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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- April 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- August 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 2-1-4
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation
- Age at study initiation: 15 to 16 weeks
- Weight at study initiation: 2.269 - 2.449 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: 6 days (rabbit N° 1) and 8 days (rabbits 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: 09 September 2013
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg moistened with 0.5 mL distilled water - Duration of treatment / exposure:
- 4 hour exposure period
- Observation period:
- Skin reactions were observed at 1, 24, 48 and 72 hours post-patch removal
- Number of animals:
- Three males.
Initially one rabbit was tested. Based on the observations at 24 hour post-patch removal, two additional rabbits were tested simultaneously to confirm the irritation response. - Details on study design:
- TEST SITE
- Area of exposure: 6 cm2 body surface area. Approximately 24 hours prior to the treatment, hair from the dorso-lumbar region at two contra-lateral sites of each rabbit was closely clipped using a clipper. Care was taken to ensure that the skin was not abraded while clipping.
- Type of wrap if used: covered with gauze patches of approximately 6 cm2 (gauze rolled) which were not more than 8-ply and were secured at the margins by non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): test item was removed with cotton soaked in distilled water
- Time after start of exposure: At the end of the 4 hour exposure period
SCORING SYSTEM:
- Is outlined in the tables below.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable/No effect
- Irritant / corrosive response data:
- At 1 h post-patch removal, the treated skin site of all rabbits revealed very slight erythema (score of 1).
The mean scores of erythema (0.00 to 0.33) and oedema (0.00) observed for the 24, 48 and 72 hours observation time-points indicated that the test item is a non-irritant under the described experimental conditions. - Other effects:
- No clinical signs were observed in any rabbit throughout the experimental period
Any other information on results incl. tables
Rabbit N° |
Site of Application |
Observations after Patch Removal |
|||||||
Erythema |
Oedema |
||||||||
Hours |
Hours |
||||||||
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
||
1 |
Right |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
Right |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Right |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean scores of erythema and oedema observed for the 24-72 hour observation period indicated that the test item is not irritating to skin and classification is not required.
- Executive summary:
An acute dermal irritation study was conducted in three adult male New Zealand White rabbits to assess the potential of X204558 (cloquintocet acid) to cause skin irritation or corrosion, according to OECD 404. The test substance (500 mg) was moistened with 50 ml of distilled water and applied to the treatment skin sites, with a surface of approximately 6 cm². The contra-lateral control skin sites were similarly treated with 0.5 mL distilled water. The treated and the control sites were covered with a semi-occlusive dressing left in place for a 4 hour exposure period, at the end of which, the residual test item was removed with cotton soaked in distilled water. The skin reactions were observed at 1, 24, 48, and 72 hours post-patch removal. Irritation was scored and general health conditions were monitored. Initially one rabbit was tested. Based on the observations at 24 hour post-patch removal, two additional rabbits were tested simultaneously to confirm the irritation response.
At the treated sites, very slight erythema (score of 1) was observed at the 1 hour time-point after patch removal. This effect was reversed by the 24 hour time-point in the first rabbit, and was reversed by the 48 hour time-point in the remaining rabbits. There were no reactions recorded at the control sites throughout the study. There were no signs of systemic adverse effects in any of the treated animals. The test substance caused a mild and transient local reaction to the treated skin. The mean dermal irritation scores at 24, 48 and 72 hours post-patch removal for individual animals were 0.00, 0.33, 0.33 for erythema and 0.00, 0.00, 0.00 for oedema. Based on the results of this study, cloquintocet acid is not classified as a skin irritant according to the CLP Regulation.
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