GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 7785-87-7 |
| Chemical Name | Manganese(II) sulphate |
| Substance ID | H29-B-037 |
| Classification year (FY) | FY2017 |
| Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
| New/Revised | Revised |
| Classification result in other fiscal year | FY2006 |
| Download of Excel format | Excel file |
REFERENCE INFORMATION
| Item | Information |
|---|---|
| Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| UN GHS document (External link) | UN GHS document |
| Definitions/Abbreviations (Excel file) | Definitions/Abbreviations |
| Model Label by MHLW (External link) | MHLW Website (in Japanese Only) |
| Model SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
| OECD/eChemPortal (External link) | eChemPortal |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Explosives | Not applicable |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. |
| 2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | Solid (GHS definition). |
| 3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | Solid (GHS definition). |
| 5 | Gases under pressure | Not applicable |
- |
- | - | Solid (GHS definition). |
| 6 | Flammable liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 7 | Flammable solids | Not classified |
- |
- | - | It is not combustible (GESTIS (Access on June 2017)). |
| 8 | Self-reactive substances and mixtures | Not applicable |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. |
| 9 | Pyrophoric liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 10 | Pyrophoric solids | Not classified |
- |
- | - | It is not combustible (GESTIS (Access on June 2017)). |
| 11 | Self-heating substances and mixtures | Not classified |
- |
- | - | It is not combustible (GESTIS (Access on June 2017)). |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not classified |
- |
- | - | It is estimated that it does not react vigorously with water from the measurement data of water solubility of 393 g/L (GESTIS (Access on June 2017)). |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 14 | Oxidizing solids | Classification not possible |
- |
- | - | It is an inorganic compound containing oxygen, but the classification is not possible due to no data. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | It is an inorganic compound. |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not available. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Category 4 |
 Warning |
H302 |
P301+P312
P264 P270 P330 P501 |
Based on a report of an LD50 value of 782 mg/kg (ATSDR (2012)) for rats, this substance was classified in Category 4. |
| 1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 5 | Germ cell mutagenicity | Category 2 |
 Warning |
H341 |
P308+P313
P201 P202 P280 P405 P501 |
As for in vivo, a micronucleus test with mouse bone marrow cells was positive (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ATSDR (2012), CICAD 12 (1999)). As for in vitro, a bacterial reverse mutation test, a mammalian cell chromosomal aberration test and a sister chromatid exchange test were positive (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ATSDR (2012), CICAD 12 (1999)). From the above, it was classified in Category 2 in accordance with the GHS Classification Guidance for the Japanese Government. |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | In a carcinogenicity study with rats and mice given manganese sulfate monohydrate (CAS RN 10034-96-5) by feeding for 2 years, it was stated that for rats, there was no increase in tumor incidence in both sexes and there was no evidence of carcinogenicity. On the other hand, mice showed thyroid follicular cell adenoma in males, and hyperplasia of thyroid follicular cells in females and it was concluded that these were equivocal evidence of carcinogenicity (NTP TR 428 (1993), CICAD 12 (1999), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2012)). In addition, there is a report that development of a tumor in the lung was observed in a test in which this substance was intraperitoneally administered to mice (22 times in 30 weeks) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), CICAD 12 (1999)). Although there is no classification result of carcinogenicity by other organizations, WHO voiced the opinion that it was not possible to conclude on the carcinogenicity of manganese because of the equivocal evidence in rodents and lack of evidence in other species (CICAD 12 (1999)). In addition, the Food Safety Commission of Japan concluded that on the carcinogenicity of manganese, there were no findings indicating carcinogenicity in humans (Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2012)). Based on the opinion of WHO etc. for manganese, it was classified as "Classification not possible" for this hazard class. |
| 7 | Reproductive toxicity | Category 1B |
Danger |
H360 |
P308+P313
P201 P202 P280 P405 P501 |
In a test of a single intraperitoneal administration of this substance to pregnant mice, embryo absorption, malformation (exencephalia), etc. were observed. However, because this was a result under a special condition where a large amount of manganese was intraperitoneally administered, it is reported that it was difficult to apply it to human (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). Other than this substance, after manganese chloride tetrahydrate (CAS RN 13446-34-9) was administered to female and male mice in drinking water for 12 weeks before mating, and then the male and female mice were mated crossover with non-treated females and males, at or above 1,000 mg/L (44-48 mg Mn/kg/day), a decrease in water consumption was observed and at 8,000 mg/L (277-309 mg Mn/kg/day), a decrease in the male fertility index in males and a decrease in the implantation index and the number of live fetuses in females were observed (Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2012), ATSDR (2012)). In a test in which trimanganese tetroxide (CAS RN 1317-35-7) was administered by feeding for 90-100 days before mating, a decrease in the pregnancy rate was observed in females at 130 mg Mn/kg/day (CICAD 12 (1999), ATSDR (2012)). In a study in which manganese chloride (CAS RN 7773-01-5) was administered to pregnant rats in drinking water throughout the pregnancy period, at 75 mg/kg/day (33 mg Mn/kg/day), an increase in embryo loss after implantation was observed in the maternal animals, and a developmental delay of bones and internal organs and the increased incidences of external malformations such as clubfoot were observed in the pups (Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2012), ATSDR (2012)). Manganese chloride tetrahydrate was administered in drinking water to female rats from 15-20 days before pregnancy to 1 month after delivery, and the brains of 40-day-old pups