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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.05 mg/m³
Most sensitive endpoint:
neurotoxicity
DNEL related information
DNEL derivation method:
other: Based on respirable IOELV for manganese
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.05 mg/m³
Most sensitive endpoint:
neurotoxicity
DNEL related information
DNEL derivation method:
other: Based on respirable IOELV for manganese

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

Manganese sulphate and manganese dichloride read-across toxicity data have been where data on the registered substance are not available. Read-across is considered justified as manganese is considered to be the main driver of the toxicity of the registered substance and the soluble sulphate and chloride salts present a "worst-case" in view of their very high water solubility and bioavailability. 

DNEL derivation

 

The critical local (dermal, respiratory tract) effects of exposure to sodium permanganate will be irritation / corrosion at the site of contact due to the corrosive nature of the substance. These effects must be managed by the use of PPE and / or engineering controls to eliminate the potential for dermal exposure to high concentrations of the substance. Local irritation may not occur following dermal or inhalation exposure to low concentrations of the substance, however this cannot be quantified and therefore DNEL values for local effects are not proposed.

 

The critical effect of exposure to the substance, based on extensive data from other manganese compounds, is assumed to be neurotoxicity. Neurotoxicity has not been specifically investigated for the substance, however it is assumed that will occur by analogy with other inorganic manganese compounds. While the majority of effects in the studies with the substance are consistent with local irritation, findings from the reproduction range-finding study indicate neurological effects in offspring. It is therefore concluded that neurotoxicity is the critical effect relevant to the derivation of systemic DNEL values.

 

The SCOEL (2011) has published a consultation on the derivation of IOEL values for manganese and inorganic manganese compounds. This consideration is based on a comprehensive review of the extensive database for this group of substances which is beyond the scope of this IUCLID dossier.

 

The SCOEL (2011) conclude that, although manganism has long been recognised as being associated with high occupational manganese exposures, recent attention has focused on more subtle neurofunctional effects that may occur at lower levels of exposure. A review of the evidence, supported by additional studies published subsequently led to the concliusion that, in humans, the critical effects associated with contemporary (low) occupational exposure to manganese are neurological. These subtle neurological effects, that is, principally small sub-clinical neuromotor effects, are considered to be of sufficient concern to warrant the establishment of an appropriate occupational exposure standard. A limited number of longitudinal investigations on these more subtle effects indicate a stability (lack of progression) of adverse effects when exposure is reduced, but also indicate that such effects, once established, may not be reversible. Furthermore, most of the neurofunctional effects observed reflect changes in neuromotor function, as is the case with overt manganism. There are a sufficient number of well-conducted studies on workers exposed to known or reasonably well-estimated amounts of manganese to use human data for the derivation of a health-based Indicative Occupational Exposure Limit Value (IOELV). SCOEL highlighted that it was not possible to identify a single critical study as the best basis for DNEL derivation, but used a global approach based on the entire dataset.

 

The indicative respirable IOELV is 0.05 mg/m3 and an inhalable IOELV is 0.2 mg/m3 for manganese and manganese inorganic compounds. While recommending these values, SCOEL recognised that the overall systemic absorption of coarser particles (> respirable) is probably substantially lower than for the respirable fraction. Thus, SCOEL recommended both a respirable and an inhalable IOELV which would need to be observed conjointly. It was recommended that workplaces should, as a default procedure, measure both respirable and inhalable manganese to ensure compliance with both limits. This will protect workers exposed to respirable manganese, such as welders, and also workers exposed to inhalable manganese in workplaces with low fractions of respirable manganese, likely the case for sodium permanganate. In each specific working circumstance, professional judgement should however, be applied to select the most appropriate fraction to be measured. It was considered that a STEL was not required. Dermal absorption of manganese is likely to be negligible (and exposure limited due to corrosivity), therefore systemic dermal DNEL values have been derived only as precautionary.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population