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EC number: 824-772-0 | CAS number: 2060540-82-9
- 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:
- 2018
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- Test item solution and control were sampled and immediately analysed when it was possible or stored at -20°C until analysis.
- Vehicle:
- no
- Details on test solutions:
- The test solutions were prepared by dilution of a primary stock solution and by directly dissolving the test item in the test solution. There were no difficulty as the test item is a 10% salt dissolved in water.
- Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- The Pseudokirchneriella subcapitata stock culture was maintained on sloped agar tubes at 4°C and regularly transferred to fresh medium at the laboratory. The algal stock culture was provided by the CCAP (Culture Collection of Algae and Protozoa), reference CCAP 1405/1.
A culture was prepared from the stock culture and maintained in an exponential growth by successive transfers every 3 to 4 days.
Culture conditions are the following:
Medium: OECD medium
Temperature: 23 ± 2°C
Light: continuous illumination between 4440 and 8880 lux - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Test temperature:
- 22.1°C - 23.2°C (min-max)
- pH:
- 7.63 - 8.00 (min-max)
- Dissolved oxygen:
- 8.5 - 8.9 mg/L (min-max)
- Nominal and measured concentrations:
- Purity of test item is 10% (90% of water). Therefore, nominal concentration of active ingredients (cyclohexylamine + dodecylbenzene sulfonate) is one tenth of the nominal concentration of the test item.
Nominal: control ; 10 ; 32 ; 100 ; 320 ; 1000 ; 3200 mg/L test item (i.e., control ; 1 ; 3.2 ; 10 ; 32 ; 100 ; 320 mg/L active ingredients)
Cyclohexylamine and dodecylbenzene sulfonate concentrations were followed independently from each other. For each constituent, concentrations were back calculated into test item concentrations, based on molecular weight, purity and measured concentrations. Each constituent yielded a different test item concentration. The lowest of the two value was considered for ECx determination (worst-case).
Measured: < LoD ; 10.3 ; 28.3 ; 106.1 ; 298.4 ; 1029.1 ; 3216 mg/L test item (i.e.,- Details on test conditions:
- TEST SYSTEM
- Test vessel: Erlenmeyer flask 250 mL capacity
- Material, size, headspace, fill volume: glass
- Aeration: none
- Type of test: static
- Initial cells density: 5000 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes (OECD 201 medium)
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: not needed
- Photoperiod: continuous lighting
- Light intensity and quality: 4400 - 8000 lx
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: electronic particle counter
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2- Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 47.7 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 10.1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Details on results:
- Results are provided in tables 1 to 4.
- Results with reference substance (positive control):
- 24h-EC50 was 1.34 mg/L
- Reported statistics and error estimates:
- Growth and yield rates were determined for each concentration. EC10 (Effect Concentration for 10% effect), EC50 and confidence limits were obtained by calculation according to Regtox® Macro (“Vindimian”), using the Hill model. The equation of Hill (1910) was described to model the binding of oxygen to haemoglobin. It was shown to be relevant for many other mechanisms like binding of a ligand to a receptor, Michaelian or non Michaelian enzymatic kinetics, dose or concentration response in toxicology and ecotoxicology (Vindimian 1983, Garric 1990). The model used in this macro is written in the form proposed by Duggleby in 1981. It fits different cases where the measurement of a biological parameter is plotted versus concentration or dose. Two parameters: Hill number and EC50 are characteristics of the probability function. The fitting is based on the algorithm of Marquardt (1963) which is robust and fast. It needs initial estimates of the parameters and optimize them by successive iterations.
