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EC number: 201-714-7 | CAS number: 86-98-6
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from authoritative database
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Toxicological Evaluations of the test chemical
- Author:
- FAO
- Year:
- 2 015
- Bibliographic source:
- Toxicological Evaluations of the test chemical, 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- 90 days repeated dose oral toxicity study was performed to evaluate the toxicological profile of the test chemical
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 3,7-dichloroquinoline-8-carboxylic acid
- EC Number:
- 402-780-1
- EC Name:
- 3,7-dichloroquinoline-8-carboxylic acid
- Cas Number:
- 84087-01-4
- Molecular formula:
- C10H5Cl2NO2
- IUPAC Name:
- 3,7-Dichloroquinoline-8-carboxylic acid
- Test material form:
- solid
- Details on test material:
- Name of the test chemical: 3,7-Dichloroquinoline-8-carboxylic acid
Common Name: Quinclorac
Molecular Weight: 242.0605 g/mol
Molecular Formula: C10H5Cl2NO2
Substance Type: Organic
Physical State: Solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Wistar (Chbb=Thom) rats
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: diet
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- 0, 1000, 4000 or 12 000 ppm for 3 months. Achieved test chemical intakes were 0, 77, 302 and 930 mg/kg bw per day for males and 0, 87, 358 and 1035 mg/kg bw per day for females, respectively.
- Duration of treatment / exposure:
- 3 months
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- 0, 1000, 4000 or 12 000 ppm for 3 months. Achieved test chemical intakes were 0, 77, 302 and 930 mg/kg bw per day for males and 0, 87, 358 and 1035 mg/kg bw per day for females, respectively.
- No. of animals per sex per dose:
- Groups of 10 male and 10 female Wistar (Chbb=Thom) rats
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- no data available
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes / No / Not specified
:
- Time schedule:
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: Yes / No / Not specified : yes
- Time schedule: Clinical signs were observed regularly
BODY WEIGHT: Yes / No / Not specified : yes
- Time schedule for examinations: body weight were observed regularly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes / No / Not specified : food consumption were observed reegularly
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / Not specified
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / Not specified
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes / No / Not specified : yes
- Time schedule for examinations: water consumption were observed regularly
OPHTHALMOSCOPIC EXAMINATION: Yes / No / Not specified : yes
- Time schedule for examinations: Ophthalmoscopy was performed on animals in the control and top-dose groups, pretest and prior to sacrifice.
- Dose groups that were examined:
HAEMATOLOGY: Yes / No / Not specified : yes
- Time schedule for collection of blood: Samples for clinical chemistry and haematology were takenon day 86.
- Anaesthetic used for blood collection: Yes (identity) / No / Not specified
- Animals fasted: Yes / No / Not specified
- How many animals:
- Parameters checked in table [No.?] were examined.
CLINICAL CHEMISTRY: Yes / No / Not specified : yes
- Time schedule for collection of blood: Samples for clinical chemistry and haematology were taken on day 86.
- Animals fasted: Yes / No / Not specified
- How many animals:
- Parameters checked in table [No.?] were examined.
URINALYSIS: Yes / No / Not specified : yes
- Time schedule for collection of urine: Urine analysis samples were obtained on day 80.
- Metabolism cages used for collection of urine: Yes / No / Not specified
- Animals fasted: Yes / No / Not specified
- Parameters checked in table [No.?] were examined.
NEUROBEHAVIOURAL EXAMINATION: Yes / No / Not specified
- Time schedule for examinations:
- Dose groups that were examined:
- Battery of functions tested: sensory activity / grip strength / motor activity / other:
IMMUNOLOGY: Yes / No / Not specified
- Time schedule for examinations:
- How many animals:
- Dose groups that were examined:
- Parameters checked in table [No.?] were examined.
OTHER: - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (see table) / No / Not specified
: All animals were subjected to a gross pathological examination followed by a microscopic examination.
HISTOPATHOLOGY: Yes (see table) / No / Not specified: Control and top-dose animals received a full microscopic examination; for the low- and intermediate-dose groups, only lungs, liver, kidneys and gross lesions were examined.
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- A initial deficit in body weight in top-dose males was associated with reduced feed consumption and, although statistically significant, was less than 10%. There were no treatment-related adverse effects in the animals of the low dose and mid dose groups
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- There were no treatment-related adverse effects in the animals of the low dose and mid dose groups. There were no treatment-related adverse effects in the animals of the low dose and mid dose groups
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- A number of water consumption were altered in top-dose animals indicative of potential liver and kidney toxicity. There were no treatment-related adverse effects in the animals of the low dose and mid dose groups
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- There were no treatment-related adverse effects in the animals of the low dose and mid dose groups
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Erythrocyte parameters were reduced in top-dose females. There were no treatment-related adverse effects in the animals of the low dose and mid dose groups
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- A number of clinical chemistry parameters were altered in top-dose animals indicative of potential liver and kidney toxicity. Plasma bilirubin was decreased dose relatedly in all male groups (Table 8), but
this is not considered to be adverse in isolation.There were no treatment-related adverse effects in the animals of the low dose and mid dose groups - Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- There were no treatment-related adverse effects in the animals of the low dose and mid dose groups
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- There were no treatment-related adverse effects in the animals of the low dose and mid dose groups
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- The only pathological findings of note were chronic interstitial nephritis and focal urothelial hyperplasia in top-dose males. There were no treatment-related adverse effects in the animals of the low dose and mid dose groups
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- The only pathological findings of note were chronic interstitial nephritis and focal urothelial hyperplasia in top-dose males.There were no treatment-related adverse effects in the animals of the low dose and mid dose groups
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 302 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- gross pathology
- haematology
- histopathology: non-neoplastic
- mortality
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The NOAEL was 4000 ppm (equal to 302 mg/kg bw per day), based on a range of clinical chemistry and haematological changes in both sexes and interstitial nephritis and urothelial hyperplasia in males at 12 000 ppm (equal to 930 mg/kg bw per day
- Executive summary:
90 days repeated dose oral toxicity study was performed to evaluate the toxicological profile of the test chemical.
Groups of 10 male and 10 female Wistar (Chbb=Thom) rats were given diets containing the test chemical dose of 0, 1000, 4000 or 12 000 ppm for 3 months. Achieved test article intakes were 0, 77, 302 and 930 mg/kg bw per day for males and 0, 87, 358 and 1035 mg/kg bw per day for females, respectively. Clinical signs, body weight, and feed and water consumption were monitored regularly. Samples for clinical chemistry and haematology were taken on day 86. Urine analysis samples were obtained on day 80. Ophthalmoscopy was performed on animals in the control and top-dose groups, pretest and prior to sacrifice. All animals were subjected to a gross pathological examination followed by a microscopic examination. Control and top-dose animals received a full microscopic examination; for the low- and intermediate-dose groups, only lungs, liver, kidneys and gross lesions were examined. and mid-dose groups. Plasma bilirubin was decreased dose relatedly in all male groups (Table 8), but this is not considered to be adverse in isolation. The NOAEL was 4000 ppm (equal to 302 mg/kg bw per day), based on a range of clinical chemistry and haematological changes in both sexes and interstitial nephritis and urothelial hyperplasia in males at 12 000 ppm (equal to 930 mg/kg bw per day
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