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EC number: 478-310-4 | CAS number: 53803-13-7
- 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:
- disregarded due to major methodological deficiencies
- Study period:
- From September 25, 2017 to June 14, 2018
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Justification for type of information:
- The acute inhalation toxicity study on Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid in the species rat was disregarded due to major methodological deficiencies of the testing procedure.
Whole-body chambers were chosen as the method of exposure instead of the recommended nose-only exposure for aerosols, without justification. The disadvantage of the whole-body chambers is, that uptake of the substance due to other routes than inhalation (oral route via preening or dermal route as described in the Guidance Document on Acute Inhalation Toxicity Testing. Environmental Health and Safety Monograph Series on Testing and Assessment No. 39) can’t be ruled out. Furthermore, the description of the testing conditions is not sufficient to ascertain whether the results could be regarded as reliable. The measurements, apart from volume of the inhalation chambers has not been described and neither the number of test animals per chamber.
The study design further deviates significantly from the OECD Guideline 403 (Acute Inhalation Toxicity) as follows:
• Age of test animals was not stated.
• Conditions of housing for the test animals was not described.
• No determination of particle size for the aerosol as strongly recommended by the OECD guideline. “The particle size distribution of aerosols should be determined at least twice during each 4 hour exposure”.
• The air flow in the testing chamber was not recorded, neither was the test atmosphere concentration as a mean to control dynamic atmosphere generation parameters.
• Relative humidity in the breathing zone was not recorded.
• Not detailed how actual concentration was measured.
• No sighting study, despite the lag of previous data.
• No observations of changes in the skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour patterns.
• Individual animal weights not recorded on day 1 and 3 (only on day 0, 7 and 14) as recommended by Guideline.
• Missing in the description of caging conditions: number (or change in number) of animals per cage, bedding material, photoperiod, and identification of diet.
• Method of randomization not described.
• Details of food and water quality not stated.
• No description of any pre-test conditioning including diet, quarantine, and treatment for disease.
• Source and description of equipment used for the exposure of animals as well as generation of atmosphere missing.
• Equipment for measuring temperature, humidity, particle-size, and actual concentration not noted.
• Source of air and treatment of air supplied/extracted and system used for conditioning not detailed.
• Methods used for calibration of equipment to ensure a homogeneous test atmosphere not described.
• Location of animals in the system for whole-body exposure not recorded.
• No location of temperature and humidity sensors and sampling of test atmosphere in the chamber stated.
• Information about the equipment used to measure oxygen and carbon dioxide missing.
• Time required to reach inhalation chamber equilibrium (t95) not recorded.
• No tabulation of chamber temperature, humidity, and airflow.
It is not possible to get a clear understanding how the test was performed and if other routes of exposure could be ruled out. Overall the number and severity of deviations from the OECD Guideline 403 led to the Klimisch ranking of reliability 3 (not reliable) and the disregard of the study result.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- GLP compliance:
- not specified
Test material
- Reference substance name:
- -
- EC Number:
- 478-310-4
- EC Name:
- -
- Cas Number:
- 53803-13-7
- Molecular formula:
- C9H21NO2
- IUPAC Name:
- Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: Evonik Specialty Chemicals (Nanjing) Co., Ltd. , Lot Number: Ten.17.812
- Purity, including information on contaminants, isomers, etc.: 99.5%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Keep away from light at room temperature.
FORM AS APPLIED IN THE TEST (if different from that of starting material)
- Specify the relevant form characteristics if different from those in the starting material, such as state of aggregation, shape of particles or particle size distribution:
The test substance was dissolved in distilled water and tested as aerosol.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Slac JingDa Laboratory Animal Co., Ltd., Hunan Province
- Females (if applicable) nulliparous and non-pregnant: yes, 20 females
- Weight at study initiation: 189 - 224 g
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23°C
- Humidity (%): 62-68%
Food: Supplied by TianQin biotechnology Ltd, Changsha
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- water
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Inhalation chamber
- Exposure chamber volume: 0.3m³
- Source and rate of air (airflow): dynamic air flow
- System of generating particulates/aerosols: Atomized by atomizer generator
- Temperature, humidity, pressure in air chamber: 22-23°C, humidity 62-68%
VEHICLE
- Composition of vehicle (if applicable): distilled water
- Concentration of test material in vehicle (if applicable):
200, 500, 800, 1100 mg/m³
0.875%, 2.19%, 3.5%, 4.81% - Duration of exposure:
- ca. 4 h
- Concentrations:
- Actual exposure concentration
211, 520, 837, 1130 mg/m³ - No. of animals per sex per dose:
- 20 males, 20 females
- Control animals:
- no
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- >= 224.7 - <= 1 773.7 mg/m³ air
- 95% CL:
- ca. 624.1
- Exp. duration:
- 4 h
- Key result
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- >= 131.3 - <= 1 373.8 mg/m³ air
- 95% CL:
- ca. 424.7
- Exp. duration:
- 4 h
- Mortality:
- Female
- 211 mg/m³ - 0 animals deceased
- 520 mg/m³ - 3 of 5 animals deceased
1 died during exposure
2 died 3.5 h after exposure
- 837 mg/m³ - 3 of 5 animals deceased
3 died 4 h after exposure
- 1130 mg/m³ - 4 of 5 animals deceased
1 died during exposure
3 died 15 h after exposure
Male
-211 mg/m³ - 1 of 5 animals deceased
1 died 4.5 h after exposure
-520 mg/m³ - 3 of 5 animals deceased
1 died during exposure
2 died 3.5 h after exposure
-837 mg/m³ - 3 of 5 animals deceased
2 died during exposure
1 died 4 h after exposure
-1130 mg/m³ - 5 of 5 animals deceased
3 died during exposure
2 died 15 h after exposure - Clinical signs:
- lethargy (hypoactivity)
- Remarks:
- During the exposure the animals exposed to 500, 800 and 1100 mg/m³ substance were less dynamic and had a slow reaction time. They recovered 23.5-72 hrs after exposure. The animals exposed to 200 mg/m³ showed similar reactions and recovered after 22.5 hrs.
- Body weight:
- The body weight of the surviving animals increased 7 and 14 days after exposure.
Details are to be found in the attached table. - Gross pathology:
- The animals that died during the 4h exposure time showed liver congestion. No abnormal necropsy finding occured in other test animals.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- The study has major methodological deficiencies.
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