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EC number: 270-156-4 | CAS number: 68411-97-2
- 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
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Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to the analogue justification attached to chapter 13.
- Reason / purpose for cross-reference:
- read-across source
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 4.448 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other:
- Remarks:
- source: CAS 30364-51-3, Chemex, 2017, P. subcapitata, 72 h, RL1
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 13.47 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other:
- Remarks:
- source: CAS 30364-51-3, Chemex, 2017, P. subcapitata, 72 h, RL1
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 3.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other:
- Remarks:
- source: CAS 30364-51-3, Chemex, 2017, P. subcapitata, 72 h, RL1
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 - 26 Jan 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Version / remarks:
- 2011
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A stock solution of 100 mg/L (nominal) was prepared by heating the solution to 56 °C and stirring for 15 min until the test item was fully dissolved. The test concentrations were prepared by dilution of the stock solution with nutrient growth medium (aliquots of 1.6 - 160 mL stock solution were filled up to 500 mL with nutrient growth medium).
- Controls: Test medium without test item under same test conditions.
- Evidence of undissolved material: The stock solution was clear and colourless. Foam was observed during the preparation of the stock solution (during heating and stirring) but no foaming was recorded during pipetting or during the preparation of the dilutions. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Unicellular freshwater alga
- Strain: CCAP 278/4
- Source: Culture Collection of Algae and Protozoa, SAMS Research Services Ltd, Scottish Marine Institute, Oban, Scotland, UK
- Method of cultivation: Algae were cultured in deionised water with added nutrients according to OECD 201 at 22.0 - 22.2 °C, 6440 - 7920 lux continuous white light and orbiting at 200 rpm. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Test temperature:
- 21.0 - 24.0 °C (test solution)
21.7 - 23.9 °C (incubator) - pH:
- 7.73 - 8.10
- Nominal and measured concentrations:
- Control, 0.32, 1.0, 3.2, 10.0, and 32.0 mg/L (nominal)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL conical flask filled with 100 mL test volume
- Initial cell density (0 h): 1.0E04 cells/mL (mean)
- Control end cell density (72 h): 150.9E4 cells/mL (mean)
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: Yes, sterilised deionised water with added nutrients according to OECD guideline 201
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dilution water for the preparation of the culture/test media was prepared by sterilization (autoclaving at 120 °C for 15 min) of de-ionised, filtered water.
- Culture medium different from test medium: Culture medium same as test medium.
- Intervals of water quality measurement: The temperature and light intensity in the incubator were recorded at 0, 24, 48, and 72 h. The pH and temperature in the test solution were recorded at the beginning of the test (0 h) in each replicate and at the end of the test (72 h) in pooled replicates.
OTHER TEST CONDITIONS
- Adjustment of pH: The pH of the control medium was adjusted from 7.80 to 7.10.
- Photoperiod: Continuous light
- Light intensity: 6440 - 7920 lux
EFFECT PARAMETERS MEASURED:
- Determination of cell concentrations: Direct cell counts using a haemocytometer and microscope after 0, 24, 48, and 72 h.
- Other: Morphological abnormalities by microscopy after 0, 24, 48, and 72 h.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.125 - 3.2
- Range finding study: Yes
- Test concentrations: 0.1, 1.0, 10, 100, and 1000 mg/L
- Results used to determine the conditions for the definitive study: Yes, after 72 h 94% inhibition was observed at the 100 and 1000 mg/L treatment levels and 75% at the 10 mg/L concentration level. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate (K2Cr2O7)
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 4.448 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% confidence interval: 2.00 -6.40 mg/L
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 13.47 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% confidence interval: 10.56 - 17.71 mg/L
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 3.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- - Exponential growth in the control: Yes
- Observation of abnormalities: No morphological abnormalities
- Any stimulation of growth found in any treatment: Stimulation of growth rate was observed at the 0.32 and 1.0 mg/L treatment levels after 72 h.
- Any observations that might cause a difference between measured and nominal values: All test concentrations appeared clear and colourless.
- Effect concentrations exceeding solubility of substance in test medium: No - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- ErC50 (72 h): 1.188 mg/L (potassium dichromate) with 95% confidence limits of 0.979 - 1.444 mg/L
- Other: Exposure from 10 - 13 May 2016 - Reported statistics and error estimates:
- EC50 values were estimated graphically where possible and 95% confidence limits were calculated according to the method of ToxCalc Version 5.0 "Comprehensive Toxicity Data Analysis and Database Software (copyright 1994 - 1996).
The EC50 for growth rate and yield inhibition were determined by Maximum Likelihood-Probit/Logit, respectively. - Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
Referenceopen allclose all
VALIDITY CRITERIA
The study fulfilled the validity criteria laid down by the OECD guideline 201 (Table 1).
