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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June - August 2013
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Identifier: EXP1200078
Appearance: Very dark brown (almost black) viscous liquid
Batch: E00275-350
Sample Expiration Date: end-2013
Purity:100% - Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- Individual WAF solutions were prepared by mixing a calculated amount of the test substance in freshwater AAP medium at nominal loading rates of 6.3, 13, 25, 50 and 100 mg/L. The required mass of EXP1200078 test substance for each solution was weighed in a tared glass beaker and rinsed into a 4000 mL glass aspirator bottle with freshwater AAP medium. WAF solutions were mixed by stirring with a Teflon-coated stirbar and magnetic stirplate for 47 hours. A 30% vortex was maintained throughout the mixing period. After stirring, the test solutions were allowed to settle for one hour prior to use. Test substance was observed in the water column and on the surface of the solutions during mixing at the end of the one hour settling period. The test solutions were decanted from mid-depth and vacuum filtered through a 0.45 µm alpha cellulose disc prior to distribution into the replicate test vessels. All test solutions appeared clear and colorless following filtering as all particulate matter was removed.
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Original algal cultures were obtained from the University of Toronto Culture Collection, and had been maintained in culture medium at Wildlife International, Easton, Maryland.
Algal cells used in this test were obtained from Wildlife International cultures that had been actively growing in culture medium for at least two weeks prior to test initiation.
Algal cells for this study were taken from a culture that had been transferred to fresh media four days prior to test initiation.
The negative control organisms were expected to exhibit exponential growth over the 96-hour exposure period. Exponential growth phase, defined as the period of growth where the algal cells are dividing at a constant rate, is indicated by the linear section of the growth curve on a logarithmic scale. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Post exposure observation period:
- none
- Hardness:
- not stated
- Test temperature:
- 24 ± 2C.
- pH:
- The pH of the medium in each treatment and control group was measured at test initiation and at test termination using a
Thermo Orion Model 4 Star Plus pH/ISE meter.
At test initiation, pH was measured in the individual batches of test solution prepared for each treatment and the control
group.
At test termination, pH was measured in pooled samples of test solution collected from each of the replicates in each
treatment and control group.
pH values at 0h = 7.3 - 8.3
pH values at 96h = 8.7 - 9.2 - Dissolved oxygen:
- no data
- Salinity:
- no data
- Nominal and measured concentrations:
- Nominal / loading: negative control, 6.3, 13, 25, 50 and 100 mg/L
- Details on test conditions:
- Test chambers were held in an environmental chamber at a temperature of 24 ± 2C
The algae were held under continuous cool-white fluorescent lighting throughout the test. The target light intensity was
6,000 lux ± 10%.
Test chambers were sterile, 250-mL Erlenmeyer flasks plugged with foam stoppers and contained 100 mL of test or control
medium. The test flasks were shaken continuously at 100 rpm.
Initial cell density: The density of the culture was 4.35 x 106 cells/mL and 0.23 mL of the culture was added to each test
chamber to achieve a nominal concentration of approximately 10,000 cells/mL at test initiation.
Replicates per concentration (including control): 3
Growt medium: AAP; US EPA - Reference substance (positive control):
- no
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Area Under Growth Curve (mg/L)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Area Under Growth Curve (mg/L)
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 13 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Area Under Groth Curve
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 13 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Area Under Growth Curve (mg/L)
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 96 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 13 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 25 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- cell number
- Remarks:
- mg/L
- Key result
- Duration:
- 96 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- cell number
- Remarks:
- mg/L
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 13 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- cell number
- Remarks:
- mg/L
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 25 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- cell number
- Remarks:
- mg/L
- Details on results:
- After 72 hours of exposure, inhibition of area under the growth curve in the 6.3, 13, 25, 50 and 100 mg/L treatment groups was 14, 13, 20, 12 and 25%, respectively, relative to the negative control. Inhibition of growth rate in the 6.3, 13, 25, 50 and 100 mg/L treatment groups was 3, 3, 4, 1 and 5%, respectively, relative to the negative control. Inhibition of yield in the 6.3, 13, 25, 50 and 100 mg/L treatment groups was 13, 13, 20, 6 and 23%, respectively, relative to the negative control. After 72 hours of exposure, mean area under the growth curve, mean growth rate and mean yield were significantly reduced (Dunnett’s test; p < 0.05) in the 25 and 100 mg/L treatment groups when compared to the negative control group (Table 4, attached). The 72-hour NOEL was determined to be 13 mg/L.
After 96 hours of exposure, inhibition of area under the growth curve in the 6.3, 13, 25, 50 and 100 mg/L treatment groups was 12, 10, 14, 13 and 26%, respectively, relative to the negative control. Inhibition of growth rate in the 6.3, 13, 25, 50 and 100 mg/L treatment groups was 2, 1, 2, 3 and 5%, respectively, relative to the negative control. Inhibition of yield in the 6.3, 13, 25, 50 and 100 mg/L treatment groups was 11, 7, 9, 16 and 27%, respectively, relative to the negative control. After 96 hours of exposure, mean growth rate and mean yield were significantly reduced (Dunnett’s test; p < 0.05) in the 50 and 100 mg/L treatment groups when compared to the negative control group. Mean area under the growth curve was significantly reduced in the 25 and 100 mg/L treatment groups (Dunnett’s test; p < 0.05) when compared to the negative control (Table 5, attached). The 96-hour NOEL was determined to be 13 mg/L, based on statistically significant reductions in area under the growth curve. - Validity criteria fulfilled:
- yes
- Remarks:
- This test achieved all validity criteria specified in the study protocol which was based on the OECD 201 guideline.
- Conclusions:
- Pseudokirchneriella subcapitata were exposed to five nominal loading rates of 6.3 to
100 mg/L and evaluated for effects on area under the growth curve, growth rate and yield. EL50
values could not be calculated since less than 50% inhibition was observed in all treatment groups for
each of the parameters examined. EL50 values for all three endpoints were empirically estimated to
be greater than the highest loading rate tested, 100 mg/L. The 72 and 96-hour NOEL values
were determined to be 13 mg/L, at both exposure intervals. - Executive summary:
Exposure of Pseudokirchneriella subcapitata to test article gave EL50 values greater than 100 mg/L which was the highest loading rate WAF.
Reference
Description of key information
A well conducted study using Pseudokirchneriella subcapitata
(OECD 201)were exposed to five nominal loading rates of 6.3 to 100 mg/L
and evaluated for effects on area under the growth curve, growth rate
and yield. EL50 values could not be calculated since less than 50%
inhibition was observed in all treatment groups for each of the
parameters examined. EL50 values for all three endpoints were
empirically estimated to be greater than the highest loading rate
tested, 100 mg/L. The 72 and 96-hour NOEL values were determined to be
13 mg/L, at both exposure intervals.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 100 mg/L
- EC10 or NOEC for freshwater algae:
- 100 mg/L
Additional information
Pseudokirchneriella subcapitata exposed to test article resulted
in EL50 values greater than 100 mg/L which was the
highest loading rate WAF.
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.