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: 925-384-5 | CAS number: 90639-98-8
Carcinogenicity
Administrative data
Description of key information
Not expect to be carcinogen
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on read across approach, the L-Carnitineanide D-Camphorated is not expected to be carcinogen.
According to the Regulation EC1272/2008 (CLP)L-Carnitineamide D-Camphoratedis classified for Acute oral Toxicity, Category 4, H302, as Harmful if swallowed.
Additional information
There are no experimental and/or literature specific data on L-CARNITINEAMIDE D-CAMPHORATED.
The analysis was carried out by calculation tools, but results werenot exhaustive, since it is a salt, public programs are outside the application field and can not be used.Therefore it has been evaluatedthe comparisonwith the base(Camphor; CAS: 76 -22 -2; EC:200 -945 -0)and the counter-ion(Levocarnitine; CAS: 541 -15 -1; EC: 208 -768 -0)of the substance,because themetabolism pathway of the substance is dissociate to its base and counter-ion, Camphor and Levocarnitine, and Camphor undergos to further transformation to Camphoric acid by ossidative metabolism.
ACGIH classified Camphor as A4: Not classifiable as a human carcinogen [*-3].
No long-term animal studies have been performed to evaluate the carcinogenic potential of Levocarnitine [*-25].
In conclusion based on read across approach, theL-Carnitineanide D-Camphorated is not expected to be carcinogen.
Any details about data available are reported in the report attached at the point 13: Assessment Report.
Reference
[*]Secondary source: Hazardous Substances Data Bank – HSDB - U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894, National Institutes of Health, Department of Health & Human Services
[3] American Conference of Governmental Industrial Hygienists TLVs and BEIs. Threshold Limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices. Cincinnati, OH, 2008, p. 17
[25] CARNITOR (levocarnitine) tablet, Sigma-Tau Pharmaceuticals, Inc., Revised: 06/2012; from secondary source: U.S. National Library of Medicine, database
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.
