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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 922-576-0 | CAS number: 1184182-45-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- BONIFACE M. et B., CAZIN J.C et LUYCKX J. Calcul, sur ordinateur, de la dose efficace par la méthode des probits : Application au calcul d’une dose létale 50. Bull Soc. Pharm. Lille, 1972, 4, 187-185
CAZIN J.L. Exemples d’utilisation de micro-ordinateurs en génie biologique et médical (Apple II et III) Diplôme d’Etudes Approfondies de Génie Biologique et Médical. 1983, Faculté de Pharmacie de Lille.
BLISS C.I. The determination of the dosage-mortalité curve from small numbers. Quart J. Pharm., 1938, 11, 1926. - GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Salt of N-acetyl-L-glutamic acid and 1-[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methanamine (1:1), monohydrate
- EC Number:
- 922-576-0
- Cas Number:
- 1184182-45-3
- Molecular formula:
- C18H28N2O8
- IUPAC Name:
- Salt of N-acetyl-L-glutamic acid and 1-[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methanamine (1:1), monohydrate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: gommi arabicum
- Doses:
- 5%
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 3 420.27 mg/kg bw
- Based on:
- test mat. (dissolved fraction)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions, the oral LD50 of the test item is 3420.27 mg/kg in rats
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.
