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Abies sachalinensis oil
Food and Chemical Toxicology 38 (Suppl ement ) (2000) SI-S 236 holdlloooial
T..mv
PERGAMON
www.e1sevier.com/locate/foodchemtox
ABIES SACHALlNENSlS OIL Syn onym s: Japanese fir needle oil; Japanese pine needle oil. Description: A colorle ss to faint yellow liquid. Components: Components include bornyl acetate, camphene, a-pinene, p-pinene, limonene, ,B-phellandrene, santene, tricyclene, ,B-caryoph yllene, myrcene, fenchyl acetate and linalyl acetate (Holm et al., 1994; Kolesnikova and Tagiltsev, 1986). Analytical data on the mat erial as tested by RIFM: Optical rotation Refractive index Specific gravity UV absorbance Gas chromatogram Infra-red spectrum
_41 ° 31' 1.4721 (20°C) 0.8810 (25°C) sho ulder 250-310 nm on file on file
Preparation: By steam distillat ion of the terminal branches a nd leaves (needles) from the tree Abies sachalinensis (Guenther, 1952). Na tural occurrence: Found in the leaves (needles) of Abies sachalinensis Masters (Fa m. Pinaceae) (Guenther, 1952). Volume of use: The worldwide volume of use (1996) as a fragrance ingredient is less than I metri c ton .
Biological data Acute toxicity Oral studies: The acute oral LD so in rats exceeded 5 g/k g based on no deaths in 10 animals tested at that dose . The rats were observed for mortality and /or systemic effects and a gross necropsy was carried out on all animals. There were no systemic effects observed during the study. At necropsy, dark lungs or dark areas in the lung were observed in all anim als; all rats displayed darkened spleens; four rats had dark kidneys and five had mottled kidneys; eight rats had mottled livers and two had enlarged intestines (RIFM, I977a) . Dermal studies: The dermal LD so in rabbits exceeded 5 g/kg based on no deaths in 10 animals tested at that dose. The animals were observed for mortality and /or system ic effects and a gross necropsy was carried out on all animals. There were no systemic effects observed during the study. At necropsy, all rabbits displa yed alopecia; nine had skin sloughing; dark livers were observed in eight animals; anogenital exuda te was observed in two animals; mo ttled liver was o bserved in one a nimal; bloated intestine was observed in one anima l, and red areas in the intestine was observed in one a nima l (RIFM, 1977a). Sk in irritation Human studies: In a pre-test for a human maximization study, no irritation was ob served after a 48-hr closed patch test with 20% Ab ies sachalinensis oil in petrol atum on the forearms or backs of 25 health y, male a nd female volunteers (RIF M, 1977b). In a pre-test for a second hum an maximization stud y, no irritat ion was ob served after a 48-hr closed patch test with 20% A . sachalinensis oil in petrolatum on the back s of 28 health y, male volunteers (RIF M, 1978). Animal studies: As part of the acute dermal LD so study described above, the dermal react ions con sisted of mild (nine rabbits) to moderate erythema (one rabbit) and mild (four rabbits) to moderate edema (six rabbits) (R IF M, I977a). As part of a phototoxicity study, irr itation was evalu ated in hairless mice and miniature swine. A 20-lll aliquot of the neat oil was applied to the skin of six mice and two miniature swine. Temporary blanching of the skin was observed (no further det ails given) (RIFM , I977c).
PlI: S 0 2 7 8- 6 9 15( 0 0 )0 00 6 3-6;
S2
c. S. Letizia et al.
Skin sensitization Human studies: A maximization test (Kligman, 1966; Kligman and Epstein, 1975) was carried out with 20% A. sachalinensis oil in petrolatum on 25 healthy, male and female volunteers. The test concentration of 20% was based on a reported maximum use concentration of 2.0% in consumer products. Application was under occlusion to the same site on the forearms or backs of all subjects for five alternate-day 48-hr periods. Patch sites were pretreated for 24 hr with 2.5% aqueous sodium lauryl sulfate (SLS) under occlusion. Following a 10-day rest period, a challenge patch was applied to a different site for 48 hr under occlusion. The challenge site was pretreated for I hr with 5%-10% SLS. The challenge site was read on removal of the patch and 24 hr thereafter. Two sensitization reactions were observed (RIFM, 1977b). A second maximization test was carried out with 20% A. sachalinensis oil in petrolatum on 28 healthy male volunteers using a new sample of A. sachalinensis oil which had BHA added to it and was collected under nitrogen. Application was under occlusion to the same site on the forearms of all subjects for five alternateday 48-hr periods. Patch sites were pretreated for 24 hr with 5% aqueous SLS under occlusion for the initial patch only. Following a 1Q--14-day rest period, challenge patches were applied under occlusion to fresh sites for 48 hr. Challenge applications were preceded by applications of aqueous SLS under occlusion on the left side whereas the test material was applied without SLS treatment on the right side. No reactions were observed that were considered significantly irritant or allergic (RIFM, 1978). Phototoxicity Animal studies: A 20-J.d aliquot of the neat oil was applied to a 5 ern- area on the backs of six hairless mice and two miniature swine. 30 min later, the treated skin areas were irradiated with UV light from either a bank of fluorescent blacklight lamps (GE F40TI2BL) for I hr or a Xenon lamp (XBF 6000W) with a WG320 filter for 40 min. Readings were taken at 2, 4, 24 and 48 hr after exposure. There were no phototoxic effects observed (RIFM, I977c).
