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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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- December 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 2-1-1
- Version / remarks:
- Novembre 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class 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:
- 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 10 weeks
- Weight at study initiation: 184.4 - 208.2 g
- Fasting period before study: overnight fasting prior to dose administration
- Housing: Three rats/cage in polypropylene rat cages covered with stainless steel grid top
- Diet ad libitum rat pellet feed Teklad certified Global High Fiber Rat and Mice Feed
- Water ad libitum UV sterilized water filtered through Kent Reverse Osmosis water filtration system
- Acclimation period: 7 days for set I rats (rat N° 1, 2 and 3) and 9 days for set II rats (rat N° 4, 5 and 6)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23
- Humidity (%): 65 to 66
- Air changes (per hr): 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
IN-LIFE DATES: From: 28 August 2013 To: 20 September 2013
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5% (w/v) in distilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: The test item was solid and mixed in 0.5% (w/v) carboxy methyl cellulose (CMC) in distilled water.
- Amount of vehicle (if gavage): Individual dose volume was adjusted according to body weight and dose level.
CLASS METHOD
- Rationale for the selection of the starting dose: Set I rats were given a single dose of 2000 mg/kg body weight. As no mortality was observed up to approximately 48 hours after dosing at this dose level, three female rats from set II were administered the same dose of 2000 mg/kg body weight. As no mortality was observed at this dose level further testing was not required. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- Six females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed for signs of toxicity and mortality at 0.5, 1, 2, 3, 4 and 6 hours post-administration on the day of dosing. Subsequently, the rats were observed twice a day for morbidity and mortality
- Necropsy of survivors performed: yes, All animals were subjected to a gross pathological examination consisting of an external examination and opening of abdominal and thoracic cavities
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: The clinical signs were recorded once a day. Individual body weight was recorded prior to dosing on day 0 and on days 7 and 14. - Statistics:
- Not required.
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- No treatment-related clinical signs were observed.
- Body weight:
- There were no apparent effects on body weight.
- Gross pathology:
- External examination of terminally sacrificed female rats did not reveal any abnormality of pathological significance.
Visceral examination of terminally sacrificed rats did not reveal any lesion of pathological significance. - Other findings:
- No other findings reported.
Any other information on results incl. tables
There was no mortality; the LD50 was therefore considered to be > 2000 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute oral LD50 of the test substance in Wistar rats was found to be greater than 2000 mg/kg bw. Classification according to the CLP Regulation is therefore not required.
- Executive summary:
An acute oral toxicity study was conducted with X204558 (cloquintocet acid), according to OECD 423. Two sets of fasted Wistar rats (3 females/set) were given a single oral dose of X204558 in 0.5% (w/v) carboxy methyl cellulose (CMC) in distilled water at a dose of 2000 mg/kg bw and observed for 14 days.
There were no treatment-related mortality, clinical signs or changes in body weight recorded. Necropsy findings of the terminally sacrificed rats did not reveal any abnormality of pathological significance. The acute oral LD50 of X204558 (cloquintocet acid) in Wistar rats was found to be greater than 2000 mg/kg bw. Based on the results of this study, cloquintocet acid is not classified for acute oral toxicity according to the CLP Regulation.
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