GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 10102-18-8 |
| Chemical Name | Sodium selenite |
| Substance ID | H29-B-104 |
| 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 | FY2014 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 | Classification not possible |
- |
- | - | There is the information that it is combustible under specific conditions (ICSC (J) (1998)), but the classification is not possible due to no data. |
| 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 estimated that it does not ignite at normal temperatures because it is stable in the air (Merck (15th, 2013)) |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | No data available. |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not classified |
- |
- | - | It contains metalloids (Se), but it is estimated that it does not react vigorously with water from the measurement data of water solubility of 89.8 g/100 g water (HSDB (Access on September 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 2 |
 Danger |
H300 |
P301+P310
P264 P270 P321 P330 P405 P501 |
Based on reported LD50 values of 4.8-7.0 mg Se/kg (a converted value equivalent to this substance: 10.5-15.3 mg/kg) (ATSDR (2003), PATTY (6th, 2012)) and 10.5-13.2 mg Se/kg (a converted value equivalent to this substance: 23.0-28.9 mg/kg) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) for rats, it was classified in Category 2. |
| 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 | Category 2 |
 Warning |
H315 |
P302+P352
P332+P313 P362+P364 P264 P280 P321 |
As for humans, based on the descriptions that selenium compounds showed skin irritation in occupational exposure (ATSDR (2003)) and that this substance was an irritant in an in vitro skin irritation test with reconstructed human epidermis (according to OECD TG 439) (ECHA registration dossier (Access on November 2017)), it was classified in Category 2. |
| 3 | Serious eye damage/eye irritation | Category 2 |
Warning |
H319 |
P305+P351+P338
P337+P313 P264 P280 |
Based on the description that selenium compounds showed eye irritation in occupational exposure in humans (ATSDR (2003)), it was classified in Category 2. Besides, there is a description that in opacity and permeability tests with bovine corneas (according to OECD TG 437), this substance was not corrosive (ECHA registration dossier (Access on November 2017)). |
| 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. Besides, there is a description of a case of a laboratory technician who handled selenium and developed pruritic vesicles between the fingers 6 months after exposure, and after 2 years, developed eczema on the face and neck, and lacrimation, and two asthmatic attacks in 2 months and showed a positive result to this substance and selenium in a patch test (ATSDR (2003)). In the EU CLP classification, this substance is classified as "Skin Sens. 1, H 317" (ECHA CL Inventory (Access on August 2017)). |
| 5 | Germ cell mutagenicity | Category 2 |
 Warning |
H341 |
P308+P313
P201 P202 P280 P405 P501 |
As for in vivo, it was positive in a micronucleus test with mouse bone marrow cells, positive in chromosome aberration tests with rat and mouse bone marrow cells, and negative in a chromosome aberration test with rat peripheral blood (ATSDR (2003), Environmental Risk Assessment for Chemical Substances Vol.14 (Ministry of the Environment, 2016)). As for in vitro, it was positive in bacterial reverse mutation tests, and chromosome aberration tests and sister chromatid exchange tests with mammalian cultured cells (ATSDR (2003), Environmental Risk Assessment for Chemical Substances Vol.14 (Ministry of the Environment, 2016)). 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 |
- |
- | - | Selenium and selenium compounds are classified in Group 3 by IARC (IARC Suppl. 7 (1987)) and in D (not classifiable as to human carcinogenicity) by EPA (IRIS (1991)). Therefore, it was classified as "Classification not possible." |
| 7 | Reproductive toxicity | Category 2 |
Warning |
H361 |
P308+P313
P201 P202 P280 P405 P501 |
As for humans, there are reports that ingestion of food containing a high content of selenium affected the quality of sperm such as a decrease in sperm motility. On the other hand, there are reports that there was no effect (ATSDR (2003)). An increased trend in spontaneous abortion (relative risk [RR] = 1.73; 95% CI = 0.62-4.80) was observed in Italian women who consumed drinking water containing selenate, but this was not a statistically significant increase. In addition, infants at birth in the selenium exposure group had no difference in body weight and height compared with those in the selenium non-exposure group, and there was no increased prevalence of congenital abnormalities (ATSDR (2003)). As for experimental animals, there are reports that this substance has adverse effects on male sexual function as follows: after male rabbits were orally dosed by gavage with this substance at 0.001 mg Se/kg/day for 6 weeks (once a week), a significant reduction in serum testosterone levels and an increase in the percentage of sperm morphological abnormality (defect of acrosome) were observed; and after male rats were given this substance by drinking water at 0.234 mg Se/kg/day for 12-14 weeks, testicular hypertrophy was observed (ATSDR (2003)). In addition, in a test in which this substance or sodium selenate (CAS RN 13410-01-0) was orally administered to rats, suppression of body weight gain, prolongation of estrus cycle, decreases in the number of corpus luteum/implantation, the number of surviving fetuses, the number of births, a lower body weight of pups, etc. were reported (Environmental Risk Assessment for Chemical Substances Vol.14 (Ministry of the Environment, 2016), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). From the above, based on the results of the animal tests using this substance and the classification result of sodium selenate which is a related compound (FY2016: Category 2 (reproductive toxicity)), it was classified in Category 2 for this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (central nervous system, respiratory organs, heart, liver, kidney, gastrointestinal tract) |
