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p-cresyl isobutyrate
Fragrance raw materials monographs
773
p..CRESYL ISOBUTYRATE
Synonym: p-Tolyl isobutyrate. Structure: CHz.C6H4.OCO.CH(CHa) 2. Description and physical properties: EOA Spec. no. 232. Occurrence: Has apparently not been reported to occur in nature. Preparation: From p-cresol and isobutyric acid by esterification. Uses: In public use since the 1930s. Use in fragrances in the USA amounts to less than 1000 lb/yr. Concentration in final product (~o): Usual Maximum
Soap 0.005 0"03
Detergent 0.0005 0.003
Creams, lotions 0.0025 0.01
Perilune 0.04 0.25
Analytical data: Gas chromatogram, RIFM no. 74--64; infra-red curve, RIFM no. 74-64. Status
p-Cresyl isobutyrate was given GRAS status by FEMA (1965) and is approved by the FDA for food use (21 CFR 121.1164). The Council of Europe (1974) included p-cresyt isobutyrate at a level of 0-15 ppm in the list of artificial flavouring substances that may be added to foodstuffs without hazard to public health. The Food Chemicals Codex (1972) has a monograph on p-cresyl isobutyrate. Biological data
Acute toxicity. The acute oral LDs0 value in rats was reported as 4 ml/kg (3.53-4,68 ml/kg) and the acute dermal LDs0 value in rabbits as 3.97 ml/kg (Levenstein, 1974). Irritation. p-Cresyl isobutyrate applied full strength to the intact or abraded skin of rabbits for 24 hr under occlusion was mildly irritating (Levenstein, 1974). Tested on human subjects by a 48-hr occluded-patch test at 4~o in petrolatum, the material was not irritating (Kligman, 1974). Sensitization. A maximization test (Kligman, 1966; Kligman & Epstein, 1975) was carried out on 25 volunteers using 4 ~ p-cresyl isobutyrate in petrolatum and produced no sensitization reactions (Kligman, 1974). References
Council of Europe (1974). Natural Flavouring Substances, Their Sources, and Added Artificial Flavouring Substances. Partial Agreement in the Social and Public Health Field. List 1, no. 304, p. 188. Strasbourg. Flavoring Extract Manufacturers' Association (1965). Survey of flavoring ingredient usage levels. No. 3075. Fd Technol., Champaign 19 (2), part 2, 155. Food Chemicals Codex (1972). 2nd ed. Prepared by the Committee on Specifications, Food Chemicals Codex, of the Committee on Food Protection. p. 831. National Academy of Sciences-National Research Council Publ. 1406, Washington, D.C. Kligman, A. M. (1966). The identification of contact allergens by human assay. III. The maximization test. A procedure for screening and rating contact sensitizers. J. inoest. Derm. 47, 393. Kligman, A. M. (1974). Report to RIFM, 5 June. Kligman, A. M. & Epstein, W. (1975). Updating the maximization test for identifying contact allergens. Contact Dermatitis 1, 231. Levenstein, I. (1974). Report to RIFM, 18 March.
773
p..CRESYL ISOBUTYRATE
Synonym: p-Tolyl isobutyrate. Structure: CHz.C6H4.OCO.CH(CHa) 2. Description and physical properties: EOA Spec. no. 232. Occurrence: Has apparently not been reported to occur in nature. Preparation: From p-cresol and isobutyric acid by esterification. Uses: In public use since the 1930s. Use in fragrances in the USA amounts to less than 1000 lb/yr. Concentration in final product (~o): Usual Maximum
Soap 0.005 0"03
Detergent 0.0005 0.003
Creams, lotions 0.0025 0.01
Perilune 0.04 0.25
Analytical data: Gas chromatogram, RIFM no. 74--64; infra-red curve, RIFM no. 74-64. Status
p-Cresyl isobutyrate was given GRAS status by FEMA (1965) and is approved by the FDA for food use (21 CFR 121.1164). The Council of Europe (1974) included p-cresyt isobutyrate at a level of 0-15 ppm in the list of artificial flavouring substances that may be added to foodstuffs without hazard to public health. The Food Chemicals Codex (1972) has a monograph on p-cresyl isobutyrate. Biological data
Acute toxicity. The acute oral LDs0 value in rats was reported as 4 ml/kg (3.53-4,68 ml/kg) and the acute dermal LDs0 value in rabbits as 3.97 ml/kg (Levenstein, 1974). Irritation. p-Cresyl isobutyrate applied full strength to the intact or abraded skin of rabbits for 24 hr under occlusion was mildly irritating (Levenstein, 1974). Tested on human subjects by a 48-hr occluded-patch test at 4~o in petrolatum, the material was not irritating (Kligman, 1974). Sensitization. A maximization test (Kligman, 1966; Kligman & Epstein, 1975) was carried out on 25 volunteers using 4 ~ p-cresyl isobutyrate in petrolatum and produced no sensitization reactions (Kligman, 1974). References
Council of Europe (1974). Natural Flavouring Substances, Their Sources, and Added Artificial Flavouring Substances. Partial Agreement in the Social and Public Health Field. List 1, no. 304, p. 188. Strasbourg. Flavoring Extract Manufacturers' Association (1965). Survey of flavoring ingredient usage levels. No. 3075. Fd Technol., Champaign 19 (2), part 2, 155. Food Chemicals Codex (1972). 2nd ed. Prepared by the Committee on Specifications, Food Chemicals Codex, of the Committee on Food Protection. p. 831. National Academy of Sciences-National Research Council Publ. 1406, Washington, D.C. Kligman, A. M. (1966). The identification of contact allergens by human assay. III. The maximization test. A procedure for screening and rating contact sensitizers. J. inoest. Derm. 47, 393. Kligman, A. M. (1974). Report to RIFM, 5 June. Kligman, A. M. & Epstein, W. (1975). Updating the maximization test for identifying contact allergens. Contact Dermatitis 1, 231. Levenstein, I. (1974). Report to RIFM, 18 March.