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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.