Danger |
H370 |
P308+P311
P260 P264 P270 P321 P405 P501 |
As for humans, there is a report that a 23-year-old woman who drank a culture medium for microorganisms containing approximately 400 mg/kg of this substance developed symptoms of severe gastroenteritis such as nausea, vomiting, abdominal pain, and hematemesis and acute renal failure, and was hospitalized, and increased heart rate by electrocardiogram, and necrosis of the proximal tubule epithelium by renal biopsy were seen, but these resolved after 4 weeks of hemodialysis treatment (PATTY (6th, 2012)). In addition, there is a report that a 56-year-old man who orally ingested 11 mg Se/kg of this substance (a converted value equivalent to this substance: 24 mg/kg) in a suicide attempt showed symptoms of vomiting, diarrhea, abdominal pain and severe gastroenteritis (PATTY (6th, 2012), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) and a report that a patient who ingested 1.7 g of this substance developed severe gastroenteritis and transient electrocardiogram changes, a slight elevation of serum bilirubin concentration was observed (HSDB (Access on August 2017)). Furthermore, although not this substance, there is a report that in acute selenium toxicosis due to ingestion of selenium in grams, by intentional or accidental ingestion of an oxide film treating agent, gun blue, containing selenious acid (CAS RN 7783-00-8), nitric acid and copper nitrate, severe gastrointestinal disorders, nervous system disorders, respiratory insufficiency syndrome, myocardial infarction, and renal failure were seen (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). In addition, there is a report that a 15-year-old girl showed diarrhea and abnormality in her electroencephalogram, and elevation of the serum bilirubin concentration and the alkaline phosphatase activity were observed after ingestion of about 22 Se mg/kg (a converted value equivalent to sodium selenate: about 52.6 mg/kg) of sodium selenate (CAS RN 13410-01-0) with suicidal intent (ATSDR (2003), HSDB (Access on September 2016)). From the above information on the effects of ingestion of this substance or other selenium compounds in humans, it was classified in Category 1 (central nervous system, respiratory organs, heart, liver, kidney, gastrointestinal tract). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (skin, hair, nail, teeth, central nervous system, haemal system, liver, kidney, genetic organs (men)) |
Danger |
H372 |
P260
P264 P270 P314 P501 |
As for humans, although it was not this substance, there is a report of selenium toxicosis accompanied by alopecia and morphological changes of the nails in Enshi in the Hubei Province, China where the concentration of selenium in food is high (Environmental Risk Assessment for Chemical Substances Vol.14 (Ministry of the Environment, 2016), IRIS (1991), ATSDR (2003)). Furthermore, hemoglobin reduction, mottled teeth, skin lesions, effects on the central nervous system (peripheral anesthesia, acroparesthesia and pain in the extremities) are reported (IRIS (1991)). This substance is soluble in water and is considered to cause similar selenium toxicosis by ingestion. As for experimental animals, it is reported that in multiple tests in which the substance was administered by feeding to rats for 4-13 weeks, at the dose corresponding to Category 1 (a converted guidance value for sodium selenite: 0.0044-1.88 mg/kg/day), effects on the liver (centrilobular diffuse nodules, dilation of sinusoids, hepatocellular necrosis, portal vein invasion of mononuclear cells, etc.), kidney (degeneration and necrosis of renal papilla), haemal system (a decrease in hemoglobin concentration, hypertrophy of spleen), and testis (reduced weight, morphological abnormality of sperm, a decrease in epididymal sperm count) were observed (NITE Initial Risk Assessment (2008), ATSDR (2003)), and it is reported that in a 60-day feeding study with guinea pigs, haemal toxicity (anemia, lymphocytopenia) was found at the dose of Category 1 (15 ppm = 0.75 mg Se/kg/day; a converted guidance value for sodium selenite: 1.09 mg/kg/day), and in a 2-year feeding study with rats, effects on the liver (degeneration and hyperplasia of the liver parenchyma) and kidney (nephritis) were observed at the dose corresponding to Category 1 (0.1 mg/kg/day) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ATSDR (2003)). From the above, it was classified in Category 1 (skin, hair, nail, teeth, central nervous system, haemal system, liver, kidney, genetic organs (men)). Besides, since the new information source was used, the classification result was different from the previous classification. |
| 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 2 |
- |
H401 |
P273
P501 |
From 96-hour LC50 = 1.48 mg/L [converted value 0.676 mgSe/L] for crustacea (Hyalella azteca) (ECETOC TR91: 2003, Environmental Risk Assessment for Chemical Substances vol. 14 (Ministry of the Environment, 2016)), it was classified in Category 2. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 1 |
 Warning |
H410 |
P273
P391 P501 |
Although the behavior of metal salt in water is unknown, metal is regarded to be non-biodegradable due to an element, water solubility is 898,000 mg/L, and 90-day NOEC (survival rate) is 0.046 mg/L [converted value 0.021 mgSe/L] for fish (Oncorhynchus mykiss) (Environmental Risk Assessment for Chemical Substances vol. 14 (Ministry of the Environment, 2016)). Therefore, it was classified in Category 1. |
| 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. |