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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
exposure considerations
Justification for data waiving:
the study does not need to be conducted because (i) the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), (ii) it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and (iii) there is no or no significant human exposure
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Study scientifically unjustified as the substance is a biological material, and is used as substrate in culture media, so it is unlikely to be reprotoxic or foetotoxic. Peptones are considered readily biodegradable, considered non-hazardous, and often used as feeding source for testing microbial activity. See attached documentation.

Data source

Materials and methods

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

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