The confidence intervals on the parameters are estimated by a bootstrap simulation which is entirely non parametric and is considered to be well adapted to non linear models (Efron 1990). The statistical evaluation (NOEC - No Observed Effect Concentration - and the LOEC - Lowest Observed Effect Concentration - determination) was conducted with R software. Since data were not consistent with a normal distribution (Shapiro-Wilk test) or the variance homogeneity was not confirmed (Bartlett test), data were analysed for significant differences compared to the control using the non-parametric tests Kruskal-Wallis plus Dunn (p = 0.05).Table 1: Results of the control group
Number of cells at 0 h
Measure at 24 h (cells / mL)
Measure at 48 h (cells / mL)
Measure at 72 h (cells / mL)
Specific growth rate 0 h – 24 h
Specific growth rate 24 h – 48 h
Specific growth rate 48 h – 72 h
Growth rate (day-1)
Yield (cells / mL)
Control
5000
22056
165000
1619000
1,484
2,012
2,284
1,927
1614000
5000
20344
157000
1378000
1,403
2,043
2,172
1,873
1373000
5000
22240
203700
2198000
1,492
2,215
2,379
2,029
2193000
5000
17920
162100
1751000
1,276
2,202
2,380
1,953
1746000
5000
15984
163900
3899000
1,162
2,328
3,169
2,220
3894000
5000
14696
202900
1642000
1,078
2,625
2,091
1,931
1637000
Mean
5000
18873
175767
2081167
1,316
2,238
2,412
1,989
2076167
Table 2: Results of the treated groups. Concentrations are given as analytically estimated test item concentration
Rates
Number of cells at 0 h
Measure at 24 h (cells / mL)
Measure at 48 h (cells / mL)
Measure at 72 h (cells / mL)
Growth rate (day-1)
CV (%)
Growth rate inhibition (%) compared to control
Yield (cells / mL)
CV (%)
Yield inhibition (%) compared to control
mg test item / L
10,269
5000
21320
185400
1348000
1,866
0,347
6,188
1343000
1,948
35,313
5000
34784
193300
1318000
1,858
6,565
1313000
36,758
5000
9952
190000
1297000
1,853
6,834
1292000
37,770
Mean
5000
22019
189567
1321000
1,859
6,529
1316000
36,614
28,322
5000
32464
171300
1321000
1,859
0,986
6,527
1316000
5,478
36,614
5000
18176
173000
1244000
1,839
7,534
1239000
40,323
5000
10720
180100
1185000
1,823
8,348
1180000
43,164
Mean
5000
20453
174800
1250000
1,840
7,470
1245000
40,034
106,071
5000
11144
112500
959600
1,752
20,109
11,884
954600
65,692
54,021
5000
7760
114400
1143000
1,811
8,953
1138000
45,187
5000
8648
49400
198800
1,228
38,270
193800
90,665
Mean
5000
9184
92100
767133
1,597
19,703
762133
63,291
298,364
5000
5760
50280
319300
1,386
1,829
30,328
314300
7,557
84,862
5000
5848
64480
275100
1,336
32,826
270100
86,990
5000
8768
67720
299400
1,364
31,407
294400
85,820
Mean
5000
6792
60827
297933
1,362
31,520
292933
85,891
1029,114
5000
6040
31760
37440
0,671
45,808
66,254
32440
86,024
98,438
5000
2984
16520
12680
0,310
84,402
7680
99,630
5000
3368
14120
13720
0,336
83,081
8720
99,580
Mean
5000
4131
20800
21280
0,439
77,912
16280
99,216
3215,941
5000
0
14520
9360
0,209
108,166
89,491
4360
120,425
99,790
5000
0
11760
5720
0,045
97,745
720
99,965
5000
0
10080
5400
0,026
98,710
400
99,981
Mean
5000
0
12120
6827
0,093
95,315
1827
99,912
Treatment groups significantly different from the control(Kruskal-wallis plus Dunn test, see Appendix).
Table 3: Dissolved oxygen and pH at 0 and 72 h in all treatments
Control
10 mg/L
32 mg/L
100 mg/L
320 mg/L
1000 mg/L
3200 mg/L
pH at 0 h
7.63
7.64
7.75
7.73
7.75
7.83
8
O2at 0 h
8.9
pH at 72 h
7.78
7.93
7.85
7.79
7.70
7.80
7.80
O2at 72 h
8.84
8.7
8.54
8.51
8.58
8.56
8.53
Table 4: Conditions of temperature and light intensity throughout the test
Time
0 h
24 h
48 h
72 h
Temperature (°C)
23.1
23.1
22.1
23.2
Light intensity (lux)
8750
8750
8200
8500
- Validity criteria fulfilled:
- yes
- Conclusions:
- 72h-ErC50 and 72h-ErC10 of the active substance "dodecylbenzene sulphonamide compound with cyclohexylamine 1:1" are 47.7 and 10.1 mg/L respectively.
- Executive summary:
The objective of this study was to assess the effects of test item (dodecylbenzene sulphonamide compound with cyclohexylamine 1:1) on the growth of Pseudokirchneriella subcapitata over a period of 72 hours according to OECD 201 Guideline. Pseudokirchneriella subcapitata is a freshwater green algae that is recommended by the OECD Guideline 201.The test item is a soluble substance under the test conditions and the test solutions were prepared by dilution of a primary stock solution and by directly dissolving the test item in the test solution.
