Registration Dossier

Administrative data

Description of key information

Not irritating to skin/eye/respiratory trac

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

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.

Camphor is an eye, skin and respiratory irritant; in particular about eye irritation it was reported to cause flickering, darkening or veiling of vision along with noises in the ears; corneal erosions have been reported in association with the use of inhalant capsules containing camphor [*6 -7].

Nevertheless the irritating properties of Camphor are not expected to be characterizing also for L-Carnitineanide D-Camphorated, because the counter-ion neutralizes the acid component, decreasing possibile irritating properties.

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

[6] 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**

[7] IPCS, CEC; International Chemical Safety Card on Camphor. (Date of review: May 2003). Available from, as of February 5, 2004: http://www.inchem.org/documents/icsc/icsc/eics1021.htm **PEER REVIEWED**

Justification for classification or non-classification

Based on evidences determinated by the structure and chemical/physical properties, the L-Carnitineanide D-Camphorated is not expected to be irritant to skin/eye/respiratory tract.

According to the Regulation EC1272/2008 (CLP) L-Carnitineamide D-Camphorated is classified as non irritant.