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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 fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 October - 1 November 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study according to guideline & GLP. No data on actual concentrations. The algae study from 2018 showed that the test substance is stable during 72 hours. It is reasonable to assume that the test substance remained stable in the fish test as well.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- yes
- Remarks:
- No chemical analysis
- Principles of method if other than guideline:
- No measurement of actual concentrations but substance has shown to be stable in the algae test (2018). No preliminary test. Statistics different from guideline.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- although study director page can not be read
- Analytical monitoring:
- no
- Remarks:
- In the algae study from 2018 it was shown that the test substance is stable during 72 hours under algae test conditions. It is reasonable to assume that also in this acute fish study the test substance must have remained stable.
- Vehicle:
- no
- Details on test solutions:
- Direct dispersion in water. 0.2, 0.36, 0.64, 1.12 and 2.00 g of test material were each dispensed directly into 20 litres of diluent to give the test series.
- Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- Rainbow trout (Oncorhynchus mykiss)
Source: Parkwood trout farm, Wigmore, kent, United Kingdom.
The stock of fish was held since 17 October 1991 and was acclimatised to test conditions from 17 - 28 October 1991.
The stock fish were maintained in a glass fibre tank with a single-pass water renewal system.
Fish were fed dailey with commercial trout pellets, but feeding was discontinued 24h prior to the test.
Mean standard length = 4.1 cm (SD = 0.3 cm), mean weight = 0.97 g (SD = 0.20 g), no data on age of fish. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Post exposure observation period:
- None
- Hardness:
- Approximately 50 mg/L as CaCO3
- Test temperature:
- 14.0 °C
- pH:
- 7.4 - 7.6
- Dissolved oxygen:
- 10.0 - 10.2 mg O2/L
- Salinity:
- Fresh water
- Nominal and measured concentrations:
- Nominal concentrations:
10, 18, 32, 56, 100 mg/L test substance
3, 5.4, 9.6, 16.8 and 30 mg a.i./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.
There was a dailey renewal of test media to ensure stability of the test concentrations.
The lightning was controlled at 16h light- 8 h darkness cycle.
Test vessels: Glass aquaria holding 20L of test media. 5 test concentrations plus 1 control (10 animals per test concentration).
Fish were placed at random in prepared test media, loading 0.49 g bodyweight/L.
Aeration via narrow bore glass tubes.
Criteria of death: absence of (i) respiratory movement and (ii) response to a physical stimulation. - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 4 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CL: 3 - 5.4 mg/L
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 13 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CL: 10 - 18 mg/L
- Duration:
- 72 h
- Dose descriptor:
- LC50
- Effect conc.:
- 13 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CL: 10 - 18 mg/L
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- 24 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CL: 18 - 32 mg/L
- Duration:
- 24 h
- Dose descriptor:
- LC50
- Effect conc.:
- 28 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CL: 24 - 34 mg/L
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Details on results:
- The highest concentration test substance resulting in 0% mortality = 10 mg/L and the lowest test concentration resulting in 100% mortality = 18 mg/L.
At 100 mg/L all fish died within 3 h after exposure. Apart from mortality, only loss of equilibrium was observed at concentrations >= 32 mg/L.
The LC50 (96h) was concluded at 13 mg/L , the NOEC (96h) was concluded at 10 mg/L on a nominal basis. - Results with reference substance (positive control):
- n.a.
- Reported statistics and error estimates:
- Analysis of mortality was carried out by the method of Thompson (1947)
- Sublethal observations / clinical signs:
Number of surviving animals
Conc (mg/L)
0h
3h
6h
24h
48h
72h
96h
Control
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
18
10
10
10
10
10
0
0
32
10
10
10
3
0
0
0
56
10
10
0
0
0
0
0
100
10
0
0
0
0
0
0
- Validity criteria fulfilled:
- yes
- Conclusions:
- The study was performed according to GLP and guideline. Based on the available data, the highest concentration resulting in 0% mortality = 10 mg/L and the lowest test concentration resulting in 100% mortality = 18 mg/L. At 100 mg/L all fish died within 3 h after exposure. Apart from mortality, only loss of equilibrium was observed at concentrations >= 32 mg/L. The LC50 (96h) was concluded at 13 mg/L , the NOEC (96h) was concluded at 10 mg/L on a nominal basis.
- Executive summary:
The acute toxicity of Ampholak YCE to rainbow trout (Oncorhynchus mykiss) was evaluated according to OECD203 and was performed under GLP. It was carried out as a semi-static test, with dose levels of nominally 10, 18, 32, 56 and 100 mg/L. The LC50 (96h) was observed to be 13 mg/L of test substance or 4 mg a.i./L, the NOEC (96h) was concluded at 10 mg/L (or 3 mg a.i./L) on a nominal basis. Loss of equilibrium was observed in animals exposed to concentrations of >= 32 mg/L (or 9.6 mg a.i./L).
Reference
Description of key information
Two acute fish studies have been performed with Sodium cocopropylenediamine propionate.
One acute fish study with Sodium cocopropylenediamine propionate was performed in 1992. The study from Sewell and Wetton (1992) resulted in a 96h LC50 for rainbow trout of 4.00 mg a.i./L based on nominal test concentrations. The test was performed semi-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 1992.
In 2022 an additional acute fish study with Sodium cocopropylenediamine propionate was performed with a limit test concentration of 10.0 mg test item/L (3.14 mg a.i/L based on 31.4 % active ingredient). The selection of the test concentration was based on the derivation of a threshold concentration (TC) from the data of the test item of results of a daphnia toxicity test (EC 50 (48h) = 20.4 mg test item/L and of an algae toxicity test (ErC50 (0-72 h) > 10.0 mg test item/L) from Scheerbaum (2022) and Klix (2018). The acute fish study from Scheerbaum (2022) resulted in a 96 h LC0 for zebrafish of 3.14 mg a.i./L based on nominal test item concentrations and consequently an LC50 > 3.14. The test was performed under static conditions and the measured concentrations of the test item based on the main components C12-amine dipropionate, C14-amine dipropionate, C12-diamine tripropionate and C14-diamine tripropionate were in the range of 80-120% of nominal. Therefore, the effect concentration is based on nominal value.
Both acute fish tests show similar effect values. Since no analytical measurement was performed in the study from Sewell & Wetton (1992) the data are less reliable compared to the study from Scheerbaum (2022). Therefore the 96 h LC50 of >3.14 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 fish
Fresh water fish
- Dose descriptor:
- LC50
- Effect concentration:
- > 3.14 mg/L
Additional information
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