Lack of sensitization for trimellitate, phthalate, terephthalate and isobutyrate plasticizers in a human repeated insult patch test.
Two hundred and three human volunteers were tested for evidence of sensitization to several plasticizers following 3 weeks of dermal application three times a week. Tris(2-ethylhexyl)mellitate (TOTM; 1%, v/v), 2,2,4-trimethyl-1,3-pentanediol-diisobutyrate (TXIB; 1%, v/v), di(2-ethylhexyl)terephthalate (DEHT; 0.5%, v/v) and diethylphthalate (DEP; 2%, v/v) were applied to the skin of volunteers under semi-occlusive patch for 3 consecutive weeks and the reactions to a challenge application noted following a 2-week rest period. Slight erythema was observed in four individuals exposed to TOTM, two of which resolved within 96 h and one that occurred only after 96 h. Slight erythema was noted in three subjects exposed to TXIB, one of which resolved by 96 h and one that occurred only after 96 h. Two subjects had slight erythema to DEHT, one that resolved by 96 h and one that occurred only after 96 h. One reaction occurred with DEP at 96 h after challenge. Of the positive responses, one subject reacted to all test substances. No subject had a response grade of 1.0 or greater. Because of the low response, the overall conclusion is that none of the plasticizers demonstrated evidence of sensitization or irritation.
David
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Health and Environment Laboratories, Eastman Kodak Company, Rochester, New York, USA. raymond.david@kodak.com
Lockhart
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Ruble
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D000293:Adolescent; D000328:Adult; D000368:Aged; D001565:Benzoates / Q000009:adverse effects / Q000633:toxicity*; D002087:Butyrates / Q000009:adverse effects / Q000633:toxicity*; D003877:Dermatitis, Contact / Q000473:pathology*; D004890:Erythema / Q000139:chemically induced / Q000473:pathology; D005260:Female; D006018:Glycols / Q000032:analysis / Q000633:toxicity*; D006801:Humans; D007509:Irritants / Q000633:toxicity; D008297:Male; D008875:Middle Aged; D010328:Patch Tests; D010795:Phthalic Acids / Q000009:adverse effects / Q000633:toxicity*; D010968:Plasticizers / Q000009:adverse effects / Q000633:toxicity*; D012867:Skin / Q000473:pathology
D001565:Benzoates; D002087:Butyrates; D006018:Glycols; D007509:Irritants; D010795:Phthalic Acids; D010968:Plasticizers; C036101:tri-(2-ethylhexyl)trimellitate; C001508:2,2,4-trimethyl-1,3-pentanediol diisobutyrate; C011363:terephthalic acid