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EC number: 402-130-7 | CAS number: 106246-33-7
- 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 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- Test concentration was verified by chemical analysis. Water samples (100 rnl in duplicate) were taken from solvent control and test cultures at 0 hours and at 72 hours (replicates pooled) and sent to the analytical laboratory of the test institute. At 0 hours, additional samples were also taken from the 10 mgll dispersion in algal medium and either filtered or centrifuged prior to analysis. The filtered samples were passed through two in-line filters (0.22 um) to remove any particulate matter prior to analysis. The centrifuged samples were spun down at a speed of 4000 n/min Exp.-1 for 30 minutes prior to analysis. Additional flasks containing cultures of the 10 mg/l exposure level were incubated with the test vessels in order to provide sufficent sampling volume at 72 hours. At 72 hours, additional samples were taken from test and satellite vessels (replicates pooled), in order to obtain information on the extent of adsorption / absorption of the test substance by the algal cells and either filtered or centrifuged prior to analysis, as outlined above.
- Vehicle:
- yes
- Details on test solutions:
- The test substance was dissolved in an auxiliary solvent, 10% Tween 80 dimethylformamide, to give a preliminary stock solution of 100 mglml. An aliquot (200 ul) of this stock solution was added to 2 litres of algal medium to give the final test concentration of 10 mg/l. A subsample (200 ml) of the 10 mg/l dispersion was incubated under the conditions of the test in order to provide a comparison between cultures with and without algal cells present. The exposure level was achieved by adding 4 ml of concentrated algal suspension to one litre of the 10 mg/l test dispersion. The control was prepared by adding 4 ml of the concentrated algal inoculum to one litre of sterile nutrient medium. The solvent control was prepared as for the control but with an aliquot (100 ul) of auxiliary solvent added to one litre of the control preparation.
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Algae were supplied by Culture Centre of Algae & Protozoa c/o Freshwater Biological Association, Cumbria, UK. Sterile nutrient medium was inoculated from a master culture and incubated under continuous illumination (2: 7000 lux) and aeration via narrow bore glass tube at 24°C to give an algal
suspension in log phase growth characterised by a cell density of 2.4 x 10 Exp.6 cells per ml. The suspension was concentrated by centrifugation to give a cell density of 9.7 x 10 Exp.6 cells per ml prior to use. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Post exposure observation period:
- None
- Hardness:
- Not calculated
- Test temperature:
- 24°C
- pH:
- 7.7 - 10.0
- Dissolved oxygen:
- Not available
- Salinity:
- Freshwater used
- Nominal and measured concentrations:
- - Nominal test concentration: 10 mg/l
- Mean measured concentration: 7.4 mg/l
One test concentration was used and one solvent control (100 ul auxiliary solvent per litre) of six replicates each, and one untreated control in triplicate. - Details on test conditions:
- Conical flasks (250 ml) each containing 100 ml of test or control culture were loosely capped with foil and placed at random in a Gallenkarnp Illuminated Orbital Incubator. The cultures were incubated, without media renewal, for 72 hours under continuous illumination of approximately 7000 lux provided by 7 x 30 W "universal white" 1 metre fluorescent tubes. The temperature was maintained at 24°C and gaseous exchange and suspension of the algal cells was ensured by the action of the orbital shaker oscillating at 120 cycles per minute.
- Reference substance (positive control):
- no
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks on result:
- other: 95% CL could not be calculated
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CL could not be calculated
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CL could not be calculated
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks on result:
- other: 95% CL could not be calculated
- Results with reference substance (positive control):
- No positive control tested
- Reported statistics and error estimates:
- Reference: Bartlett, M.S., 1937, Properties of sufficiency and statistical tests. Proceedings of the Royal Society. Series A, 160, 268 - 282).
- Validity criteria fulfilled:
- yes
- Conclusions:
- The EbC50 and ErC50 were determined to be > 1 mg/l (measured concentration of filtered algal media). If the results are expressed as mean measured concentration of the test dispersion, the ErC50 and EbC50 were both > 7.4 mg/l.
- Executive summary:
The study was performed in 1996 as GLP-test following EU-testing method C.3 on the green algae species Selenastrum capricornutum. The test was performed under static conditions as limit test with a nominal test item concentrations of 10.0 mg/l in the main study. Due to the low solubility, the test item was dissolved in an auxiliary solvent, 10% Tween 80 dimethylformamide mixture to give a preliminary stock solution of 100 mg/ml. The loss of concentration of test item over the test period was 26%, therefore 74% of the nominal concentration was found at the end of the study.
Statistically significant inhibition of growth (21 %) was found in the test cultures, when compared to the biomass of the solvent control using the student's t-test. Bartlett's test for homogeneity confirms the difference was not due to replicate variation. However, since the percentage inhibition was less than 25% and the concentration of the test dispersion is well in excess of the water solubility of the test substance (2.5 x 10 Exp.-5 g/l) this is not considered to be biologically significant.
Reference
The analytical results are expressed in terms of the mean measured concentration, which was 74% of nominal in this study. The measured concentration of the test exposure level was 88% of nominal at the start of the study. Over the course of the study, approximately 25% was lost from dispersion, with 63% of nominal remaining at 72 hours. This loss of test substance from dispersion was also reflected in the measured concentrations of the test dispersion, incubated without algal cells present (32% of nominal lost over 72 hours cf: 25%). This indicates that the presence of algal cells did not affect the stability of the test dispersion. The losses of test substance from dispersion over the duration of the study are considered to be due to the inherent difficulties in maintaining a test dispersion at a concentration well in excess of the water solubility of the test substance.
The maximum concentration employed in this study was nominally 10 mg/l, the highest concentration at which it was possible to obtain a visually stable test dispersion. It was considered unnecessary and unrealistic to test at concentrations in excess of this value given the low solubility of the test substance in water and having regard for the maximum amount of auxiliary solvent permitted under the constraints of this study. The apparent instability indicated by comparison of the fresh and expired solutions for the filtered and centrifuged samples would suggest that the presence of algal cells has compromised the effectiveness of these methods for determination of the amount of P5367 truly in solution.
Description of key information
The study was performed in 1996 as GLP-test following EU-testing method C.3 on the green algae species Selenastrum capricornutum. The test was performed under static conditions as limit test with a nominal test item concentrations of 10.0 mg/L in the main study. Due to the low solubility, the test item was dissolved in an auxiliary solvent, 10% Tween 80 dimethylformamide mixture to give a preliminary stock solution of 100 mg/ml. The loss of concentration of test item over the test period was 26%, therefore 74% of the nominal concentration was found at the end of the study. Statistically significant inhibition of growth (21 %) was found in the test cultures, when compared to the biomass of the solvent control using the student's t-test. Bartlett's test for homogeneity confirms the difference was not due to replicate variation. However, since the percentage inhibition was less than 25% and the concentration of the test dispersion is well in excess of the water solubility of the test substance (2.5 x 10 Exp.-5 g/L), this is not considered to be biologically significant.
The EbC50 and ErC50 were determined to be > 1 mg/L (measured concentration of filtered algal media). If the results are expressed as mean measured concentration of the test dispersion, the ErC50 and EbC50 were both > 7.4 mg/l.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 7.4 mg/L
Additional information
Source: GLP-report
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