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EC number: 223-445-4 | CAS number: 3896-11-5
- 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
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Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- The test substance is insoluble in water (information from sponsor). Therefore the test solution was prepared following general guidance provided in OECD 23. The test solution was prepared by directly adding test substance to test medium. The mixture was ultrasonicated for 15 minutes at 40°C. Then the test solution was stirred on a magnetic stir plate for approx. 24 hours.
Prior to toxicity testing, each solution was filtered (Schott glass filtration unit with 0.2 μm nylon membrane, Whatman) to assure the removal of any undissolved test substance. Filters were first wetted and rinsed with at least 100 mL of highly distilled water (Milipore water). Once wet, filters were not allowed to dry out, so some residual water was left standing over the filter. Approximately 800 mL of the test solution was then added to the filtration unit and the first 50 – 90 mL were discarded in order to saturate the filter. The remainder of the test solution was bulk filtered to the point where approximately 10 mL remained standing over the filter. The filtered test solution was used for toxicity testing. Control test media was similarly filtered.
Undissolved test substance/particulate material was visible in the whole test solution. After filtration, all test solutions were visibly colorless and clear throughout each renewal period.
Although there was no evidence to suggest exposure concentration instability, fresh test solutions were prepared daily as a precautionary measure to help maintain consistent exposure to the test substance. Further the test vessels were saturated with the test solution 24-h prior to test initiation.
The concentration of the stock solution was 10 mg/L.
Analytical methods for the quantitative determination of the test substance dissolved in aqueous test media were investigated in previous aquatic toxicity and physical chemistry studies. The dissolved concentrations of the test substance were below analytical detection limits (<0.05 mg/L) and could not be confirmed (information from the sponsor).
Due to its poor water solubility, the stability of the test substance in aqueous solution could only be evaluated by preparing a solution as a co-solvent mixture of test media and 0.01% acetone. The wLOQ by this method was 0.4 mg/L. The test substance was stable in this aqueous solution at room temperature for up to 48 h. The test solutions were visibly homogeneous.
Analyses of the test substance preparations were not conducted, since a reliable method for analyses in the required concentration range could not be developed. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Test species : Daphnia magna STRAUS
Reason for selection of the test species: Recommended species in the test guidelines
Origin : The clone of Daphnia magna STRAUS 1820 used was supplied by the Institut National de Recherche Chimique Appliquée, France, in 1978. From this date on this clone was cultured and bred continuously in the Ecotoxicology Laboratory of Experimental Toxicology and Ecology, BASF SE, Ludwigshafen Germany.
Culture conditions: Daphnia brood stock are kept in mass cultures consisting of approx. 20 – 30 individuals for a maximum of 4 weeks. All individuals in the mass culture originate from a single female. After approximately 14 days the adults have produced at least 3 broods and the young can be used in tests. Offspring are removed from the mass cultures at least once daily during the normal work week to ensure that young daphnia are <24-h old (first instar) at test initiation. Detailed records are kept (in test facility archives) to monitor the health of Daphnia brood stock cultures including observations of young production, mortality, ephippia, and measurement of water chemistry parameters. Only young from healthy cultures without signs of stress are used for testing.
Acclimatization: The Daphnia are cultured under the identical conditions as the test including test media (Elendt M4), water quality, temperature (20 ±1°C), and diet.
Age at test initiation: < 24 h
Reference substance testing: In order to verify that the Daphnia magna culture is responding normally to toxic stress, tests with a reference substance are conducted monthly. Reference substance tests are conducted generally according to the OECD 202 guideline and in accordance with GLP, but without a GLP status. The EC50(48 h) of the reference substance sodium chloride (NaCl) was 5.25 g/L (experiment date: 20 Nov 2013). This result is within the range of 3.88 – 7.22 g/L, which represents ±2 standard deviations from the published EC50(48 h) of 5.55 g/L and indicates that the culture of Daphnia magna used in this study is responding normally to toxic stress. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 21 d
- Hardness:
- 2.43 - 2.48 mmol/L
- Test temperature:
- 20 - 21 ºC
- pH:
- 7.9 - 8.2
- Dissolved oxygen:
- 3.6 - 5.9 in the freshly prepared test solutions
8.7 - 8.9 before renewal in the old solutions - Salinity:
- n/a
- Nominal and measured concentrations:
- nominal 10 mg/L
- Details on test conditions:
- Test medium: A synthetic fresh water (Elendt M4) is used as media for culture and test purposes. For the composition of this M4 medium see OECD 211. The general properties of this medium are as follows.
