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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

A single dose of manganese dioxide (250 mg/kg intratracheal administration) in rabbits caused severe degenerative changes in the seminiferous tubules and these effects led to sterility. This effect did not occur immediately but developed slowly over the period of 4~8 months following the exposure. A LOAEL was 250 mg/kg/day in male rabbit (see Seth at all, Effects of manganese on rabbits testes, Environmental and physiological biochemistry, 3(6): 263-267, 1973 mentioned in SIDS Dossier of MnO2 approved at SIAM 25 (17 -18 October 2007).


Short description of key information:
The available information on animals suggests that manganese dioxide causes probably negative effects on fertility but based on human data no classification is reasonably possible. The data on human male are equivocal and there are no data for female (see section 7.10 IUCLID).

Effects on developmental toxicity

Description of key information
The available information on animal suggests that manganese dioxide shows developmental toxicity (locomotory deseases in the offspring) but there are no sufficient data for classification.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available (further information necessary)
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

As reported in SIDS Dossier of MnO2 approved at SIAM 25 (17 -18 October 2007) with reference to Lown et all, Effects on the postnatal development of the mouse of preconception, postconception and/or suckling exposure to manganese via maternal inhalation exposure to MnO2 dust,Neurotoxicology,5(1): 119-129, 1984 effects on pup body weight and locomotor activity were observed on mice after inhalation exposure of of 61 mg/m3/day.Female mice were exposed either to MnO2 dust (7 hours/day, 5 days/week) or filtered air (control group) for 16 weeks prior to conception. Compared to control mothers, mothers exposed to MnO2 prior to conception produced significantly larger litters. Prenatal exposure resulted in reduced neonatal activity scores and retarded offspring growth that persisted into adulthood. The study cannot be used for a quantitative risk assessment, as only one exposure condition was tested.

Justification for classification or non-classification

Regarding fertility, the available information on animals suggests that manganese dioxide causes probably negative effects on fertility but based on human data no classification is reasonably possible. The data on human male are equivocal and there are no data for female (See section 7.10 IUCLID). MnO2 is not classified for toxicity to reproduction according to annex VI of CLP Regulation (EC n.1272/2008).

Additional information