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Diss Factsheets
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EC number: 446-640-8 | 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:
- repeated dose toxicity: oral
- Remarks:
- other: according to method
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- 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:
- other: Directive 96/54/EC, B.7
- GLP compliance:
- yes
- Limit test:
- no
Test material
Constituent 1
Test animals
- Species:
- other: Rat, HanIbm (Wistar)
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: Bidistilled water
- Details on oral exposure:
- Method of administration:
Gavage - Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 200 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 200 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
MORTALITY:
No mortality occured during the study.
CLINICAL SIGNS:
No test item-related clinical signs were noted during the
study.
FUNCTIONAL OBSERVATIONAL BATTERY:
No treatment-related changes noted.
FOOD CONSUMPTION/BODY WEIGHTS:
There were no effects on food consumption and body weights
noted.
Laboratory findings:
HEMATOLOGY:
No test item-related changes were observed in males or
females.
BIOCHEMISTRY:
All differences noted were considered to be unrelated to the
treatement.
Effects in organs:
ORGAN WEIGHTS:
No test item-related changes on organ weights observed.
MACROSCOPIC & MICROSCOPIC FINDINGS:
No test item-related findings noted.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Classified as: Not classified
- Executive summary:
GENERAL In this subacute toxicity study, ucb 22060 was administered daily by oral gavage to SPF-bred Wlstar rats of both sexes at dose levels of 50, 200 and 1000 mg/kg body weight/day for a period of 28 days. A control group was treated similarly with the vehicle, bidistilled water, only. The groups comprised 5 animals per sex which were sacrificed after 28 days of treatment. Clinical signs, outside cage observation, food consumption and body weights were recorded periodically during pretest and the treatment periods. Functional observational battery, locomotor activity and grip strength were performed during week 4. At the end of the dosing period, blood samples were withdrawn for hematology and plasma chemistry analyses, All animals were killed, necropsied and examined post mortem. Histological examinations were performed on organs and tissues from all control and high dose animals, and all gross lesions from all animals. From the animals of the low and middle dose groups, bone marrow, kidneys, male thyroid gland were examined to establish a no-effect level. MORTALITY 1VIABILITY All animals survived until scheduled necropsy. CLINICAL SIGNS No test item-related clinical signs were noted during daily observations or weekly behavioral observations (weeks 1-3). FUNCTIONAL OBSERVATIONAL BATTERY No test item-related clinical signs were evident during functional observational battery (week 4). Grip Strength The mean fore- and hindlimb grip strength values of test item-treated and control animals were similar. Locomotor Activity The mean locomotor activity of the male and female rats treated with 1000 mg/kg/day were generally reduced when compared with the respective controls. These differences were considered likely to be test item-related effects. FOOD CONSUMPTION No test item-related differences in mean food consumption were noted at any dose level. BODY WEIGHT No test item-related differences in mean body weights were noted at any dose level.
CLINICAL LABORATORY INVESTIGATIONS Hematology No test item-related differences in the hematology parameters were noted at any dose level tested. Clinical Biochemistry All differences noted in the clinical biochemistry parameters were considered to be fortuitous and unrelated at the treatment with the test item. ORGAN WEIGHTS None of the slight differences in mean absolute and relative organ weights were considered to be of toxicological relevance. MACROSCOPIC / MICROSCOPIC FINDINGS At necropsy, there were no macroscopic findings indicating an effect of the test item. Microscopic examination demonstrated that the test item produced morphological alterations in the male bone marrow, kidneys and thyroid gland. The findings in the bone marrow were minimally increased fatty atrophy at 1000 mg/kg/day. The thyroid gland had increased hypertrophy of follicular cells at 1000 mg/kg/day, The kidneys of all male treated groups had higher incidence and grading of tubular hyaline change, probably due to accumulation of alpha-2-microglobulins.
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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