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EC number: 602-927-1 | CAS number: 123312-89-0
- 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:
- 25 May 1995 to 08 Jun 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA FIFRA Guideline 123-2
- Version / remarks:
- 1989
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- Analytical determination of the test substance concentration (active ingredient) was performed with 40 mL samples collected from each test concentration prior to its addition into the triplicate test vessels at the beginning of the test. Approximately 13 mL from each replicate test vessel was sampled at the end of the test and replicate samples were pooled prior to analysis. samples were stored in 40 mL amber glass bottles. samples or extracts were refrigerated if not analysed on the day of collection. Analysis of the test substance at 0 and at 120 hour.
- Vehicle:
- no
- Remarks:
- sterile synthetic media
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A 100 mg/L stock solution was formulated by adding 0.0509 g test substance to sterile synthetic media and adjusting the final volume to 500 mL. The stock solution was sonicated to aid in the dissolution of the test substance. Appropriate amounts of this stock solution were added directly to sterile media to formulate test concentrations. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Green algae
- Age of inoculum (at test initiation): 8 days
ACCLIMATION
- Acclimation period: 14 day
- Culturing media and conditions: same as the test
- Any deformed or abnormal cells observed: no abnormal cells observed. Culture was actively growing at the start of the test. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 120 h
- Test temperature:
- 23.4 – 23.8 °C
- pH:
- - pH at study initiation: 7.5
- pH at study termination: 7.9 - 8.9 - Nominal and measured concentrations:
- Nominal concentrations: 0 mg/L (control), 6.3, 13, 25, 50, and 100 mg/L
Measured concentrations: <2.53 mg/L (control), 6.28, 12.8, 23.2, 47.1, and 96.7 mg/L (see 'Any other information on materials and methods incl. tables'). - Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL erlenmeyer flasks
- Material, size, headspace, fill volume: 50 mL
- Control end cells density: 1,986E+06 cells/mL
- No. of vessels per concentration: 3
- No. of vessels per control: 3
TEST MEDIUM / WATER PARAMETERS
- Total organic carbon: not detected
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: water used for acclimation of test organisms and for all toxicity testing was sterile enriched media with a target pH of 7.5 ± 0.1.
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: No
- Photoperiod: A 24 hour light and 0 hour dark photoperiod was automatically maintained
- Light intensity and quality: Cool-white fluorescent lights that provided a light intensity of 3600 lux.
WATER QUALITY PARAMETERS
Temperature of the incubator was measured and recorded daily and pH (Beckman model pHI 12 meter) was determined in each test vessel at the beginning and end of the test. The temperature of a representative flask of water incubated among the test vessels was recorded continuously.
EFFECT PARAMETERS MEASURED: cell density
The number of algal cells/ml in each test vessel was determined microscopically using a hemacytometer after 24, 48, 72, 96, and 120 hours of exposure.
RANGE-FINDING STUDY
A screening test was conducted from April 20 to 25, 1995. The test was performed with a control and 5 concentrations of the test substance (0.010, 0.10, 1.0, 10, and 100 mg/L). After 120 hours there was <1% of control growth at 100 mg/L, and at least 88% of the control growth at 0,010, 0.10, 1.0, and 10 mg/L. - Reference substance (positive control):
- no
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 6.28 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 23.8 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Remarks on result:
- other:
- Remarks:
- 95% confidence intervals: 15.0 to 37.8 mg/L
- Duration:
- 72 h
- Dose descriptor:
- other: EC25
- Effect conc.:
- 6.87 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Remarks on result:
- other:
- Remarks:
- 95% confidence intervals: 3.23 to 14.6 mg/L
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 6.28 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Duration:
- 96 h
- Dose descriptor:
- EC50
- Effect conc.:
- 16.9 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Remarks on result:
- other:
- Remarks:
- 95% confidence intervals: 9.89 to 28.7 mg/L
- Duration:
- 96 h
- Dose descriptor:
- other: EC25
- Effect conc.:
- 5.86 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Remarks on result:
- other:
- Remarks:
- 95% confidence intervals: 2.58 to 13.3 mg/L
- Duration:
- 120 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 6.28 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Duration:
- 120 h
- Dose descriptor:
- EC50
- Effect conc.:
- 21.6 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Remarks on result:
- other:
- Remarks:
- 95% confidence intervals: 11.1 to 42.1 mg/L
- Duration:
- 120 h
- Dose descriptor:
- other: C25
- Effect conc.:
- 6.5 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Remarks on result:
- other:
- Remarks:
- 95% confidence intervals: 2.22 to 19.1 mg/L
- Details on results:
- The results are tabulated in 'Any other information on results incl. tables'.
- Test item solubility: Insoluble material was not observed in any test vessel during the test.
- Exponential growth in the control (for algal test): yes, the algal population in the control vessels grew well, resulting in an average of 1,986,000 cells/mL after 120 hours. The slope of the 120 hour dose response curve is 1.6.
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Because measured concentrations at 120 hours were all less than 70% of nominal concentrations, initial measured concentrations were used for all calculations - Reported statistics and error estimates:
- All statistical analyses were performed using the initial measured concentrations of the test substance. The weighted least squares non-linear regression method was used to calculate EC25 and EC50 values and 95% confidence intervals (Bruce and Versteeg, 1992). The no observed effect concentration (NOEC) for algal growth was statistically calculated (TOXSTAT; Gulley, et. al., 1990). A Shapiro Wilks test was used to determine that data were normally distributed and Bartlett's test was used to determine that variances were homogeneous. Because data were normally distributed and variances were homogeneous, a parametric one-way analysis of variance (ANOVA) and Dunnett's t-test were used to compare treatment and control data. The slope of the 120 dose response curve was calculated using the probit method (Stephan, 1983).
