Registration Dossier

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

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

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.