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EC number: 811-213-0 | CAS number: 66711-86-2
- 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
Specific investigations: other studies
Administrative data
- Endpoint:
- specific investigations: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
- Principles of method if other than guideline:
- The potential of the test substance to sensitize the heart to a challenge of epinephrine injection was tested in Beagle dogs.
- GLP compliance:
- yes
- Type of method:
- in vivo
- Endpoint addressed:
- other: cardiac sensitization
Test material
- Reference substance name:
- 66711-86-2
- Cas Number:
- 66711-86-2
- IUPAC Name:
- 66711-86-2
- Test material form:
- other: colourless gas
- Details on test material:
- - Analytical purity: 99.91413%
Constituent 1
Test animals
- Species:
- dog
- Strain:
- Beagle
- Sex:
- male
Administration / exposure
- Route of administration:
- inhalation: gas
- Vehicle:
- air
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- air approximately 7 minutes
test substance approximately 10 minutes - Frequency of treatment:
- one time exposure
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
70000 ppm [7%]; 80000 ppm [8%]; 90000 ppm [9%]
- Remarks:
- Doses / Concentrations:
71477 ppm with SD of 3238; 82286 ppm with SD of 571; 90416 ppm with SD of 1179
- No. of animals per sex per dose:
- 6 dogs exposed to 70000 ppm
1 dog exposed to 90000 ppm
1 dog exposed to 80000 ppm
Results and discussion
- Details on results:
- After exposure to 70000 ppm test substance, 2 of the 6 animals displayed continuous convulsions and excessive salivation and one animal had dilated pupils in both eyes.
After exposure to 90000 ppm test substance, intermittent and then continuous convulsions, excessive salivation, and dilated pupils of both eyes were noted for this animal. Exposure was terminated due to the severity of the observed clinical signs. No other animal was exposed to the test substance at 90000 ppm due to the adverse reaction shown.
After exposure to 80000 ppm test substance, intermittent and then continuous convulsions and excessive salivation were noted for this animal. Exposure was terminated due to the severity of the observed clinical signs. No other animal was exposed to the test substance at 80000 ppm due to the adverse clinical observations noted.
Due to the lack of PVCs with confluency, ventricular tachycardia, and fibrillation following the exposure of 70000 ppm test substance where animals were challenged with epinephrine, it was determined that exposure at this level did not result in cardiac sensitization. Because the epinephrine challenge was unable to be administered following exposure of 80000 and 90000 ppm, the potential for cardiac sensitization at these exposure levels was unable to be assessed.
Applicant's summary and conclusion
- Conclusions:
- The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
The no-observed-effect concentration (NOEC) for cardiac sensitization was 70000 ppm test substance. - Executive summary:
The objective of this study was to evaluate the cardiac sensitization potential during acute inhalation exposures by assessing the response to various concentrations of the test substance in Beagle dogs. Cardiac sensitization in this context refers to the potential for the test substance to increase the sensitivity of the heart to the pharmacological effects of epinephrine.
The test substance was administered to animals via a muzzle only inhalation apparatus as acute exposures (gas) at concentrations of 7%, 9%, and 8% (70000, 90000, and 80000 ppm [parts per million], respectively). One group of up to 6 male dogs per exposure level was used on this study with a minimum of 48 hours between exposure concentrations for each animal. Each dog served as its own control. Baseline responses to the epinephrine challenge doses were collected 5 days prior to exposure to the test substance. A predetermined challenge dose was established during this baseline prior to exposure for each individual animal. Escalating doses of epinephrine (2, 3, 4, 6, or 8 μg/kg) were administered as bolus intravenous (IV) injections (approximately 0.1 mL/kg delivered at a rate of approximately 0.1 mL/sec) until significant or dangerous cardiac effects were noted or the dose of 8 μg/kg elicited no effects, whichever was higher. For the 70000, 90000, and 80000 ppm groups, animals were administered the predetermined challenge dose of 8 μg/kg epinephrine via an appropriate vein beginning approximately 5 minutes prior to exposure to the test substance as well as approximately 5 minutes following exposure to the test substance. Two animals displayed an adverse reaction to the 70000 ppm dose and were replaced for subsequent exposures. The replacement animals were not exposed to the first exposure level of 70000 ppm. One animal displayed a severe adverse reaction to the second exposure level of 90000 ppm; no other animals were exposed to this level. The third exposure level of 80000 ppm was selected and was discontinued after a similar reaction (as that observed for the 90000 ppm exposure) was noted in the only animal to be exposed to this level. No further exposures were conducted. Following the final exposure, all animals were returned to the Test Facility's cardiovascular stock colony. Individual body weights were recorded on exposure days for calculation of epinephrine doses. Electrocardiographic (ECG) data were recorded continuously throughout the pre-exposure period, exposure to the test substance and throughout administration of the challenge epinephrine dose (up to approximately 17 minutes).
During the first exposure of 70000 ppm test substance, 2 of the 6 animals displayed continuous convulsions, excessive salivation, and/or dilated pupils following test substance exposure. During the next exposure of 90000 ppm test substance, 1 animal displayed continuous convulsions, excessive salivation, and dilated pupils during test substance exposure. No further animals were exposed to this concentration. During the last exposure of 80000 ppm test substance, the first animal exposed displayed continuous convulsions and excessive salivation during test substance exposure similar to that noted in the 90000 ppm exposure group. No further animals were exposed. All test substance exposures were terminated as soon as convulsions were apparent. There were no signs of cardiac sensitization after exposure to 70000 ppm. However, cardiac sensitization could not be evaluated following exposure to 80000 and 90000 ppm since the adverse clinical signs observed precluded the administration of epinephrine challenge.
Based on the results of this study, muzzle-only vapour exposure to 70000 ppm test substance in Beagle dogs followed by intravenous administration of 8 μg/kg epinephrine did not produce evidence of cardiac sensitization. Evaluation for cardiac sensitization was not possible in the 80000 and 90000 ppm test substance exposure groups due to adverse clinical signs that precluded the administration of epinephrine. Therefore, the no-observed-effect concentration (NOEC) for cardiac sensitization was 70000 ppm.
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