Registration Dossier
Registration Dossier
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EC number: 293-426-3 | CAS number: 91079-38-8
Toxicity to reproduction
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
