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EC number: 946-436-3 | 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:
- 21 October 2016 - 22 March 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Version / remarks:
- 23 March 2006; Annex 5 corrected 28 July 2011
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance document on aquatic toxicity testing of difficult items and mixtures, OECD series on testing and assessment number 23.
- Version / remarks:
- 14 December 2000
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- nitrate amine salt of N-[3-dimethylaminopropyl]- C14-C20 amides, saturated, reaction products with ethylene oxide
- EC Number:
- 946-436-3
- Molecular formula:
- UVCB
- IUPAC Name:
- nitrate amine salt of N-[3-dimethylaminopropyl]- C14-C20 amides, saturated, reaction products with ethylene oxide
- Reference substance name:
- (p-chlorophenoxy)isobutyroyl chloride
- EC Number:
- 255-286-1
- EC Name:
- (p-chlorophenoxy)isobutyroyl chloride
- Cas Number:
- 41267-93-0
- Molecular formula:
- C10H10Cl2O2
- IUPAC Name:
- 2-(4-chlorophenoxy)-2-methylpropanoyl chloride
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Dihydrogen oxide
- Test material form:
- solid
- Details on test material:
- Identification: Nitrate amine salt of N-[3-dimethylaminopropyl]- C14-C20 amides, saturated, reaction products with ethylene oxide
Appearance: Light yellow lumps
Test item storage: At room temperature; Store in closed container
Constituent 1
impurity 1
impurity 2
- Specific details on test material used for the study:
- - Irritant or corrosive: yes
- Solubility in water: 5-10%
- Stability in water: stable
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Samples were taken from all test concentrations and the control according to the schedule below.
Frequency: at t=0, t=24 and t=72
Volume: 2.0 mL
Storage: Samples were stored in silanised vials in a freezer (≤ -15°C) until analysis.
At the end of the exposure period, the replicates were pooled at each concentration before sampling.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION:
- Method (for definitive test): No correction was made for the purity/composition of the test item. Test item was ground prior to preparation. Preparation of test solutions started with the highest concentration of 1.0 mg/L applying 17-25 minutes of magnetic stirring to accelerate the dissolution of the test item in test medium. This resulted in a clear and colorless solution. The lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium. All final test solutions were clear and colorless.
Glassware was incubated with test concentrations 24 hours prior to the start of the test to improve the stability of the exposure concentrations, as the test item tended to absorb to glass. Test solutions used for the incubation of the glassware were discarded prior to the start of the test and algal cells were exposed to freshly prepared solutions.
- Controls: test medium without test item or other additives (blank-control).
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: in-house laboratory culture.
CULTIVATION:
- Method: algae 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.
- Light intensity: 60 to 120 µE/m2/s when measured in the photosynthetically effective wavelength range of 400 to 700 nm
- Medium different from test medium: yes, M1
- Pre-culture: 3-4 days before the start of the test, cells from the algal stock culture were inoculated in culture medium at a cell density of 1 x 10^4 cells/mL. The pre-culture was maintained under the same conditions as used in the test. The cell density was measured immediately before use.
Pre-culture medium different from test medium: for the definitive test, the algae were not pre-cultured but used directly from the stock.
ACCLIMATION
- Acclimation period: no
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Hardness:
- 24 mg CaCO3 mg/L
- Test temperature:
- 22 - 23°C
- pH:
- At the start of the test: 7.9-8.0
At the end of the test: 8.0-8.1 - Nominal and measured concentrations:
- Nominal test concentrations: 0.32, 1.6, 8.0, 40, 200 and 1000 µg/L
Measured test concentrations: see table 1
As actual exposure concentrations could not be reliably calculated based on the analytical results, it was decided to express the effect parameters in terms of nominal concentrations. See 'Overall remarks' for justification of using nominal concentrations. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 mL, all-glass, open, fill volume: 50 mL
- Initial cells density: 1 x 10^4 cells/mL
- Control end cells density (mean): 110.8 x 10^4
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
- Other: 1 or 2 replicates of each concentration without algae; 1 or 2 replicates for each test concentration for sampling purposes at t=24 h.
TEST MEDIUM / WATER PARAMETERS
- Standard test medium used: yes, M2
- Source of dilution water: Milli-RO water
- Culture medium different from test medium: yes, M1
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Light intensity and quality: continuous illumination using TLD-lamps with a light intensity within the range of 81 to 84 µE/m^2/s
- Incubation: Capped vessels were distributed at random in the incubator and daily repositioned. During incubation the algal cells were kept in suspension by continuous shaking.
EFFECT PARAMETERS MEASURED: growth rate and yield at 72 hours.
