NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	10102-18-8
Chemical Name	Sodium selenite
Substance ID	m-nite-10102-18-8_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

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)

PHYSICAL HAZARDS

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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2017	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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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))	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2017	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 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)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	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 the classification is not possible due to no data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	It is an inorganic compound.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

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 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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)).	FY2017	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	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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (skin, hair, nail, teeth, central nervous system, blood system, liver, kidney, reproductive organs (male))	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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

ENVIRONMENTAL HAZARDS

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)	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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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