Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 August 2013 - 04 October 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 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- October 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- August 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 2-1-5
- Version / remarks:
- November 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation
- Age at study initiation: 15 to 16 weeks
- Weight at study initiation: 2.199 - 2.296 kg
- Housing: Individual stainless steel bottom rabbit cages with bedding material
- Diet ad libitum Teklad Certified Global High fiber rabbit pellet feed
- Water ad libitum UV sterilised drinking water filtered through Kent Reverse Osmosis
- Acclimation period: 7 days for rabbit N° 1 and 9 days for rabbit N° 2 and 3
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23
- Humidity (%): 64 to 66
- Air changes (per hr): Minimum 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 h artificial light and 12 h darkness
IN-LIFE DATES: From: 29 August 2013 To: 10 September 2013
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 47.8, 48.9 and 48.1 mg (equivalent to 0.1 mL) - Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- The eyes of all rabbits were observed for signs of ocular irritation at 1, 24, 48 and 72 h
- Number of animals or in vitro replicates:
- Three females
Initially one rabbit was tested. Based on the observations at 24 hours post application, two additional rabbits were tested simultaneously to confirm the response. - Details on study design:
- - Pre-treatment checks of the eyes were performed to confirm they were free of pre-existing irritation
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated and the control eyes were gently washed with normal saline
- Time after start of exposure: at 1 h (to remove residual test item) and 24 h post-treatment
SCORING SYSTEM:
- Is presented in the tables below.
TOOL USED TO ASSESS SCORE: The treated and the control eyes of each rabbit were examined using fluorescein dye staining at 24 h post test item application.
One to two drops of fluorescein stain was instilled into the eye. The eye was washed using 0.9% normal saline to remove the residual stain from the eye and the eye was examined with the aid of Ophthalmoscope through a cobalt blue filter [disruption of corneal epithelium (% area) showing as green fluorescein staining] and any corneal damage was recorded post application.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable/No effect
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable/No effects
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.45
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Conjunctival effects were evident at 1, 24, 48 hours in all three rabbits and resolved by 72 hours after treatment. At the 1 hour post application time-point, the treated eye of all rabbits revealed conjunctival redness [score of 1] and conjunctival chemosis [score of 1]. The individual animal mean (n=3) eye irritation scores of 24, 48 and 72 hours post application observations were 0.00, 0.00, 0.00 for corneal opacity, 0.00, 0.00, 0.00 for iris effects, 1.00, 1.00, 1.00 for conjunctival redness and 0.67, 0.00, 0.67 for conjunctival chemosis for rabbit N° 1, 2 and 3, respectively. The test substance showed mild eye irritation which resolved by 72 h post application.
- Other effects:
- No signs of systemic toxicity including clinical observation and body weight were observed in the rabbits throughout the experimental period
Any other information on results incl. tables
Rabbit N° |
Mean Score at 24, 48 and 72 Hours |
|||
Corneal Opacity |
Iris Lesion |
Conjunctivae Redness |
Conjunctivae Chemosis |
|
1 |
0.00 |
0.00 |
1.00 |
0.67 |
2 |
0.00 |
0.00 |
1.00 |
0.00 |
3 |
0.00 |
0.00 |
1.00 |
0.67 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance showed mild eye irritation which resolved by 72 hours post application, classification is not required.
- Executive summary:
An acute eye irritation study was conducted in 3 adult female New Zealand White rabbits to assess the potential of X204558 (cloquintocet acid) to cause irritation or corrosion to the eye, according to OECD 405. A single ocular application of 0.1 mL of the test substance was administered to one eye of each the rabbits while the contralateral eye remained untreated and served as the control. Initially one rabbit was tested. Based on the results obtained at 24 hours post-application, the irritation response was confirmed by testing two additional rabbits simultaneously. Observations were made at 1, 24, 48 and 72 hours post application. Fluorescein dye staining was additionally carried out to evaluate corneal damage at 24 hours post application. General health status was also checked.
Conjunctival effects, consisting of mild redness (score of 1 or 2) and very slight chemosis (score of 1) were evident with recovery by 72 hours post-application. Examination with fluorescein dye and cobalt blue filter confirmed no corneal area damage at 24 hours in all rabbits. The control eyes did not show any abnormal reactions during the study. Moreover, there were no signs of systemic toxicity in any animal observed. The test substance caused a mild eye irritation which resolved by 72 hours post-test item application. The individual animal mean eye irritation scores at the 24, 48 and 72 h observation were 0.00, 0.00, 0.00 for corneal opacity, 0.00, 0.00, 0.00 for iris effects, 1.00, 1.00, 1.00 for conjunctival redness and 0.67, 0.00, 0.67 for conjunctival chemosis for rabbit N° 1, 2 and 3, respectively. Based on the results of this study, cloquintocet acid is not classified as an eye irritant according to the CLP Regulation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.