Status
IFRA (1976) has published a guideline recommending that essential oils and isolates derived from the Pinacea family, including Pinus and Abies genera, should only be used when the level of peroxides is kept to the lowest practicable level, for instance by adding antioxidants at the time of production. Such products should have a peroxide value of less than 10 mmol peroxide per litre, determined according to the EOA method.
References Guenther E. (\952) The Essential Oils, Vol. VI, p. 217. D. Van Nostrand, Inc., Princeton, NJ. Holm Y., Laakso I. and Hiltunen R. (1994) The enantiomeric composition of monoterpene hydrocarbons as a chemotaxonomic marker in Abies sachalinensis (Fr. Schm.) Mast. and A. mayriana Miy. et Kudo needle essential oils. Flavour and Fragrance Journal 9,223-227. IFRA (1976) Code of Practice, May. International Fragrance Association, Geneva. Kligman A.M. (\ 966) The identification of contact allergens by human assay. III. The maximization test. A procedure for screening and rating contact sensitizers. Journal of Investigative Dermatology 47, 393-409. [Submitted only for the methodology] Kligman A.M. and Epstein W. (1975) Updating the maximization test for identifying contact allergens. Contact Dermatitis 1,231-239. [Submitted only for the methodology] Kolesnikova R.D. and Tagiltsev Y.G. (1986) New data on the content and composition of essential oils for some species of genus Abies. In Flavors and Fragrances: A World Perspective, ed. B.M. Lawrence, B.D. Mookherjee and B.J. Willis, pp. 601-605. Proceedings of the 10th International Congress of Essential Oils, Washington DC, 16-20 November 1986. Research Institute for Fragrance Materials, Inc. (1977a) Acute toxicity study in rats and rabbits. RIFM report number 1695, August 22. Research Institute for Fragrance Materials, Inc. (\977b) Human maximization studies. RIFM report number 1702, May 24C. Research Institute for Fragrance Materials, Inc. (\ 977c) Phototoxicity testing of fragrance materials in hairless mice and miniature swine. RIFM report number 1814, June 29. Research Institute for Fragrance Materials, Inc. (1978) Human maximization studies. RIFM report number 1698, January 13A.
T..mv
PERGAMON
www.e1sevier.com/locate/foodchemtox
ABIES SACHALlNENSlS OIL Syn onym s: Japanese fir needle oil; Japanese pine needle oil. Description: A colorle ss to faint yellow liquid. Components: Components include bornyl acetate, camphene, a-pinene, p-pinene, limonene, ,B-phellandrene, santene, tricyclene, ,B-caryoph yllene, myrcene, fenchyl acetate and linalyl acetate (Holm et al., 1994; Kolesnikova and Tagiltsev, 1986). Analytical data on the mat erial as tested by RIFM: Optical rotation Refractive index Specific gravity UV absorbance Gas chromatogram Infra-red spectrum
_41 ° 31' 1.4721 (20°C) 0.8810 (25°C) sho ulder 250-310 nm on file on file
Preparation: By steam distillat ion of the terminal branches a nd leaves (needles) from the tree Abies sachalinensis (Guenther, 1952). Na tural occurrence: Found in the leaves (needles) of Abies sachalinensis Masters (Fa m. Pinaceae) (Guenther, 1952). Volume of use: The worldwide volume of use (1996) as a fragrance ingredient is less than I metri c ton .
Biological data Acute toxicity Oral studies: The acute oral LD so in rats exceeded 5 g/k g based on no deaths in 10 animals tested at that dose . The rats were observed for mortality and /or systemic effects and a gross necropsy was carried out on all animals. There were no systemic effects observed during the study. At necropsy, dark lungs or dark areas in the lung were observed in all anim als; all rats displayed darkened spleens; four rats had dark kidneys and five had mottled kidneys; eight rats had mottled livers and two had enlarged intestines (RIFM, I977a) . Dermal studies: The dermal LD so in rabbits exceeded 5 g/kg based on no deaths in 10 animals tested at that dose. The animals were observed for mortality and /or system ic effects and a gross necropsy was carried out on all animals. There were no systemic effects observed during the study. At necropsy, all rabbits displa yed alopecia; nine had skin sloughing; dark livers were observed in eight animals; anogenital exuda te was observed in two animals; mo ttled liver was o bserved in one a nimal; bloated intestine was observed in one anima l, and red areas in the intestine was observed in one a nima l (RIFM, 1977a). Sk in irritation Human studies: In a pre-test for a human maximization study, no irritation was ob served after a 48-hr closed patch test with 20% Ab ies sachalinensis oil in petrol atum on the forearms or backs of 25 health y, male a nd female volunteers (RIF M, 1977b). In a pre-test for a second hum an maximization stud y, no irritat ion was ob served after a 48-hr closed patch test with 20% A . sachalinensis oil in petrolatum on the back s of 28 health y, male volunteers (RIF M, 1978). Animal studies: As part of the acute dermal LD so study described above, the dermal react ions con sisted of mild (nine rabbits) to moderate erythema (one rabbit) and mild (four rabbits) to moderate edema (six rabbits) (R IF M, I977a). As part of a phototoxicity study, irr itation was evalu ated in hairless mice and miniature swine. A 20-lll aliquot of the neat oil was applied to the skin of six mice and two miniature swine. Temporary blanching of the skin was observed (no further det ails given) (RIFM , I977c).
