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EC number: 237-163-4 | CAS number: 13676-54-5
- 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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 July 2012 - 24 December 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- EC No. 440/2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- June 2012
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: from control and all test concentrations.
- Sampling method: Two, mid-vessel samples of 10 mL of media taken from control and test vessels at 0 and 72 hrs (fresh media) and at 24 and 96 hours (expired media)
- Sample storage conditions before analysis: One sample analysed, second stored frozen in case of further analysis - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Test glassware was pre-exposed overnight at the test concentration before use in test, to reduce loss of BMI by sorption.
In duplicate, the test substance (7.64 mg, corrected for purity) was added to the dilution medium (20 L) and stirred for approximately 20 minutes. One batch was used as the test medium at a nominal concentration of 360 μg/L and aliquots of the second batch, (9111, 4133, 1878 or 856 mL) were added to dilution medium and adjusted to volume (20 L) to provide test media at nominal concentrations of 164, 74.4, 33.8 and 15.4 μg/L.
- Controls: diluent water - Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- TEST ORGANISM
- Common name: Rainbow trout
- Source: commercial fish farm in the UK
- Length at study initiation: mean total length 4.23 cm
- Weight at study initiation: mean wet weight 0.71 g
- Method of breeding: The eggs were obtained from the supplier and were kept in an aerated supply of diluent water under flow-through conditions until use.
- Feeding during test: No
ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): yes
- Type and amount of food: commercial fish food (TROUW (UK) Ltd; Nutra Fry 02), equivalent to between 3 and 4% of the total wet-weight of fish in the holding tank. No food was given during the 24-hour period immediately before exposure.
- Feeding frequency: daily
- Health during acclimation: No medication was given during the holding period, and mortalities were recorded as <1 % in the 14 days before the definitive test. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 154-158 mg/L as CaCO3
- Test temperature:
- 13.1 - 14.2 °C
- pH:
- 8.02 - 8.48
- Dissolved oxygen:
- 89 - 102 % air saturation value
- Nominal and measured concentrations:
- Nominal concentrations, control, 15.4, 33.8, 74.4, 164, 360 ug/L
Measured concentrations, 0, 6.96, 15.1, 30.9, 59.1, 145 ug/L (geometric mean values; see Table 1 in 'Any other information on results' for details on measured concentrations). - Details on test conditions:
- TEST SYSTEM
- Test vessel: Aquarium
- Type: open
- Material, size, headspace, fill volume: glass, 20 L of medium to a depth of 20 cm.
- Aeration: narrow bore glass tubes
- Renewal rate of test solution (frequency/flow rate): Daily batch renewal of the media
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.2489 g bw/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: laboratory tap water, dechlorinated and softened by passage through a water purification system. It was passed through a high grade activated carbon filter to remove chlorine and any organic contaminants. A proportion of the supply then passed through a water softener before final reverse osmosis treatment to produce a highly purified water supply. The two grades of dechlorinated water were then remixed to give a supply with the desired water hardness. This water was then held in an intermediate tank where it was equilibrated to the test temperature and gently aerated before being supplied to the holding and test areas.
- Total organic carbon: 0.65 mg/L
- Particulate matter: <3 mg/L
- Pesticides: <0.17 ug/L
- Chlorine: 0.05 mg/L
- Conductivity: 300 us/cm
- Culture medium different from test medium: no
- Intervals of water quality measurement: Daily records of temperature, pH and dissolved oxygen were kept for each control and test vessel together with measurements of total hardness for selected vessels at 0 hours.
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hrs light, 8 hrs dark
- Light intensity: periods of subdued lighting at the beginning and end of each light phase
EFFECT PARAMETERS MEASURED:
- Mortality, at approximately 2, 4, 24, 48, 72 and 96 hours, subjective assessments were also made on the incidence and type of any sub-lethal effects compared with control fish.
TEST CONCENTRATIONS
- Range finding study: A range-finding study using a stated limit of aqueous solubility was conducted.
- Test concentrations: 360 ug/mL
- Results used to determine the conditions for the definitive study: Yes, significant mortality and sub-lethal effects were observed at the nominal test concentration of 360 μg/L. - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 145 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 145 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities: none
- Mortality of control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no
Measured concentrations of BMI in samples of the freshly prepared test media (on days 0 or 3) ranged between 59 and 111% of their nominal values. In samples of expired media on days 1 and 4 ranged between 14 and 27% of their nominal values (between 14 and 38% of their initial values). Based on a geometric mean, the overall mean measured levels of BMI were 6.96, 15.1, 30.9, 59.1 and 145 μg/L, and these values have been used to determine the study end points.
