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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
Toxicity to soil macroorganisms except arthropods
Administrative data
- Endpoint:
- toxicity to soil macroorganisms except arthropods: short-term
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 6 January 2010 - 11 February 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
- Deviations:
- yes
- Remarks:
- Some of the temperatures were observed to be slightly in excess of the 20 ± 2 °C given in the study plan. However, this deviation was considered not to have affected the outcome or the validity of the test.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Calcium carbonate
- EC Number:
- 207-439-9
- EC Name:
- Calcium carbonate
- Cas Number:
- 471-34-1
- Molecular formula:
- CH2O3.Ca
- IUPAC Name:
- calcium carbonate
- Test material form:
- solid: nanoform, no surface treatment
- Details on test material:
- - Name of test material (as cited in study report): Calcium carbonate (nano)
- Description: White powder
- Batch No.: GICM014427
- Storage condition of test material: Room temperature in the dark
The nano form of calcium carbonate was tested because this form was anticipated to represent the worst case as it is likely to be more soluble than the bulk form due to the smaller particle size and hence greater surface area.
Constituent 1
- Specific details on test material used for the study:
- uncoated nano CaCO3
Sampling and analysis
- Analytical monitoring:
- no
- Details on sampling:
- Not applicable
Test substrate
- Vehicle:
- no
- Details on preparation and application of test substrate:
- - Method of mixing into soil: The test item was prepared by direct addition to the basic soil substrate. An amount of test item (3500 mg) was added to approximately 100 g premix of artificial soil and carefully mixed with a spatula until homogenous. This premix was then incorporated into 3.5 kg (dry weight) of artificial soil with 1000 mL of deionised reverse osmosis water and mixed using a Hobart A200N mixer.
- Controls: The control was prepared in an identical manner using 2.5 kg (dry weight) of artificial soil and 710 mL of deionised reverse osmosis water, without the addition of test item.
Test organisms
- Test organisms (species):
- Eisenia fetida
- Animal group:
- annelids
- Details on test organisms:
- TEST ORGANISM
- Common name: Earthworms
- Source: Original Organics Limited, Langlands Business Park, Devon, UK
- Age at test initiation (mean and range, SD): at least 2 months old with clitellum
- Weight at test initiation (mean and range, SD): 0.44 - 0.52 g (mean 0.49 g)
ACCLIMATION
- Acclimation period: The earthworms were transferred into artificial soil (without test item) approximately 24 hours prior to the start of the test.
Study design
- Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- yes
- Total exposure duration:
- 14 d
- Post exposure observation period:
- Earthworms were observed for up to 14 days
Test conditions
- Test temperature:
- 19 to 23 °C
- pH:
- Test initiation: 5.8 - 7.1
Test termination: 6.3 - 6.6 - Moisture:
- The actual moisture content of the soil used in the definitive test was 29% of dry weight of basic substrate on Day 0 and 23% and 24% on Day 14.
- Details on test conditions:
- TEST SYSTEM
- Test container (material, size): 1 L glass beakers were used
- Amount of soil or substrate: The test vessels contained approximately 3.5 kg (dry weight) of artificial soil and the control vessels contained 2.5 kg.
- No. of organisms per container (treatment): 10 earthworms per test and control vessel
- No. of replicates per treatment group: 6
- No. of replicates per control: 4
SOURCE AND PROPERTIES OF SUBSTRATE
- Composition of the artificial soil:
Industrial quartz sand - 70% w/w
Kaolinite clay - 20% w/w
Sphagnum moss peat - 10% w/w
- Maximum water holding capacity (in % dry weight): Nominal: 30% (this level of moisture has been shown to ensure that a good crumb structure is formed within the soil).
- Stability and homogeneity of test material in the medium: No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation.
OTHER TEST CONDITIONS
- Photoperiod: Continuous illumination
- Light intensity: 684 to 714 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : The weight of each earthworm was recorded on Day 0 before addition to the test or control vessels. Each surviving earthworm was weighed on Day 14.
Any mortalities were recorded 7 and 14 days after the start of the treatment and any sub-lethal effects were recorded daily. The criterion of death was taken to be the absence of any reaction to a physical stimulus at either end of the body.
