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eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Justification for type of information:
Study scientifically unjustified as the test substance is used in humans for so many years as a safely cosmetic in the area of the eyes. The FDA approval 21CFR Part 73.2775 for the substance covers externally applied skin contact cosmetics including lipsticks and those used in the area of the eye; no certification is necessary. It is also listed under reference no. 18 in Annex III part 2 (d) of the EEC Directive 76/768/EEC as a pigment which may be used without restriction.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

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