Registration Dossier

Diss Factsheets

Administrative data

screening for reproductive / developmental toxicity
Data waiving:
other justification
Justification for data waiving:
Justification for type of information:
Indole is an organic heterocyclic compound with a bicyclic structure having a nitrogen-composed pyyrole ring fused to a benzene ring. Indoles are primarily produced within the human body as a byproduct of the degradation process of the amino acid, tryptophan. It is processed and usually found to accumulate in human feces, and at high concentrations, indoles possess a strong, unpleasant fecal odor. Surprisingly, at very low concentrations, they have a pleasant, flowery smell and are used often as a constituent in flower scents, like orange blossom3. The compound is aromatic and solid at room temperature, and it has many applications in the fragrance industry, and increasingly, the pharmaceutical industry.

It is always present in humans its use in perfumes is about 2 % about 1 ppm = 1ug /ml = 1000ug/L which is below the Treshold of Toxicological Concern ( TCC =90 µg/person/d corresponding to 1.5 µg/kg bw/d for substances without genotoxicity alerts)1, so at the level used does not increase the reproductive risk.

The biodegradation of Amino acids causes the formation of Indoles as well, as many of the amino acids have an Indole back bone. Indole cannot accumulate in the body as the human body does not have a reuptake system for it, thus it gets excreted through faecal matter.2

Performing unnecessary animal experiment is increasing the sacrificing of experimental animals.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion