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EC number: 458-930-1 | CAS number: -
- 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:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- other: clear liquid
- Details on test material:
- - Name of test material (as cited in study report): Ceraphyl 55
- Data received: 7/01/04
- Physical state: clear liquid
- Sample preparation: Used as received
- Lot/batch No.: P1743
- Storage condition of test material: Room temperature and humidity
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Boyertown, PA
- Received on: 7/13/04
- Date of birth: 5/25/04
- Weight at study initiation: 164-195 grams
- Housing: The animals were housed 1/cage in suspended stainless wire bottom cages and individually identified by a uniquely numbered ear tag.
- Diet (e.g. ad libitum): Certified Purina Rodent Chow Diet #5002M was provided ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 67-72
- Humidity (%): 50-94
- Photoperiod (hrs dark / hrs light): 12 hr light/12 hr dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
Group 1-Control group (Distilled Water)
Volume: 1.0 ml/kg (Day 1)-1.15 ml/kg (Day 2-28)
Animals: 5 males - 5 Females
Group 2- 1000 mg/kg/day-High Dose
Volume: 1.15 ml/kg
Animals: 5 males - 5 Females
Group 3- 500 mg/kg/day-Mid Dose
Volume: 0.57 ml/kg
Animals: 5 males - 5 Females
Group 4- 500 mg/kg/day-Low Dose
Volume: 0.115 ml/kg
Animals: 5 males - 5 Females
VEHICLE
- Distilled Water
- Source: MB Research Laboratories
- Description: Clear liquid
- Sample preparation: Used as received
- Storage: Room temperature and humidity - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 28 Days
- Frequency of treatment:
- The test article was administrated once daily, by gavage
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 500 and 1000 mg/kg
Basis:
nominal in water
- No. of animals per sex per dose:
- 5 females and 5 males
- Control animals:
- yes
- Details on study design:
- Five groups of five females and 5 males Wistar albino rats were dosed orally with Ceraphyl 55 using a syringe and 16 gauge call-tipped feeding needle. Doses were administrated once daily, for 28 consecutive days.
Based on the results of a preliminary screening, 1000 mg/kg/day was chosen as high dose (group 2).
The mid (group 3) and low (group 4) doses selected were 500 and 100 mg/kg/day. - Positive control:
- Group 1-Control group (Distilled Water)
Volume: 1.0 ml/kg (Day 1)-1.15 ml/kg (Day 2-28)
Animals: 5 males - 5 Females
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Once daily, all animals were observed for toxicity, pharmacological effects and twice daily for morbidity and mortality
DETAILED CLINICAL OBSERVATIONS: Yes / No / No data
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations: Body weights were recorded on the day following receipt, at the end of the first week of equilibration, before the test, weekly, at death and on the day prior to study termination for the survivors.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Measured amounts of diet were present weekly. The amount consumed was calculated each week.
HAEMATOLOGY: Yes
- Time schedule for collection of blood: On Day 28, animals were fasted overnight, and on Day 29 each animals was anesthetized with ether prior to collecting blood from aorta.
- Parameters checked: red blood cell count, haemoglobin concentration, haematocrit, mean corpuscular volume, mean corpuscular haemoglobin and mean corpuscular haemoglobin concentration, white blood cell count, differential leukocyte count, platelet count and prothrombin time.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: same as haematology
- Parameters checked: magnesium, sodium, alanine aminotransferase, sorbitol aminotransferase, sorbitol dehydrogenase, blood urea, nitrogen, total bilirubin, calcium, phosphorous, aspartate aminotransferase, albumin, globulin, total cholesterol, triglycerides, chloride, potassium, alkaline phosphatase, gamma glutamyl transpeptidase, creatinine, glucose, total proteins.
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: On Day 25, gross neurotoxicity and neurobehavioral changes was conducted in the surviving animals - Sacrifice and pathology:
- On day 29, all animals were humanely sacrificed using either and exsanguination.
Gross necropsy was performed in each animal. Examinations included the external surfaces of the body, all orifices, and the cranial, thoracic and abdominal cavities and their contents.
The adrenals, kidneys, liver and testes (with epididymides, thymus, spleen, brain and heart were trimmed and weighted wet after dissection. - Statistics:
- A mean and a standard deviation was calculated for all non-discrete data from clinical chemistry, haematology, organ weights, body weights, organ/body weight ratios, functional observation battery and food consumption.
