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EC number: - | 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
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 - 13 August 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 13 April 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-(aminocarbonyl)-1-ß-D-ribofuranosyl-pyridinium bromide
- Cas Number:
- 78687-39-5
- Molecular formula:
- C11H15BrN2O5
- IUPAC Name:
- 3-(aminocarbonyl)-1-ß-D-ribofuranosyl-pyridinium bromide
- Reference substance name:
- Nicotinamide
- EC Number:
- 202-713-4
- EC Name:
- Nicotinamide
- Cas Number:
- 98-92-0
- Molecular formula:
- C6H6N2O
- IUPAC Name:
- nicotinamide
- Reference substance name:
- Methanol
- EC Number:
- 200-659-6
- EC Name:
- Methanol
- Cas Number:
- 67-56-1
- Molecular formula:
- CH4O
- IUPAC Name:
- methanol
- Reference substance name:
- Ethyl acetate
- EC Number:
- 205-500-4
- EC Name:
- Ethyl acetate
- Cas Number:
- 141-78-6
- Molecular formula:
- C4H8O2
- IUPAC Name:
- ethyl acetate
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Oxidane
- Reference substance name:
- inorganic salts by sulphated ash
- IUPAC Name:
- inorganic salts by sulphated ash
- Reference substance name:
- Bromic acid
- EC Number:
- 232-158-3
- EC Name:
- Bromic acid
- Cas Number:
- 7789-31-3
- Molecular formula:
- BrHO3
- IUPAC Name:
- bromic acid
- Reference substance name:
- Unknown impurities.
- Molecular formula:
- Not available as unknown impurities.
- IUPAC Name:
- Unknown impurities.
- Test material form:
- solid
- Details on test material:
- Batch / Lot No. 1000146/01
Constituent 1
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
impurity 6
impurity 7
- Specific details on test material used for the study:
- Lot no.: 1000146/01
Storage conditions: At approximately -15 °C
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Samples were taken from all test media at the start of the test as well as after 24 and 48 hours of exposure. At the start of the test, the samples were taken from the freshly prepared test solutions as well as from the pure test water serving as control. For all subsequent sampling time points, aliquots from the respective replicates of the test media were pooled before sampling.
Immediately after sampling, acetonitrile containing 0.2% acetic acid was added to each sample to obtain a composition of sample:acetonitrile (1:1; v:v) containing 0.1% acetic acid. Thereafter, all samples were stored deep-frozen (at about -20 °C). In pre-experiments for investigation of the storage stability of the samples (non-GLP), the test item proved to be stable under these storage conditions.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
The following test vessels were set up:
- Test solution: containing test water with test item (four replicates per concentration with five daphnids each)
- Control: containing pure test water (four replicates with five daphnids each)
Since the test item is soluble, the test solution was prepared by adding 100 mg/l of test item to test water in glassware. Pure test water served as control.
The test vessels were filled with 50 ml of the respective test medium. Daphnia, aged less than 24 hours and already acclimatized to the test water, were introduced into the test media and the vessels were covered with a glass plate. The Daphnia were not fed during the test and the test vessels were not aerated.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISMS
- Test organism: Daphnia magna Straus, supplied by IES Ltd., 4108 Witterswil, Switzerland
- Breeding: The daphnids are cultivated in Elendt M4 medium at 18–22 °C, controlled at ±1 °C
- Illumination: 16 h per day, about 550-1100 lux, source: overhead white fluorescent tubes
- Medium: Reconstituted water (Elendt M4 medium)
- Feed: Suspension of Desmodesmus subspicatus in Elendt M4 medium with an optical density OD680 of about 12 units. This results in a final concentration of about 0.1 units from Monday to Thursday and 0.4 units on Fridays in the culture vessel.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 2.5 mM (based on the sum of Ca2+ and Mg2+), Carbonate Alkalinity: 0.8 mM
- Test temperature:
- 18–22°C, controlled at ±1 °C
- pH:
- 7.5 - 7.6
- Dissolved oxygen:
- >=3 mg O2/l (required >=3 mg O2/l)
- Salinity:
- not reported
- Conductivity:
- 638 µS cm-1
- Nominal and measured concentrations:
- NOMINAL CONCENTRATIONS
The definitive test was performed as a static limit-test at a nominal concentration of 100 mg/l.
