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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-757-3 | 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
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 July - 09 August 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted under GLP with measured exposure concentrations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- ISO 8692 (Water Quality - Fresh Water Algal Growth Inhibition Test with Scenedesmus subspicatus and Selenastrum capricornutum)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23, December 14, 2000
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1224866-76-5
- Cas Number:
- 1224866-76-5
- IUPAC Name:
- 1224866-76-5
- Details on test material:
- - Name of test material (as cited in study report): Glypho
- Substance type: pure active substance
- Physical state: liquid
- Stability under test conditions: Stable
- Storage condition of test material: Dessication, darkness, 2-8°C
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Sampling method: Duplicate 4-mL samples were taken from all test concentrations and the control at time 0 and at 72-hours. At 72-hours, algae-containing replicates were pooled within each concentration before sampling.
Sample storage conditions before analysis: Samples were stored in a freezer until analysis.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: WAFs prepared at loading rates of 10, 18, 32, 56 and 100 mg/L in the test medium. Each WAF prepared separately by applying two days of magnetic stirring followed by not stirring for one hour to stabilize. The clear and colorless WAF were taken out by siphoning and used as test concentrations.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): Final test solutions were clear and colorless.
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata
- Strain: NIVA CHL 1
- Source (laboratory, culture collection): In-house laboratory culture
- Age of inoculum (at test initiation): Three days before the start of the test, cells from the algal stock culture were inoculated in culture medium. This pre-culture was maintained under the same conditions as used in the test.
- Method of cultivation: Stock cultures were started by inoculating growth medium with algal cells from a pure culture on agar. The suspensions were continuously aerated and exposed to light in a climate room at a temperature of 21- 24°C.
ACCLIMATION
- Acclimation period: None
- Culturing media and conditions (same as test or not): Pre-culture conditions were the same
- Any deformed or abnormal cells observed: not reported
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Hardness:
- 24 mg CaCO3/L
- Test temperature:
- 21.1 - 23.4°C
- pH:
- 7.1 - 8.3
- Dissolved oxygen:
- not applicable
- Salinity:
- not applicable
- Nominal and measured concentrations:
- Nominal WAF loading: 10, 18, 32, 56, 100 mg/L
Mean measured concentrations: < LOQ, 3.7, 7.6, 17, 30, 49 mg/L
See Table 1 - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 mL all-glass
- Type (delete if not applicable): open / closed: capped but not sealed
- Material, size, headspace, fill volume: 50 mL of test solution
- Aeration: Continuous shaking
- Renewal rate of test solution (frequency/flow rate): None
- Initial cells density: ca. 1.0E+04 cells/mL
- Control end cells density: 135.8E+04 cells/mL
- No. of vessels per concentration (replicates): Three
- No. of vessels per control (replicates): Six plus one abiotic control at the highest concentration
GROWTH MEDIUM
- Standard medium used: Yes, test conducted in M2 medium
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Milli-Q water (tap water purified by reverse osmosis (Milli-RO) and subsequently passed over activated carbon and ion-exchange cartridges: Milli-Q water; Millipore Corp., Bedford, Mass., USA)
- Culture medium different from test medium: Cultures maintained on M1 medium but passaged for 72 hours in M2 before test.
OTHER TEST CONDITIONS
- Sterile test conditions: Not reported
- Adjustment of pH: None
- Photoperiod: Continuous light
- Light intensity and quality: TLD-lamps of the type ‘Cool-white’ of 30 Watt, with a light intensity within the range of 75 to 86 mE.m-2.s-1.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: Counting chamber at test initiation; spectophotometer all other observations periods.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Range finding study: Yes
- Test concentrations: Loading rates of 10% of 1.0, 1.0, 10, and 100 mg/L
- Results used to determine the conditions for the definitive study: Yes - Reference substance (positive control):
- yes
- Remarks:
- K2Cr2O7 at 0.18, 0.32, 0.56, 1.0, 1.8 and 3.2 mg/L
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 49 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% C.I. Not calculable
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 30 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: NOEC for biomass was also 30 mg/L
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: Not calculable
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 56 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: NOEC for biomass was also 56 mg/l
- Details on results:
- - Exponential growth in the control (for algal test): Yes
- Observation of abnormalities (for algal test): None observed. All cells appeared normal.
- Any stimulation of growth found in any treatment: No
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Test substance chromatographs showed a number of peaks. Concentration was monitored using peaks 7, 9 and 25. Integrated peak areas were stable over the test period for peaks 7 and 9, but declined for peak 25. This decline was essentially identical for both the abiotic test vessel and biotic vessels (Table 1). Substance peaks were not identified and toxicity could not be assigned to any specific fraction. Therefore, it was decided to base the effect parameters on both the average concentrations calculated from the measurements on peak 25 and on the initial loading rates.
- Effect concentrations exceeding solubility of substance in test medium: No - Results with reference substance (positive control):
- - Results with reference substance valid? Yes. Results were found to be within the historical range for this laboratory.