Total hardness: 2.20 – 3.20 mmol/L
Acid capacity up to pH 4.3: 0.80 – 1.00 mmol/L
Molar ratio Ca:Mg: about 4 : 1
pH value: 7.5 – 8.5
Conductivity: 550 - 650 μS/cm
Total organic carbon: < 2 mg/L
Dissolved oxygen: Must remain ≥ 3mg/L during the test. To assure optimal dissolved oxygen levels, the M4 medium is aerated for approximately 24 h prior to use.
Test vessels : Numbered glass beakers (nominal volume 100 mL), covered with glass Petri plates to slow evaporation.
Test volume: 50 mL
Biological loading: 1 animal / test vessel (0.02 animals / mL)
Light intensity / Photo period: 668-715 lux at a wave length of 400-750 nm (recommended values in lux units provided in ISO 10706 [Ref. 4]); 16 h light : 8 h darkness
Aeration: none
Test solution renewal: Semi-static, daily renewal
Diet: During the test daphnids were fed daily a diet of live green algae Desmodesmus subspicatus, cultured in a synthetic medium. The algae were separated from their culture medium by centrifugation, resuspended in daphnid's medium (M4) corresponding to concentrations of 1270 mg TOC/L, 1770 mg TOC/L and 1960 mg TOC/L (respectively) in the algal concentrates used. The daphnids were fed a defined volume (≤157 μL) of the concentrate to reach the amount of food defined in the table below. The algae were stored in a refrigerator (dark, about 4-8°C) for maximum 21 days.
By adding the algal concentrate the test solution was slightly diluted. During a 24 h test interval with 1 feedings, 0.157 mL are added to 50 mL test volume resulting in a maximal dilution of 0.3%. - Reference substance (positive control):
- yes
- Remarks:
- sodium chloride
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Details on results:
- No significant mortality or any other additional significant adverse effects or abnormal behavior were observed in any of the test treatments. The data were not sufficient to calculate ECx values for reproduction or mortality.
The concentration of test substance in test media could not be verified analytically. According to guidance in OECD 23, for tests with chemicals that cannot be quantified by analytical methods at the concentrations causing effects, the effect concentration can be expressed based on the nominal concentrations.
The results in this study are consistent with all validity criteria and the test is valid according to the guidelines of this study. No deviations from test guidelines or other incidents occurred during the course of the reported test which may have influenced the results. - Validity criteria fulfilled:
- yes
- Conclusions:
- No significant mortality, reduced reproduction or any other additional significant adverse effects or abnormal behavior were observed in any of the test treatments. The data were not sufficient to calculate ECx values for reproduction or mortality.
Reference
Description of key information
Based on long-term (chronic) toxicity study data, the product is very likely not harmful to aquatic invertebrates.
Key value for chemical safety assessment
Additional information
To assess the toxic potential of the substance a chronic toxicity study according to GLP guideline 211 and under consideration of GLP was conducted (BASF 2014). The test was conducted as limit test with a nominal loading rate of 10 mg/L. Concentration control analysis was not performed befause a reliable method for analyses in the required concentration range could not be developed. However, all reasonable efforts were taken to produce a saturated solution of the test substance in test media, following the guidance in OECD 23 and the test solutions were freshly prepared and exchanged daily to ensure consistent exposure conditions for the duration of the test. No significant mortality, reduced reproduction or any other additional significant adverse effects or abnormal behavior were observed in any of the test treatments. The LOEC was determined as > 10 mg/L and the NOEC as >= 10 mg/L.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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