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EC number: 204-029-1 | CAS number: 113-48-4
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 November 2004 to 21 April 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- May 12, 1981
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Version / remarks:
- August 1998
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- traditional method
- Limit test:
- no
Test material
- Reference substance name:
- N-(2-ethylhexyl)-8,9,10-trinorborn-5-ene-2,3-dicarboximide
- EC Number:
- 204-029-1
- EC Name:
- N-(2-ethylhexyl)-8,9,10-trinorborn-5-ene-2,3-dicarboximide
- Cas Number:
- 113-48-4
- Molecular formula:
- C17H25NO2
- IUPAC Name:
- N-(2-ethylhexyl)-8,9,10-trinorborn-5-ene-2,3-dicarboximide
- Reference substance name:
- (E)-1,4-Bis(2-ethylhexylamino)-2-butene-1,4-dione
- Molecular formula:
- C20H38N2O2
- IUPAC Name:
- (E)-1,4-Bis(2-ethylhexylamino)-2-butene-1,4-dione
- Reference substance name:
- 1-(2-ethylhexyl)-1H-pyrrole-2,5-dione
- Molecular formula:
- C12H19NO2
- IUPAC Name:
- 1-(2-ethylhexyl)-1H-pyrrole-2,5-dione
- Test material form:
- liquid
- Details on test material:
- Purity and characterisation analysis conducted on the following sample; Supplier: McLaughlin Gormley King ; Batch Number: AB9500
Constituent 1
impurity 1
impurity 2
- Specific details on test material used for the study:
- MGK® 264
Lot No.: AA7093
Purity: 95.2% MGK 264 (From CofA)
Lot No. AA7207 - addtional shipment required to complete the study
Purity: 99.04%
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals
Young adult, Hsd: Sprague Dawley SD rats were received from Harlan Sprague Dawley Inc., Indianapolis, Indiana.
Environment
The animal room temperature and relative humidity ranges were 65-72°F (18-22°C) and 34-59%, respectively. Environmental control equipment was monitored and adjusted as necessary to minimize fluctuations in the animal room environment. Light timers were set to maintain a 12-hour light/12-hour dark cycle and room ventilation was set to produce 10-15 air changes/hour. The animal room temperature and relative humidity were recorded a minimum of once daily.
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: Conditioned external air
- Mass median aerodynamic diameter (MMAD):
- >= 2.2 - <= 3.6 µm
- Geometric standard deviation (GSD):
- >= 1.94 - <= 2.46
- Remark on MMAD/GSD:
- For 0.55mg/L dose MMAD = 2.2µ, GSD=1.94
For 0.55mg/L dose MMAD = 3.6µ, GSD=2.10
For 0.55mg/L dose MMAD = 3.0µ, GSD=2.46 - Details on inhalation exposure:
- The aerosol exposures consisted of a 21-minute (0.55 and 2.23 mg/L dose level) or an 18-minute (1.01 mg/L dose level) T99 equilibration period, a 240-minute exposure period and a 21-minute (0.55 and 2.23 mg/L dose level) or an 18-minute (1.01 mg/L dose level) de-equilibration period equal to the T99 equilibration period. After the aerosol exposure, the animals were removed from the chamber and residual test article was removed from the animal's exterior surfaces (where practical) by rinsing the haircoat with lukewarm tap water and wiping the haircoat with a dry towel. The animals were then returned to ad libitum feed and water.
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- the concentration of the test item aerosol was ollected in the inhalation chamber by gravimetric technique.
- Duration of exposure:
- 240 min
- Concentrations:
- 0.55, 1.01 and 2.23 mg/L
- No. of animals per sex per dose:
- 5 Male, 5 Female per dose level
- Control animals:
- no
- Details on study design:
- The 4h whole-body inhalation toxicity of MGK® 264 was evaluated in Sprague Dawley rats. A LC50 study was performed in which three groups of five male and five female rats received a 4h whole-body inhalation exposure to a time-weighted average aerosol concentration (gravimetrically determined). Following the exposure, the rats were observed daily and weighed weekly. A gross necropsy examination was performed on all test animals at the time of scheduled euthanasia (day 14).
- Statistics:
- The LC50 and 95% confidence intervals were calculated separately for males, females and the combined sexes using a computer adaptation of the method of Litchfield and Wilcoxon.
