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EC number: 413-370-7 | CAS number: 17351-75-6 RAPICURE CHVE
- 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)
Endpoint summary
Administrative data
Description of key information
A valid NOAEL of 200 mg/kg/day was established in a guideline conform 28 days oral toxiyity study with rats. Marked to moderate hairloss and a 10 % body weight loss were the most prominet effect observed in this study.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was according to Japanese MHW-MITI Regulations and in compliance with GLP. The Guideline used is similar to OECD guideline 407.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK (Margate, Kent, England)
- Age at study initiation: ca. 4 weeks
- Weight at study initiation: 75 - 84 g
- Housing: groups of 5 in polypropylene cages
- Diet (e.g. ad libitum): ad libitum(except when urine was collected and overnight befor blood sampling) Diet type: LAD-1, Biosur, Manea, Cambridgeshire, England
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C (18-25°C)
- Humidity (%): 55 % (40-70 % )
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h - Route of administration:
- oral: gavage
- Vehicle:
- maize oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Formulations of the test substance were prepared for adminitration as a series of graded concentrations in maize oil to provide the required dosages at a constant volume-dosage of 5 ml/kg. All formulations were prepared freshly each day
VEHICLE
- Justification for use and choice of vehicle (if other than water): solubility - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Duplicate samples form each formulation prepared on day 1 and 26 were analyzed.
- Duration of treatment / exposure:
- 28 days and 14 days recovery period
- Frequency of treatment:
- once daily by gavage
- Remarks:
- Doses / Concentrations:
0, 40, 200, 1000 mg/kg
Basis:
other: oral gavage - No. of animals per sex per dose:
- 0 and 1000 mg/kg: 10 /sex
40, 200 mg/kg: 5/sex - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: pilot study (3 males and 3 female were gavaged 200, 500 and 100 mg/kg in maze oil for 7 days)
- Post-exposure recovery: 14 days - Positive control:
- not applicable
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
- Parameters examined: Observations were recorded
BODY WEIGHT: Yes
- Time schedule for examinations: Weighing was on day 0, 3, 7, 10, 14, 17, 21, 24, 27
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
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
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: after 4 weeks treatment and after 2 weeks recovery
- Anaesthetic used for blood collection: No data
- Animals fasted: Yes
- How many animals: 55
- Parameters examined: PCV, Hb, RBC, WBC, platelet, neutrophils, lymphocytes, esinophils, basophils, monocytes, reticulocytes, protrombine time, blood cell microscopy
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: after 4 weeks treatment and after 2 weeks recovery
- Animals fasted: Yes
- How many animals: 55
- Parameters examined: AP, ALT, AST, gamma GT, GGT, urea, creatinine, glucose, bilirubin, triglycerides, cholesterol, proteins ,Na, K, Cl, Ca, P,
URINALYSIS: Yes
- Time schedule for collection of urine: after 3 weeks treatment and after 1 weeks recovery
- Metabolism cages used for collection of urine: Yes / No / No data
- Animals fasted: at urine overnight collection
- Parameters examined: pH, specific gravity, protein content, glucose, ketones, bilirubin, urobilinogen, nitrite, blood, sediment (leucocytes, Erytrocytes, eppithelial cells, etc.)
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (results see below)
HISTOPATHOLOGY: Yes (results see below) - Other examinations:
- no
- Statistics:
- Different methods were used depending on the data to be compared: Student's t-test, Bartlett's test, Behrens-Fisher test, Dunnett's Test, Fisher Exact test.
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Two female rats treated at 200 mg/kg/day died on Day 5. The deaths were considered to be incidental to treatment with Rapi-cure CHVE. There was no other death (failure of gavage dosing).
Salivation at dosing was observed from Day 4 onwards in most rats treated at 1000 mg/kg/day, less frequently in animals treated at 200 mg/kg/day and on two occasions in those treated at 40 mg/kg/day. Hair loss was observed from Day 4 onwards in the majority of animals treated at 1000 mg/kg/day (9/10 females; 4/10 males). The sign persisted during the recovery period.
