Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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: 908-084-9 | 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
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 July 2017 - 06 July 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- The analysis was carried out by measuring the concentration of Copper using a suitable ICP method.
Duplicate samples were taken from each replicate at the beginning and at the end of the renewal periods at the applied test concentration levels as well as from the control. Samples were taken in plastic tubes, acidified with pure nitric acid (9 mL sample + 1 mL HNO3) in agreement with the requirements of the Principal
Investigator. To avoid any problems with microparticles, therefore the samples were membrane filtrated before acidification.
After sampling, one set of the samples was stored under test conditions and then sent to the Test Site for analysis. One set of the samples is retained as a back-up at the Test Facility, thus these samples were frozen and kept approximately at -20°C at the Test Facility, if required for any confirmatory analyses - Vehicle:
- no
- Details on test solutions:
- The test item was a multi constituent substance and poorly soluble in water, test solutions were prepared using a saturated solution method (water accommodated fraction, WAF) according to the Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, OECD No. 23.
Saturated test item solutions based on nominal loading rates of 0.125, 0.25, 0.5, 1.0 , 2.0, 4.0 and 8.0 mg/L (WAFs)] were prepared individually by dispersing/dissolving the amount of test item into the test medium (ISO Medium) two days before the start of the test. These solutions were shaken for about 24 hours at approximately 30°C and then equilibrated for about 24 hours at approximately 20°C. The non-dissolved test material was removed by filtration through a fine (0.22 μm) filter to give appropriate nominal loading rates.
As the lowest concentration cannot be prepared individually with a sufficient precision, therefore it was prepared from a serial dilution of the next concentration level (0.125 mg/L WAF) to give the 50 % saturated solution of 0.125 mg/L nominal loading rate WAF (200.0 mL 0.125 mg/L WAF solution was diluted with ISO Medium up to 400 mL).
Test solutions were prepared just before introduction of the Daphnia (start of treatments).
In absence of stability data the test was performed under semi-static conditions. The frequency of the water renewal periods was 24 hours. Prior to the treatment of the renewal periods the test item solutions were prepared by the method described above.
A vehicle control group consisting of untreated dilution water was also assessed. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Daphnia magna
Justification of strain: Daphnia magna is the standard species of the acute immobilisation test.
They were less than 24 h old at the beginning of the test.
There were 20 animals in test group and control group respectively, divided into 4 replicates (5 animals / replicate)
There was no acclimatization because the water used was similar to the culture water.
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 248 mg/L (as CaCO3)
- Test temperature:
- 20.4 – 20.8°C
- pH:
- 7.43 – 7.76
- Dissolved oxygen:
- 7.0 – 8.6 mg/L.
- Salinity:
- -
- Conductivity:
- -
- Nominal and measured concentrations:
- WAF, Nominal loading rates = 0.125, 0.25, 0.5, 1.0, 2.0, 4.0, and 8.0 mg/L. A test group at 50% of the concentration of the 0.125 mg/L loading level was also tested.
Measured concentrations were below the limit of qauanitiation (0.15 mg/L) for all test groups at each timepoint. - Details on test conditions:
- The test duration was 48 hours. Twenty animals, divided into four groups (glass beaker) of five animals each (at least 5 mL test solution/animal) were used at the test concentration and for the control group as well.
In absence of stability data the test was performed under semi-static conditions. The frequency of the water renewal periods was 24 hours. The animals were not fed during the test.
- Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- 1.99 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- The 24h EL50 value: 4.68 mg/L nominal loading rate WAF (95 % conf. limits: 3.61 – 6.56 mg/L nominal loading rate WAF)
The 48h EL50 value: 1.99 mg/L nominal loading rate WAF (95 % conf. limits: 1.69 – 2.35 mg/L nominal loading rate WAF)
The 48h EL100 value: 4.0 mg/L nominal loading rate WAF
The 48h No-Observed Effect Loading Rate (NOELR): 1.0 mg/L nominal loading rate WAF
The 48h Lowest Observed Effect Loading Rate (LOELR): 2.0 mg/L nominal loading rate WAF - Results with reference substance (positive control):
- The 24h EC50: 0.64 mg/L, (95 % confidence limits: 0.59 – 0.68 mg/L)
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of this Daphnia magna acute immobilisation study the observed endpoints for the effect of B331 was the following:
The 24h EL50 value: 4.68 mg/L nominal loading rate WAF (95 % conf. limits: 3.61 – 6.56 mg/L nominal loading rate WAF)
The 48h EL50 value: 1.99 mg/L nominal loading rate WAF (95 % conf. limits: 1.69 – 2.35 mg/L nominal loading rate WAF)
The 48h EL100 value: 4.0 mg/L nominal loading rate WAF
The 48h No-Observed Effect Loading Rate (NOELR): 1.0 mg/L nominal loading rate WAF
The 48h Lowest Observed Effect Loading Rate (LOELR): 2.0 mg/L nominal loading rate WAF
Reference
Description of key information
Daphnia magna, 48 hours: EL50 = 1.99 mg/L; NOELR = 1.0 mg/L
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 1.99 mg/L
Additional information
An acute daphnia immobilisation study was conducted (CiToxLAB Hungary, 2017) to assess the short-term effects of B331 on aquatic invertebrates. The study was conducted according to OECD test guideline 202 and EC method C2, and in compliance with GLP. The test media was prepared as a water accomodated fraction (WAF) with nominal loading rates of (50% saturated solution at 0.125 mg/L loading), 0.125, 0.25, 0.5, 1.0, 2.0, 4.0 and 8.0 mg/L; a concurrent vehicle control group (untreated dilution water) was used. Test media were replaced every 24 hours.
Analysis of the test solutions in all dose levels at each sampling timepoint revealed the test material concentration to be below the limit of quantitation of 0.15 mg/L (measured for copper concent by ICP-AES; LoQ = 0.013 mg Cu/L).
Daphnia were found immobilised in the 2.0, 4.0 and 8.0 mg/L loading rate levels at 24 and 48 hours. The 48 hour EL50 was 1.99 mg/L. The 48 hour NOELR was 1.0 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.