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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 August 2013 - 25 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 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- July 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- March 2003
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation
- Age at study initiation: 10 to 12 weeks old
- Weight at study initiation: 23.1 - 29.6 g
- Housing: Individual solid floor polypropylene mice cages
- Diet ad libitum Teklad Certified Global High Fiber Rat/Mice feed
- Water ad libitum UV sterilised water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23
- Humidity (%): 65 to 66
- Air changes (per hr): Minimum 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle
IN-LIFE DATES: From: 29 August 2013 To: 24 September 2013
Study design: in vivo (LLNA)
- Vehicle:
- other: 1% Pluronic® L92
- Concentration:
- 5%, 10%, 25% and 50% (w/v) in 1% L92 (25 μL/ear) for three consecutive days
- No. of animals per dose:
- 5 females per dose in the main study; 2 females per dose in the preliminary irritation screen
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: The test substance was not found to be soluble in any of the guideline recommended solvents, however, the test substance formed a homogenous suspension in 1% Pluronic® L92 and therefor this was used as a vehicle for the study.
- Irritation: To assess the irritant potential of the test item through ear thickness measurement and erythema, a preliminary assay was carried out. In the preliminary test, four groups of mice comprising 2 females per group were treated with X204558, applied at 5%, 10%, 25% and 50% (w/v) in 1% L92 (25 μL/ear) for three consecutive days (days 0, 1 and 2). Clinical observations were recorded daily during the experiment. Ear thickness was measured on days 0, 2 and 5 (at 72 hours post last application). Body weight was recorded on days 0 and 5. Dose concentrations of 5%, 10%, 25% and 50% (w/v) revealed no erythema and ear thickness increase was below 25%. Therefore, dose concentrations of 10%, 25% and 50% (w/v) X204558 were evaluated in the main study of LLNA.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
Animal assignment was randomised using in-house developed validate computer software.
TREATMENT PREPARATION AND ADMINISTRATION:
The test item was mixed with vehicle to obtain the desired dosing concentrations. Fresh dose solutions were prepared daily prior to application. The concentrations of the dose solutions were not verified analytically.
Three groups were treated topically for three consecutive days (days 0, 1 and 2) on the dorsal surface of both ears (25 μL/ear) using a calibrated micropipette with the test substance at concentrations of 10%, 25% and 50% (w/v), respectively. Mice from vehicle control group and positive control group were handled in the same manner but received 25 μL/ear of vehicle (1% L92) or 25% α-Hexylcinnamaldehyde (v/v) in vehicle (1% L92), respectively.
On day 5 (approximately 72 h after the last treatment), all mice from the vehicle control, positive control and all the treatment groups were injected with 250 μL of sterile phosphate buffered saline (PBS) containing approximately 20 ± 1 μCi (740 KBq) of 3H-methyl thymidine via the tail vein.
Observations:
Body weights of individual mice were recorded on the first day of dosing (day 0) and prior to administration of 3H-methyl thymidine (day 5)
Individual animals were observed for clinical signs and local irritation at the site of application and systemic toxicity. the table below was used for scoring irritation
On day 5, 5 hours post-administration of 3H-methyl thymidine, all mice from the vehicle control, positive control and all the treatment groups were sacrificed and the draining auricular lymph nodes from each mouse were excised and cell suspensions were prepared.
- Lymph node proliferation response: Incorporation of 3H-methyl thymidine was measured by β-scintillation counting as disintegrations per minute (DPM) for each mouse and expressed as DPM/mouse
- Name of test method: Final results were expressed as the Stimulation Index (SI) which is calculated as a ratio of the mean DPM of test group divided by mean DPM of vehicle control group.
- Criteria used to consider a positive response: A Stimulation Index (SI) of three or more (SI value of treated group over the control) indicates potential to cause skin sensitisation. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- In addition to an assessment of the magnitude of the SI, statistical analysis was carried out for the assessment of the dose response relationship and pair-wise comparison made between the treatment and the solvent/vehicle control group. All the parameters characterised by continuous data such as body weight and radioactive disintegrations per minute (DPM) were subjected to Bartlett’s test to meet the homogeneity of variance before conducting Analysis of Variance (ANOVA). To compare vehicle and positive control data, Student's t-test was performed to calculate significance. Also Grubb’s test was also performed to check the outlier in the study.
Results and discussion
- Positive control results:
- The DPM value for positive control (25% α-Hexylcinnamaldehyde) was found to be 7210.80. The SI value for the 25% HCA treated positive control group was 8.66 which showed a greater than three-fold increase over the control value indicating a clear positive response for this known weak sensitiser that confirmed the reliability of this test procedure.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 0.91
- Test group / Remarks:
- 10% test concentration
- Key result
- Parameter:
- SI
- Value:
- 0.93
- Test group / Remarks:
- 25% test concentration
- Parameter:
- SI
- Value:
- 0.51
- Test group / Remarks:
- 50% test concentration
Any other information on results incl. tables
Group mean DPM values were 833.00, 755.00, 774.60 and 428.60 for the vehicle control (1% L92), 10%, 25% and 50% (w/v) dose concentrations of the test substance, respectively. Group mean body weights of treated animals were comparable with the control group and there were no indications of clinical or systemic toxicity in the test substance treated animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The SI obtained for the test substance at all the tested concentrations showed a less than three-fold increase over the control value. Therefore, the test substance did not demonstrate dermal sensitisation potential in the LLNA and classification is not required.
- Executive summary:
A local lymph node assay (LLNA) was conducted to evaluate the skin sensitisation potential of X204558 (cloquintocet acid) in CBA/J strain mice, according to OECD 429. A preliminary assay was conducted to identify the appropriate test concentrations for the main study. Based on the results from a preliminary assay, five groups of mice (each comprising 5 females) were selected for the experiment. Three groups were treated with X204558 at concentrations of 10%, 25% and 50% (w/v) in 1% L92 applied for three consecutive days (days 0, 1 and 2) on the dorsum of both ears (25 μL per ear). One group served as vehicle control and was treated with 1% L92 and another group served as positive control and was treated with HCA (α-hexylcinnamaldehyde) at a concentration of 25% (v/v) in 1% L92.
Group mean body weights of treated animals were comparable with the control group and there were no indications of clinical or systemic toxicity in treated animals. On day 5, the uptake of 3H-methyl thymidine into the auricular (local) lymph nodes draining at the site of chemical application was measured (5 hours post-administration) to assess the lymph node proliferative response. A positive response for HCA (SI = 8.66) confirmed the reliability of the test procedure. Stimulation indices for the 10%, 25% and 50% (w/v) treated groups were 0.91, 0.93 and 0.51, respectively. The SI obtained at all tested concentrations showed a less than three-fold increase over the control value; therefore cloquintocet acid did not demonstrate dermal sensitisation potential under the conditions of the study. Based on the results of this study, cloquintocet acid is not classified as a skin sensitiser 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.