Registration Dossier

Administrative data

Key value for chemical safety assessment

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 were not exhaustive, since it is a salt, public programs are outside the application field and can not be used. Therefore it has been evaluated the comparison with 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 the metabolism 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.

Data available on Camphor [*-15, 16, 17] reported slight adverse effects at high dose administrated, while data available on Levocarnitine [*21, 22] do not report mutagenic affects.

In both cases substances are consider as NON mutagent agents and the L-Carnitineamide D-Champorated is not expected to be mutagen, too.

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

[15] National Poisons Information Service Center, United Kingdom; Poisons Information Monograph: Camphor. (March 1996). Available from, as of February 6, 2004:http://www.intox.org/databank/documents/pharm/camphor/ukpid19.htm **PEER REVIEWED**

[16] Goel HC et al; Mutat Res 224 (2): 157-60 (1989) **PEER REVIEWED**

[17] Gomes-Carneiro MR et al; Mutat Res 416 (1-2): 129-36 (1998) **PEER REVIEWED**

[21] Thorne Research, Inc.; Monograph on Acetyl-L-Carnitine; Alternative Medicine Review 4(6) p.439 (1999). Available from, as of February 26, 2008: http://www.thorne.com/altmedrev/.fulltext/4/6/438.pdf **PEER REVIEWED**

[22] Thorne Research, Inc.; Monograph on L-Carnitine; Alternative Medicine Review 10(1) p.47 (2005). Available from, as of February 25, 2008: http://www.thorne.com/altmedrev/.fulltext/10/1/42.pdf **PEER REVIEWED**


Short description of key information:
Non mutagen

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on read across evaluation, the L-Carnitineanide D-Camphorated is not expected to be mutagen.

According to the Regulation EC 1272/2008 (CLP) L-Carnitineamide D-Camphorated is classified as non mutagen.