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Diss Factsheets
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EC number: 946-364-2 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Toxicity to fish
The acute toxicity of the test substance towards towards rainbow trout (Oncorhynchus mykiss) was determined according to OECD Guideline 203 and EU Method C.1 in compliance with GLP (Sacker, 2015(a)).
In accordance with the recommendations of REACH, the test was conducted according to the threshold approach recommended by ECHA. Using this approach the lowest EL50value from either the Algal Growth Inhibition study or Acute Toxicity to Daphnia magna study is set as the threshold loading rate and a "Limit test" is conducted at this threshold loading rate. If no mortalities are observed this indicates that fish are not the most sensitive species and that the LL50is greater than the threshold loading rate.
Therefore seven fish were exposed to a Water Accommodated Fraction (WAF) of the test material, at a single nominal loading rate of 100 mg/L for a period of 96 hours at a temperature of approximately 14°C to 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.
The 96-Hour LL50(Lethal Loading rate) 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.
Toxicity to aquatic invertebrates
In the key study, the toxicity of the test item under static conditions was investigated by Sacker, 2015(b) in accordance with OECD Guideline 202 under GLP compliance. Following a preliminary range-finding test, twenty daphnids (four replicates of five animals) were exposed to a Water Accommodated Fraction (WAF) of the test item, at a single nominal loading rate of 100 mg/L for 48 hours at a temperature of 21 °C to 22 °C under static test conditions. Immobilisation and any adverse reactions to exposure were recorded after 24 and 48 hours. The EL50 (48h) for 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.
Toxicity to aquatic algae
A study (Vryenhoef, 2016) was performed to assess the effect of the test item on the growth of the green algae Pseudokirchneriella subcapitata. The method followed was designed to be compatible with the OECD Guideline 201 referenced as EU Method C.3.
Following a preliminary range-finding test, Pseudokirchneriella subcapitata was exposed to a Water Accommodated Fraction (WAF) of the test item, 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.
Analysis of the 100 mg/L loading rate WAF test preparations at 0 and 72 hours showed measured test concentrations of less than the limit of quantification (LOQ) of the analytical method which was determined to be 0.19 mg/L. This does not infer that no test item was in solution, just that any dissolved test item was at a concentration of less than the LOQ.
Exposure of Pseudokirchneriella subcapitata to the test item gave ErL50 values and EbL50 of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading Rate referring to growth rate and yield (biomass) was 100 mg/L loading rate WAF.
No effects (size differences, unusual cell shapes) were noted during the test.
Toxicity to aquatic microorganisms
The test item was used in an experiment according to OECD Guideline 209 by Best, 2015 (A).
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 a temperature of approximately 19 °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 EC50value of greater than 1000 mg/L. The No Observed Effect Concentration (NOEC) after 3 hours exposure was 1000 mg/L.
Additional information
General considerations
Ecotoxicological investigations were performed for the substance itself via experimental data concerning toxicity towards fish, aquatic invertebrates (daphnia), algae and bacteria.
Based on the intrinsic properties of the test item, Water Accommodated Fractions (WAFs) were prepared for testing (except for toxicitx toward bacteria). This procedure is in accordance with the OECD Guidance document on aquatic toxicity testing of difficult substances and mixtures (Series on testing and assessment - Number 23; OECD, 2000). The term WAF is applied to aqueous media containing only the fraction of multi-component substances that is dissolved and / or present as a stable dispersion or emulsion. These fractions are prepared individually and not by serial dilution of a single stock WAF. As the term indicates, only a fraction of the total mass of multi-component substances responsible for the composition may be present in the WAF. The "loading rate" is the mass to volume ratio of the mixture to medium used in the preparation. The obtained LL50/ EL50 values are comparable to LC50/ EC50 values, as well as the NOELR (No Observable Effect Loading Rate) to NOEC (No Observable Effect Concentration).
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.
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