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Diss Factsheets
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EC number: 210-259-3 | CAS number: 611-20-1
- 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
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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:
- weight of evidence
- Study period:
- 10 May 2010 - 13 May 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- yes
- Remarks:
- No analytical monitoring
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- yes
- Remarks:
- No analytical monitoring
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- no
- Details on sampling:
- Not applicable
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock solution of nominal 46 mg/L was prepared by dissolving 46.1 mg of test item in 1000 mL of test water using ultrasonic treatment for 15 minutes and intense stirring for 15 minutes. This was diluted with test water to produce the range of test item concentrations.
- Controls: Blank control (test water only). Potassium dichromate is tested as a positive control twice a year.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): No - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Strain: Clone 5
- Source: In lab culture, original source University of Sheffield / UK in 1992
- Age at study initiation (mean and range, SD): 6-24 hours
- Feeding during test: no
ACCLIMATION
- Acclimation period: Breeding conditions same light and temperature conditions as test. Parental daphnids maintained in test water for ≤ 48 hours prior to test start
- Acclimation conditions (same as test or not): Yes - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- None
- Hardness:
- 150 mg CaCO3/L
- Test temperature:
- 20-21°C
- pH:
- 7.0 - 7.8
- Dissolved oxygen:
- 8.0 - 8.5 mg/L
- Salinity:
- Not applicable
- Nominal and measured concentrations:
- Nominal concentrations: Control, 1.0, 2.2, 4.6, 10, 22, 46 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Beakers
- Type (delete if not applicable): closed (covered with glass plates)
- Material, size, headspace, fill volume: 250 mL glass beakers filled with 125 mL of test medium
- Aeration: Prior to test but not during.
- 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: Reconstituted test water (analytical grade salts dissolved in purified water) according to ISO 6341, with hardness lowered to meet OECD and EPA guideline requirements.
- Intervals of water quality measurement: Beginning and end of test. Appearance of test media also evaluated at 24 hours.
OTHER TEST CONDITIONS
- Adjustment of pH: None reported
- Photoperiod: 16:8 light/dark cycle with 30 minute transition period.
- Light intensity: 520-680 Lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobility. Daphnids considered immobile if they do not swim after 15 seconds of gentle agitation.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.15
- Range finding study: Yes
- Results used to determine the conditions for the definitive study: Yes - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate, tested twice a year
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 40 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% CL: 30 - 73 mg/L
- Duration:
- 24 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 18 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% CL: 14-24 mg/L
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 4.6 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- See table 1.
- Results with reference substance (positive control):
- Most recent test (March 2010, study C86933) reported an EC50 of 0.43 mg potassium dichromate/L. This demonstates the senstivity of the test organisms and is within the internal historical range (0.43 - 1.1 mg/L)
- Reported statistics and error estimates:
- 24- and 48-hour EC50s and 95% confidence limites calculated by Probit analysis.
NOEC determined directly from the raw data. - Validity criteria fulfilled:
- yes
- Remarks:
- Mortality in controls <10%; DO levels at end of test > 3 mg/L
- Conclusions:
- The 48-EC50 for Daphnia magna exposed to the test material was determined to be 18 mg/L. The 48-hour NOEC was determined to be 4.6 mg/L
- Executive summary:
The sensitivity of Daphnia magna to the substance was determined in a GLP-compliant test performed to standard guidelines. The 48-hour EC50 was found to be 18 mg/L with 95 % confidence intervals of 14 - 24 mg/L. The 48-hour NOEC was determined to be 4.6 mg/L. All results are based on nominal concentrations.
Reference
Table 1. Effect of the substance on the Mobility of Daphnia magna
Nominal test item concentration (mg CA3688A/L) |
No. of daphnids tested | Immobilized daphnids after 24 hours | Immobilized daphnids after 48 hours | ||
No. | % | No. | % | ||
Control | 20 | 0 | 0 | 0 | 0 |
1 | 20 | 0 | 0 | 0 | 0 |
2.2 | 20 | 0 | 0 | 0 | 0 |
4.6 | 20 | 0 | 0 | 0 | 0 |
10 | 20 | 0 | 0 | 6 | 30 |
22 | 20 | 7 | 35 | 11 | 55 |
46 | 20 | 10 | 50 | 18 | 90 |
Description of key information
EC50=18mg/L, 48h, Daphnia magna, OECD 202, Höger 2010
EC50=19.8mg/L, 48h, Ceriodaphnia cf. dubia, no guideline, Westbury 2004
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 18 mg/L
Additional information
Westbury (2004) determined the acute toxicity of the substance to Ceriodaphnia cf. dubia, as part of the development of a QSAR model for substituted phenols. The experimental procedure was similar to OECD guideline 202, with a potentially reduced number of animals (replicates). Concentrations were monitored analytically at both beginning and end of the experiment. The 48h EC50 was reported to be 19.8mg/L; it was not stated whether this was based on measured initial concentration, or the geometric mean of initial and final concentrations. As stated by the authors, the methodology and validity criteria were adhered to. However, the lack of reported raw data prevents the independent interpretation of the experimental data.
The acute toxicity of the substance to Daphnia magna was determined in a 48-hour static test under GLP and according to OECD Guideline 202 (2004), by Höger (2010). The nominal test item concentrations tested were control group, 1.0, 2.2, 4.6, 10, 22 and 46 mg/L. No analytical measurements were performed in the test. The 48h EC50 was found to be 18mg/L (14-24mg/L, CI=95%).
The chemical structure is not expected to be hydrolytically unstable, nor is there experimental evidence to suggest this. The stability of the test substance in the test media of an algae growth inhibition study (OECD 201) over a 96h-hour period was confirmed by Liedtke (2010) with analytical monitoring. Test concentrations were between 100 and 107% at the end of the study.
The two available studies both have shortcomings in either the experimental design or extent of reported data. However, it is considered that these deficiencies are independent and the similar toxicities reported (despite the possible differing species sensitivities) lend credibility to the results. Finally, no evidence of hydrolytic instability was observed in a subsequent algae study with analytical monitoring of the test material concentrations.
The lowest effect concentration, EC50=18mg/L, is selected from the two available studies as being the most conservative value for risk assessment and classification purposes.
As a result the available data is considered to be adequate for classification and labelling and risk assessment based on the weight-of-evidence, in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.2.
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.
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