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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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:
- From 2013-05-28 to 2013-07-25
- 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)
- Version / remarks:
- (Adopted: 13 April 2004)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Testing Methods for New Chemical Substances, 2011.03.31, No. 0331-07, Ministry of Health, Labor and Welfare; 2011.03.29 No 5, Ministry of Economy, Trade and Industry; No. 110331009, Ministry of Environment, Japan; V. Daphnids acute immobilization test.
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Analytical purity: 100%
- Lot/batch No.: KNC110310 - Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: control, 10, 18, 32, 56, 100 mg/L
- Sampling method: An aliquot was taken from the remaining unused test solution of each test group at initiation and termination of the test. The samples were taken from mid-depth of each replicate without agitation. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A 0.12 g aliquot of a test substance was weighted. A stock solution was prepared by mixing the test substance with dilution water to volume 120 mg/L. Each test solution was prepared by diluting appropriate volumes of stock solution with the dilution water to volume 500 mL.
- Eluate: no
- Differential loading: no
- Controls: yes, test medium control - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Source: in-house culture (originally obtained from National Institute for Environmental Studies, Japan (Independent Administrative Institution): 28 Oct 1996)
- Age at study initiation: < 24 hours; females
- Feeding during test: none
ACCLIMATION
- Parental acclimation period: 14 d
- Parental acclimation conditions (same as test or not): same as test
- Type and amount of food: Commercial condensed live Chlorella vulgaris and YCT (suspended solution of yeast, dried alfalfa and Tetramin); amount: 0.1 - 0.2 mg C/daphnid/day depending on their reproductive activity.
- Health during acclimation (any mortality observed): mortality was below 5% (practically 3.8%) - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 230 mg CaCO3/L, measured by Total hardness test kit HA-DT (HACH COMPANY Ltd.)
- Test temperature:
- 20.0 - 20.8 °C, measured by Water temperature meter CT-460WR (Custom Corporation)
- pH:
- 7.9, measured by pH meter D-51 (Horiba Ltd.)
- Dissolved oxygen:
- 8.4 - 8.6 mg/L, measured by DO meter Model 58 (YSI/Nanotech Inc.)
- Nominal and measured concentrations:
- Nominal: 0, 10, 18, 32, 56, 100 mg/L
Measured: 0, 10, 18, 32.3, 56.0, 100 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 mL glass beakers closed with a lid (100 mL fill volume)
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: artificial dilution water, Elendt M4.
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light / 8 h dark
- Light intensity: room lightning (6.18 - 9.22 µE/m²/s)
EFFECT PARAMETERS MEASURED: mobility and toxic symptoms after 24 and 48 h; DO and pH of the test solutions in all groups measured at initiation and termination of the exposure.
TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 0, 10, 32, 100 mg/L
- Results used to determine the conditions for the definitive study: As the 48 hour EC50 in the range finding test was found to be around 100 mg/L, the definitive test was conducted at nominal concentrations of 10, 18, 32, 56 and 100 mg/L with a spacing factor of 1.8. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: Immobilization was not observed, apart from the concentration 100 mg/L after 48 hours where immobilization reached 20%.
- Mortality of control: none
- Abnormal responses: Decrease of spontaneous swimming was observed at 32 mg/L and above after 48 h exposure. - Results with reference substance (positive control):
- EC50 (48h): 0.84 mg/L. The reference substance was tested in a 6-month interval.
- Reported statistics and error estimates:
- Immobilization rates (%) were calculated for each test group by dividing number of immobile daphnids by number of daphnids tested. A computer program (StatLight#08 regression analysis, version 2.00, Yukms Co., Ltd.) is used to perform the statistical analyses including Probit, Moving average or Binomial method.
- Validity criteria fulfilled:
- yes
- Conclusions:
- A 48-hour median effect concentration (EC50) of test item for Daphnía magna was >100 mg/L based on the mean measured concentration.
- Executive summary:
A 48-hour EC50 of test item for Daphnía magna was determined from an acute immobilization test based on OECD 202. A static definitive test was conducted at nominal concentrations of 10, 18, 32, 56 and 100 mg/L with a spacing factor of 1.8 according to the results of a range finding test.
Abnormal swimming (decrease of spontaneous swimming) was observed at 32.3 mg/L and above after 48-hour exposure.
Immobilization rates at 10.0, 18.0, 32.3, 56.0 and 100 mg/L were 0, 0, 0, 0 and 20%, respectively, after 48-hour exposure.
Therefore, 48-hour median effect concentration (EC50) of test item for Daphnía magna was >100 mg/L based on the mean measured concentration.
Reference
Table 1: Immobilization rate of Daphnia magna
Immobilization [%] | ||
Nominal concentration [mg/L] | 24 hours | 48 hours |
0 | 0 | 0 |
10 | 0 | 0 |
18 | 0 | 0 |
32 | 0 | 0 |
56 | 0 | 0 |
100 | 0 | 20 |
The measured test concentrations were in the range of 100 - 101% of nominal.
Description of key information
The acute toxicity of test item for Daphnía magna was determined from an acute immobilization test based on OECD 202. The 48-hour median effect concentration (EC50) of test item for Daphnía magna was >100 mg/L based on the mean measured concentration.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 100 mg/L
Additional information
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.