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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
Endpoint summary
Administrative data
Description of key information
The substance BMI is non-toxic via oral route but toxic by inhalation. The oral LD50 in rats is >2000 mg/kg/body weight. The inhalation LC50 in rats is >0.515 <1 mg/L air (4 hr exposure). No test data regarding dermal exposure are available. Testing of dermal exposure was waived as scientifically unjustified due to the availability of the oral and inhalation data and the fact that BMI is a skin sensitiser.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 March 2012 - 03 July 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Acute oral toxicity (2-1-1), 12 Nousan No 8147, Agricultural Production Bureau, November 24, 2000.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- d.d. 12-12-11
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Crl:CD "SD"
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 - 12 weeks prior to dosing
- Weight at study initiation: 211 to 249 g
- Fasting period before study: Food supply was withdrawn overnight before dosing, and for 4 hours after dosing
- Housing: Solid bottomed polycarbonate cages with stainless steel lids.
- Diet (e.g. ad libitum): Free access to diet, except during fasting period described above
- Water (e.g. ad libitum): free access
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 40 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours light per 24 hours
IN-LIFE DATES: From: 17 April 2012 (Date of first treatment) To: 10 May 2012 (date of last necropsy) - Route of administration:
- oral: gavage
- Vehicle:
- other: 1% (w/v) Aqueous methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 or 200 mg/mL (Depending on dose level)
- Amount of vehicle (if gavage): 10 mL/kg bodyweight
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As no previous toxicological information was available, 300 mg/kg was chosen as the starting dose, in compliance with the test guidelines. - Doses:
- 300 mg/kg, 2000 mg/kg
- No. of animals per sex per dose:
- 6 females per dose group (2x3 females)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at least twice daily after dosing. Bodyweights were recorded on days 1 (prior to dosing), 8, and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination of organs - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no deaths during the study
- Clinical signs:
- other: There were no clinical signs of reaction to treatment throughout the study
- Gross pathology:
- No abnormalities were noted in any animal at the macroscopic examination at study termination on day 15
- Interpretation of results:
- other: Not classified
- Remarks:
- According to Regulation (EC) No 1272/2008
- Conclusions:
- The acute median lethal oral dose (LD50) to rats of BMI was demonstrated to be greater than 2000 mg/kg bodyweight.
- Executive summary:
An acute oral toxicity study in rats was performed by oral gavage according to internationally accepted guidelines and in accordance with GLP principles. Following a preliminary dose at 300 mg/kg/bw that showed no lethality, a limit test was conducted at 2000 mg/kg/bw. No mortality or adverse signs were observed. This results in an LD50 >2000 mg/kg/bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 May 2012 - 28 September 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- d.d. 12/12/11
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Crl:CD (SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 326 to 376 g (Males) or 215 to 257 g (Females)
- Housing: Polycarbonate cages with stainless steel mesh lids.
- Diet (e.g. ad libitum): Free access to diet whilst in home cage.
- Water (e.g. ad libitum): Free access to potable water.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 40 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours / 12 hours.
IN-LIFE DATES: From: 14 May 2012 To: 31 July 2012 - Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Snout-only inhalation chamber
- Exposure chamber volume: Approximately 30 litres; a chamber liner was added filling 9.9 liters, giving a final volume of 20.1 liters.
- Method of holding animals in test chamber: Restraining tubes
- Source and rate of air: Compressed air, 25 litres/minute
- Method of conditioning air: Filtered and dried
- System of generating particulates/aerosols: Wright Dust Feed (WDF)
- Method of particle size determination: Atmosphere samples from chamber were drawn through a Cascade Impactor using a pump.
- Treatment of exhaust air: Extraction system incorporated a filtration system to remove particulate material.
- Temperature, humidity, pressure in air chamber: Mean temperature = 23.8°C (group 1), 22.6°C (group 2), 22.6°C (group 3). Mean relative humitidy = 48.3% (group 1), 16.6% (group 2), 9.7% (group 3).
TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric analysis of glass fibre filters over which a known volume of the test atmosphere was drawn. Mean of five measurements during exposure period was used.
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.):
Group 1 (average achieved chamber concentration = 2.02 mg/L): Mean MMAD = 4.0µm; GSD = 2.33
Group 2 (average achieved chamber concentration = 1.09 mg/L): Mean MMAD = 3.8µm; GSD = 2.53
Group 3 (average achieved chamber concentration = 0.515 mg/L): Mean MMAD = 3.5µm; GSD = 2.27 - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- See details above
- Duration of exposure:
- 4 h
- Concentrations:
- Group 1: Target concentration = 2 mg/L; Average achieved chamber concentration = 2.02 mg/L
Group 2: Target concentration = 1 mg/L; Average achieved chamber concentration = 1.09 mg/L
Group 3: Target concentration = 0.5 mg/L; Average achieved chamber concentration = 0.515 mg/L - No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations taken at least twice daily. Bodyweights recorded during acclimatisation, on day 1 prior to dosing, and on days 2,4,8, and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic pathology - Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 0.515 - < 1 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- 2 males and 2 females died at 2.02 mg/L.