Body weight means and standard deviations were calculated separately for males and females. The aerodynamic particle-size distribution of the test article aerosol was plotted using an Excel computer adaptation of the three cycle logarithmic probability paper as per the ITP Cascade Impactor instruction manual. The mass median aerodynamic diameter, geometric standard deviation and particles S 4.0 11 were determined based on the plotted distribution.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 1.98 mg/L air
- Based on:
- test mat.
- 95% CL:
- > 1.506 - < 2.606
- Exp. duration:
- 240 min
- Key result
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 1.94 mg/L air
- Based on:
- test mat.
- 95% CL:
- > 1.233 - < 3.043
- Exp. duration:
- 240 min
- Key result
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- 1.94 mg/L air
- Based on:
- test mat.
- 95% CL:
- > 1.233 - < 3.043
- Exp. duration:
- 240 min
- Mortality:
- No mortality occurred at the 0.55 and 1.01 mglL dose levels.
Mortality occurred by study day 2 for the 2.23 mgIL dose level. 3/5 Males deceased, 3/5 Females deceased. - Clinical signs:
- other: For the 0.55 mg/L dose level, clinical abnormalities included breathing abnormalities, decreased defecation, rough haircoat, hunched posture, urine stain, unkempt appearance, swelling around nose, nasal discharge and dark material around the facial area.
- Body weight:
- For the 0.55 mg/L dose level, body weight gain was noted for all animals during the test period.
For the 1.01 mg/L dose level, slight body weight loss was noted in four males and one female during the day 0 to 7 body weight interval. Body weight gain/maintenance was noted for all other animals during the test period. All animals exceeded their initial body weight by study termination.
For the 2.23 mg/L dose level, slight body weight loss was noted in two surviving males during the day 0 to 7 body weight interval. Body weight gain was noted for all other surviving animals during the test period. All surviving animals exceeded their initial body weight by study termination. - Gross pathology:
- For the 0.55 mg/L dose level, no significant gross internal findings were observed at necropsy on study day 14.
For the 1.01 mg/L dose level, no significant gross internal findings were observed at necropsy on study day 14.
For the 2.23 mg/L dose level, the most notable gross internal findings were noted in the animals that died and included foci on the stomach, mottled lung lobes, abnormal content of the digestive tract/trachea/nasal tissues/larynx/urinary bladder, pale liver lobes and dark red kidney. No significant gross internal findings were observed at necropsy on study day 14.
Applicant's summary and conclusion
- Interpretation of results:
- other: EC 1272/2008 this would be classified as a category 4 toxicity hazard for inhalation
- Conclusions:
- Under the conditions of this test, the acute inhalation LC50 of MGK 264 in the male rat was determined to be 1.94 mg/L. In the female rat, the acute inhalation LC50 was determined to be 1.94 mg/L. In the sexes combined, the LC50 was determined to be 1.98 mg/L.
The acute inhalation lethal dose (LC50) of the test material, in female Sprague-Dawley rats (1.94 mg/L) was found to be between 1.0 and 5.0 mg/l. According to EC 1272/2008 this would be classified as a category 4 toxicity hazard for inhalation.
Signal Word: Warning
Hazard Statement: H332: Harmful if inhaled - Executive summary:
The 4h whole-body inhalation toxicity of MGK® 264 was evaluated in Sprague Dawley rats. A LC50 study was performed in which three groups of five male and five female rats received a 4h whole-body inhalation exposure to a time-weighted average aerosol concentration (gravimetrically determined) of 0.55, 1.01 and 2.23 mg/L, respectively. The mass median aerodynamic diameter and geometric standard deviation of the sampled particles were 2.2 µand 1.94, 3.6 µand 2.1 0, and 3.0 µand 2.46, respectively. The percentage of particles ≤ 4.0 µ was determined to be 82%, 56% and 62%, respectively. Following the exposure, the rats were observed daily and weighed weekly. A gross necropsy examination was performed on all test animals at the time of scheduled euthanasia (day 14).
Under the conditions of this test, the acute inhalation LC50 of MGK 264 in the male rat was determined to be 1.94 mg/L. In the female rat, the acute inhalation LC50 was determined to be 1.94 mg/L. In the sexes combined, the LC50 was determined to be 1.98 mg/L. The test article would be assigned an EPA-OPPTS Toxicity Category III for labelling.
The acute inhalation lethal dose (LC50) of the test material, in female Sprague-Dawley rats (1.94 mg/L) was found to be between 1.0 and 5.0 mg/l. According to EC 1272/2008 this would be classified as a category 4 toxicity hazard for inhalation.
Signal Word: Warning
Hazard Statement: H332: Harmful if inhaled
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