Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Fish
OECD 203 Fish, Acute Toxicity Test
Exposure of rainbow trout to the test item gave LL50 values of greater than 1.0 mg/L loading rate WAF. The No Observed Effect Loading Rate was 1.0 mg/L loading rate WAF. The study showed that the test item was not toxic to rainbow trout at a concentration in excess of the water solubility of the substance.
Daphnia
OECD 202 Daphnia sp., Acute Immobilisation Test
Exposure of Daphnia magna to the test item gave EL50 values of greater than 1.0 mg/L loading rate rate WAF. The No Observed Effect Loading Rate was 1.0 mg/L loading rate WAF. This study showed that the test item was not toxic to Daphnia magna at a concentration in excess of the water solubility.
Algae
OECD 201 Freshwater Alga and Cyanobacteria, Growth Inhibition Test
Exposure of Pseudokirchneriella subcapitata to the test item gave ErL50 (0 -72 h) 0.51 mg/L loading rate WAF. However, it was not possible to calculate 95 % confidence limits for the ErL50 value as the data generated did not fit the models available for calculation of confidence limits. The No Observed Effect Loading Rate (NOEL) based on growth rate was 0.10 mg/L loading rate WAF and the Lowest Observed Effect Loading Rate (LOEL) based on growth rate was 0.32 mg/L loading rate WAF.
Exposure of Pseudokirchneriella subcapitata to the test item gave EyL50 (0 -72 h) 0.34 mg/L loading rate WAF (95 % confidence limits 0.29 -0.39 mg/L loading rate WAF). The No Observed Effect Loading Rate (NOEL) based on yield was 0.10 mg/L loading rate WAF and the Lowest Observed Effect Loading Rate (LOEL) based on yield was 0.32 mg/L loading rate WAF.
Sewage sludge microorganisms
OECD 209 Activated Sludge, Respiration Inhibition Test (Carbon and Ammonium Oxidation).
The effect of the test item on the respiration of activated sewage sludge microorganisms gave a 3 hour EC50 value of greater than 1000 mg/L and a 3 hour EC10 value of 750 mg/L. The No Observed Effect Concentration (NOEC) after 3 hours exposure was between 100 and 1000 mg/L.
Additional information
Fish
A key study was performed to assess acute toxicity of the test item to rainbow trout (Oncorhynchus mykiss). The method was designed to be compatible with the OECD Guidelines for Testing of Chemicals (1992) No 203 "Fish, Acute Toxicity Test" referenced as Method C.1 of Commission Regulation (EC) No. 440/2008.
Due to the low aqueous solubility and complex nature of the test item, the test medium was prepared as a Water Accommodated Fraction (WAF).
Following a preliminary range-finding test, seven fish were exposed to a Water Accommodated Fraction (WAF) of the test item, at a single nominal loading rate of 1.0 mg/L for a period of 96 hours at a temperature of approximately 15 °C under semi-static test conditions. 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.
Chemical analysis of the freshly prepared 1.0 mg/L loading rate test preparation at 0 and 72 hours showed that measured concentrations of 0.143 and 0.0923 mg/L were obtained respectively. Analysis of the old or expired test preparations at 24 and 96 hours showed that measured concentrations of 0.0774 and 0.0714 mg/L were obtained respectively.
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 rate only.
Exposure of rainbow trout to the test item gave LL50 values of greater than 1.0 mg/L loading rate WAF. The No Observed Effect Loading Rate was 1.0 mg/L loading rate WAF. The study showed that the test item was not toxic to rainbow trout at a concentration in excess of the water solubility of the substance.
Daphnia
Acute toxicity of the test item to Daphnia magna was assessed in a key study designed to be compatible with the OECD Guidelines for Testing of Chemicals (April 2004) No 202 "Daphnia sp., Acute Immobilisation Test" referenced as Method C.2 of Commission Regulation (EC) No 440/2008.