- EC50 for K2Cr2O7 (reference substance): 72-hour ErC50 = 2.3 (1.9 - 2.9) mg/L (growth rate) - Reported statistics and error estimates:
- Determination of calibration curve for spectrophotometric determination of cell count: Based on a calibration curve. Cell density was plotted versus extinction using spectrophotometric measurements of a minimum of six dilutions of an algal suspension with different cell densities. The calibration curve was composed using linear regression. The software automatically calculates the cell densities (Table 2) based on this curve for the spectrophotometric measurements at the various points in time during the test period.
For determination of the NOEC and the EC50 the approaches recommended in the OECD guideline 201 were used. An effect was considered to be significant if statistical analysis of the data obtained for the test concentrations compared with those obtained in the negative control revealed significant reduction of growth rate (Table 3) (ANOVA, Bonferroni t-Test, TOXSTAT Release 3.5, 1996, D.D. Gulley, A.M. Boelter, H.L. Bergman). Statistically significant reduction of growth rate was found at the highest test concentration of 49 mg/l (Bonferroni t-Test, α = 0.05), however neither 10% nor 50% effect were reached at this concentration. Neither EC10 nor EC50 could be derived from the data.
Any other information on results incl. tables
Table 1, Concentrations of the test substance based on peak 25 in test medium - final test |
|||
Time of sampling |
Loading rate2 |
Concentration analysed |
Relative to initial |
|
|
|
|
0 |
0 |
n.d. |
|
|
0 |
n.d. |
|
|
10 |
8.93 |
|
|
10 |
8.71 |
|
|
18 |
14.1 |
|
|
18 |
13.9 |
|
|
32 |
29.7 |
|
|
32 |
29.8 |
|
|
56 |
52.8 |
|
|
56 |
52.9 |
|
|
100 |
89.3 |
|
|
100 |
89.8 |
|
|
1004 |
92.3 |
|
|
1004 |
91.9 |
|
|
|
|
|
72 |
0 |
n.d. |
n.a. |
|
0 |
n.d. |
n.a. |
|
10 |
1.623 |
18 |
|
10 |
1.483 |
17 |
|
18 |
4.183 |
30 |
|
18 |
4.203 |
30 |
|
32 |
9.70 |
33 |
|
32 |
9.78 |
33 |
|
56 |
16.7 |
32 |
|
56 |
16.5 |
31 |
|
100 |
26.7 |
30 |
|
100 |
26.7 |
30 |
|
1004 |
28.0 |
30 |
|
1004 |
28.0 |
30 |
|
|
|
|
1, Samples were stored in the freezer (≤ -15°C) until the day of analysis. 2, A water soluble fraction (WSF) prepared at the loading rate. 3, Obtained by extrapolation of the calibration curve. 4, Without algae (abiotic). n.d., Not detected. (MDL, 1.2 mg/L) n.a., Not applicable. |
Table 2, Individual cell densities |
|||||
Loading rate1 Glypho (mg/l) |
Vessel number |
Cell density (x 1E+04) at exposure time: |
|||
0 hours² |
24 hours |
48 hours |
72 hours |
||
control |
1 |
1.00 |
4.62 |
30.85 |
138.37 |
2 |
1.00 |
4.11 |
30.37 |
134.67 |
|
3 |
1.00 |
3.71 |
29.41 |
119.06 |
|
4 |
1.00 |
4.53 |
33.35 |
137.05 |
|
5 |
1.00 |
4.42 |
32.16 |
142.62 |
|
6 |
1.00 |
4.49 |
34.59 |
142.94 |
|
10 (3.7) |
1 |
1.00 |
5.42 |
35.05 |
142.57 |
2 |
1.00 |
4.97 |
38.26 |
148.15 |
|
3 |
1.00 |
4.40 |
30.31 |
130.41 |
|
18 (7.6) |
1 |
1.00 |
4.36 |
33.02 |
140.97 |
2 |
1.00 |
4.44 |
29.11 |
114.36 |
|
3 |
1.00 |
4.29 |
32.28 |
133.82 |
|
32 (17) |
1 |
1.00 |
4.92 |
30.36 |
152.08 |
2 |
1.00 |
4.01 |
29.81 |
141.98 |
|
3 |
1.00 |
4.70 |
33.31 |
142.56 |
|
56 (30) |
1 |
1.00 |
4.07 |
26.15 |
118.64 |
2 |
1.00 |
4.61 |
28.12 |
124.65 |
|
3 |
1.00 |
5.04 |
27.91 |
115.75 |
|
100 (49) |
1 |
1.00 |
4.33 |
18.75 |
88.81 |
2 |
1.00 |
4.45 |
25.14 |
104.03 |
|
3 |
1.00 |
4.35 |
23.35 |
101.02 |
|
1WAF prepared at the given loading rate. Average concentration, measured, is given in parentheses. ² Number of inoculated cells at t=0: 1E+04 cells/ml |
Table 3,Calculation of growth rate and rate reduction |
|||||||||
Loading rate¹ (mg/l) |
Vessel number |
Growth rate (µ) |
Growth rate reduction (%) |
