Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 465-100-2 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- Batch number: 022401
Constituent 1
- Specific details on test material used for the study:
- Appearance: white powder
Storage: Ambient temperature, in the dark.
pH pH = 5.80 (1% solution in deionised water, w/v, determined with a pH-Meter WTW pH 340).
The sequence of dosing of the test substance was:
• Step 1: 300 mg per kg body weight.
• Step 2: 300 mg per kg body weight.
• Step 3: 2000 mg per kg body weight.
The test substance was suspended in deionised water.
The suspensions were prepared freshly before administrati :m and were administered within 20 minutes after the preparation.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Hygiene: Optimal hygienic conditions
Room temperature: Average of 22.1 °C (contim ous control and recording).
Relative humidity: Average of 47.3 % (continu)US control and recording).
Air exchange: 12 per hour.
Light: Artificial light from 6 a.m. to 6 p.m.
Cages: Single caging in Makrolon c ages type Ill (39 cm x 23 cm bottom area, 18 cm height). Wire mesh lids. Sanitation of cages once a week.
Bedding material: Aspen wood chips (Fa. ABE:DD Dominik Mayr KEG, A-8580 Koflach}, autoclaved. The bedding material was changed weekly.
Environmental enrichment: Nibbling wood bricks (10 en, x 2 cm x 2 cm) and nesting material (Finn Tapvei Oy, SF-73620 Kortteinen), were offered to the animals once a week.
Feed: Altromin 1324 forte, gamma irradiated with 25 kGy 60Co, ad libitum (Producer: Altromin GmbH, 0-32791 Lage).
Exception: The feed was withdrawn the evening before the administration of the test substance and was offered again about three hours afterwards. Random samples of the fee d are analysed for contaminants by Altromin.
Age: Approximately 8 weeks at the time of the administration.
Water: Tap water from an automat c watering system, ad libitum.
Identification: Labelling with felt-tipped pen on the tail and on the cage.
Acckumatisation: at least 5 days.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Deionised water (suspension).
- Details on oral exposure:
- A peroral administration was performed once in the morning by stomach intubation using a metal gavage.
The dose volume was 10 ml per kg body weight. The individual dose volumes were calculated using the body weights determined on the day af the administration.As no prior information on the toxicity of the test substance was available, a starting dose of 300 mg of the test substance per kg body weight was chosen. - Doses:
- The sequence of dosing of the test substance was:
• Step 1: 300 mg per kg body weight.
• Step 2: 300 mg per kg body weight.
• Step 3: 2000 mg per kg body weight. - No. of animals per sex per dose:
- No. Step Animal Dose (mg/kg b.w.)
3 1 141, 142, 143 300
3 2 146, 147, 148 300
3 3 151, 152, 153 2000 - Control animals:
- no
- Details on study design:
- Observations were performed within the periods 0 - 0.5, 0.5 - 1, 1 - 2, 2 - 4 and 4 - 6 hours after administration (p.a.) of the test substance and then at least once a day for a total of 2 weeks. Observations included but were not limited to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions.
Body weights were determined
• before administration.
• 7 days p.a.
• 14 days p.a.
Body weight gain was calculated for each week of the study, i.e. between
• 0 and 7 days p.a.
• 7 and 14 days p.a
Deceased animals were dissected and examined macroscopically in an attempt to identify the target organs.
Surviving animals were killed by inhalation of 80 % CO2+ 2O % air 14 days p.a. and subjected to a necropsy including a gross pathological examination.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 300 - < 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Female: 300 mg/kg bw; Number of animals: 6; Number of deaths: 1
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 3 - Clinical signs:
- other: Signs of toxicity related to dose levels: Mortality: between 5 min and 30 min p.a. Body weight: There were indications of a reduced body weight gain of the surviving rats in the second week. Clinical observations: 300 mg/kg bw: clonic convulsion
- Gross pathology:
- Effects on organs:
Maximally filled urinary bladder in one animal at 300 mg/kg.
Systolic heart arrest (2000 mg/kg).
Any other information on results incl. tables
Dose (mg/kg) | Step No. | Animal Nos. | Number of animals | ||
exposed | affected | deceased | |||
300 | 1 | 141, 142, 143 | 3 | 3 | 1 |
300 | 2 | 146, 147, 148 | 3 | 1 | 0 |
2000 | 3 | 151, 152, 153 | 3 | 3 | 3 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- In a single dose toxicity study in rats, animals were orally administered 300 and 2000 mg/kg of STI571 F8 suspended in deionised water. The test substance caused mainly nervous effects, which were also the cause of death. LD50 for STI571 F8 is estimated to be between 300 and 500 mg/kg body weight in rats.
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.
Although ECHA is providing a lot of online material in your language, part of this page is only in English. More about ECHA’s multilingual practice.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
the-echa-website-uses-cookies
find-out-more-on how-we-use-cookies