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EC number: 293-878-1 | CAS number: 91648-19-0
- 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:
- 5 december 2008 - 30 january 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study performed according to an international guideline and according to GLP. The validity criteria were fulfilled except the lack of data relating to the analytical monitoring showing that the concentrations of the test item were maintained during the test. However, the test has been performed under semi-static conditions and according to the long-term toxicity to Daphnia, the substance is stable over 48 hours. Thus, we can consider that in a short-term study, the substance is also stable.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- ISO 10253 (Water quality - Marine Algal Growth Inhibition Test with Skeletonema costatum and Phaeodactylum tricornutum)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Complementary information on test material: aqueous solution at 42% w/w of active content (= surface-active fraction, i.e. alkylamidopropylhydroxysultaine).
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION :
- Method : the test solutions were prepared without using of any organic solvent
- Stock solution : 0.01006 g test item in 1000 ml treated water in order to obtain a nominal concentration of 10.06 mg/L
- Controls : treated seawater without test item
- Evidence of undissolved material (e.g; precipate, surface film, etc) : No - Test organisms (species):
- Skeletonema costatum
- Details on test organisms:
- TEST ORGANISM
- Common name:Skeletonema costatun
- Culture number : C5B2A
- Method of cultivation: pre-cultures in the exponential growth phase were prepared from stock laboratory cultures by inoculating treated seawater with nutrient medium (culture medium) to a cell density of approximately 2 x 10E3 to 10E4 cells per millilitre. The pre-cultures were incubated at approximately 20 +/- 2°C under constant illumination for 3 days +/6 1 day, and where uses as the iniculum source for the test.
ACCLIMATION
- Acclimation period: not stated
- Culturing media and conditions: see method of cultivation above
- Any deformed or abnormal cells observed: data not available - Test type:
- static
- Water media type:
- saltwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Test temperature:
- At 0h : 20.2 - 21.4
At 24h : 19.1 - 21.0
At 48h : 19.9 - 21-3
At 72h : 19.7 - 21.6 - pH:
- - pH during the test in the control : 8.11 - 9.10
- pH at pre 0h/0h in the culture medium and the test material stocks : 8.14 - 8.16 (see table 2 below) - Dissolved oxygen:
- No data
- Salinity:
- 36 (salinity of diluent water at 0h)
- Nominal and measured concentrations:
- 1.0 - 1.8 - 3.2 - 5.6 - 10.06 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Type: Borosilicate glass conical flasks
- Material, size, headspace, fill volume: 100-mL flasks, filled with 80mL of algal suspension
- Aeration: During the test, the test solutions were continuously stirred by orbital shaker.
- Type of flow-through (e.g. peristaltic or proportional diluter): none (static test)
- Renewal rate of test solution (frequency/flow rate): a static, non-renewal exposure system was used
- Initial cells density: 10000 algal cells per mL of test medium
- Control end cells density:
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS :
Culture medium is prepared from natural seawater supplied by pump from Scapa Flow, Orkney. All seawater was UV sterilised and filtered to 0.2 µm. The filtered treated seawater was enriched with nutrients and vitamins in accordance with ISO Guidelines. The salinity of the enriched natural seawater at àh was 36 °/oo +/- 4°/oo.
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: at 0h for the test concentration of 10 mg/L
- Photoperiod: continuously illuminated
- Light intensity and quality: the measured light intensity (7160 - 8900) was achieved by four 40W tubes mounted at a distance of approximatively 40 cm directly above the test area. Light intensity values were measured daily during the test.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: Counts of algal cell numbers were carried out daily by fluorometer measurements. Three readings were performed on each test vessel.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: not stated
- Justification for using less concentrations than requested by guideline: Not applicable.
- Range finding study: Yes
- Test concentrations: 1 - 10 - 100 - 1000 mg/L
- Results used to determine the conditions for the definitive study: Yes - Reference substance (positive control):
- yes
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 5.38 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% confidence limits = 4.99 - 5.84 mg/L
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 2.26 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.76 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Results with reference substance (positive control):
- For evaluation of the quality of the aquatic organisms and the experimental conditions, 3,5-dichlorophenol is tested as a positive control.
