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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

Inhalation: The particle size distribution test indicates that inhalation is a possible route of exposure. However, an investigation on the bioavailability of the registered substance in artificial lung fluid demonstrates the very low bioavailability of the substance (see Andersen K, section 7.12). To support this, MnS is not acutely toxic by the oral route (IUCLID section 7.2.1) and not acutely harmful 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 (Furnes B and Strupp C, (2009) MANGANESE AND ITS INORGANIC COMPOUNDS: 1. REPROTOXICITY ASPECTS) showed equivocal evidence of reproductive toxicity with no report or incidence on MnS specifically. The SCOEL (SUM/127;2011) state that there is little evidence for reprotoxicity for manganese and its inorganic compounds.Therefore, taking into account both the very low bioavailability of MnS and animal welfare, this test is not considered scientifically necessary in accordance with Annex XI, section 1.1.  

Dermal: The registered substance is very poorly water soluble (IUCLID section 4.8); hence 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 and this is supported by the result of the study on MnCl2 (see IUCLID section 7.1.2, which showed only 0.79% available Mn was absorbed). Furthermore, there were no systemic effects or any other evidence of absorption seen in the skin and eye irritation studies (IUCLID section 7.3). The SCOEL (SUM/127;2011) state that there is little evidence for reprotoxicity for manganese and its inorganic compounds. Moreover, this is not the most likely route of systemic exposure. Therefore, according to Column 2, Section 8.6 of Regulation No 1907/2006, this test is not considered necessary.   

Oral: MnS is used in industrial settings where good industrial hygiene is employed. Exposure via the oral route is therefore implausible. Therefore, this is not a likely route of exposure. However, in the unlikely event of accidental consumption, the acute oral toxicity test for MnS (IUCLID 5 section 7.2.1) confirms no evidence of toxicity via this route. The SCOEL (SUM/127;2011) state that there is little evidence for reprotoxicity for manganese and its inorganic compounds. Therefore in accordance with Annex XI section 1.1, this test is not considered necessary. 

Link to relevant study records

Referenceopen allclose all

Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
Inhalation: The particle size distribution test indicates that inhalation is a possible route of exposure. However, an investigation on the bioavailability of the registered substance in artificial lung fluid demonstrates the very low bioavailability of the substance (see Andersen K, section 7.12). To support this, MnS is not acutely toxic by the oral route (IUCLID section 7.2.1) and not acutely harmful 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 (Furnes B and Strupp C, (2009) MANGANESE AND ITS INORGANIC COMPOUNDS: 1. REPROTOXICITY ASPECTS) showed equivocal evidence of reproductive toxicity with no report or incidence on MnS specifically. The SCOEL (SUM/127;2011) state that there is little evidence for reprotoxicity for manganese and its inorganic compounds.Therefore, taking into account both the very low bioavailability of MnS and animal welfare, this test is not considered scientifically necessary in accordance with Annex XI, section 1.1.
Dermal: The registered substance is very poorly water soluble (IUCLID section 4.8); hence 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 and this is supported by the result of the study on MnCl2 (see IUCLID section 7.1.2, which showed only 0.79% available Mn was absorbed). Furthermore, there were no systemic effects or any other evidence of absorption seen in the skin and eye irritation studies (IUCLID section 7.3). The SCOEL (SUM/127;2011) state that there is little evidence for reprotoxicity for manganese and its inorganic compounds. Moreover, this is not the most likely route of systemic exposure. Therefore, according to Column 2, Section 8.6 of Regulation No 1907/2006, this test is not considered necessary.
Oral: MnS is used in industrial settings where good industrial hygiene is employed. Exposure via the oral route is therefore implausible. Therefore, this is not a likely route of exposure. However, in the unlikely event of accidental consumption, the acute oral toxicity test for MnS (IUCLID 5 section 7.2.1) confirms no evidence of toxicity via this route. The SCOEL (SUM/127;2011) state that there is little evidence for reprotoxicity for manganese and its inorganic compounds. Therefore in accordance with Annex XI section 1.1, this test is not considered necessary.
Endpoint:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Reproductive effects observed:
not specified

Effects on developmental toxicity

Description of key information

Inhalation: The particle size distribution test indicates that inhalation is a possible route of exposure . However, an investigation on the bioavailability of the registered substance in artificial lung fluid demonstrates the very low bioavailability of the substance (see Andersen K, section 7.12). To support this,  MnS is not acutely toxic by the oral route (IUCLID section 7.2.1) and not acutely harmful 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 (Furnes B and Strupp C, (2009) MANGANESE AND ITS INORGANIC COMPOUNDS: 1. REPROTOXICITY ASPECTS) showed equivocal evidence of reproductive toxicity with no report or incidence on MnS specifically. The SCOEL (SUM/127;2011) state that there is little evidence for development toxicity for manganese and its inorganic compounds. Therefore, taking into account both the very low bioavailability of MnS and animal welfare, this test is not considered scientifically necessary in accordance with Annex XI, section 1.1.

