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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
Endpoint summary
Administrative data
Description of key information
The NOAEL for repeated dose oral toxicity in rats was the highest dose tested, 2100 ppm, which corresponded to time-weighted average concentrations of 116.0 and 127.0 mg/kg bw/day in males and females, respectively. On this basis, low toxicity is also predicted for the inhalation and dermal routes of exposure.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 116 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The 90-day repeated oral toxicity study in the rat (Sura et al, 2014) is assigned Klimisch score = 1 as it is a modern study compliant with current test guidelines and GLP. The remaining studies were non-guideline non-GLP preliminary investigations carried out with the purpose of identifying and resolving palatability issues in addition to toxicological screening and dose range selection.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
90-Day Repeat Oral Toxicity:
A 90-day repeated dose oral toxicity study (Sura et al, 2014) was conducted according to OECD test guideline 408 to evaluate the potential toxicity of cloquintocet acid in rats following dietary administration for at least 90 days. Recovery groups of the control and high concentration of cloquintocet acid were given untreated diets for an additional 28-days to evaluate the reversibility or persistence of any potential effects induced after 90 days of dietary exposure. There were no treatment-related effects in clinical signs, functional tests, ophthalmic examinations, prothrombin time, or serum thyroid hormone parameters. There were no treatment related, gross or histopathologic observations. Treatment-related decreases in body weights, body weight gains and feed consumption were attributed to decreased palatability. Treatment-related changes in platelet counts, blood urea nitrogen, urine volumes and spleen weights at the highest tested concentration were interpreted to be non-adverse. Under the conditions of this study, the NOAEL was the highest tested concentration of 2100 ppm cloquintocet acid that corresponded to time-weighted average concentrations of 116.0 or 127.0 mg/kg bw/day in males and females, respectively.
14 -Day Dietary Toxicity Screening and Palatability Study:
A 14 -day dietary toxicity screening and palatability study (Sura and Andrus, 2014a) was conducted to evaluate the potential toxicity and palatability of cloquintocet acid in F344/DuCrl rats following dietary administration for 14 days. There were no treatment-related effects or clinical signs. Treatment-related decreases in body weights/body weight gain, and feed consumption were attributed to reduced palatability of the feed. There were no treatment-related organ weight effects, gross or histopathologic observations in any of the treated groups. Based on the treatment-related effects on body weight and feed consumption at higher concentrations, the NOEL for F344/DuCrl rats of either sex was 500 ppm, corresponding to 40.3 mg/kg/day for males and 42.6 mg/kg/day for females.
14 -Day Dietary Palatability Study:
A 14 -day palatability study was conducted to evaluate the palatability of cloquintocet acid in Crl:Wistar Han rats. There were no treatment-related clinical observations in any dose group. Treatment-related decreases in feed consumption, body weight, and body weight gain were observed for cloquintocet acid. Based on the findings of the study it was concluded that future dietary administration studies may benefit from initiating test diet administration at a lower initial concentration such as 700 ppm and increasing to a target high dose concentration such as 2100 ppm.
7 -Day Dietary Palatability Study:
A study was conducted to determine if a ‘ramp-up’ study design could alleviate the previously identified palatability issues of cloquintocet acid. A treatment-related decrease in feed consumption was evident on the day following cloquintocet acid initiation and to a lesser extent following the concentration increase on test day 4. Under the conditions of the study, cloquintocet acid at dose levels of 700 and 2100 ppm may be considered for subsequent studies.
Justification for classification or non-classification
Cloquintocet acid was shown to be of relatively low toxicity following repeat oral administration; the results of the studies available for cloquintocet acid do not indicate any severe toxicity and do not show any adverse effects at dose the highest tested doses. Low toxicity is also predicted for the inhalation and dermal exposure routes. Cloquintocet acid is therefore not classified for repeated dose toxicity according to CLP Regulation No 1272/2008.
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.
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