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EC number: 635-476-4 | CAS number: 88349-88-6
- 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:
- 21 August 2013 - 14 November 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- September 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Version / remarks:
- May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 2-1-3
- Version / remarks:
- March 2005
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- [(5-chloroquinolin-8-yl)oxy]acetic acid
- Cas Number:
- 88349-88-6
- Molecular formula:
- C11H8ClNO3
- IUPAC Name:
- [(5-chloroquinolin-8-yl)oxy]acetic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- powder
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): X204558
- Physical state: Tan solid
- Analytical purity: 98.3% ± 0.03% wt/wt
- Purity test date: 14 September 2014
- Lot/batch No.: 2GHB0002
- Storage condition of test material: in its original container at ambient condition
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation
- Age at study initiation: 8 to 9 weeks
- Weight at study initiation: 200.1 - 256.2 g for male, 159.2 - 212.8 g for female
- Fasting period before study: not applicable
- Housing: Five rats/cage in polypropylene rat cages covered with stainless steel grid top
- Diet ad libitum Teklad certified Global High Fiber Rat/Mice Feed
- Water ad libitum UV sterilized water filtered through Kent Reverse Osmosis water filtration system
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23
- Humidity (%): 65 to 67
- Air changes (per hr): 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
IN-LIFE DATES: From: 4 September 2013 To: 24 September 2013
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Remarks:
- The solid test material was pre-mixed with iron grit.
- Mass median aerodynamic diameter (MMAD):
- 2.37 µm
- Geometric standard deviation (GSD):
- 2.42
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: A dynamic inhalation exposure system consisting of a flow-past head/nose-only inhalation exposure chamber with Perspex rat exposure/restraint tubes, air compressor, flow meter, 2” fluidized bed dust (dry powder) aerosol generator, cascade impactor, temperature and humidity probe (thermo-hygrometer), oxygen monitor, carbon dioxide monitor, and open-face gravimetric filter sampler.
- Exposure chamber volume: The total capacity of the chamber is 63.5 litres. The dynamic inhalation equipment has 3 main parts namely inlet, exposure and outlet chambers. Each part is 30 cm in height and 30 cm in internal diameter. The inlet unit (upper) consists of a glass cylinder with facility for the attachment of a dust inlet tube. The exposure unit (middle) is made of stainless steel with 20 portholes to accommodate transparent perspex rat exposure tubes. The outlet unit (lower) is made up of stainless steel with an outlet provision connected to a suction pump.
- Method of holding animals in test chamber: Rat exposure tubes which are provided with orifices to eliminate excreta and urine, which are collected in a dropping tray. These exposure tubes are accommodated in the portholes of the inhalation chamber. The adjustable unit of the exposure tube is set in such a way that rats breathe the test item aerosol through the window panel of the exposure tube.
- Source and rate of air: dynamic air flow rate of 51 to 52 air changes per hour
- Method of conditioning air: The exposure system designed to sustain a dynamic air flow rate of 51 to 52 air changes per hour, ensure an adequate oxygen content of at least 19% and a homogeneous, evenly distributed, respirable test aerosol with a mass median aerodynamic diameter (MMAD) particle size ranging between 1 and 4 microns. The pressure inside the exposure chamber was maintained slightly negative to the atmospheric pressure of the room to prevent leakage of the test aerosol into the surrounding area. Exposure atmosphere CO2 levels were less than 1%.
- System of generating particulates/aerosols: The dust generator system works on the principle of fluidized bed dispersion. The fluid bed is a long assembly of tubing having several tube fittings attached. The feed system consists of a hopper and small diameter tubing with valve attached that is connected to the upper part of the bed chamber and an overflow that is near the bottom of the bed chamber. The flow of air into the tubing leading from the hopper facilitates the uniform flow of test item into the bed chamber. The flow of air into the bed plenum generates the aerosol of the test item, dispersing it into the test atmosphere and carrying it to the exposure chamber.
- Method of particle size determination: Seven Stage Cascade Impactor. Aerosols from the chamber are drawn into the cascade impactor with pre-weighed stainless steel collection plates using a vacuum pump. At the end of the sampling period, the collection plates with test item are disassembled and weighed. The increase in the weight of each collection plate is the mass of particles in the size range of that impact stage. The total mass of particles and the percent mass of particles in each size range is calculated. Mass median aerodynamic diameter (MMAD) is calculated directly from percent particle size distribution.
- Treatment of exhaust air: The outgoing air from the chamber passes through an impinger containing 1.0% sodium hydroxide solutions and moisture traps.
