[No public or meaningful name is available]

Toxicity to reproduction

Administrative data

Endpoint:

screening for reproductive / developmental toxicity

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

The amino acids in the spider silk protein are found in foods, and the daily exposure from food use would result in a much larger systemic dose than that resulting from use of spider silk proteins.

Therefore, additional testing (in experimental animals) would provide no additional toxicological knowledge about the safe use of the substance.

In conclusion, from the available data combined with the knowledge of the fate of proteins in the gastrointestinal system, it can be concluded that absorption of proteins in toxicological significant amounts through the gastrointestinal tract is unlikely. Proteins, in general, are a natural and necessary part of human and animal diets, and are subjected to rapid degradation by digestive enzymes in the gastrointestinal tract into individual amino acids and small peptides that can be absorbed by the body to support nutritional needs. Large proteins are not known to be absorbed by the intestinal epithelium (sse attached justification).