Hexamethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]

Endpoint summary

Description of key information

In an occluded Patch test in humans no irritating or sensitising effects were noted in any of the probands. (IBT, 1978)

Additional information

A human patch test with repeated insult following the procedure of Draize, J. H. , Food Drug Cosmetic Law J., 10, 722 (1955) and Shelanski, H. A., and Shelanski, M. U., Proc Sci. Sect. Toilet Goods Assoc., 20, 46 (1953) was conducted (BASF, 1978). The test material was evaluated as a 10 % suspension in PEG-400. 50 male and female test subjects were exposed to 0.1 mL of the test substance per patch. 9 occlusive induction applications were applied to the intact skin of the upper back scapular area on three consecutive days each week. The patch was left in place for 23 hours. The skin sites were graded 30 to 60 minutes following the patch removal. 12 days after the last induction application, all panelists are exposed to a single occluded patch application of the test substance as during induction phase. The challenge patch is placed adjacent to but not in contact with the site of the induction applications. Grading for irritation was done 30 to 60 minutes after patch removal. Readings for sensitisation were done after 48 and 72 hours. One subject exhibited a slight reaction following the sixth patch application during the induction phase of the study. No further evidence of irritation was noted on this or any of the remaining 49 participants throughout the course of the study. There was no evidence of skin sensitisation noted in any of the test subjects following the challenge application.

This study was performed by a discredited CRO, therefore the quality is questionable. Nevertheless, the results are in line with the results obtained by recently performed state of the art in vitro testing.