Table 1: Validity criteria for OECD 201.
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
The biomass in the control cultures should have increased exponentially by a factor of at least 16 within the 72-hour test period. |
The control cell density increased by a factor of 150.9 in 72 h (specific growth rate of 1.66/d). |
Yes |
The mean coefficient of variation for section-by-section specific growth rates (days 0-1, 1-2 and 2-3, for 72-hour tests) in the control cultures must not exceed 35% |
The variation coefficient for the section-by-section specific growth rates in the control cultures was 23.37%. |
Yes |
The coefficient of variation of average specific growth rates during the whole test period in replicate control cultures must not exceed 7% in tests with Pseudokirchneriella subcapitata. |
The variation coefficient for the 72 h period of the control cultures was 4.59%. |
Yes |
ANALYTICAL RESULTS
No analytical confirmation of the test concentrations was performed. The dissolved concentrations were likely to correspond to the reported nominal concentrations.
BIOLOGICAL RESULTS
Results are summarized in Tables 2 and 3. The LOEC (72 h) was 10 mg/L (Bonferroni t-Test).
Table 2. Percent inhibition.
Nominalconcentration(mg/l) |
Percent inhibition by yield |
Percent inhibition by growth rate |
||
0 - 48 hours |
0 - 72 hours |
0 - 48 hours |
0 - 72 hours |
|
0.32 |
15 |
-2 |
5 |
-1 |
1.0 |
-26 |
-9 |
-7 |
-1 |
3.2 |
11 |
16 |
3 |
3 |
10.0 |
85 |
84 |
53 |
37 |
32.0 |
100 |
99 |
100 |
84 |
Table 3. Effect values by yield (EyCx) and growth rate (ErCx)
Exposure Period (hours) |
EyCxvalue mg/l (95% confidence limits) |
ErCxvalue mg/l (95% confidence limits) |
||||
EyC10 |
EyC20 |
EyC50 |
ErC10 |
ErC20 |
ErC50 |
|
0 to 48 |
3.139 (2.329-3.822) |
3.991 (3.161-4.700) |
6.016 (5.170-6.899) |
4.825 * |
6.101* |
9.556* |
0 to 72 |
2.663 (1.906-3.297) |
3.510 (2.729-4.186) |
5.627 (4.781-6.631) |
4.448 (2.000-6.403) |
6.695 (3.907-8.818) |
13.47 (10.56-17.71) |
NOEC (0-72h) |
3.2mg/l (Determined by Wilcoxon Two-Sample Test$) |
3.2mg/l (Determined by Bonferroni t Test$) |
* Confidence limits not possible to determine.
All concentrations of the test substance are reported as nominal as received.
Methods used in Toxcalc v5.0: 48 hour ErCxdetermined by Maximum Likelihood-Probit and 48 hour EyCxdetermined by Maximum Likelihood-Logit. 72 hour ErCxand EyCxboth determined by Maximum Likelihood-Logit.
$Following Shapiro-Wilk’s Test for normal distribution and Bartlett’s Test for equal variances. Equality of variance could not be confirmed for 72 hour yield.
Description of key information
ErC50 (72 h) = 13.47 mg/L (nominal, OECD 201, P. subcapitata); read-across
ErC10 (72 h) = 4.448 mg/L (nominal, OECD 201, P. subcapitata); read-across
Key value for chemical safety assessment
Additional information
No studies investigating the toxicity to algae are available for Glycine, N-methyl-, N-coco acyl derivatives (CAS 68411-97-2). Therefore, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substance Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate (CAS 30364-51-3) was conducted. Based on the high degree of similarity between the structural and physico-chemical properties of the target and source substance, the source substance is considered suitable representatives for the evaluation of the toxicity to microorganisms of the target substance. The read-across approach is justified in detail within the analogue justification in IUCLID section 13.
The GLP-study with the source substance Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate (CAS 30364-51-3) was conducted according to the OECD guideline 201. The first main test did not meet the validity criteria as the coefficient of variation of the replicates for the control was > 7% for the 72-hour test period. Therefore, this main test was repeated. All validity criteria for the second main test were met. The freshwater algae Pseudokirchneriella subcapitata was exposed for 72 h to nominal test concentrations of 0.32, 1.0, 3.2, 10.0, and 32.0 mg/L. No analytical measurement was conducted. After 72 h inhibition of growth was observed in the two highest test concentrations (10 and 32 mg/L) resulting in an ErC50 (72 h) of 13.47 mg/L (nominal) and an ErC10 (72 h) of 4.448 mg/L (nominal).
Based on the available results from one structurally related read-across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by a comparable structure, it can be concluded that Glycine, N-methyl-, N-coco acyl derivatives (CAS 68411-97-2) will exhibit comparable effects on aquatic algae.
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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