Study report does not discuss difference in mortality between range-finding study ('significant mortality and sub-lethal effects' at 360 ug/L nominal) and final test ('no mortality or significant treatment-related effects' at 360 ug/L nominal) - Sublethal observations / clinical signs:
No mortality or significant treatment-related effects were noted during the test, therefore the 96-hour LC50 could not be calculated but must be >145 μg/L. The no observed effect concentration (NOEC) was 145 μg/L, and the lowest observed effect concentration must be >145 μg/L.
The measurements of water quality (temperature, pH, concentrations of dissolved oxygen and total hardness) remained within acceptable limits throughout the study. At all concentrations, the test media were colourless.
Table 1: Measured concentrations
Nominal concentration (μg/L)
0 hours [Fresh]
24 hours [Expired]
72 hours [Fresh]
96 hours [Expired]
Overall mean* (μg/L)
Control
nd
nd
nd
nd
nd
15.4
14.1
3.70
11.4
3.95
6.96
33.8
36.6
6.44
24.1
9.25
15.1
74.4
61.9
11.3
78.7
16.6
30.9
164
182
24.8
122
22.2
59.1
360
214
81.7
265
96.5
145
nd: None detected (less than the limit of detection of 2 μg/L
* geometric mean
- Validity criteria fulfilled:
- yes
- Remarks:
- See 'Overall remarks' for details on validity criteria.
- Conclusions:
- No mortality or significant treatment-related effects on the fish were noted during the test; therefore the 96-hour LC50 value could not be calculated but must be >145 μg/L.
The no observed effect concentration (NOEC) was 145 μg/L, and the lowest observed effect concentration must be >145 μg/L. - Executive summary:
A study was performed to assess the acute toxicity of BMI to rainbow trout (Oncorhynchus mykiss) under semi-static conditions, with daily renewal of the media. The study was conducted in accordance with OECD guideline 203 and EC method C1. Groups of seven juvenile fish were exposed to BMI, for 96 hours at nominal concentrations of 15.4, 33.8, 74.4, 164 and 360 μg/L. The test media were prepared by direct addition of the test substance to dilution water; to aid dissolution, stirring was employed. The Measured concentrations of BMI in samples of the freshly prepared test media (on days 0 and 3) ranged between 59 and 111% of their nominal values. In samples of expired media on days 1 and 4 the measured levels ranged between 14 and 27% of their nominal values (between 14 and 38% of their initial values). Based on a geometric mean, the overall mean measured levels of BMI were 6.96, 15.1, 30.9, 59.1 and 145 μg/L, and these values have been used to determine the study end points. Observations of the fish were made after approximately 2, 4, 24, 48, 72 and 96 hours of exposure. No mortality or significant treatment related effects were noted during the test. Therefore, the 96-hour LC50 value could not be calculated but must be >145 μg/L. The no observed effect concentration (NOEC) was 145 μg/L, and the lowest observed effect concentration must be >145 μg/L.
Reference
Description of key information
NOEC: 145 ug/L
LC50 and LOEC: >145 ug/L
Key value for chemical safety assessment
Additional information
A study was performed to assess the acute toxicity of BMI to rainbow trout (Oncorhynchus mykiss) under semi-static conditions, with daily renewal of the media. The study was conducted in accordance with OECD guideline 203 and EC method C1. Groups of seven juvenile fish were exposed to BMI, for 96 hours at nominal concentrations of 15.4, 33.8, 74.4, 164 and 360 μg/L. The test media were prepared by direct addition of the test substance to dilution water; to aid dissolution, stirring was employed. The Measured concentrations of BMI in samples of the freshly prepared test media (on days 0 and 3) ranged between 59 and 111% of their nominal values. In samples of expired media on days 1 and 4 the measured levels ranged between 14 and 27% of their nominal values (between 14 and 38% of their initial values). Based on a geometric mean, the overall mean measured levels of BMI were 6.96, 15.1, 30.9, 59.1 and 145 μg/L, and these values have been used to determine the study end points. Observations of the fish were made after approximately 2, 4, 24, 48, 72 and 96 hours of exposure. No mortality or significant treatment related effects were noted during the test. Therefore, the 96-hour LC50 value could not be calculated but must be >145 μg/L. The no observed effect concentration (NOEC) was 145 μg/L, and the lowest observed effect concentration must be >145 μg/L.
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