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EC number: 434-770-8 | CAS number: 55314-16-4
- 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:
- 8 September 1999 - 1 October 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed according to OECD and EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
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
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 434-770-8
- EC Name:
- -
- Cas Number:
- 55314-16-4
- Molecular formula:
- C10 H12 N2 O1
- IUPAC Name:
- 3-(dimethylamino)-1-(pyridin-3-yl)prop-2-en-1-one
- Details on test material:
- Identification: STI571 Y5A
Test substance code: 1550515
Description: Brown solid
Batch: 992301
Purity: 98.6%
Test substance storage: In refrigerator in the dark
Stability under storage conditions: Stable
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 at study initiation: Young adult animals (approx. 10-11 weeks old) were selected.
- Weight at study initiation: 207-225 gram for females, 335-362 gram for males. Body weight variation did not exceed +/- 20% of the sex mean.
- Fasting period before study: Food was withheld overnight (for a maximum of 20 hours) prior to dosing until approximately 3-4 hours after administration of the test substance.
- Housing: 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: ad libitum, standard pelleted laboratory animal diet (Carfil Quality BVBA, Oud-Turnhout, Belgium).
- Water: ad libitum.
- Acclimation period: Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
ENVIRONMENTAL CONDITIONS
A controlled environment was maintained in the room with optimal conditions considered as being approximately 15 air changes per hour, a temperature of 21°C, a relative humidity of 30-70% and 12 hours artificial fluorescent light and 12 hours dark per day.
IN-LIFE DATES: From: 8 September 1999 to: 1 October 1999
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: The concentration of the test substance in vehicle was varied to allow constant dosage volume in terms of ml/kg body weight.
- Justification for choice of vehicle: The vehicle was selected based on a pretest performed at NOTOX.
- Batch no.: 992301
- Purity: 98.6%
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg - Doses:
- 2000 mg/kg body weight.
200 mg/kg body weight. - No. of animals per sex per dose:
- 3 males and 3 females received 2000 mg/kg body weight. An additional group of 3 males was dosed at 200 mg/kg body weight.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: until day 15
- Frequency of observations and weighing: Days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology - 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:
- > 200 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 2000 mg/kg: 1/3 females and 2/3 males.
200 mg/kg (males only): no mortality. - Clinical signs:
- other: 2000 mg/kg Females: Lethargy, ventral lateral recumbency, uncoordinated movements, slow breathing and watery discharge from the eyes. 2000 mg/kg Males: Lethargy, ventral lateral recumbency, hunched posture, uncoordinated movements, shallow respiration, pi
- Gross pathology:
- Macroscopic post mortem examination of the animals that were found dead or sacrificed for ethical reasons during the study revealed:
stomach: thickening of the limiting ridge; urinary bladder: enlarged and several reddish focus/foci; prostate: enlarged, dark red or reddish discolouration, moist; seminal vesicles: enlarged and/or moist; spleen: reduced in size; body cavities containing watery fluid; thymus: light red focus/foci.
No treatment related abnormalities were found at macroscopic examination of the surviving animals. - Other findings:
- Not applicable.
Any other information on results incl. tables
Not applicable.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information if swallowed (R22) Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 value of STI571 Y5A in Wistar rats was established to be within the range or 200-2000 mg/kg body weight. Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), 8TI571 Y5A should be labelled as: harmful if swallowed (R22).
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