Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 606-728-0 | CAS number: 212322-56-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1 September - 20 November 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Principles of method if other than guideline:
- An extended acute-toxic-class (ATC) method was used. Based on the acute toxicity of the final drug, 5000mg/kg were given to 1male and 1 female.
After the dose was tolerated, the remaining 2m/2f animals were dosed subsequently. - GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- ethyl 3-{1-[3-amino-4-(methylamino)phenyl]-N-(pyridin-2-yl)formamido}propanoate
- EC Number:
- 606-728-0
- Cas Number:
- 212322-56-0
- Molecular formula:
- C18 H22 N4 O3
- IUPAC Name:
- ethyl 3-{1-[3-amino-4-(methylamino)phenyl]-N-(pyridin-2-yl)formamido}propanoate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- male and female rats
- the rats were in a body weight range of 136-175 g on Day 1
- the rats were approximately 6 weeks on Day 1
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% Natrosol 250 HX (Hydroxyethylcellulose) administration volume of 20 ml/kg
- Details on oral exposure:
- The administered volume was given by gavage based on the individual body weight of the animals determined on the day of administration.
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 3 male and 3 female
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animal died after administration and through the end of the experiment.
- Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- The body weight gain of male and female rats remained within the normal range.
- Gross pathology:
- No gross lesions were seen during necropsy
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified acc. CLP
- Conclusions:
- According CLP the test substance is to be classified: "not classified"
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.
