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EC number: 701-354-5 | 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
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 - 28 January 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study in principle according to guideline and under GLP. No data on actual concentrations but in the algae test from 2018 the test substance was shown to be stable.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- yes
- Remarks:
- No chemical analysis, water hardness less than adviced
- Principles of method if other than guideline:
- No measurement of actual concentration, hardness below recommended concentration (50 iso 140 mg/L as CaCO3). 2 reps per group iso 4. Statistics according to Thompson and not Finney.
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- Direct dispersion in water. 200 mg of test material was dispersed in aged and dechlorinated tap water and the volume adjusted to 2 litres to give a 100 mg/L test concentration from which dilutions are made to give the test series.
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Name: Daphnia magna Straus
Source: Laboratory culture originating from a strain supplied by the Institut national de Recherche Chimique Appliquée (IRCHA), France
Culture: At 21C in propylene vessels containing two litres of dechlorinated and aged tap water. Cultures were fed daily with a suspension of mixed algae (predominantly Chlorella spp.). Culture conditions ensure that reproduction is by parthogenesis. Gravid adults were isolated 24 hours prior to the initiation of the test. Young daphnids produced overnight were used for testing. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- None
- Hardness:
- 50 mg/L as CaCO3
- Test temperature:
- 22.0 C
- pH:
- 7.5 - 7.7
- Dissolved oxygen:
- 8.0 - 8.7 mgO2/L
- Nominal and measured concentrations:
- Nominal concentrations:
1.0, 1.8, 3.2, 5.6, 10, 18, 32, 56, 100 mg/L - Details on test conditions:
- The test material was suspected to absorb to glassware and so saturation of the absorption sites was achieved by soaking the test vessels overnight prior to the start of the test with the test solutions. At 0 hours the test vessels were emptied, rinsed with the solution to be tested and then refilled with the fresh test solution.
Test vessels were glass jars each containing 200 ml test solution and were covered to reduce evaporation. 1 control in duplicate and 9 test concentrations in duplicate. 20 mL test solution per organism, 10 per replicate. No aeration during the test and a 16h light - 8h dark photoperiod. Daphnia were placed in the test solutions after addition of the test material. Daphnia were considered to be immobilised if they were unable to swim for approximately 15 seconds after gentle agitation. - Reference substance (positive control):
- no
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1.56 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% CL: 1.38 - 1.77 mg/L
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% CL: 9.0 - 12 mg/L
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 5.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% CL: 4.6 - 5.9 mg/L
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 3.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Details on results:
- Concentrations >= 18 mg/L caused complete immobility within 24 hours. No immobilisation was observed up to concentrations of 3.2 mg/L during the study period. At the dose rate of 5.6 mg/L no immobilisation was apparent after 24 hours but 13/20 animals were immobilised after 48 hours. In the 10 mg/L dose group 9/20 animals were immobilised after 24 hours, whilst all animals were immobilised after 48 hours.
The EC50 24h and EC50 48h were determined at 10 and 5.2 mg/L respectively on a nominal basis.
The 48h NOEC was concluded at 3.2 mg/L nominally. - Reported statistics and error estimates:
- Analysis of the immobility data by the moving average method of Thompson (1947).
- Validity criteria fulfilled:
- yes
- Conclusions:
- Unfortunately no preliminary test was done. Instead of nine test concentrations, four would have been sufficient for the same amount of information.
