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EC number: 242-520-2 | CAS number: 18718-07-5
One key study is available for acute oral toxicity. This study is performed under the conditions of GLP and to an appropriate OECD guideline. As such, it is considered to be adequate and reliable for use a key studies for the purpose of REACH Registration and classification and labelling in accordance with EU CLP. It is not considered necessary to provide acute dermal toxicity data on the basis of the physiochemical and toxicological properties of manganese bis(dihydrogen phosphate).
Table 1. Individual clinical observations and mortality data – 300 mg/kg
Dose level mg/kg
Effects noted after dosing (hours)
Effects noted during periods after doing
0 = No signs of systemic toxicity
* = Due to a technician error observation not performed
Table 2. Individual bodyweight and bodyweight changes– 300 mg/kg bw
Bodyweight (g) at day
Bodyweight gain (g) during week
Table 3. Individual Necropsy Findings – 300 mg/kg
Time of death
Killed day 14
No abnormalities detected
Table 4. Individual clinical observations and mortality data.– 2000 mg/kg bw
Table 6. Individual bodyweight and bodyweight changes– 2000 mg/kg bw
Table 6. Individual Necropsy Findings– 2000 mg/kg
Section 8.5.2: Adaptation
The inhalation toxicity of manganese bis(dihydrogen phosphate) is influenced by the Mn2+ cation and as such the material is considered to be classified via the inhalation route 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 Commission (1). This relates primarily to cumulative exposures however the authors state that as the proposed values are not based on one single study but on a database of available data the values proposed are acceptable for use in the risk mitigation of both cumulative and peak exposures.
The values are as follows:
- Inhalable IOELV: 0.2 mg/m3
- respirable IOELV: 0.05 mg/m3
It is recommended that both values should be observed conjointly.
Based on the above, it is not considered to be scientifically justified to conduct an acute inhalation study for manganese bis(dihydrogen phosphate) on the basis of the available data and taking into account the requirements to minimise animal testing in accordance with Regulation (EC) No. 1907/2006 (REACH).
(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
Section 8.5.3: Adaptation
In accordance with Annex VIII, Section 8.5.3, Column 2 of Regulation (EC) No. 1907/2006 (REACH) testing by the dermal route is appropriate if :
1. Inhalation of the substance is unlikely; and
2. skin contact in production and/or use is likely; and
3. the physicochemical and toxicological suggest a potential for a significant rate of absorption through the skin.
Although skin contact is likely during production and use of manganese bis(dihydrogen phosphate) dermal absorption is not considered to be favourable for metal compounds. Considerations of molecular weight and logPow do not apply to metals as inorganic compounds require dissociation to metal cations prior to being able to penetrate the dermis. As metal ions have an inherent reactivity towards protein structures the likelihood of them penetrating the skin is reduced. As such, it is anticipated that the following default dermal absorption factors be used for metal cations*:
- From exposure to liquid / wet material: 1%
- From dry (dust) exposure: 0.1%
As systemic absorption will be considerably less via the dermal route as opposed to the oral route it can be reliably assumed that a full characterisation of the acute systemic toxicity profile of manganese bis(dihydrogen phosphate) can be derived from the acute oral study and from the information relating to the inhalation of inorganic manganese substances. Further in vivo testing would be unethical and could not be scientifically justified.
* Default factors taken from the ICMM (2007) HERAG: Health Risk Assessment Guidance for Metals
Acute oral toxicity: The oral LD50has been determined to be > 2000 mg/kg bw and therefore in accordance with Regulation (EC) No. 1272/2008 (EU CLP). Manganese bis(dihydrogen phosphate) is not considered to be classified as acutely toxic via the oral route.
Acute inhalation toxicity: Available data suggests that the health risks relating to manganese exposure via the inhalation route are as a result of repeated exposure. Based on the available data and taking into account the requirements to minimise animal testing in accordance with Regulation (EC) No. 1907/2006 (REACH) it is not considered to be scientifically justified to conduct further testing and no classification is proposed.
Acute dermal toxicity: Based on considerations of the physicochemical and toxicological properties of manganese bis(dihydrogen phosphate) the substance is not considered to be classified as acutely toxic via the dermal route. Further in vivo testing is not scientifically justified.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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