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EC number: 425-950-7 | CAS number: 187393-00-6
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08-Dec-1997 to 12-Mar-1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Details on test material:
- - Name of test material (as cited in study report): CFG-C-1607
- Physical state: yellow solid
- Analytical purity: >98%
- Lot/batch No.: 6
- Expiration date of the lot/batch: 30 Jul 1999
- Stability under test conditions: stable in PEG 400 for at least 2 hours
- Storage condition of test material: in well-closed container at room temperature away from direct sunlight.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, 4414 Füllinsdorf / Switzerland
- Age at study initiation: 4 weeks
- Fasting period before study: none
- Weight at study initiation: Males: 60-91g Females: 45-69 g
- Housing: Groups of five in Makrolon type-3 cages with standard softwood bedding.
- Diet (e.g. ad libitum): Pelleted standard Kliba 3433 rat maintenance diet available ad libitum.
- Water (e.g. ad libitum): Community tap water from Itengen, available ad libitum
- Acclimation period: 7 days under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 degrees centigrade
- Humidity (%): 40 - 70%
- Air changes (per hr):10 - 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From (Delivery): 1-Dec-1997; To (Termination): 13-March-1998
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test article was placed into a glass beaker on a tared Mettler PM 460 balance and the vehicle was added. A weight by volume dilution was prepared using a magnetic stirrer as homogenizer. Homogeneity of the test article in the vehicle was maintained during treatment. Test preparations made daily.
VEHICLE
- Justification for use and choice of vehicle (if other than water): solubility and stability
- Concentration in vehicle: 20, 100, and 200 mg/ml
- Amount of vehicle (if gavage): 5 ml/kg-bw - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentration, homogeneity and stability of the test article / vehicle mixtures were determined in samples taken during the first week of treatment. Intercurrent samples for homogeneity and concentration analyses were taken during the second and third month of treatment.
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- Once daily, 7 days per week.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Based on results of 14 day range-finding study
- Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
FOOD CONSUMPTION:
- Food consumption for each animal determined: Yes, weekly
FOOD EFFICIENCY:- Relative food consumption (g/kg-bw) determined: Yes, weekly
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: prior to first exposure and at week 13
- Dose groups that were examined: pre-test: 10 rats, per sex, per dose; at week 13: 10 rats, per sex, from control and high dose groups.
HAEMATOLOGY: Yes
- Time schedule for collection of blood: weeks 5, 9, and 13
- Anaesthetic used for blood collection: light ether anesthesia
- Animals fasted: Yes, 18 hours
- How many animals: 10 per sex per dose
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: weeks 5, 9, and 13
- Animals fasted: Yes, 18 hours
- How many animals: 10 per sex per dose
URINALYSIS: Yes
- Time schedule for collection of urine: weeks 5, 9, and 13
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes, 18 hours
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: pre-test and at weeks 6 and 12.
- Dose groups that were examined: all control and dose groups
- Battery of functions tested: modified Irwin screen test incl. sensory activity and motor activity; and hind-forelimb grip strength - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
All animals surviving to the end of the observation period were anesthetized by intraperitoneal injection of sodium pentobarbitone and killed by exsanguination. Five animals died spontaneously during the study, one male died accidentally after blood sampling and one animal died accidentally during anesthesia; all of them were necropsied imrnediately.
ORGAN WEIGHTS: Yes
Adrenals, Spleen, Brain, Testes, Kidneys, Thyroid, Liver, Thymus
HISTOPATHOLOGY: Yes
Adrenal glands
Aorta
Brain - including section of medulla/pons, cerebral and cerebellar cortex
Cecum
Colon
Duodenum
Epididymides
Esophagus
Exorbital lacrimal glands
Eyes with optic nerve and Harderian gland
Femur with bone marrow
Heart
Ileum
Jejunum including Peyer's patches
Kidneys
Liver
Lungs, infused with formalin
Lymph nodes - mesenteric, mandibular
Mammary gland area
Nasal turbinates
Ovaries
Pancreas
Pituitary gland
Prostate gland
Rectum
Salivary glands - mandibular, sublingual
Sciatic nerve
Semina! vesicles
Skeletal muscle
Skin
Spinal cord - cervical, midthoracic, lumbar
Spleen
Sternum with bone marrow
Stomach
Testes
Thymus
Thyroid gland / parathyroid gland
Trachea
Urinary bladder, infused with formalin
Uterus
Vagina
Zymbal's gland
All gross lesions - Statistics:
- The following statistical methods will be used to analyze the body weight, food consumption, organ weights and clinical laboratory data: If the variables can be assumed to follow a normal distribution, the Dunnett-test (many to one t-test) based on a pooled variance estimate will be applied for the comparison of the treated groups and the control groups for each sex. The Steel-test (many-one rank test) will be applied instead of the Dunnett-test when the data can not be assumed to follow a normal distribution. The exact Fisher-test will be applied to the ophthalmoscopy data and to macroscopical findings. Additional methods of statistical analysis will be used at the discretion of the statistician. The methods and the results will be described in the report.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no test substance related adverse effects observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Mortality
No test article-related cases of death occurred during the conduct of the study.
