Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
250 mg/kg bw/day
Additional information

Of the Persulfate Category, only diammonium persulfate was tested for oral reproductive/developmental toxicity in a screening test with rats according to OECD guideline no. 421. No test substance related effects were observed in P and F1 generations. A NOAEL value of 250 mg/kg/day for parental toxicity, reproduction parameters and developmental toxicity was determined. As all substances of the Persulfate Category share the same anionic persulfate moiety and similar toxicological properties a read across approach was applied for dipotassium persulfate and disodium persulfate using results obtained with diammonium persulfate.


Short description of key information:
The reproductive/developmental toxicity potential of dipotassium persulfate was assessed by a read across approach using results of a reproduction/developmental toxicity screening test according to OECD guideline no. 421 obtained with diammonium persulfate, a substance of the Persulfate Category, as this substance shows similar toxicological properties. Based on the results obtained with diammonium persulfate, a NOAEL for parental toxicity, reproductive parameters and developmental toxicity of 250 mg/kg bw/day was determined.

Effects on developmental toxicity

Description of key information

Performance of a developmental toxicity / teratogenicity study for substances of the Persulfate Category was waived in accordance with column 2 of REACH Regulation (EC) No 1907/2006, Annex IX, Sect. 8.7.

Additional information

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.

Justification for classification or non-classification

Based on the results obtained, substances of the Persulfate Category were not classified and labelled for reproduction/developmental toxicity according to Directive 67/548/EEC (DSD) and Regulation 1272/2008/EC (CLP).