72h EC50 = 2.19 mg/L (with 95% confidence limits : 2.03 - 2.34 mg/l)
(See results on tables 2 and 5 below) - Reported statistics and error estimates:
- The raw data for each duplicate vessel and time period were averaged, to give values for each concentration of celle volume. Growth rate calculated on the basis of these measurements. Daily intrinsic growth rate was calculated for each duplicate for each time period using an exponential model :
Nt = N0.ekt where :
Nt : volume or number at time t
N0 = volume or number at beginning of test
t = time in days
k = growth rate (d -1)
The average value of k for each time interval was calculated for each concentration. Since the criterion of effect was the concentration causing 50% reduction in growth rate with respect to the controls, the response for each concentration was estimated from . Effect = 1- (control k/treatment k).
The resulting values represent proportional reduction in growth rate. The EC50 for each time interval and the 72h EC90 and NOEC values were calculating using an appropriate statistical method from the ToxCalc Version 5 software. - Validity criteria fulfilled:
- yes
- Remarks:
- See "executive summary" and remarks "Rationale for reliability incl. deficienties"
- Executive summary:
The influence of the test item on the growth of a marine unicellular algae Skeletonema costatum was investigated in a 72 hour static test according to ISO 10253 (2006).
The nominal test item concentrations of 1.0, 1.8, 3.2, 5.6 and 10 mg/L were tested in parallel to a control and a positive substance (3,5 DCP)
The 72-hour EC50 of the test item was determinated to be 5.38 mg test item/L (2.26 mg active ingredient/L)
The 72-hour NOEC (highest concentration tested without toxic effects after the test period of 72 hours) of the test item was determined to be 1.80 mg test item/L (0.76 mg active ingredient/L) .
The 72-hour EC50 of the positive control was determinated to be 2.19 mg/L (with 95% confidence limits 2.03 - 2.34 mg/L).
According to available data, the validity criteria were fulfilled except the lack of data relating to the analytical monitoring showing that the concentrations of the test item were maintained during the test. However, the test has been performed under semi-static conditions and according to the long-term toxicity to Daphnia, the substance is stable during 48 hours. Thus, we can considered that in a short-term study, the substance is also stable.
Validity criteria fulfilled :
- Reference toxicant 72h EC50 was 2.0 -4.0 mg/L
- the control cell density had increased by a factor of more than 16 in 72h. this increase corresponds to a specific growth rate of 0.9 d-1
- the variation coefficient of the control specific growth rates didn't exceed 7%
- the control pH haven't increased by more than 1.0 during the test
- 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:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The source substance, C8-C18 AAPHS, has the same functional groups and general composition as the target C12-14 substance. The main variable resides in the alkyl chain distribution.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source chemical = C8-18 cocamidopropyl hydroxysultaine (EC 939-455-3).
Target chemical = C12-14 cocamidopropyl hydroxysultaine (EC 293-878-1).
3. ANALOGUE APPROACH JUSTIFICATION
Cf. attaced Read-Across Justification Document (§13 Assessment reports).
4. DATA MATRIX
Cf. attached Read-Across Justification Document (§13 Assessment reports). - Reason / purpose for cross-reference:
- read-across source
- Specific details on test material used for the study:
- Aqueous solution at 42% w/w of active content (= surface-active fraction, i.e. alkylamidopropylhydroxysultaine) is being used as a read across for 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C12-14 acyl derivs., hydroxides, inner salts
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 5.38 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% confidence limits = 4.99 - 5.84 mg/L
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 2.26 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.76 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Reported statistics and error estimates:
- The raw data for each duplicate vessel and time period were averaged, to give values for each concentration of celle volume. Growth rate calculated on the basis of these measurements. Daily intrinsic growth rate was calculated for each duplicate for each time period using an exponential model :
Nt = N0.ekt where :
Nt : volume or number at time t
N0 = volume or number at beginning of test
t = time in days
k = growth rate (d -1)
The average value of k for each time interval was calculated for each concentration. Since the criterion of effect was the concentration causing 50% reduction in growth rate with respect to the controls, the response for each concentration was estimated from . Effect = 1- (control k/treatment k).
The resulting values represent proportional reduction in growth rate. The EC50 for each time interval and the 72h EC90 and NOEC values were calculating using an appropriate statistical method from the ToxCalc Version 5 software. - Validity criteria fulfilled:
- yes
- Executive summary:
The influence of C12 -14 cocamidopropyl hydroxysultaine (C12 -14 AAPHS), on the growth of a marine unicellular algae Skeletonema costatum was estimated based on read-across from a study testing C8-18 cocamidopropyl hydroxysultaine (C8-18 AAPHS). Given that C12 -14 AAPHS and C8 -18 AAPHS share the same functional groups and general composition, the main variable being alkyl chain distribution, C8-18 AAPHS was considered appropriate for the purposes of read-across to C12 -14 AAPHS.
