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EC number: 219-006-1 | CAS number: 2312-35-8
- 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:
- 21st January 1992 to 25th February 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-3 (Acute inhalation toxicity)
- Deviations:
- yes
- Remarks:
- (relative humidity and temperature decreased on occasion below that stated in the protocol. The test chambers were cleared at a flow rate of 8 L/min after exposure instead of at the same flow rates used in the exposure phase as intended)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Deviations:
- yes
- Remarks:
- (relative humidity and temperature decreased on occasion below that stated in the protocol. The test chambers were cleared at a flow rate of 8 L/min after exposure instead of at the same flow rates used in the exposure phase as intended)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- (relative humidity and temperature decreased on occasion below that stated in the protocol. The test chambers were cleared at a flow rate of 8 L/min after exposure instead of at the same flow rates used in the exposure phase as intended)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Propargite
- EC Number:
- 219-006-1
- EC Name:
- Propargite
- Cas Number:
- 2312-35-8
- Molecular formula:
- C19H26O4S
- IUPAC Name:
- propargite
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Omite® Technical
- Stability under test conditions: at least one year at room temperature
- Storage condition of test material: sealed container at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Kingston, New York, USA
- Age at study initiation: 7-9 weeks
- Weight at study initiation: 248-333 g (males); 207-233 g (females)
- Housing: stainless steel, wire mesh cages
- Diet: Purina Mills Rodent Laboratory Chow® Brand Animal Diet #5001 ad libitum
- Water: municipal water supply ad libitum
- Acclimation period: 12 to 21 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 ºC
- Humidity: 19-66 %
- Photoperiod: 12 hours light/12 hours dark
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: cast aluminium and alloy exposure chamber
- Exposure chamber volume: 40 litres
- Method of holding animals in test chamber: polycarbonate nose-only tubes
- Exposure procedure: flask containing test material was heated to 50 ºC. House-line air was delivered through a regulator and backpressure gauge via plastic tubing to a plastic 'Y' where it split into a generation flow and a dilution flow. The generation flow was delivered to a flowmeter fitted with a backpressure gauge and regulated by a valve to a neubiliser inserted into the centre neck of the flask. The test material-laden airstream exited the flask and passed through a brass cyclone before entering the nose-only chamber. The dilution flow was delivered to a flowmeter regulated by a valve and then into the side inlet of the nose-only chamber.
- Method of particle size determination: samples were drawn each hour using a cascade impactor. Mass median aerodynamic detector, geometric standard deviation and percent of particles ≤1.0 and ≤10 µm were calculated based on the amount of material collected on the six impactor stages (stainless steel slides) and a final filter stage.
- Treatment of exhaust air: through the in-house filtration system consisting of a coarse filter, HEPA filter and an incinerator
- Temperature, humidity, pressure in air chamber: 19-23 ºC, 8-32 %
TEST ATMOSPHERE
- Brief description of analytical method used: samples were withdrawn from the exposure chamber through glass-fibre filters each hour. Once during each exposure, an extended probe was used to obtain a sample from the other side of the chamber to measure the distribution of aerosol within the chamber. Sample flow rates were 5 lpm for all groups and sample duration was 10 minutes (0.31 mg/L), 1 minute (0.8 mg/L) and 2 minutes (1.3 mg/L). Samples were analysed by GC-FID. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 0.31, 0.8 and 1.3 mg/L (air concentration)
- No. of animals per sex per dose:
- Five
- Details on study design:
- - Duration of observation period following administration: 14 days (0.31 mg/L); 21 days (0.8 and 1.3 mg/L)
- Day of exposure (day 1): all animals were observed individually prior to exposure, as a group at approximately 15 minute intervals during the first hour of exposure and hourly for the remainder of the exposure period. All animals were observed individually upon removed from the exposure chamber and hourly for two hours post-exposure.
- Days 2 through 22: detailed observations were recorded for survivors once daily; viability was assessed twice daily.
- Body weight: days 1 (prior to exposure), 2, 3, 5, 8, 15 and 22
- Necropsy of survivors performed: yes - Statistics:
- LC50 and 95 % confidence limits calculated using the method of Litchfield and Wilcoxon.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 0.89 mg/L air
- Based on:
- test mat.
- 95% CL:
- >= 0.11 - <= 7
- Exp. duration:
- 4 h
- Mortality:
- All mortalities occurred between one and seventeen days post-exposure, with the exception of a single accidental death during the first 15 minutes of exposure. This animal was immediately replaced. Total mortalities were 1/10, 2/20 and 10/10 at 0.31, 0.8 and 1.3 mg/l, respectively.
- Clinical signs:
- other: During the exposure period, the most common symptom was laboured breathing and ano-genital staining. The same signs were evident during the 2 hour post-exposure period, accompanied by nasal discharge, matted coats and several gasping animals in the 1.3 mg
- Body weight:
- Body weight was reduced by up to 32 % during the first week post-exposure. However, recovery of lost weight occurred over time and all surviving animals were in excess of their starting weight at test termination.
- Gross pathology:
- The only treatment related finding at necropsy appeared to be a reddening of the lungs of some animals that died during the course of the study.
Any other information on results incl. tables
Table 1: Summary of mortality
Mortality | |||||
Group | Conc. (mg/L) | Male | Female | Total | Day of last spontaneous death |
I | 0.31 | 1/5 | 0/5 | 1/10 | 5 |
II | 1.30 | 5/5 | 5/5 | 10/10 | 18 |
III | 0.80 | 1/5 | 1/5 | 2/10 | 4 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Classified as Category 3 in accordance with EU criteria
- Conclusions:
- The acute nose-only inhalation LC50 of the test material in rats was determined to be 0.89 mg/L.
- Executive summary:
The test material was administered by nose-only inhalation as a liquid aerosol to three groups of five rats for four hours. Exposure levels were determined gravimetrically and by GC during each hour of exposure. Particle size distributions were determined during each hour of exposure. Physical observations for abnormal signs were conducted on all exposure animals as a group, at fifteen minute intervals during the first hour of exposure and hourly for the remainder of exposure. All animals received detailed physical observations just prior to exposure, immediately upon removal from the chamber, hourly for two hours post-exposure and once daily thereafter. Body weight measurements were obtained just prior to exposure on day 1 and on days 2, 3, 5, 8, 15 and 22. After a 14 or 21 day post-exposure observation period, all survivors were sacrificed and complete post-mortem examinations performed.
The mean exposure concentrations were determined to be 0.31, 0.80 and 1.3 mg/L air resulting in mortalities of 10, 20 and 100 %, respectively. Particle size distribution determinations showed, on average, the mass median aerodynamic diameter to be 1.6 µm with a geometric standard deviation of 1.8. 22 % of the particles were <1 µm and 100 % of the particles were <10 µm in size.
The LC50, based on analytical concentrations, was determined to be 0.89 mg/L for the combined sexes with 95 % C.I. of 0.11 to 7.0 mg/L. There was no difference in lethality between males and females. Signs of treatment included respiratory responses during exposures and secretory/respiratory responses following the exposures leading to mortality within 1 to 17 days. A substantial adverse effect upon body weight was produced by treatment. Gross post-mortem examinations included possible treatment-related lung discolouration.
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