- Additional measurements: pH at the beginning and at the end of the test, temperature of the medium continuously in a temperature control vessel, appearance of the cells at the end of the final test by microscopic observations.
- Determination of cell concentrations: At the beginning of the test, cells were counted using a microscope and a counting chamber. Thereafter, cell densities were determined by spectrophotometric measurement of samples at 680 nm using a spectrophotometer with immersion probe (pathlength =20 mm). Algal medium was used as blank and the extra replicates as background for the treated solutions.
COMBINED LIMIT/ RANGE-FINDING STUDY
- Test concentrations: 1, 10 and 100 % of a saturated solution prepared at 100 mg/L
- Results used to determine the conditions for the definitive study: no
FIRST RANGE-FINDING STUDY:
- Test concentrations: 0.1, 1.0, 10 and 100 % of a saturated solution prepared at 100 mg/L
- Results used to determine the conditions for the definitive study: no
SECOND RANGE-FINDING STUDY:
- Test concentrations: 0.00010, 0.0010, 0.010, 0.10 and 1.0 mg/L
- Results used to determine the conditions for the definitive study: yes
Two full tests were performed before the definitive test. Because results of the first full test were not in line with the results from the range-finding tests, a second full study was perfomed. Since in the second test no NOEC and EC50 values could be determined, the full test was repeated. This third full test was reported as the definitive test. - Reference substance (positive control):
- yes
- Remarks:
- 3,5-dichlorophenol (February 2017)
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 9.5 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 2 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.32 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1.4 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- cell number
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.32 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- cell number
- Details on results:
- - The EC50 for growth rate inhibition (72h-ERC50) was 9.5 μg/L with a 95% confidence interval ranging from 8.7 to 10 μg/L; The 72h-NOEC for both, growth rate inhibition and yield inhibition was 0.32 μg/L; The EC10 for growth rate inhibition (72h-ERC10) was 2 μg/L with a 95% confidence interval ranging from 1.6 to 2.3 μg/L
- Exponential growth in the control (for algal test): yes
- No biological, behavioural or other abnormalities were observed.
The measured concentrations in nominally 40, 200 and 1000 μg/L were at a level of 79-89% of nominal at the start of the exposure. In the two lowest groups the measured concentrations were below the lowest calibration standard from the start of the exposure. The measured concentration in nominally 40 μg/L decreased below the lowest calibration standard already after 24 hours of exposure while measured concentrations in the two highest groups were at the level of 20 and 58% of the initial at the end of the test, respectively.
As actual exposure concentrations could not be reliably calculated based on the analytical results, it was decided to express the effect parameters in terms of nominal concentrations. A justification for using nominal concentrations was given in the 'Overall remarks' section.
Individual pH and temperature values remained within acceptable limits throughout the duration of the study. - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- ErC50: 1.2 mg/L (95% CI: 1.1-1.2 mg/L)
- Other: results fell within the historical range. - Reported statistics and error estimates:
- 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 inhibition of growth rate (Williams Multiple Sequential t-test Procedure) or inhibition of yield (Multiple Sequentially-rejective Welsh-t-test after Bonferroni-Holm, both α=0.05, one-sided, smaller).
Additionally, the EC10 and EC20 were determined to meet the recommendations as put down in "A Review of Statistical Data Analysis and Experimental Design in OECD Aquatic Toxicology Test Guidelines" by S. Pack, August 1993.
Calculation of ECx values was based on probit analysis using linear max. Likelihood regression with the percentages of growth rate inhibition and the percentages of yield inhibition versus the logarithms of the corresponding nominal concentrations of the test item.
ToxRat Professional v 3.2.1 (ToxRat Solutions® GmbH, Germany) was used to perform the analyses.
Any other information on results incl. tables
Table 1 Measured concentrations in the definitive test.
