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EC number: 251-780-6 | CAS number: 33996-33-7
- 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
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-07-03 to 2017-08-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Version / remarks:
- 2011-07-28
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No 761/2009, Annex, Part C, C.3.: "Freshwater Algae and Cyanobacteria, Growth Inhibition Test", Official Journal of the European Union (EN)
- Version / remarks:
- 2009-08-24
- Qualifier:
- according to guideline
- Guideline:
- other: SANCO/3029/99 rev.4 11/07/00: Residues: Guidance for generating and reporting methods of analysis in support of pre-registration data requirements for Annex II (part A; Section 4) and Annex III (part A; Section 5) of directive 91/414
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Nippon Rika Co., Ltd. / lot 6716-16E
- Expiration date of the lot/batch: 2018-10-23
- Purity test date: 2016-11-17
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At 20°C +/- 5°C, in the dark
- Solubility and stability of the test substance in the solvent/vehicle: highly soluble - Analytical monitoring:
- yes
- Details on sampling:
- The samples were taken from the biological phase of the study. Duplicate samples from the freshly prepared test media (containing algae) of all test concentrations and from the control were taken at the start of the test.
For the determination of the stability of the test item under the test conditions and of the maintenance of the test item concentrations during the test period, duplicate samples from the test media of all test concentrations and the control (containing algae) were taken at the end of the test (after the 72 hours test period) by pouring together the contents of the test beakers of each treatment.
The samples were diluted by a factor of two with acetonitrile.
One additional sample of the control and of the dilution solvent was taken at test start and test end without any sample treatment.
All samples were stored in a freezer (≤ - 20 °C), protected from light until analysis was performed. Afterwards the samples were again stored deep frozen (≤ -20 °C) and were kept stored up to the date of the final report.
The concentrations of the test item Oxaceprol were analysed in the duplicate test media samples from all test concentrations, and in the duplicate control samples, from both sampling times (0 and 72 hours). - Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Weighed amounts were dissolved; stock solution was diluted
- Controls: Reconstuted water, potassium dichromate (historical)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): reconstuted water (OECD medium)
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)): stock solution: 100 mg/L; test concentrations were 100, 32, 10, 3.2 and 1.0 mg/L
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): all test material dissolved - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata
- Strain: Strain No. 61.81 SAG
- Source (laboratory, culture collection): „Sammlung von Algenkulturen, Albrecht-von-Haller-Institut für Pflanzenwissenschaften, Universität Göttingen", 37073 Göttingen, Germany
acclim - Method of cultivation: The algae were cultivated in the laboratories of ibacon under standardised conditions according to the test guidelines
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Hardness:
- Calculated water hardness of the test water: 0.24 mmol/L (= 24 mg/L) as CaCO3.
- Test temperature:
- 21.9 to 22.9 °C
- pH:
- 8.0 at test start, 9.1 to 9.2 at test end
- Nominal and measured concentrations:
- fresh aged mean measured concentrations [mg/L]
mg/L % of nominal RSD % of nominal RSD
1 84 6 76 3 0.798
3.2 76 5 76 4 2.42
10 81 1 79 4 8.00
32 78 6 72 6 24.1
100 91 5 81 0 85.8
Number of analysed samples: 4 each
RSD: relative standard deviation - Details on test conditions:
- TEST SYSTEM
- Test vessel: Erlenmeyer flasks of 50 mL volume with 50 mL of test medium
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: glass
- Initial cells density: approx. 5000/mL
- Control end cells density: yes
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): positive control by historical data
- No. of vessels per vehicle control (replicates): 1 per test concentration
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
Analytical grade salts were added at the following nominal concentrations in deionised water:
Macronutrients:
NaHCO3 50.0 mg/L
CaCl2 x 2 H2O 18.0 mg/L
NH4Cl 15.0 mg/L
MgSO4 x 7 H2O 15.0 mg/L
MgCl2 x 6 H2O 12.0 mg/L
KH2PO4 1.6 mg/L
Trace elements:
Na2EDTA x 2 H2O 100.0 µg/L
FeCl3 x 6 H2O 64.0 µg/L
MnCl2 x 4 H2O 415.0 µg/L
H3BO3 185.0 µg/L
Na2MoO4 x 2 H2O 7.0 µg/L
ZnCl2 3.0 µg/L
CoCl2 x 6 H2O 1.5 µg/L
CuCl2 x 2 H2O 0.01 µg/L
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: no
- Photoperiod: continuous illumination
- Light intensity and quality: Mean light intensity: 7058 lux (range: 6320 to 7470 lux)
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: spectrophotometer
TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: 100, 32, 10, 3.2, 1.0 mg/L corresponding to following mean measured concentrations of the test item:
85.8, 24.1, 8.00, 2.42 and 0.798 mg/L - Reference substance (positive control):
- yes
- Remarks:
- Most recent test with the test item potassium dichromate perforemd in November / December 2016
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 85.8 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 85.8 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 85.8 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC20
- Effect conc.:
- > 85.8 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 85.8 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): no
- Unusual cell shape: no
- Colour differences: no
- Flocculation: no
- Results with reference substance (positive control):
- - Results with reference substance valid? yes
- EC50: 1.12 mg/L (growth rate)
- Reported statistics and error estimates:
- Based on the calculated cell densities, the 72 hours ErC50 and the 72 hours EyC50 could not be calculated by Probit analysis due to the lack of effects and were therefore determined directly from the raw data.
For the determination of the 72 hours LOEC and the 72 hours NOEC, the calculated growth rates and yields at each test concentration were tested for significant differences compared to the control values by Dunnett´s t-test.
The software used to perform the statistical analysis was ToxRat Professional, Version 3.2.1, ToxRat Solutions GmbH. - Validity criteria fulfilled:
- yes
- Conclusions:
- Oxaceprol did not exhibit aquatic toxicity to Pseudokirchneriella subcapitata in a study according to OECD 201 under the conditions of the test.
- Executive summary:
The influence of Oxaceprol on the growth of the freshwater green algae Pseudokirchneriella subcapitata was assessed in a static concentration-response test according to OECD 201. The 72-hour EyC50 was calculated to be > 85.8 mg test item/L and the 72-hour ErC50 value was calculated to be > 85.8 mg test item/L. The 72-hour NOEyC was determined to be 85.8 mg test item/L and the associated 72-hour LOEyC was > 85.8 mg test item/L. The 72-hour NOErC was determined to be 85.8 mg test item/L and the associated 72-hour LOErC was > 85.8 mg test item/L.
The quantification of the test item Oxaceprol in the test samples was performed using liquid chromatography with MS/MS detection.
At the start of the test 82% of the nominal test concentrations were found (average of all test concentrations). After 72 hours test duration, 77% of the nominal value was determined (average of all test concentrations). During the test the algae were exposed to a mean of 79% of nominal. All reported results refer to mean measured values since the initial measured concentrations of the test item were not within± 20% of the nominal concentrations.
Reference
Description of key information
Oxaceprol did not exhibit aquatic toxicity to Pseudokirchneriella subcapitata in a study according to OECD 201 under the conditions of the test.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 85.8 mg/L
Additional information
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