2-Propen-1-one, 3-(dimethylamino)-1-(3-pyridinyl)-

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:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

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

Test material information

Constituent 1

Reference substance name:

STI571 Y5A

IUPAC Name:

STI571 Y5A

Constituent 2

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

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.