TEST CONCENTRATIONS
- Range finding study
- Test concentrations: Nominal concentrations: 100 and 1000 mg/kg
- Results used to determine the conditions for the definitive study: The results showed no mortalities at the test concentrations of 100 and 1000 mg/kg. - Nominal and measured concentrations:
- Definitive test:
Nominal concentration: 1000 mg/kg of soil - Reference substance (positive control):
- yes
- Remarks:
- Chloroacetamide (nominal concentrations 5.6, 10, 18, 32 and 56 mg/kg)
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 14 d
- Dose descriptor:
- LC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 14 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: mortality and sub-lethal effects
- Details on results:
- - Mortality at end of exposure period: There were no significant mortalities or sub-lethal effects of exposure in 60 earthworms exposed to a test concentration of 1000 mg/kg for a period of 14 days. Two worms are unaccounted for on Day 14 in the 1000 mg/kg test concentration. This was considered to be possibly due to natural causes rather than a toxic effect given that this constituted less than 5% of the total number of earthworms exposed to this concentration and no other effects were observed (see table 1).
- Weight at end of exposure period: There were no significant differences between the control and the 1000 mg/kg test groups in terms of weight on Days 0 and 14 (see table 2). - Results with reference substance (positive control):
- - Results with reference substance: The results from the positive control with chloroacetamide are within the normal range for this reference item of 10 to 50 mg/kg.
- Relevant effect levels: 7 day LC50: 44 mg/kg (95% confidence limits 42-45 mg/kg); 14 day LC50: 43 mg/kg (95% confidence limits 41-45 mg/kg); NOEC: 18 mg/kg
Any other information on results incl. tables
Table 1: Cumulative mortality data in the definitive test
Nominal concentration (mg/kg) |
Cumulative mortality (initial population: 10) |
% mortality |
||
Day 0 |
Day 14 |
|||
Control |
- |
- |
- |
- |
R1 |
0 |
0 |
0 |
0 |
R2 |
0 |
0 |
0 |
0 |
R3 |
0 |
0 |
0 |
0 |
R4 |
0 |
0 |
0 |
0 |
1000 |
- |
- |
- |
- |
R1 |
0 |
0 |
0 |
0 |
R2 |
0 |
1* |
0 |
10 |
R3 |
0 |
0 |
0 |
0 |
R4 |
0 |
0 |
0 |
0 |
R5 |
0 |
0 |
0 |
0 |
R6 |
0 |
1* |
0 |
10 |
R1-R6 = Replicates 1 to 6
* Single mortality observed was considered to be possibly due to natural causes and was considered not to affect the validity of the test given that less than 5% mortality occurred at this concentration.
Table 2: Mean earthworm weights in the definitive test
Nominal concentration (mg/kg) |
Mean earthworm weight (g) |
|||
Day 0 |
Day 14 |
|||
Mean |
SD |
Mean |
SD |
|
Control |
- |
- |
- |
- |
R1 |
0.51 |
0.09 |
0.51 |
0.09 |
R2 |
0.52 |
0.08 |
0.49 |
0.10 |
R3 |
0.51 |
0.08 |
0.47 |
0.10 |
R4 |
0.49 |
0.05 |
0.51 |
0.10 |
1000 |
- |
- |
- |
- |
R1 |
0.47 |
0.07 |
0.49 |
0.06 |
R2 |
0.50 |
0.08 |
0.51 |
0.11 |
R3 |
0.50 |
0.09 |
0.49 |
0.09 |
R4 |
0.51 |
0.07 |
0.53 |
0.09 |
R5 |
0.49 |
0.09 |
0.47 |
0.09 |
R6 |
0.44 |
0.08 |
0.48 |
0.09 |
R1-R6 = Replicates 1 to 6
SD = Standard deviation
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- Mortality of control animals < 10%
- Conclusions:
- The acute toxicity of the test item, to the earthworm Eisenia foetida, in an artificial soil test gave a 14 day LC50 value of >1000 mg/kg and a NOEC of 1000 mg/kg.
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