Registration Dossier
Registration Dossier
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: 946-290-0 | CAS number: 2246580-61-8
Toxicological information
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 Oct 2018 - 28 Nov 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted in compliance with Method B1 bis of Council Regulation (EC) No 440/2008 and OECD Guidelines for Testing of Chemicals, Method 420 (adopted 17 December 2001).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Method B1 bis of Council Regulation (EC) No 440/2008
- Deviations:
- not specified
- GLP compliance:
- yes
- Remarks:
- including Compliance Statement and signatur page
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- (1S)-1-cyclopropylethanamine; (2R)-2-hydroxy-2-phenyl-acetic acid
- EC Number:
- 946-290-0
- Cas Number:
- 2246580-61-8
- Molecular formula:
- C8H7O3.C5H12N
- IUPAC Name:
- (1S)-1-cyclopropylethanamine; (2R)-2-hydroxy-2-phenyl-acetic acid
- Test material form:
- solid: bulk
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Female (nulliparous, non-pregnant) Crl:WI(Han) strain rats were obtained from Charles
River (UK) Ltd., Margate
- The rats were in a body weight range of 157 to 196 g on Day 1.
- Rats were approximately 8 to 10 weeks old on Day 1.
CONDIDITIONS
- Mains water was provided ad libitum via water bottles
- Animals had access to 5LF2 EU Rodent Diet 14%, which was freely
available to the animals at all times, except for a period of fasting from the evening of the day
prior to dosing (Day-1) until approximately 3 hours after dosing.
- The animal rooms were designed to permit 15 to 20 air changes per hour. The target
temperature and humidity ranges were 20 to 24°C and 45 to 65% respectively.
- Fluorescent lighting was controlled automatically to give a cycle of 12 hours light and
12 hours dark.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- 1% w/v at a dose volume of 10mL/kg
- Details on oral exposure:
- Doses were administered orally, by gavage, using plastic syringes and rubber catheters. Each
rat was dosed once on Day 1, by passing the tip of a catheter along the oesophagus and
instilling the test article into the gastric lumen. - Doses:
- 300 mg/kg bw (sighting study only)
2000 mg/kg bw - No. of animals per sex per dose:
- 1 female per 300mg/kg bw (sighting study)
1 female per 2000mg/kg bw (sighting study)
4 females per 2000mg/kg bw (main study) - Control animals:
- no
- Details on study design:
- All animals were observed at the beginning and the end of the working day for signs of ill
health or overt toxicity.
Treated rats were observed closely for clinical signs of reaction to treatment. Clinical signs
were recorded immediately post-dose, at approximately 15 and 30 minutes post-dose, hourly
between 1 and 4 hours post-dose (inclusive), twice daily on Days 2, 3 and 4 and once daily
from the fifth to last day of the observation period. Individual records of clinical signs were
maintained for each treated rat.
Rats were weighed on Day-1 (day before dosing) and on Days 1, 4, 8 and 15.
Results and discussion
- Preliminary study:
- In the preliminary study female fasted rats were given the test article as a single dose on
Day 1 by oral gavage at dose levels of 300 and 2000 mg/kg.
Since there were no deaths in the preliminary study at a dose level of 2000 mg/kg, a further
four fasted females were given a single oral dose of test article at a dose level of 2000 mg/kg
body weight.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: Clinical signs were confined to hunched posture and/or piloerection, which were seen 2 to 3 hours after dosing in animals treated at 2000 mg/kg.
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified acc. CLP
- Conclusions:
- The test article, BI 730357 Amin MY, was considered to have no significant acute toxic risk in respect
of its acute oral toxicity and did not meet the criteria for classification according to the
Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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.