3 males and 1 female died at 1.09 mg/L.
2 males died at 0.515 mg/L. - Clinical signs:
- other: At 2.02 mg/L two males died on the day of the exposure, clinically they were observed to have deep or noisy breathing; in addition one male was noted as having reduced activity with a hunched posture and closed eyelids. There were also two decedent female
- Body weight:
- Bodyweight losses were observed in the surviving males from Groups 1 and 3 up until Day 4, after which growth was observed until Day 15.
Bodyweight losses were observed in all surviving females on the day following the exposure; recovery was evident by the next weighing occasion after which growth continued until Day 15.
In all decedent animals the terminal bodyweights were lower than the weights recorded prior to the start of the exposure. - Gross pathology:
- The macroscopic examinations performed revealed a number of findings in the lungs. These comprised dark discoloration, incomplete collapse, firmness, adhesions and some pale areas in animals treated with 2.02 or 1.09 mg/L, many of which were found dead. Associated findings such as fluid in the thorax and gaseous distension of the gastrointestinal tract were also seen in some animals at these exposure levels.
A few pale areas in the lungs were observed in the four terminal animals treated with 0.515 mg/L. Enlargement of the tracheobronchial lymph nodes was also noted in these animals. The two decedent animals at 0.515 mg/L showed dark discoloration, incomplete collapse and firmness of the lungs consistent with the findings observed in the other groups. - Interpretation of results:
- other: Category 3
- Remarks:
- according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of this study the LC50 (4-hour) of BMI is in excess of 0.515 mg/L but not exceeding 1 mg/L for male and female rats.
- Executive summary:
An acute inhalation toxicity was performed according to internationally accepted guidelines and in accordance with GLP principles. Group 1 animals were exposed to BMI at a target concentration of 2 mg/L for a period of 4 hours. Due to a high mortality rate (4/6 animals), Group 2 animals were exposed to BMI at a target concentration of 1 mg/L. Following a high mortality rate (4/6 animals), Group 3 animals were exposed to BMI at a target concentration of 0.5 mg/mL. At this exposure level the mortality rate was 2/6 animals and effects observed in surviving animals included pale areas in the lungs and enlargement of the tracheobronchial lymph nodes. The LC50 (4 -hour) of BMI was found to be in excess of 0.515 mg/L but not exceeding 1 mg/L for male and female rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral Route
The key study for acute oral toxicity in rats was performed by oral gavage (Huntingdon Life Sciences, 2012) according to internationally accepted guidelines and in accordance with GLP principles. Following a preliminary dose at 300 mg/kg bw that showed no lethality, a limit test was conducted at 2000 mg/kg bw. No mortality or adverse signs were observed. This results in an LD50 >2000 mg/kg bw.
Inhalation Route
The key study for acute inhalation toxicity was performed (Huntingdon Life Sciences, 2012) according to internationally accepted guidelines and in accordance with GLP principles. Group 1 animals were exposed to BMI at a target concentration of 2 mg/L for a period of 4 hours. Due to a high mortality rate (4/6 animals), Group 2 animals were exposed to BMI at a target concentration of 1 mg/L. Following a high mortality rate (4/6 animals), Group 3 animals were exposed to BMI at a target concentration of 0.5 mg/L. At this exposure level the mortality rate was 2/6 animals and effects observed in surviving animals included pale areas in the lungs and enlargement of the tracheobronchial lymph nodes. The LC50 (4-hour) of BMI was found to be in excess of 0.515 mg/L but not exceeding 1 mg/L for male and female rats.
Dermal Route
This study was waived as being scientifically unjustified due to the existence of oral and inhalation data and the fact that BMI is a skin sensitiser.
Justification for selection of acute toxicity – oral endpoint
This study was carried out in accordance with GLP and to OECD guidelines and has been designated as the key study.
Justification for selection of acute toxicity – inhalation endpoint
This study was carried out in accordance with GLP and to OECD guidelines and has been designated as the key study.
Justification for selection of acute toxicity – dermal endpoint
Study waived on the basis that acute oral toxicity and acute inhalation toxicity studies are available therefore a further study is scientifically unjustified. Also the substance is a skin sensitiser therefore steps would be taken to minimise skin contact during use.
Justification for classification or non-classification
The oral LD50 exceeded 2000 mg/kg bw and no classification is warranted for BMI.
The LC50 (4-hour) for the inhalation route was found to be >0.515 but <1 mg/L for BMI. Therefore BMI is included in Category 3, according to Regulation (EC) No 1272/2008.
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