Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
The performance of a developmental toxicity/teratogenicity study for substances of the Persulfate Category is scientifically not justified. In column 2 of REACH Regulation (EC) No 1907/2006, Annex IX, Sect. 8.7., states as follows: „Reproductive toxicity studies do not need to be conducted if: - the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented, or - the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented, or - the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), 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 there is no or no significant human exposure.“ No evidence of developmental toxicity was revealed in a screening test of reproduction/developmental toxicity with diammonium persulfate in rats according to OECD guideline no. 421 (NOAEL for reproduction/developmental toxicity was >= 250 mg/kg/day). Additionally, as deduced in the toxicokinetic assessment, bioaccumulation of substances of the Persulfate Category is very unlikely to occur and 28 and 90 day oral toxicity studies do not imply of relevant toxicological activity . Therefore, it is very unlikely that persulfates would cause adverse developmental toxicity effects. Conducting such a study is thus scientifically not justified and not in line with animal welfare.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion