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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Toxicity to reproduction: other studies

Additional information

Manganese bis(dihydrogen phosphate) is only used in industrial settings where good industrial hygiene is employed, exposure via the oral route is therefore implausible.

The toxicology of manganese bis(dihydrogen phosphate) is related to the presence of the Mn2+ ion (as phosphate itself is not considered to be toxic) and as such it is considered to be scientifically justified to read-across to other soluble manganese substances which have been extensively investigated. Manganese bis(dihydrogen phosphate) is therefore considered to be classified as STOT RE2 (target organ brain) in accordance with Regulation (EC) No. 1272/2008 (EU CLP) and on the basis of neurological symptoms (neurotoxicity) observed after inhalation of manganese. Neurotoxicity is considered to be the leading health effect and as such an IOELV has been proposed and adopted by the European Commission1. This value is considered to be sufficiently protective so that the required risk management measures will defend against any unidentified health risks.

Further, in a 2-year carcinogenicity study of manganese sulphate, no evidence of any effects on the reproductive system or developmental toxicity were observed. Therefore, taking this into account together with animal welfare concerns regarding the unnecessary conduct of in vivo studies, this test is not considered to be scientifically necessary.

 

 

1‘Recommendation from the Scientific Committee on Occupational Exposure Limits for Manganese and Inorganic Manganese Compounds’. SCOEL/SUM/127 – Adopted by the European Commission, June 2011

Justification for classification or non-classification

In a number of scientific reviews1,2,3 of the toxicological data relating to the effects of manganese and inorganic manganese compounds, no evidence of reproductive or developmental toxicity was observed. For the reasons discussed above it is not considered to be scientifically justified to conduct in vivo animal studies when the risk of exposure to manganese bis(dihydrogen phosphate) is considered to be low. As such, no classification is proposed.

1‘Recommendation from the Scientific Committee on Occupational Exposure Limits for Manganese and Inorganic Manganese Compounds’. SCOEL/SUM/127 – Adopted by the European Commission, June 2011

2TOXICOLOGICAL PROFILE FOR MANGANESE. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES. Public Health Service Agency for Toxic Substances and Disease Registry. September 2012

3Occupational exposure limits: Criteria document for manganese and inorganic manganese compounds. IEH Web Report W17, October 2004

Additional information