Due to the low solubility and complex nature of the test item, for the purposes of the test, the test medium was prepared as a Water Accommodated Fraction (WAF).
Following a preliminary range-finding test, twenty daphnids (4 replicates of 5 animals) were exposed to a Water Accomodated Fraction (WAF) of the test item at a nominal loading rate of 1.0 mg/L for 48 hours at a temperature of approximately 21°C under static test conditions. The number of immobilised Daphnia and any adverse reactions to exposure were recorded after 24 and 48 hours.
Chemical analysis of the fresh 1.0 mg/L loading rate test preparation at 0 hours showed that a measured test concentration of 0.244 mg/L was obtained. Chemical analysis of the aged test preparation at 48 hours showed a measured test concentration of 0.0989 mg/L was obtained.
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.
Exposure of Daphnia magna to the test item gave EL50 values of greater than 1.0 mg/L loading rate rate WAF. The No Observed Effect Loading Rate was 1.0 mg/L loading rate WAF. This study showed that the test item was not toxic to Daphnia magna at a concentration in excess of the water solubility.
Algae
A key study was performed to assess the effect of the test item on the growth of the green alga Pseudokirchneriella subcapitata. The method was designed to be compatible with the OECD Guidelines for Testing of Chemicals (2006) No 201, "Freshwater Alga and Cyanobacteria, Growth Inhibition Test" referenced as Method C.3 of Commission Regulation (EC) 761/2009.
Due to the low aqueous solubility and complex nature of the test item, a Water Accommodated Fraction (WAF) was prepared.
Following a preliminary range-finding test,Pseudokirchneriella subcapitatawas exposed to Water Accomodated Fractions (WAFs) of the test item over a range of nominal loading rates of 0.10, 0.32 and 1.0 mg/L (three replicates per concentration) for 72 hours, under constant illumination and shaking at a temperature of 24± 1°C.
Samples of the algal populations were removed daily and cell concentrations determined for each control and treatment group using a Coulter multisizer particle counter.
Analysis of the test preparations at 0 hours showed that measured test concentrations ranged from 0.014 to 0.14 mg/L. A decline in measured concentration was observed at 72 hours in the range 0.0076 to 0.043 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.
Exposure of Pseudokirchneriella subcapitata to the test item gave ErL50 (0 -72 h) 0.51 mg/L loading rate WAF. However, it was not possible to calculate 95 % confidence limits for the ErL50 value as the data generated did not fit the models available for calculation of confidence limits. The No Observed Effect Loading Rate (NOEL) based on growth rate was 0.10 mg/L loading rate WAF and the Lowest Observed Effect Loading Rate (LOEL) based on growth rate was 0.32 mg/L loading rate WAF.
Exposure of Pseudokirchneriella subcapitata to the test item gave EyL50 (0 -72 h) 0.34 mg/L loading rate WAF (95 % confidence limits 0.29 -0.39 mg/L loading rate WAF). The No Observed Effect Loading Rate (NOEL) based on yield was 0.10 mg/L loading rate WAF and the Lowest Observed Effect Loading Rate (LOEL) based on yield was 0.32 mg/L loading rate WAF.
Sewage sludge microorganisms
A study was performed to assess the effect of the test item on the respiration of activated sewage sludge. The method was designed to be compatible with OECD Guidelines for Testing of Chemicals (2010) No 209 "Activated Sludge, Respiration Inhibition Test (Carbon and Ammonium Oxidation).
Activated sewage sludge was exposed to an aqueous dispersion of the test item at concentrations of 10, 100 and 1000 mg/L (3 replicates of the 1000 mg/L test concentration) for a period of 3 hours at temperature of 19 to 21°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 microorganisms gave a 3 hour EC50 value of greater than 1000 mg/L and a 3 hour EC10 value of 750 mg/L. The No Observed Effect Concentration (NOEC) after 3 hours exposure was between 100 and 1000 mg/L.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