The effects of the test item diluted in OECD test medium at the definitive nominal concentrations of 10; 32; 100; 320; 1000 and 3200 mg/L test item to Pseudokirchneriella subcapitata were investigated under laboratory conditions. Test item quantification was performed according to a validated analytical method using a LC-MS/MS from Sciex (Exion LC and MS QTRAP 5500) as mass spectrometry detection to measure both dodecylbenzene sulphonamide (DDBS) and cyclohexylamine (CHA) from test item concentrations at 0 and 72 hours.Theoretical nominal concentrations values for DDBS and CHA were estimated from their respective molecular weight and purity of the test item (10%). Measured DDBS and CHA concentrations were then back calculated separately from each other in equivalents of test item concentrations.
For both CHA and DDBS, since the deviation from the target or measured initial concentration was not within the range of ± 20 %, statistical analysis of the results were based on the lowest geometric mean exposure concentrations in equivalent of test item (i.e. 10.269, 28.322, 106.071, 298.364, 1029.114 and 2808.751 mg/L test item, or 1.0 ; 2.83 ; 10.6 ; 29.8 ; 102.9 and 280.9 mg/L active substance).
The study is valid since the growth multiplication factor in the control within the 72-hour test period was higher than 16 (actual value: 416), the coefficient of variation of the average specific growth rates in the control during the whole test period was less than 7% (actual value: 6.2%) and the mean coefficient of variation for section-by-section specific growth rates (days 0-1, 1-2 and 2-3) in the control was less than 35% (actual value: 29.6%).
Based on growth rate:
- The NOEC was 28.3 mg/L test item (i.e., 2.83 mg/L active substance).
- The LOEC was 106.1 mg/L test item (i.e., 10.61 mg/L active substance).
- The 72h-EC50 was 476 mg/L test item (95% confidence limits: 391 – 579 mg.L) (i.e., 47.6 mg/L active substance).
- The 72h-EC10 was 101 mg/L test item (95% confidence limits: 60.3 - 157.9 mg/L) (i.e., 10.1 mg/L active substance).
The concentration of the test item is expressed as the sum of the concentrations of its two moieties (DDBS and CHA).
Reference
Description of key information
The objective of this study was to assess the effects of test item (dodecylbenzene sulphonamide compound with cyclohexylamine 1:1) on the growth of Pseudokirchneriella subcapitata over a period of 72 hours according to OECD 201 Guideline. Pseudokirchneriella subcapitata is a freshwater green algae that is recommended by the OECD Guideline 201.The test item is a soluble substance under the test conditions and the test solutions were prepared by dilution of a primary stock solution and by directly dissolving the test item in the test solution.
The effects of the test item diluted in OECD test medium atthe definitive nominal concentrations of 10; 32; 100; 320; 1000 and 3200 mg/L test item to Pseudokirchneriella subcapitata were investigated under laboratory conditions. Test item quantification was performed according to a validated analytical methodusing a LC-MS/MS from Sciex (Exion LC and MS QTRAP 5500) as mass spectrometry detection to measure both dodecylbenzene sulphonamide (DDBS) and cyclohexylamine (CHA) from test item concentrations at 0 and 72 hours.Theoretical nominal concentrations values for DDBS and CHA were estimated from their respective molecular weight and purity of the test item (10%). Measured DDBS and CHA concentrations were then back calculated separately from each other in equivalents of test item concentrations.
For both CHA and DDBS, since the deviation from the target or measured initial concentration was not within the range of ± 20 %, statistical analysis of the results were based on the lowest geometric mean exposure concentrations in equivalent of test item (i.e. 10.269, 28.322, 106.071, 298.364,1029.114 and 2808.751 mg/L test item, or 1.0 ; 2.83 ; 10.6 ;29.8 ; 102.9and 280.9 mg/L active substance).
The study is valid since the growth multiplication factor in the control within the 72-hour test period was higher than 16 (actual value: 416), the coefficient of variation of the average specific growth rates in the control during the whole test period was less than 7% (actual value: 6.2%) and the mean coefficient of variation for section-by-section specific growth rates (days 0-1, 1-2 and 2-3) in the control was less than 35% (actual value: 29.6%).
Based on growth rate:
- The NOEC was 28.3 mg/L test item (i.e., 2.83 mg/L active substance).
- The LOEC was 106.1 mg/L test item (i.e., 10.61 mg/L active substance).
- The 72h-EC50 was 476 mg/L test item (95% confidence limits: 391 – 579 mg.L) (i.e., 47.6 mg/L active substance).
- The 72h-EC10 was 101 mg/L test item (95% confidence limits: 60.3 - 157.9 mg/L) (i.e., 10.1 mg/L active substance).
The concentration of the test item is expressed as the sum of the concentrations of its two moieties (DDBS and CHA).
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 47.7 mg/L
- EC10 or NOEC for freshwater algae:
- 10.1 mg/L
Additional information
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