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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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 402 (Acute Dermal Toxicity)
- Version / remarks:
- February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- August 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 2-1-2
- Version / remarks:
- November 2000
- 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 11 weeks
- Weight at study initiation: 222.3 - 291.5 g
- Fasting period before study: Not applicable
- Housing: individually 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: 7 days
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: 18 September 2013
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 7 × 5 cm. Fur was closely clipped from the dorsal area of the trunk of each rat using a clipper without abrading or damaging the skin 24 hours prior to application of the test item.
- % coverage: 10% of the body surface
- Type of wrap if used: The test item was held in contact with the skin using porous gauze dressing (not more than 8 ply) and a non-irritating tape throughout the 24 hours exposure period to prevent any loss of the test item and also to ensure that the rats did not lick or ingest it.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the residual test item was removed using cotton soaked in distilled water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1111.5 to 1457.5 mg
- For solids, paste formed: moistened with 0.2 mL distilled water - Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females per dose
- 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 1, 2, 3 and 5 h post-dermal application on the day of dosing (day 0). 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 dermal application on day 0 and on days 7 and 14 post application. - Statistics:
- Not required.
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed
- Clinical signs:
- No treatment related clinical signs were observed
- Body weight:
- All treated rats showed no adverse 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 male and female rats sacrificed at termination did not reveal any lesions. - Other findings:
- No other findings reported
Any other information on results incl. tables
No further information available
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 of X204558 in Wistar rats was found to be greater than 5000 mg/kg bw. Classification according to the CLP Regulation is not required.
- Executive summary:
An acute dermal toxicity study was conducted with X204558 (cloquintocet acid), according to OECD 402. A group of Wistar rats (5 males and 5 females) were dermally exposed to X204558 for 24 hours following application at a limit dose of 5000 mg/kg body weight. The required quantity (1111.5 to 1457.5 mg) of test item (moistened with 0.2 mL distilled water) was applied over the clipped area (approximately 7 × 5 cm body surface area) and the rats were observed for a period of 14 days.
There were no treatment-related mortality, clinical signs, changes in body weight or necropsy findings recorded. The acute dermal LD50 of X204558 (cloquintocet acid) in male and female Wistar rats was found to be greater than 5000 mg/kg bw. Based on the results of this study, cloquintocet acid is not classified for acute dermal toxicity according to the CLP Regulation.
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