MEASURED CONCENTRATIONS
The concentration of Nicotinamide-beta-D-riboside bromide (CAS no. 78687-39-5) in the test media at 0, 24 and 48 hours of exposure was determined by HPLC with UV detection. These analyses showed that the test item was correctly dosed and that the concentration remained stable within 80-120% of the nominal concentration over the duration of the test. Therefore, the effective concentrations ECx were assessed based on the nominal concentration of the test item, which was 100 mg/l. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 ml glass beaker containing 50 ml of test medium, covered with a glass plate to avoid evaporation and contamination of the test solutions with dust.
- Test medium: Elendt M4 medium
- Number of Daphnia: 20 individuals per test concentration and for the control divided in four groups of five individuals.
- Age: Less than 24 hours
- Light: 16 hours photoperiod per day, about 550–1100 lux, source: overhead white fluorescent tubes.
- Temperature: 18–22 °C, controlled at ±1 °C
- pH: The pH should not vary by more than 1.5 units during the exposure.
- Feed: The daphnids are not fed during the test
- Test design: Static exposure conditions
- Test duration: 48 hours
RANGE-FINDING STUDY
Prior to the definitive test a non-GLP range finding test with nominal concentrations of 1, 10 and 100 mg/l of Nicotinamide-beta-D-riboside bromide was performed (two replicates for each of the test concentration and the control; five daphnids per replicate).
EFFECT PARAMETERS MEASURED
Observations of immobilised daphnids were made after 24 and 48 hours of exposure. Any abnormal behaviour or appearance was reported. - Reference substance (positive control):
- yes
- Remarks:
- Acute reference test with potassium dichromate conducted twice a year
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- During the first 24 hours of the test, no immobilised test organism was determined in the control and in the single test concentration of 100 mg/l. Thus, the 24-hour EC50 was greater than 100 mg/l. The no observed effect concentration (NOEC) after 24 hours was determined to be 100 mg/l.
After 48 hours of exposure, no immobilised test organism was determined in the control and in the single test concentration of 100 mg/l. Thus, the 48-hour EC50 was greater than 100 mg/l. The no observed effect concentration (NOEC) after 48 hours was determined to be 100 mg/l. - Results with reference substance (positive control):
- The result of the latest positive control test performed in March 2019 showed that the sensitivity of the test system (24-hour EC50 = 0.88 mg/l) lies within the recommended range of 0.6–2.1 mg/l according to ISO 6341:2012: Water quality – determination of the inhibition of the mobility of Daphnia magna Straus (Cladocera, Crustacea) – Acute toxicity test.
- Reported statistics and error estimates:
- The effective concentration EC50 for 24 and 48 hours was estimated based on the concentration tested and immobilisation observed.
The no observed effect concentration (NOEC) is the highest test concentration for which the test item is observed to have an immobilisation rate not exceeding 10%. Thus, immobilisation rates >10% are considered to be significant.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- All validity criteria i.e. immobilization in the controls <=10% and O2 concentrations at the end of the test >=3 mg/L were fulfilled.
- Conclusions:
- In conclusion, Nicotinamide-beta-D-riboside bromide (CAS no. 78687-39-5) had no acute toxic effects on Daphnia magna up to the nominal concentration of 100 mg/l under the conditions of the test.
- Executive summary:
The acute toxicity of Nicotinamide-beta-D-riboside bromide (CAS no. 78687-39-5) to Daphnia magna was investigated according to the OECD guideline 202 under static exposure conditions over a period of 48 hours.
The test item Nicotinamide-beta-D-riboside bromide is solid, 96.2% pure and soluble in test water up to at least 100 mg/l. Consequently, the single test solution was prepared by adding 100 mg/l of the test item to test water and stirring it until dissolution. The single nominal concentration tested was 100 mg/l.
The concentration of Nicotinamide-beta-D-riboside bromide in the test media at 0, 24 and 48 hours of exposure was determined by HPLC with UV detection. These analyses showed that the test item was correctly dosed and that the concentration remained stable within 80-120% of the nominal concentration over the duration of the test. Therefore, the effective concentrations ECx were assessed based on the nominal concentration of the test item.
In the control and at the test concentration of 100 mg/l, no immobilised test organism was observed during the test period of 48 hours.
The biological test results of Nicotinamide-beta-D-riboside bromide to Daphnia magna after 24 and 48 hours of exposure are summarized in the following table based on the nominal concentration of the test item:
Parameter
Immobilisation (0-24 h) [mg/l]
Immobilisation (0-48 h) [mg/l]
EC50
>100
>100
NOEC
100
100
In conclusion, Nicotinamide-beta-D-riboside bromide (CAS no. 78687-39-5) had no acute toxic effects on Daphnia magna up to the nominal concentration of 100 mg/l under the conditions of the test.
All validity criteria were fulfilled.
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