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Diss Factsheets
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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
Long-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- July 2 to 5 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ASTM E 1440-91
- Deviations:
- yes
- Remarks:
- (Test duration extended to measure reproductive endpoints)
- Principles of method if other than guideline:
- The test protocol that follows is based on American Society of Testing and Materials E 1440-91 with modifications from the research publication “A 2-d Life Cycle Test with the Rotifer Brachionus calyciflorus” by Snell and Moffat (Env Toxicol Chem 11: 1249-1257 (1992)).
- GLP compliance:
- yes
Test material
- Details on test material:
- Sigma Aldrich Boric Acid, lot 079K0115 and lot 010m0008, 99.9% purity
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- The concentration of boron in test solutions was measured in composite test solution samples collected at 0 and 72 hours of the definitive test. Control and boric acid-fortified samples were also prepared for analysis at each sample period. Ten-milliliter samples were collected from the control and test substance treatment at 0 and 72 hours. Samples were diluted with reagent water to provide final sample concentrations within the analytical standard concentrations range. QC samples were prepared by fortifying laboratory saltwater with boric acid at concentrations of 5.05 and 116 mg B/L. All samples were directly analyzed using an ICP-MS system.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- A 0.572 mg boric acid/mL primary stock solution was prepared at test initiation by weighing 0.5727 g of boric acid, adjusting for purity (99.9%) and diluting to a volume of 1,000 mL with dilution water.
Test organisms
- Test organisms (species):
- other: Brachionus calyciflorus (Rotifera)
- Details on test organisms:
- Brachionus calyciflorus cysts were obtained from Aquatic Eco-Systems, Apopka, Florida. Rotifer cysts were placed into Petri dishes with approximately 10 mL of warm blended freshwater. The Petri dishes were placed in an environmental chamber set at 25°C under full light for 16-20 hours. Cultures were monitored to ensure collection of larval rotifers hatched within approximately two hours of each other. Rotifers were fed an algal suspension of Nannochloropsis sp. during the test, prepared along with test concentrations at study initiation. The larvae were considered acceptable with no signs of abnormal appearance or behavior, high mortality or excessive delay in hatching. Since the culturing and testing environmental parameters were equivalent (i.e., temperature, dilution water, and lighting), no acclimation period was necessary.
Rotifers were fed an algal suspension prepared for the control and each test substance treatment. The suspension contained approximately 3 x 106 Nannochloropsis cells/mL.
Six rotifers were added to test chambers for the dilution water control and each test substance treatment. Rotifers were impartially added to a set of labeled containers with each container representing one treatment. One individual was added to each labeled container starting with the control then proceeding from the low to high test substance treatments. The individuals within each container were then transferred from each container into the corresponding test chamber using a pipet. Observations of live and dead rotifers, and rotifers with eggs were made after 72 hours.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Hardness:
- 150 mg CaCO3/L
- Test temperature:
- 24.6 - 24.9
- pH:
- 7.6 - 8.2
- Dissolved oxygen:
- 7.0 - 7.5 mg/L (89 - 94% saturation)
- Nominal and measured concentrations:
- Nominal Test Concentrations: 0 (control), 6.5, 13, 25, 50, and 100 mg B/L
Mean Measured Concentrations as Total Boron: 0.775 (dilution-water control), 7.13, 14.2, 25.4, 51.7, and 108 mg B/L
Mean Measured Concentrations as Added Boron: 0 (dilution-water control), 6.35, 13.4, 24.6, 51.0, and 107 mg B/L - Details on test conditions:
- Brachionus calyciflorus cysts were obtained from Aquatic Eco-Systems, Apopka, Florida. Rotifer cysts were placed into Petri dishes with approximately 10 mL of warm blended freshwater. The Petri dishes were placed in an environmental chamber set at 25°C under full light for 16-20 hours. Cultures were monitored to ensure collection of larval rotifers hatched within approximately two hours of each other. Rotifers were fed an algal suspension of Nannochloropsis sp. during the test, prepared along with test concentrations at study initiation. The larvae were considered acceptable with no signs of abnormal appearance or behavior, high mortality or excessive delay in hatching. Since the culturing and testing environmental parameters were equivalent (i.e., temperature, dilution water, and lighting), no acclimation period was necessary.
The definitive and range-finding tests were conducted in 10-mL glass test tubes measuring 100 mm in height by 15 mm in diameter. The tubes contained 8 mL of control or test substance solution and were capped tightly with screw caps. The test tubes were placed in a rotating plastic bottle revolving at approximately 2 rpm. Tests were performed without light to prevent additional algal growth.
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 25 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- element
- Remarks:
- boron
- Basis for effect:
- mortality
- Remarks on result:
- other: added boron
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 50 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- element
- Remarks:
- boron
- Basis for effect:
- mortality
- Remarks on result:
- other: added boron
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 24.6 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- element
- Remarks:
- boron
- Basis for effect:
- mortality
- Remarks on result:
- other: added boron
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 51 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- element
- Remarks:
- boron
- Basis for effect:
- mortality
- Remarks on result:
- other: added boron
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 24.6 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- element
- Remarks:
- boron
- Basis for effect:
- other: reproduction
- Remarks on result:
- other: added boron
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 51 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- element
- Remarks:
- boron
- Basis for effect:
- other: reproduction
- Remarks on result:
- other: added boron
- Details on results:
- The nominal concentrations were used in the effect concentrations table, following the usual practice that a nominal concentration may be used if the measured values are reasonably close to the nominal.
Observations of live and dead rotifers, and rotifers with eggs were made after 72 hours. After 72 hours, the mean number of surviving rotifers was 21.2, 14.2, 21.4, 20.2, 7.2, and 5.0 live rotifers in the 0 (control), 6.5, 13, 25, 50, and 100 mg B/L treatments, respectively. One dead rotifer was observed in the 6.5, 13 and 50 mg B/L test substance treatments and four dead rotifers were observed in the 25 and 100 mg B/L treatments. Rotifers with eggs were observed in all replicates of all test substance treatments except replicates A and B of the 6.5 mg B/L treatment. After 72 hours, the mean number of rotifer reproduction was 15.2, 8.2, 15.4, 17.3, 2.0, and 0 rotifers in the 0 (control), 6.5, 13, 25, 50, and 100 mg B/L treatments, respectively. Based on mean measured total boron concentrations, the EC50 for total survival was estimated to be 48.3 mg B/L. Based on mean measured total boron concentrations, the EC50 for reproduction was estimated to be 50.0 mg B/L. The slope of the 72-hour concentration-response could not be calculated. The nominal NOEC and LOEC for total survival and reproduction was 25 and 50 mg B/L, respectively. - Reported statistics and error estimates:
- All statistical analyses were performed using SAS software (SAS version 9.1 for Windows). Inferences of statistical significance were based upon a p = 0.05 unless otherwise noted.
The no-observed-effect concentration (NOEC) and lowest-observed-effect concentration (LOEC) for mortality/immobility data were determined by using a one-tailed Dunnett’s test.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The nominal NOEC and LOEC for both survival and reproduction were 25 and 50 mg B/L, respectively.Based on mean measured total boron concentrations, the 72-hour EC50 for survival and reproduction were estimated to be 48.3 mg B/L and 50.0 mg B/L, respectivly (95% confidence limits could not be determined). The slope of the 72-hour concentration-response could not be calculated.
Based on the added measured concentrations the NOEC and LOEC for survival and reproduction were 24.6 and 51.0 mg B/L, respectively.
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.
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