Concentrations >= 18 mg/L caused complete immobility within 24 hours. No immobilisation was observed up to concentrations of 3.2 mg/L during the study period. At the dose rate of 5.6 mg/L no immobilisation was apparent after 24 hours but 13/20 animals were immobilised after 48 hours. In the 10 mg/L dose group 9/20 animals were immobilised after 24 hours, whilst all animals were immobilised after 48 hours. The EC50 24h and EC50 48h were determined at 10 and 5.2 mg/L respectively on a nominal basis. The 48h NOEC was concluded at 3.2 mg/L nominally. Expressed for active ingredient (30%) this would give EC50 values of 3.1, 1.6 and a NOEC of 0.96 mgai/L. - Executive summary:
In this study the acute toxicity of Ampholak YCE to Daphnia magna was studied according to OECD202. The test was performed under GLP as a static test. Each replicate contained 10 daphnids, 2 replicates for control and for the nine test concentrations. Concentrations >= 18 mg/L caused complete immobility within 24 hours. No immobilisation was observed up to concentrations of 3.2 mg/L during the study period. At the dose rate of 5.6 mg/L no immobilisation was apparent after 24 hours but 13/20 animals were immobilised after 48 hours. In the 10 mg/L dose group 9/20 animals were immobilised after 24 hours, whilst all animals were immobilised after 48 hours. The EC50 24h and EC50 48h were determined at 10 and 5.2 mg/L respectively on a nominal basis. The 48h NOEC was concluded at 3.2 mg/L nominally.
Reference
Number of mobile animals
Conc substance |
Test vessel |
|||
in mg/l |
number |
0 hours |
24 hours |
48 hours |
control |
1 |
10 |
10 |
10 |
2 |
10 |
10 |
10 |
|
total |
20 |
20 |
20 |
|
1.0 |
1 |
10 |
10 |
10 |
2 |
10 |
10 |
10 |
|
total |
20 |
20 |
20 |
|
1.8 |
1 |
10 |
10 |
10 |
2 |
10 |
10 |
10 |
|
total |
20 |
20 |
20 |
|
3.2 |
1 |
10 |
10 |
10 |
2 |
10 |
10 |
10 |
|
total |
20 |
20 |
20 |
|
5.6 |
1 |
10 |
10 |
4 |
2 |
10 |
10 |
3 |
|
total |
20 |
20 |
7 |
|
10 |
1 |
10 |
6 |
0 |
2 |
10 |
5 |
0 |
|
total |
20 |
11 |
0 |
|
18 |
1 |
10 |
0 |
0 |
2 |
10 |
0 |
0 |
|
total |
20 |
0 |
0 |
|
32 |
1 |
10 |
0 |
0 |
2 |
10 |
0 |
0 |
|
total |
20 |
0 |
0 |
|
56 |
1 |
10 |
0 |
0 |
2 |
10 |
0 |
0 |
|
total |
20 |
0 |
0 |
|
100 |
1 |
10 |
0 |
0 |
2 |
10 |
0 |
0 |
|
total |
20 |
0 |
0 |
Description of key information
Two short-term daphnia studies have been performed with Sodium cocopropylenediamine propionate.
One acute daphnia study with Sodium cocopropylenediamine propionateis was performed in 1993. The study from Sewell and Grant-Salmon (1993) resulted in a 48h EC50 for daphnia magna of 1.6 mg a.i./L based on nominal test concentrations. The test was performed statically and the glassware was presoaked with test solution to prevent any potential sorption to glassware. The test substance concentration was however not quantified as no suitable analytical method was available in 1993.
In 2022 an additional acute daphnia study with Sodium cocopropylenediamine propionate was performed. The study from Scheerbaum (2022) resulted in a 48 h EC50 of 6.41 mg a.i./L based on nominal test item concentrations. The test was performed under static conditions and the analytically verified measured concentrations of the test item based on the main components C12-amine dipropionate, C14-amine dipropionate, C12-diamine tripropionate and C14-diamine tripropionate at the start of the exposure (0 hours) were in the range of 101% to 119% of the nominal values. At the end of the exposure period (48 hours), the measured concentrations were in the range of 82 to 113% of the nominal values. Therefore, the EC50 value is based on the nominal concentration.
Both acute daphnia tests show similar effect values. Since no analytical measurement was performed in the study from Sewell & Grant-Salmon (1993) the data are less reliable compared to the study from Scheerbaum (2022). Therefore the EC50 of 6.41 mg a.i./L (based on an active ingredient content of 31.4%) will be used as key value for the chemical risk assessment.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- EC50
- Effect concentration:
- 6.41 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.
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