Time of sampling |
Concentration |
Relative to nominal |
Relative to initial |
|
Nominal |
Analysed |
|||
|
|
|
|
|
0 |
0 |
< 4.00* |
n.a. |
|
|
0.32 |
< 4.00* |
n.a. |
|
|
1.6 |
< 4.00* |
n.a. |
|
|
8.0 |
12.3 |
154 |
|
|
8.0** |
12.4 |
155 |
|
|
40 |
35.1 |
88 |
|
|
200 |
157 |
79 |
|
|
1000 |
892 |
89 |
|
|
|
|
|
|
|
|
|
|
|
24 |
0 |
n.d. |
n.a. |
n.a. |
|
0.32 |
n.d. |
n.a. |
n.a. |
|
1.6 |
< 4.00* |
n.a. |
n.a. |
|
8.0 |
< 4.00* |
n.a. |
n.a. |
|
8.0** |
< 4.00* |
n.a. |
n.a. |
|
40 |
< 4.00* |
n.a. |
n.a. |
|
200 |
57.4 |
29 |
36 |
|
1000 |
667 |
67 |
75 |
|
|
|
|
|
|
|
|
|
|
72 |
0 |
< 4.00* |
n.a. |
n.a. |
|
0.32 |
< 4.00* |
n.a. |
n.a. |
|
1.6 |
< 4.00* |
n.a. |
n.a. |
|
8.0 |
< 4.00* |
n.a. |
n.a. |
|
8.0** |
< 4.00* |
n.a. |
n.a. |
|
40 |
< 4.00* |
n.a. |
n.a. |
|
200 |
31.1 |
16 |
20 |
|
1000 |
514 |
51 |
58 |
* The value could not be estimated correctly, therefore it is reported as lower than the lowest acceptable calibration standard.
** Without algae.
n.d. Not detected.; n.a. Not applicable.
Table 2 Growth rate and percentage inhibition for the total test period during the definitive test
Test item Nominal concentration (µg/L) |
Mean |
Std. Dev. |
n |
%Inhibition |
Control |
1.567 |
0.0424 |
6 |
|
0.32 |
1.511 |
0.0930 |
3 |
3.6 |
1.6 |
1.307* |
0.0362 |
3 |
17 |
8.0 |
0.979* |
0.0484 |
3 |
38 |
40 |
0.063* |
0.0580 |
3 |
96 |
200 |
0.113* |
0.1032 |
3 |
93 |
1000 |
0.000* |
0.0000 |
3 |
100 |
* - effect statistically significant when compared to the control (α<0.05)
Table 3 Growth rate and percentage inhibition at different time intervals during the definitive test
Test item Nominal conc. (µg/L) |
n |
0 – 24 h |
24 – 48 h |
48 – 72h |
|||
Mean |
%Inhibition |
Mean |
%Inhibition |
Mean |
%Inhibition |
||
Control |
6 |
1.281 |
|
1.559 |
|
1.861 |
|
0.32 |
3 |
0.836 |
35 |
1.864 |
-20 |
1.834 |
1.5 |
1.6 |
3 |
0.000 |
100 |
1.897 |
-22 |
2.026 |
-8.9 |
8.0 |
3 |
0.467 |
64 |
0.261 |
83 |
2.211 |
-19 |
40 |
3 |
0.050 |
96 |
-0.050 |
103 |
0.188 |
90 |
200 |
3 |
0.010 |
99 |
-0.010 |
101 |
0.339 |
82 |
1000 |
3 |
0.084 |
94 |
-0.084 |
105 |
0.000 |
100 |
Acceptability of the test:
1). In the control, cell density increased by an average factor of > 16 within two days (i.e. 111).
2). The mean coefficient of variability for section-by-section specific growth rates in the control cultures did not exceed 35% (i.e. 21%).
3). The coefficient of variation of average specific grwoth rates during the whole test period in replicate control cultures did not exceed 7% (i.e. 2.7%).
All validity criteria were met, therefore the study was considered valid.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- For details on validity criteria see 'any other information on results' section.
- Conclusions:
- The EC50 for growth rate inhibition (72h-ERC50) was 9.5 µg/L with a 95% confidence interval ranging from 8.7 to 10 µg/L. The 72h-NOEC for both, growth rate inhibition and yield inhibition was 0.32 µg/L. The EC10 for growth rate inhibition (72h-ERC10) was 2 μg/L with a 95% confidence interval ranging from 1.6 to 2.3 μg/L
- Executive summary:
In a 72 h toxicity study conducted according to OECD guideline 201 and GLP principles, freshwater algae (Pseudokirchneriella subcapitata) were exposed to the test substance at the following nominal concentrations 0 (blank-control), 0.32, 1.6, 8.0, 8.0 (without algae), 40, 200 and 1000 µg/L. Exposure concentrations were verified to be 79 -89% of nominal at the start of the exposure for 40, 200 and 1000 µg/L. Exposure concentrations were 20 and 58% for 200 and 1000 µg/L, respectively. For other concentrations, no values could be measured at different timed during the test because concentrations decreased below the lowest calibration standard. As actual exposure concentrations could not be reliably calculated based on the analytical results, effect parameters were expressed as nominal concentrations. The EC50 for growth rate reduction (72h-ERC50) was 9.5 µg/L (95% confidence levels 8.7 - 10 µg/L) and the 72h-NOEC for growth rate reduction was 0.32 µg/L. The study is considered to be reliable without resitrictions.
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