1-Propanaminium, 3-(aminocarbonyl)-2-hydroxy-N,N,N-trimethyl-, (1R,3S)-1,2,2-trimethyl-1,3-cyclopentanedicarboxylate (1:1)

Endpoint summary

Description of key information

LD50 Mouse oral: 1310 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 310 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: 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 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 properties, 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.

The Camphor oral acute toxicity was investigated in dogs, rabbits and mice and were noted effects on central nervous system: in dogs the lethal dose was foud at 9 -14 g and the general effects were preliminary stimulation with subsequent paralysis of the central nervous system and the death was due to asphyxia ^[*-9]. In rabbits systemic camphor poisoning effects were noted on the pupils, as mydriasis; in this case no concentration was reported ^[*-10].

About the identification of Camphor base concentration toxicity an LD50 on Mouse, oral was foud at 1310 mg/kg ^{[*-11] .}

On the same specie the conunter-ion Levocarnitine LD50 reported in literature data is higher: about 19.2 g/kg ^[*-23].

Camphor meets the criteria to be classified as harmful if swallowed and, according to a precautionary approach and following the consideration reported above about metabolism pathway, it is concluded that the L-Carnitineamide D-Camphorated salt meets the creieria to be classified as harmful if swellowed, 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

^[9] Clarke, M. L., D. G. Harvey and D. J. Humphreys. Veterinary Toxicology. 2nd ed. London: Bailliere Tindall, 1981., p.125 **PEER REVIEWED**

^[10] Grant, W. M. Toxicology of the Eye. 2nd ed. Springfield, Illinois: Charles C. Thomas, 1974., p. 226 **PEER REVIEWED**

^[11] Lewis, R.J. Sax's Dangerous Properties of Industrial Materials. 9th ed. Volumes 1-3. New York, NY: Van Nostrand Reinhold, 1996., p. 641 **PEER REVIEWED**

^[23] Thomson Healthcare. PDR for Nutritional Supplements. Thomson Health Care Inc. Montvale, NJ. p.258 (2001) **PEER REVIEWED**

Justification for selection of acute toxicity – oral endpoint
Mouse oral (Lewis, 1996).

Justification for classification or non-classification

In consideration of the fact that all literatura data are found from secondary source, that the original reports are not available and that their reliability is comparable, the lowest LD50 on mouse of 1310 mg/kg (Lewis, 1996) was considered as inclonclusive to led to an official classification

According to the Regulation EC1272/2008 (CLP) L-Carnitineamide D-Camphorated is not classified for Acute oral Toxicity