An Analysis of Variance (ANOVA) was performed on absolute organ weights, body weights, organ/body weight ratios, clinical chemistry and haematology.
The results were calculated based on the relationship between the dose levels and incidence or severity of response. The No Observed Effect Level (NOEL) was estimated.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- sodium, potassium, globulin, chloride, alanine aminotransferase (SGPT) and glucose were significantly different compared to the control group
- Urinalysis findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Mean adrenal weights of animals dosed at 500 mg/kg/day were greater than the controls. The organ/body weight relationship of heart, liver and kidney was significant different from the control group.
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Details on results:
- MORTALITY:
There was no mortality due to the administration of the test material. One animal in group 2 was found dead on Day 22. Necropsy showed that the death was due to an inadvertent gavage accident.
CLINICAL SIGNS:
Group 1: Instances of localised alopecia were observed in only 2 animals.
Group 2: Instances of emaciation, wetness of the anogenital area, few faeces and a bent tail were noted in one female survivor.
Group 3: Red and swollen ears were noted in one female from Day 7 to Day 10. No abnormal signs were noticed in this animal.
Group 4: Instances of localised alopecia were noted in one animal from Day 17 to Day 26.
BODY WEIGHT AND WEIGHT GAIN:
No significant differences were recorded between control body weights and mean body weight treated with the test material. Only at Day 8 the mean of body weights of group 3 female animals was significantly less than the control.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
No significant differences in mean food consumption were recorded.
HAEMATOLOGY:
The mean prothrombin time in male animals in group 2 was significantly greater than the male controls. There were no other significant differences between any groups at any dose.
CLINICAL CHEMISTRY:
The parameters that resulted significantly different from the control group are:
Sodium: Gr4>Gr1 (Male)
Potassium: Gr4>Gr1 (Male)
Globulin: Gr2Chloride: Gr2 Glucose: Gr2 ALT (SGPT): Gr2>Gr1 (Female)
NEUROBEHAVIOUR:
No significant differences between groups in the orientation, sensory responsiveness posture, locomotion/patterned movements and integrated movement portion of the FOB.
ORGAN WEIGHTS:
The mean adrenal weight of group 3 females were significantly greater than the control group> No other significant different were recorded.
No significant differences were recorded for the organ/body weight ratios except:
Liver: Gr2>Gr1 (Male)
Adrenals: Gr3>Gr1 (Female)
Kidneys: Gr2>Gr1 (Female) and Gr3>Gr1 (Female)
Liver: Gr2>Gr1 (Female)
Heart: Gr2>Gr1 (Female)
HISTOPATHOLOGY:
No treatment-related microscopic changes were observed.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related changes in male and females rats were observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) of the test material Ceraphyl 55 considered to be greater than 1000 mg/kg/bw.
- Executive summary:
The sub-acute oral toxicity of the test material Ceraphyl 55 was investigated in 20 male and 20 females Wistar albino rats, divided in four groups. Group 1 was dosed with the vehicle (distillated water) only. Group 2, 3 and 4 were treated with Ceraphyl 55 at dose levels of 1000, 500, 100 mg/kg. Doses were administrated using a syringe and 16 gauge ball-tipped feeding middle. The highest dose was selected based on the results on a pre-screening.
All animals were observed for toxicity, pharmacological effects and twice daily for morbidity and mortality. Body weights were recorded on the day following receipt, at the end of the first week of equilibration, before the test, weekly, at death and on the day prior to study termination for the survivors. Food consumption was calculated each week. In addition haematology and clinical chemistry analysis were performed. Neurobehavioral examinations and gross necropsy was performed in each animal.
No mortalities were observed during the 28-Day administration period. One animal in Group 2 was found dead on Day 22. Necropsy showed that the death was due to an inadvertent gavage accident. Instances of abnormal physical signs of surviving animals were minimal. Significant differences were recorded between controls and animals dosed with Ceraphyl 55 in some clinical parameters. Furthermore, the mean adrenal weights of Group 3 (females) were significantly greater than the control group. Necropsy, histopathological examination and microscopic evaluation revealed no-treatment related changes in female and male rats dosed at 1000 mg/kg/day. Based on these results the NOAEL for the 28-Day Repeated dose toxicity is considered to be greater 1000 mg/kg/day.
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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