Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information
Not expected to affect fetal growth, viability, or morphological development.
Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

No data avilable


Short description of key information:
No data available

Effects on developmental toxicity

Description of key information
Not expected to impair fertility, affect fetal growth, viability, or morphological development.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Species:
other: Rats and rabbits
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Data are available on Camphor base.

Study on rats

There was no maternal mortality during the study. Absolute and relative liver weights exhibited a significant dose-related increase, but did not exceed 10% of control values in any individual group. Maternal toxicity consisted of alterations in food and water consumption (absolute and relative) and decreased weight gain during the treatment period. Food consumption was initially suppressed by both 400 and 800 mg/kg/day CAM. but recovered to control levels by the end of the treatment period. No effect on food consumption was seen at 100 mg/kg/day CAM. Unlike the dose-dependent effects of CAM on food intake, all three doses of CAM increased maternal water consumption during one or more of the following measurement periods (gd 6 to 9; gd 12 to 15; gd 15 to 18). Although maternal body weights in all treatment groups were within 5% of control values at all gestational ages, maternal weight gain during the treatment period in the 800 mg/kg/day group was significantly reduced. Examination of the uterine contents revealed that CAM, even at 800 mg/kg/day, had no adverse effect on fetal growth, viability, or morphological development. In summary, CAM does not affect fetal growth, viability, or morphological development at doses causing minor maternal toxicity. ( NTP Study: TER91018)

Study on rabbits

There was no maternal mortality in any of the experimental groups. Maternal body weights in the CAM-treated groups were comparable to controls at all gestational ages. However, maternal weight gain tended to decrease with increasing dose of CAM. Maternal food consumption in all three CAM groups was similar to controls throughout gestation. Examination of the uterine contents revealed that CAM had no effect on fetal growth, viability, or morphological development. The results from this study indicate that CAM is neither developmentally toxic nor toxic to the doe at doses as high as 400 mg/kg/day (NTP Study: TER91019)

Cases reported

Camphor crosses the placenta and has been implicated in fetal and neonatal death. It has been used to induce abortions. Camphor poisoning during pregnancy was reported in four cases and, in each case, camphorated oil was mistaken for castor oil. The topical use of camphorated oil in pregnancy was not associated with teratogenic effects (IPCS, 1989).


Justification for selection of Effect on developmental toxicity: via oral route:
- Camphor does not affect fetal growth, viability, or morphological development at doses causing minor maternal toxicity in rats (NTP Study: TER91018) and is neither developmentally toxic nor toxic for rabbit at doses as high as 400 mg/kg/day (NTP Study: TER91019).

Toxicity to reproduction: other studies

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.

No data of effects on fertility are available.

Based on read across approach with its Camphor base, L-Carnitineamide D-Camphorated salt is not expected to affect fetal growth, viability, or morphological development. Despite were reported four case in which Camphor crosses the placenta and has been implicated in fetal and neonatal death, when camphorated oil was mistaken for castor oil [*-4], controlled studies on rats [26] and rabbits [27] confirmed that Camphor not affect fetal growth, viability, or morphological development.

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

[4] IPCS; Poisons Information Monograph 095: Camphor. (May 1989). Available from, as of February 5, 2004:http://www.inchem.org/documents/pims/pharm/camphor.htm#SectionTitle:1.5%20Brand%20names,%20Trade%20na **PEER REVIEWED**

[26] Developmental Toxicity of d-Camphor (CAS No. 464-49-3) in Sprague Dawley (CD®) Rats, NTP Study: TER91018

[27] Developmental Toxicity of d-Camphor (CAS No. 464-49-3) in New Zealand White (NZW) Rabbits, NTP Study: TER91019

Justification for classification or non-classification

Based on read across approach, theL-Carnitineanide D-Camphorated is not expected to be carcinogen.

According to the Regulation EC1272/2008 (CLP)L-Carnitineamide D-Camphoratedis is classified as Non toxic to reproduction.