Monographs on fragrance raw materials

Opdyke, D.L.J.

doi:10.1016/0015-6264(73)90019-9

Cited by 22 publications

(39 citation statements)

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“…The acute oral lethal dose (LD 50 ) value for BCP in rats is reported as >5,000 mg/kg body weight (bw). 22 β-Caryophyllene has been found to be nonmutagenic in multiple Salmonella strains at concentrations up to 150 mg/plate and did not affect DNA synthesis in rat hepatocytes in concentrations up to 10 mg/plate. 23 Since subchronic/chronic studies were lacking for BCP, the current oral subchronic toxicity study was conducted as part of an investigation to examine the safety of BCP oil and adds to the publicly available preclinical safety database on BCP.…”

Section: Introductionmentioning

confidence: 97%

Toxicological Evaluation of β-Caryophyllene Oil

2016

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In a subchronic toxicity study, administration of β-caryophyllene (BCP) oil by oral gavage to Wistar rats at dosages of 0, 150, 450, or 700 mg/kg/d for 90 days, including a 21-day recovery period, did not produce any significant toxicologic manifestations. The study design also included a 28-day interim sacrifice in the control and high-dose groups. The BCP oil test article was well tolerated as evidenced by the absence of major treatment-related changes in the general condition and appearance of the rats, neurobehavioral end points, growth, feed and water intake, ophthalmoscopic examinations, routine hematology and clinical chemistry parameters, urinalysis, and necropsy findings. The no observed adverse effect level was the highest dosage level administered of 700 mg/kg body weight/d for both male and female rats. The study was conducted as part of an investigation to examine the safety of BCP oil for its proposed use in medical food products.

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Section: Introductionmentioning

confidence: 97%

Toxicological Evaluation of β-Caryophyllene Oil

2016

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Section: Toxicological Studiesmentioning

confidence: 99%

“…Of the two acute toxicity studies for castoreum extract reported in the literature, the original data are not available but rather the studies were summarized by Opdyke (1973). In one study, an acute oral LD 50 >5 g/kg was determined in rats ( N = 10 per dose), with a 20% mortality recorded at the highest dose of 5 g/kg (Opdyke 1973). In the second study, an acute dermal LD 50 >5 g/kg was established in rabbits (N = 6 per dose) as there were no deaths noted at any dose up to the highest dose of 5 g/kg (Opdyke 1973).…”

Section: Toxicological Studiesmentioning

confidence: 99%

“…2261) is a natural product prepared by direct hot-alcohol extraction of castoreum, the dried and macerated castor sac scent glands (and their secretions) of the male or female beaver (Order, Rodentia; Family, Castoridae) (Arctander 1960). Used extensively in perfumery (Opdyke 1973), castoreum extract has also been added to food as a flavor ingredient since at least 1920 (Burdock 1995). It is used in most food and beverage categories and is especially useful as an ingredient in vanilla flavored foods.…”

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confidence: 99%

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Safety Assessment of Castoreum Extract as a Food Ingredient

Burdock¹

2007

Int J Toxicol

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Castoreum extract (CAS NO. 8023-83-4; FEMA NO. 2261) is a natural product prepared by direct hot-alcohol extraction of castoreum, the dried and macerated castor sac scent glands (and their secretions) from the male or female beaver. It has been used extensively in perfumery and has been added to food as a flavor ingredient for at least 80 years. Both the Flavor and Extract Manufacturers Association (FEMA) and the Food and Drug Administration (FDA) regard castoreum extract as generally recognized as safe (GRAS). Acute toxicity studies in animals indicate that castoreum extract is nontoxic by both oral and dermal routes of administration and is not irritating or phototoxic to skin. Skin sensitization has not been observed in human subject tests. Castoreum extract possesses weak antibacterial activity. A long historical use of castoreum extract as a flavoring and fragrance ingredient has resulted in no reports of human adverse reactions. On the basis of this information, low-level, long-term exposure to castoreum extract does not pose a health risk. The objective of this review is to evaluate the safety-in-use of castoreum extract as a food ingredient.

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“…As a result of their manufacture, these esters often contain a certain percentage of free allyl alcohol. Allyl alcohol is known to have a delayed skin irritation potential and the presence of allyl alcohol in the esters may affect their irritation potential (Opdyke 1977f). Concern over the delayed irritant potential of allyl alcohol prompted the International Fragrance Association (IFRA) to recommend the use of allyl esters only when the level of free allyl alcohol is less than 0.1% (IFRA 1977).…”

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confidence: 99%

The Effects of Vehicles on the Human Dermal Irritation Potentials of Allyl Esters

et al. 2006

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Allyl esters, frequently used in the fragrance industry, often contain a certain percentage of free allyl alcohol. Allyl alcohol is known to have a potential for delayed skin irritation. Also present in the finished product are different solvent systems, or vehicles, which are used to deliver the fragrances based upon their intended application. This study was conducted to determine whether different vehicles affect the skin irritation potential of five different allyl esters. The allyl esters tested were allyl amyl glycolate, allyl caproate, allyl (cyclohexyloxy)acetate, allyl cyclohexylpropionate, and allyl phenoxyacetate in the vehicles diethyl phthalate, 3:1 diethyl phthalate:ethanol, and 1:3 diethyl phthalate:ethanol at concentrations of 0.1%, 0.5%, 1.0%, and 2.0% (w/w). A modified cumulative irritation test was conducted in 129 human subjects. Test materials (0.3 ml) were applied under occlusion to skin sites on the back for 1 day (24 h) using Hill Top chambers. Irritation was assessed at 1, 2, 4, and 5 days following application of test materials. Cumulative irritation scores varied considerably among test materials. There were no delayed irritation observations. The highest irritation scores were observed at the 2.0% concentration for all test materials. The irritation scores for allyl amyl glycolate, allyl (cyclohexyloxy)acetate, and allyl phenoxyacetate were highest in 1:3 diethyl phthalate:ethanol, thus the resulting calculated no-observed-effect levels, 0.12%, 0.03%, and 0%, respectively, were much lower for this vehicle compared to the diethyl phthalate vehicle, 0.33%, 0.26%, 0.25%, respectively. These data showed a trend for lower concentration thresholds to induce irritation when higher levels of ethanol were used in the vehicle.

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Monographs on fragrance raw materials

Cited by 22 publications

References 1 publication

Toxicological Evaluation of β-Caryophyllene Oil

Toxicological Evaluation of β-Caryophyllene Oil

Safety Assessment of Castoreum Extract as a Food Ingredient

The Effects of Vehicles on the Human Dermal Irritation Potentials of Allyl Esters

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