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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 616-017-7 | CAS number: 7377-08-4
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
According to Annex VIII, section 8.5.2, column 2 of Regulation No. 1907/2006, testing by the inhalation route is appropriate if exposure of humans via inhalation is likely. The vapour pressure of 4-aminobenzoyl-b-alanine was found to be extremely low (9.70E-05 Pa at 20°C) and in a granulometry study the DV50 of 4-aminobenzoyl-b-alanine was 258 µm. Therefore, 4-aminobenzoyl-b-alanine is not considered to be of concern for inhalation due to its extremely low volatility and that its particle size is outside the inhalable range. Inhalation exposure during use of 4-aminobenzoyl-b-alanine as an intermediate is also unlikely due to the risk mitigation measures in place in the pharmaceutical facility and that all processes are performed in accordance with Good Manufacturing Practices. Therefore, the performance of an acute inhalation study on 4-aminobenzoyl-b-alanine is considered scientifically unjustified.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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.