||||||
0-24 h |
24-48 h |
48-72 h |
0-72 h |
0-24 h |
24-48 h |
48-72 h |
0-72 h |
||
control |
1 |
0.06372 |
0.07916 |
0.06253 |
0.06847 |
─ |
─ |
─ |
─ |
2 |
0.05886 |
0.08337 |
0.06205 |
0.06809 |
─ |
─ |
─ |
─ |
|
3 |
0.05459 |
0.08629 |
0.05827 |
0.06638 |
─ |
─ |
─ |
─ |
|
4 |
0.06291 |
0.08321 |
0.05889 |
0.06834 |
─ |
─ |
─ |
─ |
|
5 |
0.06190 |
0.08270 |
0.06207 |
0.06889 |
─ |
─ |
─ |
─ |
|
6 |
0.06253 |
0.08512 |
0.05912 |
0.06892 |
─ |
─ |
─ |
─ |
|
mean |
0.06075 |
0.08331 |
0.06049 |
0.06818 |
─ |
─ |
─ |
─ |
|
CV |
6% |
3% |
3% |
1% |
─ |
─ |
─ |
─ |
|
Section CV ² |
17% |
|
|
||||||
10 (3.7) |
1 |
0.07043 |
0.07777 |
0.05846 |
0.06889 |
-16 |
7 |
3 |
-5 |
2 |
0.06678 |
0.08507 |
0.05641 |
0.06942 |
-10 |
-2 |
7 |
-9 |
|
3 |
0.06176 |
0.08038 |
0.06080 |
0.06765 |
-2 |
4 |
-1 |
4 |
|
18 (7.6) |
1 |
0.06135 |
0.08436 |
0.06048 |
0.06873 |
-1 |
-1 |
0 |
-4 |
2 |
0.06215 |
0.07831 |
0.05702 |
0.06582 |
-2 |
6 |
6 |
16 |
|
3 |
0.06069 |
0.08408 |
0.05925 |
0.06801 |
0 |
-1 |
2 |
1 |
|
32 (17) |
1 |
0.06640 |
0.07581 |
0.06713 |
0.06978 |
-9 |
9 |
-11 |
-12 |
2 |
0.05785 |
0.08360 |
0.06504 |
0.06883 |
5 |
0 |
-8 |
-5 |
|
3 |
0.06444 |
0.08164 |
0.06058 |
0.06889 |
-6 |
2 |
0 |
-5 |
|
56 (30) |
1 |
0.05849 |
0.07750 |
0.06301 |
0.06633 |
4 |
7 |
-4 |
13 |
2 |
0.06370 |
0.07532 |
0.06204 |
0.06702 |
-5 |
10 |
-3 |
8 |
|
3 |
0.06738 |
0.07133 |
0.05927 |
0.06599 |
-11 |
14 |
2 |
15 |
|
100 (49) |
1 |
0.06105 |
0.06110 |
0.06479 |
0.06231 |
0 |
27 |
-7 |
35 |
2 |
0.06219 |
0.07215 |
0.05918 |
0.06451 |
-2 |
13 |
2 |
24 |
|
3 |
0.06130 |
0.06997 |
0.06103 |
0.06410 |
-1 |
16 |
-1 |
26 |
|
¹ WAF prepared at the given loading rate. Average measured exposure concentration given in parantheses ² Mean CV for section-by-section specific growth rate |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- Control specific growth rate >0.92/day (0.06818/hr or 1.63/day), mean CV for section-specific growth rates in control cultures <35% (17%), CV for average specific growth rates over whole test period in replicate control cultures did not exceed 7% (1%)
- Conclusions:
- The 72-hour NOECgrowth rate (OECD TG 201) of the test substance to Pseudokirchneriella subcapitata is 30 mg/L based on measured substance concentration or 56 mg/L based on nominal loading rate. The EC10 and EC50 could not be determined since less than 10% inhibition was observed; there are reported as >49 mg/L based on measured substance concentration or >100 mg/L based on nominal loading rate.
- Executive summary:
Toxicity of the test substance to Pseudokirchneriella subcapitata was assessed according to OECD TG203 under GLP criteria. A number of peaks were present on chromatograms of the test substance. Analytical recovery of test substance based on peak 25 declined by the end of the test, whereas other major peaks maintained stable recovery. It was decided to base the effect parameters on both the geometric mean concentrations calculated from the measurements on peak 25 and on the initial loading rates. A statistically significant effect on growth rate less than 10% was seen in the highest concentration tested. The 72-hour NOEC for growth rate was 30 mg/L based on measured substance concentration or 56 mg/L based on nominal loading rate. The EC10 and EC50 could not be determined but are >49 mg/L based on measured substance concentration or >100 mg/L based on nominal loading rate.
The test was conducted according to internationally accepted test guidelines and under GLP criteria. It is considered reliable without restriction and is suitable for Risk Assessment, Classification & Labelling, and PBT Assessment.
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.