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Lack of sensitization for trimellitate, phthalate, terephthalate and isobutyrate plasticizers in a human repeated insult patch test.

Abstract
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.
AuthorsR M David, L K Lockhart, K M Ruble
JournalFood and chemical toxicology : an international journal published for the British Industrial Biological Research Association (Food Chem Toxicol) Vol. 41 Issue 4 Pg. 589-93 (Apr 2003) ISSN: 0278-6915 [Print] England
PMID12615132 (Publication Type: Journal Article)
CopyrightCopyright 2003 Elsevier Science Ltd.
Chemical References
  • Benzoates
  • Butyrates
  • Glycols
  • Irritants
  • Phthalic Acids
  • Plasticizers
  • tri-(2-ethylhexyl)trimellitate
  • 2,2,4-trimethyl-1,3-pentanediol diisobutyrate
  • terephthalic acid
Topics
  • Adolescent
  • Adult
  • Aged
  • Benzoates (adverse effects, toxicity)
  • Butyrates (adverse effects, toxicity)
  • Dermatitis, Contact (pathology)
  • Erythema (chemically induced, pathology)
  • Female
  • Glycols (analysis, toxicity)
  • Humans
  • Irritants (toxicity)
  • Male
  • Middle Aged
  • Patch Tests
  • Phthalic Acids (adverse effects, toxicity)
  • Plasticizers (adverse effects, toxicity)
  • Skin (pathology)

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