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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 800-765-8 | CAS number: 1424149-03-0
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
The registration substance is expected to be readily bioavailable for oral routes. Dermal adsorption is expected to be less efficient. Due to the anticipated deleterious effect on respiratory tract, the inhalation route is not relevant for the systemic bioavailbility.
The availabiel data are indicative of extensive metabolism in the liver. No bioaccumulating potential can be derived.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Assessment on the toxicokinetic profile of the registration substance
No experimental data investigating the subchronic/chronic toxicity of the registration substance is available. However, the subchronic/chronic toxicity can be reasonably derived based on:
- the provided 28-day toxicity study
- chemical structure and relevant phys-chem data
- Cytotoxicity data obtained in the preliminary studies in in-vitro genotoxicity studies.
Considering that the given molecular mass of the registration substance (392 g/mol for Na-salt, 512 g/mol for TEA salt, 370 g/mol for acid) is in the range of absorbable molecular size and that the calculated LogKow of the acid (4.92 according to EPIWIN) is indicative of high liphophilicity under acidic condition, it can be reasonably derived that the substance will be readily adsorbed for oral routes and distributed via lymphatic tissues. The dermal absorption is likely to be lower due to the given pKa of 4.6 (at pH > 4 exclusively deprotonated salt exists with a calculated Log Kow of 1.7).
The given LogPow (1.7 for salt and 4.9 for acid) is indicative that the elimination as unchanged is not likely to occur. Two cases can be imagined: the degradation is not efficient and the internal burden increases with increasing exposure duration vs. the degradation is efficient and the internal burden is less dependent on the exposure duration. The second case would correspond to “no bioaccumulating” potential.
The available experimental toxicity data are indicative of extensive metabolism. The structural feature of highly branched alkenyl moiety imply a certain degree of reluctance to be degraded and based hereupon a metabolic overload can be predicted. In the 28 –day toxicity study, liver was identified as the target organ and the alteration patterns of the findings (liver weight increase and hepatocellular hypertrophy were indicative of metabolic overload. The effects in liver disappeared completely within the recovery period of 14 days, indicating that the chemical burden decreased rapidly.
Further evidence is given in the preliminary cytotoxicity study in in-vitro genotoxicity studies. When the metabolic activation added the cytotoxicity decreased, indicating that detoxification occurs with metabolic activation. The fact that the metabolic activation by action of liver enzymes is associated with detoxification implies that the liver is likely to serve as the detoxification organ under in-vivo condition.
In conclusion, no bioaccumulating potential can be derived.
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.