PlI: S 0 2 7 8- 6 9 15( 0 0 )0 00 6 3-6;
S2
c. S. Letizia et al.
Skin sensitization Human studies: A maximization test (Kligman, 1966; Kligman and Epstein, 1975) was carried out with 20% A. sachalinensis oil in petrolatum on 25 healthy, male and female volunteers. The test concentration of 20% was based on a reported maximum use concentration of 2.0% in consumer products. Application was under occlusion to the same site on the forearms or backs of all subjects for five alternate-day 48-hr periods. Patch sites were pretreated for 24 hr with 2.5% aqueous sodium lauryl sulfate (SLS) under occlusion. Following a 10-day rest period, a challenge patch was applied to a different site for 48 hr under occlusion. The challenge site was pretreated for I hr with 5%-10% SLS. The challenge site was read on removal of the patch and 24 hr thereafter. Two sensitization reactions were observed (RIFM, 1977b). A second maximization test was carried out with 20% A. sachalinensis oil in petrolatum on 28 healthy male volunteers using a new sample of A. sachalinensis oil which had BHA added to it and was collected under nitrogen. Application was under occlusion to the same site on the forearms of all subjects for five alternateday 48-hr periods. Patch sites were pretreated for 24 hr with 5% aqueous SLS under occlusion for the initial patch only. Following a 1Q--14-day rest period, challenge patches were applied under occlusion to fresh sites for 48 hr. Challenge applications were preceded by applications of aqueous SLS under occlusion on the left side whereas the test material was applied without SLS treatment on the right side. No reactions were observed that were considered significantly irritant or allergic (RIFM, 1978). Phototoxicity Animal studies: A 20-J.d aliquot of the neat oil was applied to a 5 ern- area on the backs of six hairless mice and two miniature swine. 30 min later, the treated skin areas were irradiated with UV light from either a bank of fluorescent blacklight lamps (GE F40TI2BL) for I hr or a Xenon lamp (XBF 6000W) with a WG320 filter for 40 min. Readings were taken at 2, 4, 24 and 48 hr after exposure. There were no phototoxic effects observed (RIFM, I977c).
Status
IFRA (1976) has published a guideline recommending that essential oils and isolates derived from the Pinacea family, including Pinus and Abies genera, should only be used when the level of peroxides is kept to the lowest practicable level, for instance by adding antioxidants at the time of production. Such products should have a peroxide value of less than 10 mmol peroxide per litre, determined according to the EOA method.
References Guenther E. (\952) The Essential Oils, Vol. VI, p. 217. D. Van Nostrand, Inc., Princeton, NJ. Holm Y., Laakso I. and Hiltunen R. (1994) The enantiomeric composition of monoterpene hydrocarbons as a chemotaxonomic marker in Abies sachalinensis (Fr. Schm.) Mast. and A. mayriana Miy. et Kudo needle essential oils. Flavour and Fragrance Journal 9,223-227. IFRA (1976) Code of Practice, May. International Fragrance Association, Geneva. Kligman A.M. (\ 966) The identification of contact allergens by human assay. III. The maximization test. A procedure for screening and rating contact sensitizers. Journal of Investigative Dermatology 47, 393-409. [Submitted only for the methodology] Kligman A.M. and Epstein W. (1975) Updating the maximization test for identifying contact allergens. Contact Dermatitis 1,231-239. [Submitted only for the methodology] Kolesnikova R.D. and Tagiltsev Y.G. (1986) New data on the content and composition of essential oils for some species of genus Abies. In Flavors and Fragrances: A World Perspective, ed. B.M. Lawrence, B.D. Mookherjee and B.J. Willis, pp. 601-605. Proceedings of the 10th International Congress of Essential Oils, Washington DC, 16-20 November 1986. Research Institute for Fragrance Materials, Inc. (1977a) Acute toxicity study in rats and rabbits. RIFM report number 1695, August 22. Research Institute for Fragrance Materials, Inc. (\977b) Human maximization studies. RIFM report number 1702, May 24C. Research Institute for Fragrance Materials, Inc. (\ 977c) Phototoxicity testing of fragrance materials in hairless mice and miniature swine. RIFM report number 1814, June 29. Research Institute for Fragrance Materials, Inc. (1978) Human maximization studies. RIFM report number 1698, January 13A.