Registration Dossier
Registration Dossier
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EC number: 242-768-1 | CAS number: 19035-79-1
Endpoint summary
Administrative data
Description of key information
One study performed with human subjects is available - a repeated insult patch test. Results of the test showed that the substance has no irritation or allergenic potential in human.
Additional information
One study performed with human subjects is available - a repeated insult patch test. The purpose of the test was to determine the irritation and/or sensitization potential of the test product potassium hexadecyl hydrogen phosphate (6 %) after repeated application under occlusive patch test conditions to the skin of human subjects.
The amount of test material applied to each occlusive patch was approximately 0.2 mL. This patch was applied to the back of each subject. The subjects removed the patches 24 h later on Tuesdays, Thursdays or Saturdays. After a rest period of 24 h (Tuesday and Thursday removals) or 48 h (Saturdays removal) the next patch is applied. The application site was examined prior to the next application by trained examiner. Altogether, 9 induction applications were done.
Challenge:
After a 10 to 21-day rest period, the challenge patch was applied to a previously untreated site. This site was scored 24 and 48 h after application.
Results
A total of 53 subjects completed the procedures. Scattered, barely perceptible non specific patch test responses were seen in 2 subjects both during induction and challenge phase. This reaction had disappeared after 72 h. In all other subjects no skin reactions were noted.
Conclusion
The test substance was neither considered irritant nor allergen in humans.
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