- Validity criteria fulfilled:
- not specified
- Conclusions:
- The 72-h ErC50 and NOErC were determined to be 23.8 mg/L (15.0 to 37.8 mg/L) and 6.28 mg/L, respectively.
- RAR interpretation statement:
In a toxicity test in freshwater algae, the NOEC of the test subatstance amounts to 6.28 mg/L for all endpoints and assessment intervals ≥ 72 hours. Risk of the test substance to aquatic organisms is clearly not determined by its toxicity to algae. - Executive summary:
The toxicity of the test substance to the freshwater alga, Pseudokirchneriella subcapitata, was investigated, in accordance with US EPA FIFRA Guideline 123-2 and in compliance with GLP-criteria. The test, which was designed to establish the 72, 96, and 120 hour EC25s and EC50s, and no observed effect concentrations (NOECs), was performed under static conditions with five concentrations of test substance and a dilution water control at a temperature of 24 ± 2°C. The dilution water was sterile enriched media with a pH of 7.5. cell counts were determined microscopically using a hemacytometer after 24, 48, 72, 96, and 120 hours of exposure. Nominal concentrations of the active ingredient of the test substance were: 0 mg/L (control), 6.3, 13, 25, 50, and 100 mg/L. Measured concentrations of the test substance ranged from 93 to 100% of nominal values at the start of the test. Initial measured concentrations were <2.53 mg/L (LOD; control), 6.28, 12.8, 23.2, 47.1, and 96.7 mg/L. Because measured concentrations at 120 hours were all less than 70% of nominal concentrations, initial measured concentrations were used for all calculations. The exposure of Pseudokirchneriella subcapitata to the test substance for 120 hours resulted in a median effective concentration (EC50) of 21.6 mg/L, with a 95% confidence interval of 11.1 to 42.1 mg/L. The 120 hour no observed effect concentration (NOEC) was 6 .28 mg/L. Further. the exposure of Pseudokirchneriella subcapitata to the test substance for 72 hours resulted in a median effective concentration (EC50) of 23.8 mg/L, with a 95% confidence interval of 15.0 to 37.8 mg/L. The 72 hour no observed effect concentration (NOEC) was 6.28 mg/L.
Reference
cell growth data from the toxicity test with the test substance and the freshwater alga, Pseudokirchneriella subcapitata
Initial Measured Concentration |
Number of Cells/mL (x10E+03) |
|
|||||
|
Replicate |
0h |
24h |
48h |
72h |
96h |
120h |
<2.53 Control |
1 |
3 |
6 |
24 |
166 |
618 |
1700 |
|
2 |
3 |
10 |
18 |
206 |
842 |
2162 |
|
3 |
3 |
8 |
28 |
202 |
760 |
2096 |
|
Mean |
3 |
8 |
23 |
191 |
740 |
1986 |
|
%control |
|
|
|
|
|
|
6.28 |
1 |
3 |
8 |
20 |
168 |
782 |
1980 |
|
2 |
3 |
8 |
24 |
172 |
650 |
2206 |
|
3 |
3 |
8 |
18 |
182 |
746 |
2118 |
|
Mean |
3 |
8 |
2 |
174 |
726 |
2101 |
|
%control |
100 |
100 |
91 |
91 |
98 |
106 |
12.8 |
1 |
3 |
6 |
118 |
118 |
304 |
1108 |
|
2 |
3 |
6 |
122 |
122 |
380 |
1012 |
|
3 |
3 |
10 |
102 |
102 |
322 |
758 |
|
Mean |
3 |
7 |
114 |
114 |
335 |
959 |
|
%control |
100 |
88 |
60 |
60 |
45 |
48 |
23.2 |
1 |
3 |
8 |
92 |
92 |
278 |
1010 |
|
2 |
3 |
6 |
104 |
104 |
306 |
950 |
|
3 |
3 |
8 |
74 |
74 |
290 |
942 |
|
Mean |
3 |
788 |
90 |
90 |
291 |
967 |
|
%control |
100 |
6 |
47 |
47 |
39 |
49 |
47.1 |
1 |
3 |
6 |
72 |
72 |
212 |
620 |
|
2 |
3 |
6 |
50 |
50 |
182 |
518 |
|
3 |
3 |
8 |
82 |
82 |
232 |
618 |
|
Mean |
3 |
7 |
68 |
68 |
209 |
585 |
|
%control |
100 |
88 |
36 |
36 |
28 |
29 |
96.7 |
1 |
3 |
<3 |
48 |
48 |
93 |
564 |
|
2 |
3 |
<3 |
62 |
62 |
158 |
528 |
|
3 |
3 |
<3 |
38 |
38 |
106 |
526 |
|
Mean |
3 |
<3 |
49 |
49 |
119 |
539 |
|
%control |
100 |
<38 |
26 |
26 |
16 |
27 |
Description of key information
All available data was assessed and the studies representing the worst-case effects were included as weight-of-evidence studies. Other studies are included as supporting information. The weight-of-evidence studies are considered to be worst-case and were selected for the CSA.
- 72-h ErC50 = 23.8 mg/L and NOErC = 6.28 mg/L in aquatic algae (Pseudokirchneriella subcapitata), US EPA FIFRA Guideline 123-2, Boeri 1995.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 23.8 mg/L
- EC10 or NOEC for freshwater algae:
- 6.28 mg/L
Additional information
Table: Overview of aquatic algae toxicity data available for the substance:
Species |
Guideline / GLP |
Endpoint |
Effect value |
Comment |
Reference |
Pseudokirchneriella subcapitata |
US EPA FIFRA Guideline 123-2 / GLP |
72-h ErC50 72-h NOErC |
23.8 mg/L 6.28 mg/L |
Static regime. Based on nominal concentrations and growth rates. |
Boeri, 1995 |
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.
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