Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
study scientifically not necessary / other information available
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

Data source

Materials and methods

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
According to column 2 of REACH Annexes on standard information requirements, the reproductive toxicity test does not have to be performed because toxicokinetics evidences do not support the adsorption (after oral administration) and the subsequently reaching of the target tissue by the substance. Furthermore, according to column 2 of REACH Annexes on standard information requirements, the substance does not have wide dispersive use and the human exposure is limited to the workplaces where RMM can effectively limit the extent of the exposure. In light of above issues, no reproduction toxicity test has been carried out and no testing is proposed at the present.
Executive summary:

According to column 2 of REACH Annexes on standard information requirements, the reproductive toxicity test does not have to be performed because toxicokinetics evidences do not support the adsorption (after oral administration) and the subsequently reaching of the target tissue by the substance. Furthermore, according to column 2 of REACH Annexes on standard information requirements, the substance does not have wide dispersive use and the human exposure is limited to the workplaces where RMM can effectively limit the extent of the exposure. In light of above issues, no reproduction toxicity test has been carried out and no testing is proposed at the present.