API TR 403-1995

$20.15

Closed-Patch Repeated Insult Dermal Sensitization Study of Tertiary Amyl Methyl Ether (TAME) in Guinea Pigs

Published By	Publication Date	Number of Pages
API	1995	33

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Description

This study was conducted for American Petroleum Institute in order to evaluate the allergic contact sensitization potential of Tertiary hyl Methyl Ether (TAME) in guinea pigs. This study was performed at Pharmaco LSR Inc., Toxicology Service North America, P.O. Box 2360, Mettlers Road, East Millstone, New Jersey 08875-2360.

TAME was administered as received to twenty Dunkin Hartley guinea pigs (lO/sex). Animals were clipped free of hair, the test material was applied to saturation (approximately 0.3 mls) beneath a Hilltop Chamber". The chamber was occluded and left in place for six hours. This was performed once a week, for three weeks, for a total of three induction exposures. Twenty control animals (5/sex/control material) were similarly treated with Light Mineral Oil (control) or Dinitrochlorobenzene (DNCB; positive control). Challenge treatments followed the same administration procedure as the Induction Phase but at naive sites. In order to differentiate dermal reactions produced by irritation from those produced by sensitization, ten (5/sex) previously untreated animals were subjected to the same challenge procedures, with Light Mineral Oil, DNCB and TAME applied at three separate sites.

Observations for mortality were made twice daily. Body weights were obtained pretest and two days after challenge. Animals were also observed prior to treatment and weekly during the study for general health. Dermal evaluation were made approximately 24 and 48 hours after the first induction exposure and 24 and 48 hours after the challenge exposure.

All animals survived throughout the study. Most animals gained weight throughout the study; Animal No. 8082 (found dead one week after study termination) lost 18 grams of weight during the study.

All ten control animals challenged with 100% light mineral oil were free of significant dermal responses, as were the irritation control animals. The Incidence Index of sensitization to the mineral oil was O%. The Severity Indices at 24 and 48 hours were O, for both mineral oil-treated animals and irritation control animals.

All ten positive control animals treated with 0.3% DNCB exhibited clear dermal responses which were of greater incidence and severity than the responses seen in the irritation control animals to the same concentration. The Incidence Index of sensitization to DNCBwas 100%. The Severity Indices at 24 and 48 hours were 1.8 and 2.1, respectively, for the positive control animals, compared the indices of 0.2 and 1.4 for the irritation control animals. This positive response to a known sensitizer demonstrated the susceptibility of this shipment of animals to sensitization.

All twenty animals challenged with 100% TAME were free of dermal responses as were the irritation control animals. The Incidence Index of sensitization to TAME was O%. The Severity Indices at 24 and 48 hours were O, for test material treated animals and irritation control animals.

Under conditions of this study, TAME did not exhibit any potential to produce dermal sensitization in guinea pigs.

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