The influence of the test item on the growth of a marine unicellular algae Skeletonema costatum was investigated in a 72 hour static test according to ISO 10253 (2006). The nominal test item concentrations of 1.0, 1.8, 3.2, 5.6 and 10 mg/L were tested in parallel to a control and a positive substance (3,5 DCP).
According to available data, the validity criteria were fulfilled except the lack of data relating to the analytical monitoring showing that the concentrations of the test item were maintained during the test. However, the test has been performed under semi-static conditions and according to the long-term toxicity to Daphnia, the substance is stable during 48 hours. Thus, we can consider that in a short-term study, the substance is also stable.
Validity criteria were fulfilled :
- Reference toxicant 72h EC50 was 2.0 -4.0 mg/L
- the control cell density had increased by a factor of more than 16 in 72h. this increase corresponds to a specific growth rate of 0.9 d-1
- the variation coefficient of the control specific growth rates didn't exceed 7%
- the control pH haven't increased by more than 1.0 during the test
The 72-hour EC50 of C8 -18 AAPHS was determined to be 5.38 mg test item/L (2.26 mg C8-18 AAPHS /L)
The 72-hour NOEC (highest concentration tested without toxic effects after the test period of 72 hours) of the test item was determined to be 1.80 mg test item/L (0.76 mg C8-18 AAPHS /L).
The 72-hour EC50 of the positive control was determined to be 2.19 mg/L (with 95% confidence limits 2.03 - 2.34 mg/L).
C8-18 AAPHS is considered appropriate for read-across purposes to C12 -14 AAPHS.
Referenceopen allclose all
Table 4 - Fluorescence measurements (ppb) in test vessels after 24, 48 and 72h
Concentration (mg/L) |
24h |
48h |
72h |
1.00a |
2.195 |
25.606 |
48.091 |
1.00a |
2.170 |
25.802 |
48.660 |
1.00a |
2.265 |
25.702 |
49.169 |
1.00b |
3.307 |
24.599 |
47.314 |
1.00b |
2.309 |
24.662 |
47.756 |
1.00b |
2.256 |
24.586 |
48.137 |
1.80a |
1.697 |
20.980 |
40.686 |
1.80a |
1.651 |
20.832 |
41.037 |
1.80a |
1.647 |
21.025 |
41.390 |
1.80b |
2.090 |
23.245 |
48.156 |
1.80b |
2.133 |
23.268 |
48.455 |
1.80b |
2.102 |
23.333 |
48.818 |
3.20a |
0.623 |
6.235 |
32.901 |
3.20a |
0.603 |
6.265 |
32.724 |
3.20a |
0.607 |
6.255 |
32.876 |
3.20b |
0.536 |
7.087 |
34.907 |
3.20b |
0.573 |
6.967 |
35.041 |
3.20b |
0.578 |
6.961 |
35.008 |
5.60a |
0.140 |
0.313 |
3.955 |
5.60a |
0.132 |
- |
3.911 |
5.60a |
0.127 |
- |
3.821 |
5.60b |
0.145 |
0.530 |
4.617 |
5.60b |
0.148 |
- |
4.647 |
5.60b |
0.130 |
- |
4.630 |
10.0a |
0.003 |
0.000 |
0.129 |
10.0a |
0.002 |
- |
- |
10.0a |
0.008 |
- |
- |
10.0b |
0.009 |
-0.004 |
0.108 |
10.0b |
0.013 |
- |
- |
10.0b |
0.002 |
- |
- |
Table 5 - Fluorescence measurements (ppb) in control and referencesubstance (3,5 -DCP) after 72h
Concentrations (mg/L) |
72h |
Rep growth |
Mean growth |
||
Measurement 1 |
Measurement 2 |
Measurement 3 |
|||
Control 1 |
47.406 |
47.489 |
44.259 |
1.00 |
1.00 |
Control 2 |
44.461 |
44.858 |
45.081 |
1.03 |
|
Control 3 |
55.560 |
55.454 |