BODY WEIGHT AND WEIGHT GAIN
The body weight gain of rats receiving 1000 mg/kg/day was about inferior to that of controls during the treatment period (p<0.001 males; <0.05 females). The body weight of rats receiving 1000 mg/kg/day was about 10% less to that of controls.
FOOD EFFICIENCY
Food consumption and food utilisation efficiency were considered to have been unaffected by treatment with Rapi-cure CHVE.
HAEMATOLOGY
The packed cell volumes, haemoglobin concentrations and erythrocyte numbers of animals treated at 1000 mg/kg/day were slightly but significantly lower than those of the controls. In addition, neutrophil numbers of rats treated at 1000 mg/kg/day were slightly higher than those of the controls (p<0.05). Most of the differences were still observed after the two weeks recovery period.
CLINICAL CHEMISTRY
The plasma alkaline phosphatase activities were higher and sodium and chloride concentrations lower in rats treated at 1000 mg/kg/day than in the control animals. These differences were not apparent two weeks after cessation of treatment. Urea (male) ALT and gamma GT (females) were also higher slightly but significantly higher at 1000 mg/kg/day. These differences, however, numerically small and were not considered toxicologically relevant.
URINALYSIS
Urinary volumes of rats treated at 1000 mg/kg/day and of male rats treated at 200 mg/kg/day were higher than those of the controls. The specific gravity of the urine of males treated at 200 or 1000 mg/kg/day was slightly lower than that of the controls. Urinary protein concentrations of male rats treated at 1000 mg/kg/day were marginally lower than those of the male controls and blood was detected in two males and one female treated at this dosage. Blood was also detected in these animals in the recovery period.
ORGAN WEIGHTS
After four weeks of treatment, kidney weights of males and females treated at 1000 mg/kg/day and of males treated at 200 mg/kg/day were slightly higher than those of the control animals. The liver weights of animals treated at 1000 mg/kg/day were higher and those of animals treated at 200 mg/kg/day slightly higher than the liver weights of the control animals. Two weeks after cessation of treatment, liver and kidney weights relative to bodyweight of male rats treated at 1000 mg/kg/day were still slightly higher than those of the male controls.
GROSS PATHOLOGY
There was no organ macroscopic change which was attributed to treatment with Rapi-cure CHVE.
HISTOPATHOLOGY: NON-NEOPLASTIC
There were no histopathological changes in test animals which were considered to be substance related and of toxicological significance.
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: overall effects clinical signs; body weight; organ weights; other: hair loss
- Critical effects observed:
- not specified
- Executive summary:
0, 40, 200 and 1000 mg/kg/day Rapi-cure CHVE was administered by gavage to male and female CD rats in a guideline conform 28 days study. The study was according to Japanese MHW-MITI Regulations and in compliance with GLP. The Guideline used is similar to OECD guideline 407. The study included a 14 days recovery period. Marked to moderate hair loss was observed in 9/10 female and 4 /10 males at 1000 mg/kg. An increase of alkaline phosphatase, ALT and gamma GT and increased absolute kidney and liver weights were observed. Effects were numerically small but significant. Beyond this a reduction of the bodyweight about 10 % in comparison to the control was observed. Effects were still present at the end of the recovery period.
A oral NOAEL of 200 mg/kg was established in this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
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
0, 40, 200 and 1000 mg/kg/day Rapi-cure CHVE was administered by gavage to male and female CD rats in a guideline conform 28 days study. The study was according to Japanese MHW-MITI Regulations and in compliance with GLP. The Guideline used is similar to OECD guideline 407. The study included a 14 days recovery period. Salivation after dosing was the most prominent clinical sign. Marked to moderate hair loss was observed in 9/10 female and 4 /10 males at 1000 mg/kg. An increase of alkaline phosphatase, ALT and gamma GT and increased absolute kidney and liver weights were observed. Effects were significant but numerically small and were not considered toxicologically relevant.. Beyond this a reduction of the bodyweight about 10 % in comparison to the control was observed. Effects were still present at the end of the recovery period.
Repeated dose toxicity: via oral route - systemic effects (target organ) other: all gross lesions and masses
Justification for classification or non-classification
Classification for repeated dose toxicity is not warranted according to the criteria of EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) 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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