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Registration Dossier
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EC number: 611-255-8 | CAS number: 55314-16-4
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.
- Justification for data waiving:
- other:
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:
- STI571 Y5A
- IUPAC Name:
- STI571 Y5A
- Reference substance name:
- 3-Dimethylamino-1-(3-pyridinyl)-2-propen-1-one
- Cas Number:
- 55314-16-4
- Molecular formula:
- C10 H12 N2 O
- IUPAC Name:
- 3-Dimethylamino-1-(3-pyridinyl)-2-propen-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
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- 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
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 200 - < 2 000 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
The incidence of mortality was at 2000 mg/kg (females) 1/3, at 2000 mg/kg (males) 2/3 and at 200 mg/kg (males) 0/3. Macroscopic post mortem examination of the animals that were found dead during the study revealed multiple effects at several target organs.
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) and according CLP EEC 1272/2008 cassified in Category 4, acute oral toxicity.
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