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Diss Factsheets
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EC number: 402-400-4 | CAS number: 54660-00-3
- 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
- Study period:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- May 12, 1981
- GLP compliance:
- yes
- Remarks:
- Research and Consulting Company AG, RCC Umweltchemie AG, Itingen, Switzerland
- Limit test:
- no
Test material
- Details on test material:
- - Physical state: solid
- Analytical purity: commercial grade
- Lot/batch No.: Op. 10002
- Stability under test conditions: stable for at least 2 hours
- Storage condition of test material: room temperature, dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: KFM Kleintierfarm Madoerin AG, Fuellinsdorf/Switzerland
- Age at study initiation: 7 - 9 weeks
- Weight at study initiation: males: 144 - 168 g, females: 151 - 179 g
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: The test article was weighed into a glass beaker on a tared Mettler PK 300 balance and the vehicle, polyethylene glycol (PEG 400) was added. The mixture was prepared daily prior to administration using a homogenizer and kept stable during application with a magnetic stirrer.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The analyses are performed by photometric measurement.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Based upon data received from the following acute studies carried out at RCC:
- acute oral toxicity in rats, RCC Project 062190, Ciba-Geigy Project 85 1229
- acute dermal toxicity in rats, RCC Project 062223, Ciba-Geigy Project 85 1232
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 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: No
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: No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: at termination of treatment
- Dose groups that were examined: all animals
HAEMATOLOGY: Yes
- Time schedule for collection of blood: after 4 weeks
- Anaesthetic used for blood collection: Yes: ether anesthesia
- Animals fasted: Yes
- How many animals: all
- Parameters examined: Erythrocyte count (RBC), Hemoglobin (HB), Hematocrit (HCT), Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), Platelet count (PLATELETS), Reticulocyte count (RETIC), Nucleated erythrocytes normoblasts (NEN), Total leukocyte count (WBC), Differential leukocyte count (Diff. WBC Count), Red cell morphology, Thromboplastin time (PT), Partial thromboplastin time (PTT)
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: after 4 weeks
- Animals fasted: Yes
- How many animals: all
- Parameters examined: Glucose, Urea, Creatinine, Bilirubin, total (BILL T), Cholesterol, total (CHOLEST. T.), Aspartate aminotransferase (ASAT(GOT)), Alanine aminotransferase (ALAT(GPT)), Lactate dehydrogenase (LDH), Alkaline phosphatase (ALP), Calcium, Phosphorus, Sodium, Potassium, Chloride, Albumin, Protein, total
URINALYSIS: Yes
- Time schedule for collection of urine: after 4 weeks
- Metabolism cages used for collection of urine: Yes
- Animals fasted: No
- Parameters examined: Specific gravity (SPEC. GRAV.), pH, Protein, Glucose, Ketone, Bilirubin, Blood, Nitrite, Urobilinogen (UROBILI.), Urine Sediment (SED. MICRO.)
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- The following statistical methods were used to analyze the body weights, food consumption, organ weights and clinical laboratory data:
Univariate one-way analysis of variance was used to assess the significance of intergroup differences.
If the variables could be assumed to follow a normal distribution, the Dunnett-test (many to one t-test) based on a pooled variance estimate was applied for the comparison between the treated groups and the control groups.
The Steel-test (many-one rank test) was applied when the data could not be assumed to follow a normal distribution.
For the overall spontaneous mortality data, the Fisher's exact test for 2x2 tables was applied.
Group means were calculated for continuous data and medians were calculated for discrete data (scores) in the summary tables. Individual values, means, standard deviations and statistics were rounded off before printing. For example, test statistics were calculated on the basis of exact values for means and pooled variances and then rounded off to two decimal places. Therefore, two groups may display the same printed means for a given parameter, yet display different test statistics values.
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY: No death occurred. All animals survived to scheduled necropsy. No signs of toxicity which could be related to test article treatment were observed.
BODY WEIGHT AND WEIGHT GAIN: No significant differences in body weight gain was observed between the animals of the test article and control groups during the experiment.
FOOD CONSUMPTION: No significant differences in food consumption was observed between the animals of the test article and control groups during the experiment.
OPHTHALMOSCOPIC EXAMINATION: No treatment-related findings were noted.
HAEMATOLOGY: The assessment of hematology data indicated no changes of toxicological significance at termination of the treatment.
CLINICAL CHEMISTRY: The assessment of clinical biochemistry data indicated no changes of toxicological significance at termination of the treatment.
URINALYSIS: The assessment of urinanalysis data indicated no changes of toxicological significance at termination of the treatment.
ORGAN WEIGHTS: No significant differences were observed in absolute and relative organ weights between the animals of the control and test article-treated group.
GROSS PATHOLOGY: All pathologic findings recorded were of a spontaneous nature common to rats of this age and strain. There was no evidence of abnormal histopathological findings, resulting from treatment with the test substance.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Dose descriptor:
- NOEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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