Propyl Gallate-Contact Sensitization and Orally-Induced Tolerance

Kahn, Guinter; Phanuphak, Praphan; Claman, Henry N.

doi:10.1001/archderm.1974.01630040016003

Cited by 40 publications

(16 citation statements)

References 6 publications

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“…They are usually cheilitis and dermatitis of the hands. Previous exposure and orally induced tolerance, may explained the low rates of allergic contact dermatitis to propyl gallate (Kahn, 1974). Due to this potential, it has been recommended to limit its concentration in cosmetics (Cosmetic Ingredient Review Expert Panel, 2007).…”

Section: Sensitisationmentioning

confidence: 99%

Scientific Opinion on the re‐evaluation of propyl gallate (E 310) as a food additive

2014

EFS2

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The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion reevaluating the safety of propyl gallate (E 310). Propyl gallate is an antioxidant authorised as a food additive in the EU. In 1976, the SCF established a group ADI of 0-0.2 mg/kg bw for three gallates (propyl, octyl, dodecyl). JECFA in its last evaluation in 1996 allocated an ADI only to propyl gallate of 0-1.4 mg/kg bw and did not establish ADIs for octyl and dodecyl gallate. The Panel considered that no substantial new toxicological data have emerged since this last evaluation. The Panel concluded that the 90-day toxicity study in rats was the key study for the evaluation of propyl gallate considering the uncertainties and lack of a NOAEL in the carcinogenicity database on propyl gallate. Based on the NOAEL of 135 mg propyl gallate/kg bw/day of this study and taking account of the Opinion of the Scientific Committee of EFSA on Default values, the Panel concluded that an uncertainty factor of 300 should be applied for extrapolation from a subchronic to chronic data and due to the limitations in the reproductive toxicity database and derived an ADI of 0.5 mg/kg bw/day for propyl gallate.The Panel also concluded that there was no longer a basis for the present group ADI and that propyl, octyl and dodecyl gallates should be evaluated separately and the present group ADI should be withdrawn. The high level of exposure exceeded the ADI in adults and the elderly. However, given the conservatism of the exposure assessment, the Panel concluded that the use of propyl gallate as food additive at the current uses and use levels is not of safety concern.

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Section: Sensitisationmentioning

confidence: 99%

Scientific Opinion on the re‐evaluation of propyl gallate (E 310) as a food additive

2014

EFS2

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“…Patch testing with a 20% solution in 70% ethanol resulted in pruritus and erythema in 5 of 10 healthy volunteers (Kahn et al 1974). Patch testing with a 20% solution in 70% ethanol resulted in pruritus and erythema in 5 of 10 healthy volunteers (Kahn et al 1974).…”

Section: Jo22 Dermatological Effectsmentioning

confidence: 99%

“…Sensitisation appears to occur rarely in patients with normal, intact skin (Cusano et al 1987). Conversely, prior oral feedings to guinea pigs produced tolerance to the sensitising effects and may explain the scarcity of reported cases in humans (Kahn et al 1974). Sensitisation presumably occurred from prior oral ingestion.…”

Section: Jo22 Dermatological Effectsmentioning

confidence: 99%

Pharmaceutical Excipients

et al. 1988

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“…28 Unfortunately, five of ten test subjects developed erythema and pruritu s and the authors (Hakn et al) felt it was unsuitable for general u se. 49 Fusaro and Runge reported the use of a topical agent that gave photoprotection by a chemical reaction with keratin. 50 Three percent dihydroxyacetone in a 50 % isopropyl alcohol-water vehicle, and 0.25 % naphthoquinone in a similar carrier, were applied separately for several days until the skin achieved a tanned color; they were then applied as needed to maintain protection.…”

Section: Chemical Agentsmentioning

confidence: 99%