Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
As indicated in the attached article ( Clark), the typical use of indole is around 200 ppm to 0.01%.
Sometimes this goes up to 1% but above that the odour becomes unpleasant.
Fine fragrances are at most 15-30 % of the total, so at maximum, in an extreme case there would be 0.3 % indole in the end product.
More typically, for say a shampoo or functional product, the fragrance element is only up to 1% of the total product (often 0.2-0.5%) so the amount of indole is extremely low. In any event, the amounts we are talking about in the fragrances themselves are extremely small. The exposure can be negligible.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion