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Administrative data

Description of key information

Inconclusive

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

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 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.

Studies available:

On Camphor

- Repeated dose toxicity oral in mice: a significant increase in the activities of cytochrome P450, aryl hydrocarbon hydroxylase and glutathione S- transferase only at high doses was observed [*-12].

- Chronic exposure/carcinogenicity: the only data available is relative to the cancer promoter croton oil and it is not known how the relevance of these findings for Camphor [*-13].

On Levocarnitine

- Repeated dose toxicity oral in rats: the investigation conclusions focused on the downregulation of OCTN2 at the renal level, in the presence of high levels of carnitine [*-19].

The findings on Camphor and Levocarnitine are not sufficient to consider substance as dangerous, or to expect relevat adverse effects; nevertheless data are also not enough to completely exclude any adverse effects and/or further investigations.

Note that is not clear how these considerations are adeguate to L-Carnitineamide D-Champorated; therefore the evaluation for this endpoint is considered inconclusive.

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

[12] Banerjee S et al; Cancer Lett 88 (2): 163-9 (1995) **PEER REVIEWED**

[13] American Conference of Governmental Industrial Hygienists. Documentation of Threshold Limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices for 2001. Cincinnati, OH. 2001., p. 1 **PEER REVIEWED

[19] Gomez-Amores L et al; Pharm Res 20 (8): 1133-40 (2003)] **PEER REVIEWED**

Justification for classification or non-classification

Inconclusive: L-Carnitineanide D-Camphorated is not expected to have repeated dose toxicity, but data available are not sufficient to exclude any advers affect.

According to the Regulation EC1272/2008 (CLP)L-Carnitineamide D-Camphoratedis not classified for repeated dose toxicity , based on inconclusive data.

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