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Diss Factsheets
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EC number: 433-930-4 | CAS number: 247089-62-9
- 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)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline conform study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age and weight at study initiation: Young adult animals (approx. 7 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean.
- Housing: Accommodation Group housing of 3 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material (SAWI, Jelu Werk, Rosenberg, Germany).
- Diet (e.g. ad libitum): Free access to standard pelleted laboratory animal diet (from Carfil Quality BVBA, Oud- Turnhout, Belgium).
- Water (e.g. ad libitum): Free access to tap-water. Certificates of quarteriy analysis were examined and then retained in the NOTOX archives.
- Acclimation period: Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
- Fasting: Food was withheld overnight (for a maximum of 20 hours) prior to dosing until approximately 3-4 hours after administration of the test
substance.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES:
Start : 18 January 2000
End : 03 February 2000
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- Oral gavage, using a stainless steel stomach tube. Food was withheld overnight (for a maximum of 20 hours) prior to dosing until approximately 3-4 hours after administration of the test substance
Vehicle: The vehicle was selected based on a pretest performed at NOTOX.
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg (10 ml/kg) body weight.
DOSAGE PREPARATION:
The formulation (w/w) was prepared within 4 hours prior to dosing.
Homogeneity was accomplished to a visually acceptable level.
Adjustment was made for specific gravity of vehicle. - Doses:
- Single dosage, on day 1. Dose level (volume) 2000 mg/kg (10 ml/kg) body weight
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- The toxicity of the test substance was assessed by stepwise treatment of groups of 3 animals. The first group was treated at a dose level of 2000 mg/kg body weight. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were to be taken into account for determination of the time interval between the dose groups
- Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing: Twice daily. Weighing: days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
At the end of the observation period, all animals were sacrificed by
asphyxiation using an oxygen/carbon dioxide procedure and
subjected to necropsy. Descriptions of all internal macroscopic
abnormalities were recorded.
- Other examinations performed: clinical signs, body weight,organ weights - Statistics:
- No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Alopecia was noted in one female on days 3 and 4, and red staining of the nose was noted in one male immediately after dosing. A red skin of various body parts and/or red faeces due to staining by the test substance was noted in all animals during the obs
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Applicant's summary and conclusion
- Conclusions:
- The oral LD50 value of TKP 50048 in Wistar rats was established to exceed 2000 mg/kg body weight.
- Executive summary:
TKP 50048 was administered by oral gavage to three Wistar rats of each sex at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15).
No mortality occurred.
Alopecia was noted in one female on days 3 and 4, and red staining of the nose was noted in one male immediately after dosing. A red skin of various body parts and/or red faeces due to staining by the test substance was noted in all animals during the observation period. No further clinical signs were noted. The body weight gain shown by the animals over the study period was considered to be normal.
No abnormalities were found at macroscopic post mortem examination of the animals.
The oral LD50 value of TKP 50048 in Wistar rats was established to exceed 2000 mg/kg body weight.
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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