water.

Analysis of the freshly prepared test preparations at 0 and 72 hours showed measured test concentrations to range from 1.27 to 1.90 mg/L (calculated from analysis of dissolved zinc determined to range from 0.18 to 0.27 mg/L). There was no significant change in the measured concentrations at 24 and 96 hours and so the results are based on the average initial measured test concentration only.

The test was considered to be valid given that none of the control fish died or showed signs of stress during the test and the oxygen concentration at the end of the test was ≥60% of ASV (6.1 mg O2/L) in the control and test vessels.

Exposure of Rainbow trout (Oncorhynchus mykiss) to the test item gave an LC50 value based on the average initial measured test concentration of greater than 1.6 mg/L. This study showed that there were no toxic effects at saturation.

Daphnia

In accordance with the Column 2 specific rules for adaptation, an acute toxicity study in aquatic invertebrate species Daphnia is not required as a long-term 21-day reproduction study in this species is available.

Algae

A key study was performed to assess the effect of the test material on the growth of green algae, Scenedesmus subspicatus. The method followed OECD Guideline No 201 and EC Method C3.

Following a preliminary range finding test, Scenedesmus subspicatus was exposed to a Water Accomodated Fraction (WAF) of the test material, at a single nominal loading rate of 100 mg/L (six replicate flasks) for 72 hours under constant illumination and shaking at a temperature of 24 ± 1°C.

The effect of the test material on the growth of Scenedesmus subspicatus gave EL50 values greater than 100 mg/L Loading rate WAF and a corresponding NOELR of 100 mg/L Loading rate WAF. It was considered unnecessary and unrealistic to test loading rates in excess of 100 mg/L.

Sewage sludge micro-organisms

A study was performed to assess the effect of the test item on the respiration of activated sewage sludge. The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals No. 209 "Activated Sludge, Respiration Inhibition Test".

Activated sewage sludge was exposed to an aqueous dispersion of the test item at concentrations of 1,10, 100, 1000 and 10000 mg/L for a period of 3 hours at a temperature of 20 ± 2 deg. C with the addition of a synthetic sewage as a respiratory substrate. The rate of respiration was determined after 3 hours contact time and compared to data for the control and a reference item, 3,5-dichlorophenol.

The effect of the test item on the respiration of activated sewage sludge gave a 3-Hour EC50 value of greater than 10000 mg/Land a No Observed Effect Concentration (NOEC) of 10000 mg/L. The reference item gave a 3-Hour EC50 value of 18.0 mg/L.

Chronic toxicity

Daphnia

A key study was performed to assess the effect of the test material on the reproduction of Daphnia magna over a 21-day period. The method followed that described in the OECD Guidelines for Testing of Chemicals No 211 (1998) "Daphnia magna, Reproduction Test", referenced as Method C.20 of Commission Directive 2001/59/EC (which constitutes Annex V of Council Directive 67/548/EEC).

Based on the results of a preliminary range-finding test, Daphnia magna were exposed (10 replicates of a single daphnid per group) to a Water Accommodated Fraction (WAF) of the test material over a range of loading rates of 1.0, 3.2, 10, 32 and 100 mg/L Loading rate WAF for a period of 21 days. The WAFs were renewed 3 times per week. The numbers of live and dead adult Daphnia and young daphnids (live and dead) were determined daily. The Daphnia were fed daily with an algal suspension.

The 14 and 21-Day EL50* (immobilisation) values, based on nominal loading rates, for the parental Daphnia generation (P1) were calculated to be 53 and 37 mg/L Loading rate WAF with 95% confidence limits of 31 - 120 mg/L and 21 - 75 mg/L Loading rate WAF respectively. The 21-Day EL50* (reproduction) value based on nominal loading rates was calculated to be 20 mg/L Loading rate WAF with 95% confidence limits of 8.7 - 59 mg/L Loading rate WAF. The "Lowest Observed Effect Concentration" was considered to be 10 mg/L Loading rate WAF on the basis that at this test concentration significantly fewer live young per adult ( P<0.05) were produced when compared to the control. The "No Observed Effect Concentration" was considered to be 3.2 mg/L Loading rate WAF on the basis that at this test concentration 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 3.2 mg/L Loading rate WAF test group in terms of numbers of live young produced per adult by Day 21.