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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 217-568-2 | CAS number: 1889-67-4
- 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
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Study period:
- from 2012-12-10 to 2012-12-13
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- adopted 2006
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Version / remarks:
- adopted 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.5400 (Algal Toxicity, Tiers I and II) (January 2012)
- Version / remarks:
- adopted 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- Concentrations of the test item were analytically determined at the start and at the end of the test.
- Vehicle:
- yes
- Details on test solutions:
- Test concentrations were prepared by appropriate diluting of a saturated stock solution. This saturated stock solution was prepared with a loading rate of 1000 mg/L (i.e. 100 % v/v saturated solution) thereby simulating worst-case scenario conditions.
Based on the results of pre-experiments the following five test concentrations were tested in a geometric series (with a separation factor of 1.7): 12.0; 20.4; 34.6; 58.8; and 100.0 % v/v saturated solution (nominal). - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: green algae
- Strain: 61.81 SAG (identical strains: CCAP 278/4; UTEX 1648; ATCC 22662)
- Source (laboratory, culture collection): Collection of Algal Cultures, Inst. Plant Physiology, University of Göttingen, Nikolausberger Weg 18, D-37073 Göttingen, Germany - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Test temperature:
- 21.4 – 22.8 °C
- pH:
- 7.75 – 9.98
- Nominal and measured concentrations:
- Five test concentrations were tested in a geometric series (with a separation factor of 1.7): 12.0; 20.4; 34.6; 58.8; and 100.0 % v/v saturated solution (nominal). Following analytical determination most of the test concentrations were below the limit of quantification. Thus, the results were based on the respective loading rates.
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Erlenmeyer flasks of ~250 mL volume with 100 mL test medium.
- Initial cells density: 1E04 cells/mL
- No. of vessels per concentration: three replicates per test concentration
- No. of vessels per control: three replicates
- No. of vessels per vehicle control: six replicates
- Additional test solution control: An additional test item solution control group (1.25 mg/L) without addition of algae was included in the experiment and analysed at the same occasions as the test concentrations in order to check the possibility of the adsorption of test item on algal biomass.
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- in accordance to the guideline
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: continuously illuminated
- Light intensity and quality: 7914 lux, which was ensured with fluorescent lamps (with a spectral range of 400 - 700 nm).
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Determination of Cell Number: The cell numbers were determined at 24, 48 and 72 hours after starting the test by manual cell counting using a microscope with counting chamber.
Morphological Changes of Algal Cells: The morphological changes of algal cells compared to the control were examined at 24, 48 and 72 hours after starting the test using a microscope.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2 - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 100 - < 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: Test concentration based on loading rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: Test concentration based on loading rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- > 100 - < 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: Test concentration based on loading rate
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 100 - < 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: Test concentration based on loading rate
- Details on results:
- The test item had a statistically significant inhibitory effect on the growth of Pseudokirchneriella subcapitata after the exposure period of 72 hours based on the average specific growth rate and yield at 34.6, 58.8 and 100 % v/v saturated solution (nominal). Statistically significantly difference compared to the control was not observed in the two lowest concentrations of 12.0; 20.4 v/v saturated solution (nominal). As most of the test concentrations were below the limit of quantification, the 72-hour NOEC related to growth rate and the LOEC were expressed based on the loading rate and the corresponding dilutions. Accordingly, the 72-hour NOEC related to growth rate and the LOEC value were in the range of 100 – 1000 mg/L (loading rate). Similarly, the 72-h ErC10 was determined to be in the range of 100 – 1000 mg/L (loading rate), the 72-h ErC50 to be > 1000 mg/L (loading rate). After 48 and 72 hours of exposure, smaller cells were detected at nominal concentration of 34.6 % v/v saturated solution.
Thin and swollen cells were noticed at the nominal concentrations of 58.8 and 100 % v/v saturated solution after 24, 48 and 72 hours. Additionally, pinches were observed on the cells at the highest concentration (100 % v/v saturated solution) at the 24 and 48-h observation period.