- Temperature, humidity, pressure in air chamber: The chamber temperature during the exposure period was 21.3 to 21.5 °C, while the relative humidity was 63.0 to 67.3%. The chamber oxygen concentration recorded during the exposure period was 20.7 to 20.9%. The chamber carbon dioxide concentration recorded during the exposure period was 0.03 to 0.05%.
TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric samples were collected and analyzed to determine the chamber aerosol concentration. The concentration of aerosol present in the chamber was determined gravimetrically three times during the four-hour exposure period. The aerosol particles were collected on pre-weighed glass fibre filters using an open-face filter sampler. After each exposure atmosphere sampling, the filter was reweighed to obtain the total weight of the particles collected. The time-weighted average (TWA) exposure concentration was calculated from the aerosol
gravimetric measurements. After the target aerosol concentration (> 5 mg/L air) was verified, the test animals loaded to the exposure chamber. On the day of the acute 4-hour inhalation exposure, the time-weighted average (TWA) exposure concentration was calculated (6.11 mg/L air) from the combined aerosol.
- Samples taken from breathing zone: yes. Each sample was taken by drawing chamber atmosphere from the animal breathing zone at a set rate using a constant flow air sampling pump.
VEHICLE
- Composition of vehicle (if applicable): air, 360 g of the test substance was pre-mixed with 7200 mL inert bed material (Iron grit) to provide a test item stock of uniform concentration 50 mg/mL (mass cloquintocet acid/volume of inert bed material) - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Gravimetric
- Duration of exposure:
- 4 h
- Concentrations:
- The time-weighted average (TWA) exposure concentration was 6.11 mg/L air.
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All rats were observed for any signs of toxicity and mortality at hourly intervals during the 4 hour exposure period and at 1 and 2 hours after the exposure. Subsequently, the surviving rats were observed twice a day for morbidity and mortality. The clinical signs were recorded once a day.
- Necropsy of survivors performed: yes, the necropsy consisted of an external examination and the opening of the nasal passage, abdominal and thoracic cavities.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Body weights were recorded prior to exposure on day 0 and on post-exposure days 1, 3, 7 and 14. - Statistics:
- No statistical analysis was required.
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 6.11 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: No treatment-related clinical signs were observed.
- Body weight:
- There were no apparent effects on body weight.
- Gross pathology:
- External examination of terminally sacrificed male and female rats did not reveal any abnormalities of pathological significance.
Visceral examination of terminally sacrificed male and female rats did not reveal any abnormal lesions. - Other findings:
- No further data
Any other information on results incl. tables
Particle Size Range (μm) |
ECD (μm) |
Particle Size During Exposure |
Mean Percent Size |
Cumulative Percent Size |
|
1 Hour % |
3 Hour % |
||||
> 6.35 |
6.35 |
17.33 |
17.39 |
17.36 |
99.99 |
4.25 – 6.35 |
4.25 |
7.67 |
7.73 |
7.70 |
82.63 |
2.85 – 4.25 |
2.85 |
10.00 |
10.79 |
10.39 |
74.93 |
1.95 – 2.85 |
1.95 |
16.83 |
17.39 |
17.11 |
64.54 |
1.45 – 1.95 |
1.45 |
24.67 |
23.03 |
23.85 |
47.43 |
0.97 – 1.45 |
0.97 |
13.50 |
13.85 |
13.67 |
23.58 |
0.64 – 0.97 |
0.64 |
6.50 |
6.76 |
6.63 |
9.91 |
0 – 0.64 |
- |
3.50 |
3.06 |
3.28 |
3.28 |
Total mass in 8.85 litres |
100.00 |
100.00 |
- |
- |
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the conditions of this study, the 4 hour acute inhalation LC50 of X204558 in male and female Wistar rats was found to be greater than 6.11 mg/L air. Classification according to the CLP Regulation is not required.
- Executive summary:
An acute inhalation toxicity study was conducted with X204558 (cloquintocet acid), according to OECD 423. A group of 5 male and 5 female Wistar rats were exposed to a time-weighted average (TWA) concentration of 6.11 mg X204558/L air (limit test) using a nose-only inhalation exposure system. The solid test material was pre-mixed with iron grit. The rats were exposed for 4 hours followed by a 14-day post-exposure observation period.
The mass median aerodynamic diameter (MMAD) of aerosolized X204558 was determined to be 2.37 μm with an average geometric standard deviation (GSD) of 2.42. There was no treatment-related mortality, no clinical signs of toxicity, no effects on body weight changes, and no abnormalities observed at necropsy. The 4 hour acute LC50 of X204558 (cloquintocet acid) in male and female Wistar rats was found to be greater than 6.11 mg/L air. Based on the results of this study, cloquintocet acid is not classified for acute inhalation toxicity according to the CLP Regulation.
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