Registration Dossier
Registration Dossier
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EC number: 930-776-4 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Justification for classification or non-classification
Classification by the oral route is not justified based on the lack of significant toxicity observed in the 28 day study (IUCLID 7.5.1) and acute oral toxicity study (IUCLID section 7.2.1). Effects seen in neonates are not considered classifiable for developmental effects (as stated in the CLP regulation), and in the cases where effects are seen, they are related to effects of iron deficiency rather than any direct harmful effect of oral exposure to Mn3O4. Mn3O4 is mostly used in industrial settings where good industrial hygiene is employed. Therefore, this is not a likely route of exposure. However, in the unlikely event of accidental consumption, the acute oral toxicity test confirms no evidence of toxicity via this route.
Classification by the inhalation route is not justified because leaching in artificial lung fluid is very low , hence systemic exposure will also be very low. The very poor solubility in water (0.79 mg/L, see IUCLID section 4.8) is likely to mean that a significant percentage of any particles inhaled will undergo mucociliary escalation back into the gastro-intestinal tract where there is a low level of oral toxicity.
An investigation on the bioavailability of the registered substance in artificial lung fluid demonstrates the low bioavailability of the substance in the lungs (0.000047%, see IUCLID section 7.12). To support this, Mn3O4 is not acutely toxic by the inhalation route ( IUCLID section 7.2.2). A literature review of available human and animal data on reproductive toxicity to manganese-based compounds showed equivocal evidence of reproductive toxicity with no report or incidence on inhaled Mn3O4 specifically
Classification by the dermal route is not justified due to the very poor water solubility of Mn3O4 and hence a minimal amount of the potential substance is made available for systemic absorption via the dermal route.
Even if minimally available from exposure, the physiological properties of the registered substance do not indicate a significant rate of absorption through the skin. Furthermore, there were no systemic effects or any other evidence of absorption seen in the skin and eye irritation studies .
Additional information
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