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EC number: 258-416-5 | CAS number: 53179-11-6
- 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
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From August 11 to August 13, 2015
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Loperamide
- EC Number:
- 258-416-5
- EC Name:
- Loperamide
- Cas Number:
- 53179-11-6
- Molecular formula:
- C29H33ClN2O2
- IUPAC Name:
- 4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]-N,N-dimethyl-2,2-diphenylbutanamide
- Details on test material:
- Name Loperamide base (CAS 53179-11-6)
Batch no. 02742200215
Appearance White solid
Purity 99.5 %
Homogeneity homogeneous
Expiry date 20. Aug. 2015
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
Test solutions
- Details on test solutions:
- During validation, solubility in daphnia medium was estimated as 0.6 mg/L. Therefore in this daphnia study the concentration 0.6 mg/L was tested. A stock solution containing 6000 mg/L in acetone was prepared. For the solvent control, acetone in a concentration of 0.1 mL/L was used.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Strain Berlin
Sex female
Age between 0 and 24 hours
Origin Umweltbundesamt Berlin
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 250 mg CaCO3/l
- Test temperature:
- 19.5 – 20.7 °C
- pH:
- 7.6
- Nominal and measured concentrations:
- At the start and at the end of the test, the content of the test item in the test solutions was
determined using HPLC. The measured concentration was 86°% the nominal concentration
at the start of the test.
At the end of the test significant amounts of the test item were detected in the blank and
the solvent control. This was probably caused by contamination during the sample preparation
before measurement via HPLC. As the detected value in the solvent control was
higher than in the blank control, this value was subtracted from the determined concentration
in treatment at the end of the test.
Thus the measured concentration was 53 % of the nominal concentration at the end of the
test.
Therefore the geometric mean of the measured concentration was used for the determination of the results. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 0.41 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 0.41 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- >= 0.41 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- In the blank control, solvent control and the treatment none of the Daphnia were immobilised.
- Results with reference substance (positive control):
- The 24h-EC50 value was determined as 1.6 mg/L, lying within the demanded range of 0.6 – 1.7 mg/L.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- One valid experiment was performed.
20 Daphnia were exposed to the test item for the blank control, the solvent control and the treatment for 48 hours in a static test system.
The treatment showed no toxicity. None of the animals were immobilised in the control and in the solvent control.
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