In the control and in the nominal concentrations range of 12.0 and 20.4 % v/v saturated solution abnormal appearance of algal cells was not observed during the experiment. - Results with reference substance (positive control):
- The 72-h ErC50 potassium dichromate: 1.36 mg/L, (95 % confidence limits: 1.25 – 1.49 mg/L
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of this acute algal growth inhibition test on Pseudokirchneriella subcapitata the observed results were the following: The 72-h EC50 value based on growth rate was determined to be > 1000 mg/L (loading rate), the 72-h NOEC value was determined to be in the range of 100 – 1000 mg/L (loading rate).
- Executive summary:
The growth inhibition effect of the test item on Algae (Pseudokirchneriella subcapitata) over an exposure period of 72 hours in a static system was assessed according to OECD Guideline 201 and EU method C.3. Due to the test item's poor water solubility (maximum water solubility determined to be 0.08 mg/L), a supersaturated solution was prepared thereby simulating worst-case scenario conditions with this 72-h algal growth inhibition test with Pseudokirchneriella subcapitata. Five different concentrations arranged in a geometric series (with a separation factor of 1.7) and concurrent control group were tested. The nominal test item concentrations were 12.0; 20.4; 34.6; 58.8; and 100.0 % v/v saturated solution. The test item had a statistically significant inhibitory effect on the growth of Pseudokirchneriella subcapitata after the exposure period of 72 hours based on the average specific growth rate at 34.6, 58.8 and 100 % v/v saturated solution (nominal). Statistically significantly difference compared to the control was not observed in the two lowest concentrations of 12.0; 20.4 v/v saturated solution (nominal). As most of the test concentrations were below the limit of quantification, the results were expressed based on the loading rate. The 72-hour NOEC related to growth rate and the LOEC value were in the range of 100 – 1000 mg/L (loading rate). Similarly, the 72-h ErC10 was determined to be in the range of 100 – 1000 mg/L (loading rate), the 72-h ErC50 to be > 1000 mg/L (loading rate).
Referenceopen allclose all
Description of key information
A study according to OECD 211 has been requested in decision CCH-D-2114543301-63-01/F and work on it is currently ongoing. The endpoint will be updated with the new information by the set deadline in the final decision.
Under the conditions of an acute algal growth inhibition test on Pseudokirchneriella subcapitata the observed results were the following: The 72-h EC50 value based on growth rate was determined to be >1000 mg/L (loading rate), the 72-h NOEC value was determined to be in the range of 100 – 1000 mg/L (loading rate). This study is considered as disregarded due to the deficiencies in the test solution preparation methodology.
Key value for chemical safety assessment
Additional information
The below described study has been considered as disregarded and a new algae study according to OECD 201 has been requested. The study is ongoing and will be submitted by the set deadline in the final ECHA decision.
The growth inhibition effect of the test item on Algae (Pseudokirchneriella subcapitata) over an exposure period of 72 hours in a static system was assessed according to OECD Guideline 201 and EU method C.3. Due to the test item's poor water solubility (maximum water solubility determined to be 0.08 mg/L), a supersaturated solution was prepared thereby simulating worst-case scenario conditions with this 72-h algal growth inhibition test with Pseudokirchneriella subcapitata. Five different concentrations arranged in a geometric series (with a separation factor of 1.7) and concurrent control group were tested. The nominal test item concentrations were 12.0; 20.4; 34.6; 58.8; and 100.0 % v/v saturated solution. The test item had a statistically significant inhibitory effect on the growth of Pseudokirchneriella subcapitata after the exposure period of 72 hours based on the average specific growth rate at 34.6, 58.8 and 100 % v/v saturated solution (nominal). Statistically significantly difference compared to the control was not observed in the two lowest concentrations of 12.0; 20.4 v/v saturated solution (nominal). As most of the test concentrations were below the limit of quantification, the results were expressed based on the loading rate. The 72-hour NOEC related to growth rate and the LOEC value were in the range of 100 – 1000 mg/L (loading rate). Similarly, the 72-h ErC10 was determined to be in the range of 100 – 1000 mg/L (loading rate), the 72-h ErC50 to be > 1000 mg/L (loading rate).
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.