There were some cases of death that are considered to be not test article-related:
- 1 (control)/2 (low dose) male rats and 1 (control) / 1 (high dose) female rat died spontaneously. According to the findings seen at necropsy, these animals are assumed to have died after accidental administration of the test article into the respiratory tract.
- 1 male rat (mid dose) died accidentally after blood sampling.
- 1 female rat (mid dose) died accidentally during anesthesia.
Clinical Signs
There were no test article-related clinical signs noted in any dose group.
Functional Observational Battery
At 6 and 12 weeks neither the functional observational battery nor the evaluation of hind- and forelimb grip strength revealed test article-related findings.
Body Weight / Body weight gain
There was no effect on body weight / body weight gain.
Food Consumption / Relative Food Consumption
There were no effects on food consumption or relative food consumption.
Ophthalmoscopic Examinations
There were no test article-related ophthalmologic findings.
Hematology
No test article-related remarkable findings were noted at 5, 9 and 13 weeks of treatment. In addition, there were no adverse effects on the immune system, i.e. no changes with regard to the total leucocyte count or to peripheral blood lymphocytes, monocytes and polymorphonuclear leucocyte populations in the differential leucocyte count.
Clinical Biochemistry
There were no toxicologically relevant effects on clinical biochemistry data at 5, 9 and 13 weeks of treatment. Any intergroup variation was considered to be within the range of the background data seen commonly in rats of this strain and age.
Urinalysis
There were no toxicologically relevant effects on urinalysis data at 5, 9 and 13 weeks of treatment. Any intergroup variation was considered to be within the range of the background data seen commonly in rats of this strain and age.
Organ Weights and Organ Weight Ratios
There were no test article-related changes in organ weights and ratios.
Macroscopical Findings
Necropsy revealed no pathomorphologic lesions considered to be related to the treatment with the test article.
Microscopical Findings
No microscopical findings considered to be related to the treatment with the test article were recorded. In particular, no adverse effect on the immune system was recorded and there was no evidence of any neurotoxic effect of the test article.
Applicant's summary and conclusion
- Conclusions:
- The oral administration of CGF-C-1607 to Wistar rats at doses of 100, 500 or 1000 mg/kg/day, for at least 92 days, resulted in no evidence, either on the in-life or pathomorphologic parameters, of toxic effects of the test article. In particular, no adverse effect on the immune system was recorded and there was no evidence of any neurotoxic effect of the test article. The few changes noted in clinical biochemistry and urinalysis parameters were considered to be typical findings within the range of biological variation and the historical control data. Based on the results of this study, the no-observed-adverse-effect-level (NOAEL) for CGF-C-1607 was >= 1000 mg/kg.
- Executive summary:
In a subchronic toxicity study, CGF-C-1607 was administered orally by gavage to SPF-bred Wistar rats of both sexes at dose levels of 100, 500 or 1000 mg/kg body weight/day, daily for a period of at least 92 days. Each group comprised 20 animals per sex. A similarly constituted group received the vehicle only and served as a control. Mortality/viability, clinical signs, food consumption and body weights were recorded periodically during the acclimatization and treatment period. Ophthalmoscopic examinations were performed during acclimatization and in the last week of the treatment period (control and high dose animals only). A functional observational battery including an evaluation of hind- and forelimb grip strength was performed during pretest and at weeks 6 and 12. At weeks 5, 9 and 13, blood samples were withdrawn from the 10 rats with the lowest identification numbers per sex and group for hematology and clinical biochemistry analyses, and urine samples were collected for urinalysis. All animals were killed, necropsied and examined post mortem after at least 92 days of treatment. The weights of the adrenals, brain, kidneys, liver, spleen, testes, thyroid and thymus were recorded. Organs and tissues from all animals of any groups, as well as gross lesions from all animals, were processed as hematoxylin and eosin stained slides and examined by light microscopy.
The oral administration of CGF-C-1607 to Wistar rats at doses of 100, 500 or 1000 mg/kg/day, for at least 92 days, resulted in no evidence, either on the in-life or pathomorphologic parameters, of toxic effects of the test article. In particular, no adverse effect on the immune system was recorded and there was no evidence of any neurotoxic effect of the test article. The few changes noted in clinical biochemistry and urinalysis parameters were considered to be typical findings within the range of biological variation and the historical control data. Based on the results of this study, the no-observed-effect-level (NOEL) for CGF-C-1607 was defined as 1000 mg/kg.
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