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EC number: 944-170-2 | 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
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- Nanomaterial pour density
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- 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:
- 2014-11-03 to 2014-11-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- The limit concentration and the control were analytically verified from freshly prepared test media after 0 and 72 h and from corresponding 24 h aged test media after 24 and 96 h.
Analytical evaluation of the test item was carried out via LC-MS/MS. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
The stock solution was prepared by directly weighing the test item into the test medium. The test media were mixed with an ultraturrax (1 min, 17000 rpm). - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebrafish
- Strain: Danio rerio
- Source: Umweltbundesamt, Schichauweg 58, 12307 Berlin, Germany
- Length at study initiation (mean): 2.5 cm
- Weight at study initiation (mean): 0.227 g
- Feeding during test: no; the test fish were not fed 24 h before test start
ACCLIMATION
- Acclimation conditions (same as test or not): Tap water; 23 ± 2°C, diffuse light (0.1 - 10 µmoI . m-2 . s-1, natural photoperiod); water changes at least once per week; dissolved oxygen concentration > 80 % of the air saturation value
- Type and amount of food: Sera Vipan; SERA GMBH, 52518 Heinsberg, Germany; the amount of food was 4% of the fish body weight per feeding day
- Feeding frequency: 3 times per week
- acclimation: at least 12 days; fish with mortality < 5 % within these days prior to start of the exposure were used in the test - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 231 mg/L as CaCO3
- Test temperature:
- 22.9 ± 0.3
- pH:
- 7.46 - 7.93
- Dissolved oxygen:
- 80 - 100%
- Nominal and measured concentrations:
- nominal: 0, 100 mg a.i./L
measured concentrations were in the range of 99-108% - Details on test conditions:
- TEST SYSTEM
- Test vessel: 3 L glass aquaria, filled with 2 L of natural river water (dimensions: 11.5/13/20 cm, depth of water: at least 13.5 cm), and covered with glass plates
- Aeration: yes
- Renewal rate of test solution (frequency): daily
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.79 g fish per litre test solution
TEST MEDIUM / WATER PARAMETERS
river water as specified in section "any other information on materials and methods"
The natural river water was stored at 15 ± 2°C. At least 24 h before use, the natural river water was temperated to 23 ± 2°C and aerated.
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 9.5 hours light
- Light intensity: 0.42 to 0.64 (mean value 0.52) µmol photons : m-2 . S-1
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
mortality at 24, 48, 72 and 96 h
Records were kept of visible abnormalities (e.g. loss of equilibrium, swimming behaviour, respiratory function, pigmentation, etc.)
TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: The limit concentration was extrapolated from the results of a preliminary range finding test conducted under semi-static conditions, with natural river water and the nominal Betaine concentrations of 34.6 and 3.46 mg a.i./L. As no mortality was observed in the limit concentration, no additional testing of further concentrations was carried out. - Reference substance (positive control):
- not required
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Mortality of control: 0/7
- Results with reference substance (positive control):
- n.a.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 96 h LC50 of C8-10 Alkylamidopropyl betaine was > 100 mg a.i./L in zebrafish (Danio rerio) using natural river water.
- Executive summary:
In a 96 h acute toxicity study according to OECD guideline 203, adopted 17 July 1992, zebrafish (Danio rerio) were exposed to C8-10
Alkylamidopropyl betaine at nominal concentrations of 0 (control) and 100 mg/L under semi-static conditions in natural river water containing 3.46 mg/L TOC (2.71 mg/L DOC). Measured test item concentrations were in agreement with nominal (99-108%). These concentrations remained stable during both renewal periods. Given these results, effect parameters can be based on the nominal test concentrations.
No mortality or other clinical effect was observed at the limit concentration and the control during the 96-hour test period. The 96 h LC50 was >100 mg a.i./L.
This study is classified as acceptable and satisfies the guideline requirements for an acute toxicity study with Danio rerio..
Results Synopsis
Test organism size/age (mean wet weight or length): Zebrafish (Danio rerio) (2.5 cm / 0.227 g)
Test Type: Static Renewal
LC50: >100 mg a.i./L
Endpoint(s) Effected: mortality
Reference
Description of key information
96 h LC50 >100 mg a.i./L (analytically verified nominal concentration); OECD TG 203, Danio rerio, semi-static, GLP, RL1; natural river water containing 3.46 mg/L TOC
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 100 mg/L
Additional information
In a 96 h acute toxicity study according to OECD guideline 203, adopted 17 July 1992, zebrafish (Danio rerio) were exposed to C8-10 Alkylamidopropyl betaine at nominal concentrations of 0 (control) and 100 mg/L under semi-static conditions in natural river water containing 3.46 mg/L TOC (2.71 mg/L DOC). Measured test item concentrations were in agreement with nominal (99-108%). These concentrations remained stable during both renewal periods. Given these results, effect parameters can be based on the nominal test concentrations.
No mortality or other clinical effect was observed at the limit concentration and the control during the 96-hour test period. The 96 h LC50 was >100 mg a.i./L.
The following results were obtained with the closely related read-across substances C8-18 and C18 unsatd. AAPB, C8-18 AAPB and Formamidopropylbetaine (included in the dossier to support the read-across for other endpoints):
The acute toxicity of C8-18 and C18 unsatd. AAPB to fish (Pimephales promelas) was investigated in a study conducted according to OECD Guideline 203 and EU Method C.1. A 96 h LC50=1.11 mg a.i./L nominal (=3.7 mg product/L) was determined.
In a 28-d toxicity study conducted according to OECD Guideline 204 under flow-through conditions and using rainbow trouts (Oncorhynchus mykiss) as test organism, the 28-d NOEC and LOEC of C8-18 AAPB were 0.16 and 0.5 mg a.i./L nominal based on mortality and sublethal effects.
Formamidopropylbetaine induced no visible effects in carp at 100 mg/L (NOEC). The 96h-LC50 was> 100 mg/L based on analytically confirmed nominal concentrations.
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