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EC number: 603-923-2 | CAS number: 135590-91-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-3 (Acute inhalation toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- diethyl 1-(2,4-dichlorophenyl)-5-methyl-4,5-dihydro-1H-pyrazole-3,5-dicarboxylate
- EC Number:
- 603-923-2
- Cas Number:
- 135590-91-9
- Molecular formula:
- C16H18Cl2N2O4
- IUPAC Name:
- diethyl 1-(2,4-dichlorophenyl)-5-methyl-4,5-dihydro-1H-pyrazole-3,5-dicarboxylate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF breeding colony
- Age at study initiation: 8-10 weeks
- Weight at study initiation: mean males 192 g, females 188 g
- Housing: in fully air-conditioned rooms in Makrolon cages (Type 4) on soft wood granulate, in groups of 5 animals
- Diet: Altromin 1324 rat diet (Altromin GmbH, Lage/Lippe), ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: polyethylene glycol/ethanol
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Stainless-steel and glass cylinder, standing in a vent pipe with a volume of approx. 4 m³. The chambers have proved to yield a uniform distribution of aerosols at the different breathing zones of the animals.
- Exposure chamber volume: 60 L
- Method of holding animals in test chamber: individually in cylindrical plastic cages
- Source and rate of air: air was pumped at a pressure of 4 bar into a special nozzle with a welded-in supply tube for the test substance. The air supply at the nozzle was maintained at 800 L/h by means of an air-calibrated rotameter (Rota, Wehr). A suction device at the bottom of the exposure chamber drew off the aerosol at a rate of 1100 L/h through a cotton-wool filter, a Buehler filter, a washing flask filled with 10% sodium hydroxide solution and a calcium chloride flask. The difference in rate between the introduction of air at 800 L/h through the nozzle and its extraction at 1100 L/h is necessary to maintain the kinetic energy of the aerosol particles and to ensure a laminar flow of the aerosol from the top to the bottom of the exposure chamber.
- Method of conditioning air: passing through an oil separation filter and an absolute filter. In order to ensure the higher atmospheric humidity required by the current guidelines, air was passed via a porous stone at a rate of 100 L/h through a 1000 ml vacuum filter flask filled with water. The moisturised air was then conducted straight into the exposure chamber.
- System of generating particulates/aerosols: Hoe 107892 00 ZC97 0001 was injected into a nozzle at a constant speed by means of a continuous infusion apparatus. The primary aerosol was formed in a separator. Smaller aerosol particles (secondary aerosol) passed through a rising tube into the exposure chamber.
- Method of particle size determination:
- Treatment of exhaust air: Particles of test substance escaping from the exposure chamber into the vent pipe were drawn off and neutralised by gas-cleaning equipment.
- Temperature, humidity, pressure in air chamber: 20 - 22°C, 58.6 - 63.7%, no data on pressure
TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric analysis of the aerosol-concentration in the breathing zone of the animals was performed at intervalls of about 15 minutes. For this purpose, the test atmosphere was drawn off through a rotary gas counter, then through a glass fiber filter and a membrane filter with a pore width of 0.65 µm. The extraction rate was 3 L/minute, resulting in a flow rate of 1.25 m/sec. Before use, the filters were stored in an exsiccator filled with calcium chloride for 24 hours. The filters were weighed before and after sampling by means of an electronic balance. In order to determine the exact quantity of Hoe 107892 00 ZC97 0001 in the exposure chamber, chemical-analytical examinations were carried out. For this purpose, 31 L were drawn from the inhalation chamber over a period of 60 minutes and passed successively through three gas-washing flasks filled with Acetonitril and kept standing in a cold bath. Sampling was carried out within the breathing zone of the animals. Additionally two of the filters used for gravimetric measurements were floated with 30 ml Acetonitril and also analysed. Hoe 107892 00 ZC97 0001 was isolated by HPLC and determined spectrophotometrically.
Determination of the aerosol particle size distribution was performed with an Anderson 7 stage cascade impactor (Model Mark III, Anderson Samples Inc., Atlanta, U.S.A.). The test atmosphere was impacted at each stage onto steel discs which were weighed before and after sampling. Sampling was performed at a volume rate of 9.5 L/minute, resulting in a flow velocity of 1.25 m/s. Mass median aerodynamic diameter, standard deviation and other parameters of the particle size distribution were calculated using linear regression (probit values versus the logarithm of the particle size).
- Samples taken from breathing zone: yes
VEHICLE
- Composition of vehicle (if applicable): Hoe 107892 00 ZC97 0001 was tested as solution in polyethylene glycol 400/ Ethanol p.a.
- Concentration of test material in vehicle (if applicable): 15%
- Justification of choice of vehicle: substance could not be dispersed in its original form, stability and homogeneity of the solution for a period of 6 hours was verified before start of the study.
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: < 0.6 to > 10.3 µm
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 1.18 µm/3.36 µm (1st measurement), 1.02 µm/2.65 µm (2nd measurement) - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetric and chemical-analytical
- Duration of exposure:
- 4 h
- Concentrations:
- 1.32 mg/L air
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: behaviour continuously during exposure, thereafter twice daily; weighing on day 8 and day 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Means and standard deviations of body weights and body weight gains, linear regression and probit analysis for calculation of particle size distribution parameters.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1.32 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: Highest technically administrable dose.
- Mortality:
- No deaths occurred.
- Clinical signs:
- other: Irregular breathing, stilted gait, uncoordinated gait, ataxic gait and squatting posture. Additionally, ruffled coat was observed. The animals treated with the vehicle alone also showed irregular breathing, uncoordinated gait, ataxic gait and squatting p
- Body weight:
- Body weight development was not impaired.
- Gross pathology:
- The animals killed at the end of the observation period showed no macroscopically visible abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: Not classified
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