Item | Information |
---|---|
CAS RN | 10034-96-5 |
Chemical Name | Manganese sulphate monohydrate |
Substance ID | m-nite-10034-96-5_v1 |
Download of Excel format | Excel file |
Item | Information |
---|---|
Guidance used for the classification (External link) | To Guidance List |
UN GHS document (External link) | To UN GHS document |
FAQ(GHS classification results by the Japanese Government) | To FAQ |
List of Information Sources (Excel file) | List of Information Sources |
List of Definitions/Abbreviations | Definitions/Abbreviations |
Sample Label by MHLW (External link) | MHLW Website (in Japanese Only) |
Sample SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
OECD/eChemPortal (External link) | To OECD/eChemPortal (External link) |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
1 | Explosives | Not classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
6 | Flammable liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
7 | Flammable solids | Not classified |
- |
- | - | It was classified as "Not classified" from information that it is not combustible (ICSC (2018)). | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
8 | Self-reactive substances and mixtures | Not classified (Not applicable) |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
9 | Pyrophoric liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
10 | Pyrophoric solids | Not classified |
- |
- | - | It was classified as "Not classified" from information that it is not combustible (ICSC (2018)). | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
11 | Self-heating substances and mixtures | Not classified |
- |
- | - | It was classified as "Not classified" from information that it is not combustible (ICSC (2018)). | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
12 | Substances and mixtures which, in contact with water, emit flammable gases | Not classified |
- |
- | - | It contains a metalloid (Mn), but it was classified as "Not classified" because it is estimated that it does not react vigorously with water from water solubility data of 76.2 g/100 mL (20 deg C) (ICSC (2018)). | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
14 | Oxidizing solids | Classification not possible |
- |
- | - | It is an inorganic compound containing oxygen (but not halogen). However, the classification is not possible due to no data. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Inorganic compound. It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
16 | Corrosive to metals | Classification not possible |
- |
- | - | Classification is not possible because test methods applicable to solid substances are not available. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
17 | Desensitized explosives | Not classified |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Category 4 |
Warning |
H302 | P301+P312 P264 P270 P330 P501 |
[Rationale for the Classification] Based on (1), it was classified in Category 4. The category was changed from the previous classification by the use of new information sources. [Evidence Data] (1) LD50 (anhydrate) for rats: 782 mg/kg (a converted value equivalent to this substance: 875.2 mg/kg) (ATSDR (2012), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), CICAD 12 (1999)) |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Inhalation: Gases) | Not classified (Not applicable) |
- |
- | - | [Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)." |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
2 | Skin corrosion/irritation | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1), it was classified as "Not classified." The category was changed due to new data obtained. [Evidence Data] (1) In two skin irritation tests with rabbits according to OECD TG 404, no skin reaction was observed, and the mean scores at 24/48/72 hours were all 0 (REACH registration dossier (Access on September 2019)). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
3 | Serious eye damage/eye irritation | Category 1 |
Danger |
H318 | P305+P351+P338 P280 P310 |
[Rationale for the Classification] Based on (1), it was classified in Category 1. The category was changed due to new data obtained. [Evidence Data] (1) In an eye irritation test with rabbits according to OECD TG 405 (only one animal, humanely killed after 7 days), since irreversible symptoms were observed, it was judged to be corrosive (REACH registration dossier (Access on September 2019)). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
4 | Skin sensitization | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
5 | Germ cell mutagenicity | Category 2 |
Warning |
H341 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2. [Evidence Data] (1) As for in vivo, there are reports of positive results in a micronucleus test and a chromosomal aberration test with mouse bone marrow (CICAD 12 (1999), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). (2) As for in vitro, there are reports of a negative result in a bacterial reverse mutation test and a positive result in a mammalian cell chromosomal aberration test (NTP TR428 (1993), NTP DB (Access on July 2019)). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
6 | Carcinogenicity | Classification not possible |
- |
- | - | [Rationale for the Classification] There are no classification results by domestic and international organizations. There are no available reports on humans. Though there is a report in (1), based on the WHO opinion in (2), it was classified as "Classification not possible" due to lack of data. [Evidence Data] (1) In carcinogenicity tests in which this substance was administered to rats and mice by feeding for 2 years, as for rats, no increased incidence of tumors was observed in both sexes, and it was judged that there was no evidence of carcinogenicity. On the other hand, as for mice, thyroid gland follicular cell adenoma was observed in males, and follicular cell hyperplasia was observed in females. Therefore, it was concluded that there was equivocal evidence of carcinogenicity (NTP TR428 (1993)). (2) The WHO expressed an opinion that firm conclusions on the carcinogenic potential of manganese could not be made based on the equivocal evidence for rodents and the paucity of evidence from other species (CICAD 12 (1999)). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
7 | Reproductive toxicity | Category 1B |