55.601 |
0.98 |
|
Control 4 |
49.561 |
49.809 |
49.812 |
0.99 |
|
1.0a |
42.755 |
50.684 |
51.023 |
1.00 |
0.99 |
1.0b |
46.574 |
46.256 |
46.355 |
0.99 |
|
1.8a |
13.181 |
13.169 |
13.138 |
0.71 |
0.69 |
1.8b |
11.148 |
11.116 |
11.037 |
0.67 |
|
3.2a |
0.608 |
0.585 |
0.566 |
0.02 |
0.01 |
3.2b |
0.473 |
0.479 |
0.478 |
0.00 |
Table - Coefficient of variation at 24, 48 and 72h (%)
24 h control CV % |
7.59 |
48 h control CV % |
1.53 |
72 h control CV % |
2.10 |
Table - Summary of compliance guideline criteria and test values recorded
Table 4 - Fluorescence measurements (ppb) in test vessels after 24, 48 and 72h
Concentration (mg/L) |
24h |
48h |
72h |
1.00a |
2.195 |
25.606 |
48.091 |
1.00a |
2.170 |
25.802 |
48.660 |
1.00a |
2.265 |
25.702 |
49.169 |
1.00b |
3.307 |
24.599 |
47.314 |
1.00b |
2.309 |
24.662 |
47.756 |
1.00b |
2.256 |
24.586 |
48.137 |
1.80a |
1.697 |
20.980 |
40.686 |
1.80a |
1.651 |
20.832 |
41.037 |
1.80a |
1.647 |
21.025 |
41.390 |
1.80b |
2.090 |
23.245 |
48.156 |
1.80b |
2.133 |
23.268 |
48.455 |
1.80b |
2.102 |
23.333 |
48.818 |
3.20a |
0.623 |
6.235 |
32.901 |
3.20a |
0.603 |
6.265 |
32.724 |
3.20a |
0.607 |
6.255 |
32.876 |
3.20b |
0.536 |
7.087 |
34.907 |
3.20b |
0.573 |
6.967 |
35.041 |
3.20b |
0.578 |
6.961 |
35.008 |
5.60a |
0.140 |
0.313 |
3.955 |
5.60a |
0.132 |
- |
3.911 |
5.60a |
0.127 |
- |
3.821 |
5.60b |
0.145 |
0.530 |
4.617 |
5.60b |
0.148 |
- |
4.647 |
5.60b |
0.130 |
- |
4.630 |
10.0a |
0.003 |
0.000 |
0.129 |
10.0a |
0.002 |
- |
- |
10.0a |
0.008 |
- |
- |
10.0b |
0.009 |
-0.004 |
0.108 |
10.0b |
0.013 |
- |
- |
10.0b |
0.002 |
- |
- |
Table 5 - Fluorescence measurements (ppb) in control and referencesubstance (3,5 -DCP) after 72h
Concentrations (mg/L) |
72h |
Rep growth |
Mean growth |
||
Measurement 1 |
Measurement 2 |
Measurement 3 |
|||
Control 1 |
47.406 |
47.489 |
44.259 |
1.00 |
1.00 |
Control 2 |
44.461 |
44.858 |
45.081 |
1.03 |
|
Control 3 |
55.560 |
55.454 |
55.601 |
0.98 |
|
Control 4 |
49.561 |
49.809 |
49.812 |
0.99 |
|
1.0a |
42.755 |
50.684 |
51.023 |
1.00 |
0.99 |
1.0b |
46.574 |
46.256 |
46.355 |
0.99 |
|
1.8a |
13.181 |
13.169 |
13.138 |
0.71 |
0.69 |
1.8b |
11.148 |
11.116 |
11.037 |
0.67 |
|
3.2a |
0.608 |
0.585 |
0.566 |
0.02 |
0.01 |
3.2b |
0.473 |
0.479 |
0.478 |
0.00 |
Table - Coefficient of variation at 24, 48 and 72h (%)
24 h control CV % |
7.59 |
48 h control CV % |
1.53 |
72 h control CV % |
2.10 |
Table - Summary of compliance guideline criteria and test values recorded
Description of key information
The 72-hour EC50 of the test item (C8 -18 cocamidopropyl hydroxysultaine) was determined to be 5.38 mg test item/L (equivalent to 2.26 mg C8 -18 AAPHS /L) and the 72 -hour NOEC was determined to be
1.80 mg test item/L (equivalent to 0.76 mg C8 -18 AAPHS /L), and are considered appropriate for read-across purposes to C12 -14 AAPHS.
Key value for chemical safety assessment
- EC50 for marine water algae:
- 2.26 mg/L
- EC10 or NOEC for marine water algae:
- 0.76 mg/L
Additional information
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.