Registration Dossier
Registration Dossier
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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
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