Danger |
H360 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] Though there are no data on this substance, based on (1)-(4), it was classified in Category 1B. The classification result was changed due to classification as a manganese compound. [Evidence Data] (1) Japan Society For Occupational Health (JSOH) classified manganese and manganese compounds as reproductive toxicants Group 2 (corresponding to Category 1B) (OEL Documentations (Japan Society For Occupational Health (JSOH), 2014)). (2) As a result of cross-over mating in which male and female mice were exposed to manganese chloride tetrahydrate (CAS RN 13446-34-9) by drinking water for 12 weeks and were mated with unexposed females and males, respectively, at the dose where decreased drinking water consumption was observed in parental animals, lower fertility rate in males, and decreases in implantation rate and the number of surviving fetuses in females, were observed (Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2012), ATSDR (2012)) (3) In a test in which manganese chloride (CAS RN 7773-01-5) was administered to pregnant rats by drinking water throughout gestation, an increase in post-implantation embryonic loss in maternal animals, and developmental retardation of the skeleton and internal organs, and an increased incidence of external malformations such as clubfoot in pups, were observed (Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2012), ATSDR (2012)). (4) As a result of a test in which manganese chloride tetrahydrate (CAS RN 13446-34-9) was administered to rats by drinking water from 15-20 days before gestation up to 1 month after delivery, and the brains of 40-day-old pups were examined, increased manganese concentrations in the cerebral cortex, changes in 7-10% of the neurocytes in all brain parts, a dose-related increase in the number of glia cells, and noticeable gliosis in the nucleus accumbens were observed (Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2012)). [Reference Data, etc.] (5) Manganese sulfate (II) (CAS RN 7785-87-7), the anhydrate of this substance, was classified in Category 1B in GHS classification of Japan (FY 2017). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - | [Rationale for the Classification] There is no report of single exposure to this substance in humans and experimental animals. Therefore, it was classified as "Classification not possible" due to lack of data. [Reference Data, etc.] (1) As for manganese sulfate (II) (CAS RN 7785-87-7), the anhydrate of this substance, there is no information of the effects on a single exposure to itself, and there is no useful information of other soluble manganese compounds. Therefore, it was classified as "Classification not possible" in the GHS classification in Japan (FY 2017). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (central nervous system, respiratory organs) |
Danger |
H372 | P260 P264 P270 P314 P501 |
[Rationale for the Classification] Based on (1)-(3), it may cause effects on the central nervous system and respiratory organs as exposure to manganese compounds in humans. Based on (4)-(6), as a result of experimental animal studies with manganese sulfate (as the anhydrate or dihydrate), effects on the central nervous system and respiratory organs were observed within the range of Category 1. Therefore, it was classified in Category 1 (central nervous system, respiratory organs). The classification result was changed from the previous classification by adding information of manganese compounds and reviewing. [Evidence Data] (1) The potential risk on the industry handling manganese sulfate is chronic manganism, and its main target organs are the central nervous system and lungs. In factories manufacturing manganese dioxide (CAS RN 1313-13-9) and manganese salts, slight disorders of lung functions such as bronchitis were observed in workers exposed to an average airborne concentration of 1.13 mg/m3 of manganese for years. In addition, by exposure to high concentrations of manganese, central nervous system disorders (headache, memory disorder, vertigo, weakness and fatigue, then, gait and speech disorders, muscle dystonia, tremors, and finally, convulsive paralyzed extremities) were observed (GESTIS (Access on August 2019)). (2) In a case of ingesting well water containing high concentrations of manganese, and in epidemiological studies of residents living in the area of high concentrations of manganese, the symptoms like manganese toxicity such as a masklike face, muscle rigidity, tremors and psychiatric disorders were reported (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). (3) In factories manufacturing manganese oxides and manganese salts, effects on neurobehavioral function were reported due to exposure to the dust of manganese dioxide, manganese tetroxide and manganese salts (sulfates, carbonates, nitrates) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). (4) In a test in which rats were exposed to manganese sulfate anhydrate (CAS RN 7785-87-7) by inhalation (6 hours/day, 5 days/week) for 90 days, transient inflammation was observed in the olfactory epithelium in the nasal cavity at 0.5 mg/m3 (converted guidance value: 0.001 mg/L, within the range of Category 1) (ATSDR (2012)). (5) In a test in which rats were exposed to manganese sulfate dihydrate by inhalation (6 hours/day, 5 days/week) for 90 days, increased locomotor activity was observed at 1.5 mg/m3 (converted guidance value: 0.001 mg/L, within the range of Category 1) (ATSDR (2012)). (6) In a test in which monkeys were exposed to manganese sulfate anhydrate by inhalation (6 hours/day, 5 days/week) for 90 days, bronchiolitis and alveolar duct inflammation were observed at 1.5 mg/m3 (converted guidance value: 0.001 mg/L, within the range of Category 1) (ATSDR (2012)). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
10 | Aspiration hazard | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
11 | Hazardous to the aquatic environment Short term (Acute) | Classification not possible |
- |
- | - | - | FY2006 | GHS Classification Manual (10 Feb, 2006) |
11 | Hazardous to the aquatic environment Long term (Chronic) | Classification not possible |
- |
- | - | - | FY2006 | GHS Classification Manual (10 Feb, 2006) |
12 | Hazardous to the ozone layer | - |
- |
- | - | - | - | - |
|