Dermal: The registered substance is very poorly water soluble (IUCLID section 4.8); hence 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 and this is supported by the result of the study on MnCl2 (see IUCLID section 7.1.2, which showed only 0.79% available Mn was absorbed). Furthermore, there were no systemic effects or any other evidence of absorption seen in the skin and eye irritation studies (IUCLID section 7.3). The SCOEL (SUM/127;2011) state that there is little evidence for development toxicity for manganese and its inorganic compounds. Moreover, this is not the most likely route of systemic exposure. Therefore, according to Column 2, Section 8.6 of Regulation No 1907/2006 , this test is not considered necessary.

Oral: MnS is mostly used in industrial settings where good industrial hygiene is employed. Outside these industrial settings, the registered substance is used by trained professionals. Exposure via the oral route is therefore implausible. Therefore, this is not a likely route of exposure. However, in the unlikely event of accidental consumption, the acute oral toxicity test for MnS (IUCLID 5 section 7.2.1) confirms no evidence of toxicity via this route. The SCOEL (SUM/127;2011) state that there is little evidence for development toxicity for manganese and its inorganic compounds. Therefore in accordance with Annex XI section 1.1, this test is not considered necessary. 

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
Inhalation: The particle size distribution test indicates that inhalation is a possible route of exposure . However, an investigation on the bioavailability of the registered substance in artificial lung fluid demonstrates the very low bioavailability of the substance (see Andersen K, section 7.12). To support this, MnS is not acutely toxic by the oral route (IUCLID section 7.2.1) and not acutely harmful 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 (Furnes B and Strupp C, (2009) MANGANESE AND ITS INORGANIC COMPOUNDS: 1. REPROTOXICITY ASPECTS) showed equivocal evidence of reproductive toxicity with no report or incidence on MnS specifically. The SCOEL (SUM/127;2011) state that there is little evidence for development toxicity for manganese and its inorganic compounds. Therefore, taking into account both the very low bioavailability of MnS and animal welfare, this test is not considered scientifically necessary in accordance with Annex XI, section 1.1.
Dermal: The registered substance is very poorly water soluble (IUCLID section 4.8); hence 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 and this is supported by the result of the study on MnCl2 (see IUCLID section 7.1.2, which showed only 0.79% available Mn was absorbed). Furthermore, there were no systemic effects or any other evidence of absorption seen in the skin and eye irritation studies (IUCLID section 7.3). The SCOEL (SUM/127;2011) state that there is little evidence for development toxicity for manganese and its inorganic compounds. Moreover, this is not the most likely route of systemic exposure. Therefore, according to Column 2, Section 8.6 of Regulation No 1907/2006 , this test is not considered necessary.
Oral: MnS is mostly used in industrial settings where good industrial hygiene is employed. Outside these industrial settings, the registered substance is used by trained professionals. Exposure via the oral route is therefore implausible. Therefore, this is not a likely route of exposure. However, in the unlikely event of accidental consumption, the acute oral toxicity test for MnS (IUCLID 5 section 7.2.1) confirms no evidence of toxicity via this route. The SCOEL (SUM/127;2011) state that there is little evidence for development toxicity for manganese and its inorganic compounds. Therefore in accordance with Annex XI section 1.1, this test is not considered necessary.
Species:
rabbit
Abnormalities:
not specified
Developmental effects observed:
not specified

Justification for classification or non-classification

Classification via the inhalation route is not justified because the bioavailability of MnS in artificial lung fluid demonstrates the low bioavailability of the substance (IUCLID section 7.12, Anderson KA). To support this, MnS not acutely harmful by the inhalation route ( IUCLID section 7.2.2, Griffiths DR). 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 MnS specifically.

Classification via the dermal route is not justified because MnS is only slightly water soluble (IUCLID section 4.8, O'Connor and Mullee), hence 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 MnS 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 IUCLID section 7.3, Warren N) .

Classification via the oral route is not justified because MnS is mostly used in industrial settings where good industrial hygiene is employed. Outside these industrial settings, the registered substance is used by trained professionals. Exposure via the oral route is therefore implausible. Therefore, this is not a likely route of exposure. However, in the unlikely event of accidental consumption, the acute oral toxicity test for MnS (IUCLID section 7.2.1, Pooles A) confirms no evidence of toxicity via this route. Low oral absorption of Mn due to the homeostatic mechanism, further supports this justification.

Additional information