were examined. As the result, at or above 10 mg/kg/day (2.8 mg Mn/kg/day), an increased concentration of manganese in the cerebral cortex, a change in 7-10% of the neurons in the whole brain region, a dose-dependent increase in the glial cell number, and remarkable gliosis in the nucleus accumbens were observed (Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2012)). As for classifications by other organizations, the Japan Society For Occupational Health (JSOH) classifies manganese and manganese compounds as reproductive toxicants Group 2 (corresponding to Category 1B) (Recommendation of Occupational Exposure Limits (2016)). As the above, as the reproductive and developmental toxicity of manganese compounds, on the basis that, at doses at which general toxic effects on parent animals were generally unclear, there are findings such as reduced fertility in both females and males, and growth retardation, external malformations and effects on the cranial nervous system in the pups, and based on the classification results of the Japan Society For Occupational Health (JSOH), it was classified in Category 1B for this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - |
Classification not possible due to lack of data. There is no information on single exposures of this substance in humans and experimental animals. This substance is an inorganic manganese compound and there is information that it is soluble in water (Environmental Risk Assessment for Chemical Substances Vol.6 (Ministry of the Environment, 2008)). For other soluble manganese compounds, there was no information on the single exposure effects of manganese (II) acetate (CAS RN 638-38-0), manganese nitrate (II) (CAS RN 10377-66-9), and manganese (II) chloride tetrahydrate (CAS RN 13446-34-9), as well as this substance, and all were classified as "Classification not possible" due to lack of data in the GHS classification of FY2016. Although it is not the information on this substance, effects on the lungs were reported in humans in the case of manganese dioxide (CAS RN 1313-13-9), which is an insoluble manganese compound, and manganese dust (CICAD 12 (1999)). This substance was classified in Category 1 (respiratory system) in the previous classification, using this information as a reference. However, this substance, which is soluble, may have different effects on the respiratory organs from the insoluble manganese dust in the inhalation exposure. As described above, since there is no information on the effects of this substance and there is no information that can be referred to even with respect to other manganese compounds, this substance was classified as "Classification not possible." The classification result was changed from the previous classification. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (nervous system, respiratory organs) |
Danger |
H372 |
P260
P264 P270 P314 P501 |
As for humans, although there is no information on this substance, when humans were exposed to excess amounts of manganese by the oral or inhalation route, memory disorder, psychiatric symptoms, etc. were observed as acute effects, and as chronic effects, symptoms of manganese addiction similar to those of Parkinson's disease, such as gait disturbance and speech disorders were seen. Serious effects were observed especially in inhalation exposure (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). As for the oral route, in cases of drinking well water containing high concentrations of manganese, and in epidemiological investigations on residents living in regions with high manganese concentration, symptoms similar to manganese addiction such as mask-like faces, muscle rigidity, tremors and psychiatric disorders were reported (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). The influence on neurobehavioral function by exposure to the dust of manganese dioxide, trimanganese tetraoxide, and manganese salts (sulfate, carbonate, nitrate) in plants manufacturing manganese oxides and manganese salts were reported (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). It is reported that neurotoxicity due to manganese addiction occurred by occupational exposure to manganese dioxide. In addition to deterioration in visual simple reaction time and eye-hand coordination, rigidity of the hands was observed (SIDS (2012), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ATSDR (2012)). Furthermore, many case reports revealed that manganese compounds, mainly manganese dioxide, produce respiratory disorders (cough, bronchitis, pneumonia, etc.) (ATSDR (2012)). As for experimental animals, there is no information on this substance, but there is information on the monohydrate. In 13-week repeated dose toxicity tests with rats and mice dosed by feeding and in 2-year repeated dose toxicity tests with rats and mice dosed by feeding, no adverse effects were observed within the range of guidance value for Category 2 (NTP TR428 (1993), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). As the above, since this substance may have effects on the nervous system and respiratory organs in humans, this substance was classified in Category 1 (nervous system, respiratory organs). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Category 3 |
- |
H402 |
P273
P501 |
From 48-hour EC50 = 22.8 mg/L [converted value 8.28 mgMn/L] for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008), Initial Risk Assessment (NITE, CERI, NEDO, 2008)), it was classified in Category 3. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 3 |
- |
H412 |
P273
P501 |
If chronic toxicity data are used, then it is classified as "Not classified" because metal is regarded to be non-biodegradable due to an element though the behavior of a metal salt in water is unknown, and due to water solubility of 389,000 mg/L, and 100-day NOEC (survival rate) = 2.1 mg/L [converted value 0.77 mgMn/L] for fish (Oncorhynchus mykiss) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 3 because metal is regarded to be non-biodegradable due to an element though the behavior of a metal salt in water is unknown, and due to water solubility of 389,000 mg/L, and 96-hour EC50 (POP, non-chelated medium) = 70.6 mg/L [25.7 mgMn/L] for algae (Nitzschia closterium) (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)). From the above results, it was classified in Category 3. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
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* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users. * This is a provisional English translation of classification results and is subject to revision without notice. * The responsibility for any resulting GHS labelling and SDS referenced from this site is with users. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |