Observations placeholder
Safety evaluation and risk assessment of d-Limonene
Identifier
016778
Type of Spiritual Experience
None
Background
A description of the experience
J Toxicol Environ Health B Crit Rev. 2013;16(1):17-38. doi: 10.1080/10937404.2013.769418.
Safety evaluation and risk assessment of d-Limonene.
Kim YW1, Kim MJ, Chung BY, Bang du Y, Lim SK, Choi SM, Lim DS, Cho MC, Yoon K, Kim HS, Kim KB, Kim YS, Kwack SJ, Lee BM.
d-Limonene, a major constituent of citrus oils, is a monoterpene widely used as a flavor/fragrance additive in cosmetics, foods, and industrial solvents as it possesses a pleasant lemon-like odor.
d-Limonene has been designated as a chemical with low toxicity based upon lethal dose (LD50) and repeated-dose toxicity studies when administered orally to animals. However, skin irritation or sensitizing potential was reported following widespread use of this agent in various consumer products.
In experimental animals and humans, oxidation products or metabolites of d-limonene were shown to act as skin irritants.
Carcinogenic effects have also been observed in male rats, but the mode of action (MOA) is considered irrelevant for humans as the protein α(2u)-globulin responsible for this effect in rodents is absent in humans. Thus, the liver was identified as a critical target organ following oral administration of d-limonene.
Other than the adverse dermal effects noted in humans, other notable toxic effects of d-limonene have not been reported.
The reference dose (RfD), the no-observed-adverse-effect level (NOAEL), and the systemic exposure dose (SED) were determined and found to be 2.5 mg/kg/d, 250 mg/kg//d, and 1.48 mg/kg/d, respectively. Consequently, the margin of exposure (MOE = NOAEL/SED) of 169 was derived based upon the data, and the hazard index (HI = SED/RfD) for d-limonene is 0.592.
Taking into consideration conservative estimation, d-limonene appears to exert no serious risk for human exposure. Based on adverse effects and risk assessments, d-limonene may be regarded as a safe ingredient.
However, the potential occurrence of skin irritation necessitates regulation of this chemical as an ingredient in cosmetics.
PMID: 23573938
The source of the experience
PubMedConcepts, symbols and science items
Concepts
Symbols
Science Items
Activities and commonsteps
Activities
Overloads
Asthma and allergyDermatitis
Food additives
Food allergy
Skin diseases
Suppressions
Essential oilsLimonene