NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	7758-09-0
Chemical Name	potassium nitrite
Substance ID	23B5577
Classification year (FY)	FY2011
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)	Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
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

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Explosives	Not classified	- -	-	-	The substance is a nitrite containing a chemical group associated with explosive properties (N-O), but it was classified as "Not classified" because it is classified in Division 5.1, PG II in UNRTDG (UN1488). Besides, this substance is highly reactive and may explode on contact with various substances, fire, and heat (ICSC (J) 2000), (Sax, 11th, 2004).
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 (ICSC (J), (2000)).
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	It was classified as an oxidizing solid.
9	Pyrophoric liquids	Not applicable	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Not classified	- -	-	-	It is not combustible (ICSC (J), (2000)).
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is not combustible (ICSC (J), (2000)).
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	The substance contains a metal (K), but from water solubility data: 312 g/100 g of water at 25 deg C (HSDB (2007)), it is estimated that it does not react vigorously with water.
13	Oxidizing liquids	Not applicable	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Category 2	Danger	H272	P370+P378 P210 P220 P221 P280 P501	It was classified in Category 2 because it is classified in Division 5.1, PG II in UNRTDG (UN1488).
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.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Classification not possible	- -	-	-	No data available. Besides, as for health hazards, please also refer to those for sodium nitrite (CAS RN 7632-00-0), the related substance.
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	It was classified as "Not classified" based on an LC50 value for mice of 85 g/m3/2 hours (converted 4-hour equivalent value: 42.5 mg/L/4 hours) (HSDB (2007)).
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Data are lacking. Besides, it is described that it is irritating to the skin (HSDB (2007)), although the details are unknown.
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Data are lacking. Besides, it is described that it is irritating to the eyes (HSDB (2007)), although the details are unknown.
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Classification not possible	- -	-	-	No data available.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Data are lacking. Besides, although it is unknown if it was this substance, a UDS test with spermatids after administration of nitrite to mice was negative (in vivo germ cell genotoxicity test) (JECFA 844 (1998)). As for an in vitro test, a positive result was reported in an Ames test on this substance (IARC 94 (2010)).
6	Carcinogenicity	Classification not possible	- -	-	-	No data available. Besides, it is described in IARC (IARC Vol.94 (2010)) that there is limited evidence in humans for the carcinogenicity of nitrite in food, nitrite in food is associated with an increased incidence of stomach cancer, and there is limited evidence in experimental animals for the carcinogenicity of nitrite. Furthermore, IARC classified ingested nitrate or nitrite under conditions that result in endogenous nitrosation in 2A for carcinogenicity. IARC added the following in its overall evaluation. Nitrate and nitrite are interconvertible in vivo in humans. Nitrosating agents that arise from nitrite under acidic gastric conditions react readily with nitrosatable compounds, especially secondary amines and amides, to generate N-nitroso compounds. These nitrosating conditions are enhanced following ingestion of additional nitrate, nitrite, or nitrosatable compounds. Some of the N-nitroso compounds that could be formed under these conditions are known carcinogens.
7	Reproductive toxicity	Category 2, Additional category: Effects on or via lactation	Warning	H361 H362	P308+P313 P201 P202 P280 P405 P501	In a test by drinking water administration of 300-10000 mg/kg bw to guinea pigs for 100-240 days, reproduction was maintained at lower exposure levels, and apparently, male fertility was not affected since conception took place at all levels. However, females were considerably affected, fetal losses were 100% in dams at or above 5000 mg/kg, and one maternal animal died. Also, uterine and cervical inflammatory lesions and degenerative placental lesions were present in dams in which the fetuses had been aborted, mummified, or absorbed (EHC (1978)). Reduced weight gain was observed in parent animals in the high exposure group. From the above, because reproductive and developmental toxicity was found at the dose where general toxicity occurred, it was classified in Category 2. Furthermore, it is described that in a test by oral administration of sodium nitrite to rats from pregnancy to lactation, pups from treated maternal animals developed severe anemia and showed a significant decrease in liver iron content in addition to decreases in red blood cell counts and hemoglobin level, and milk from treated dams was found to have a lower iron content than that of control animals, which was responsible for the adverse effects on the offspring (anemia). Because breast milk transfer was also suggested for this substance, it was classified in the Additional category: Effects on or via lactation.
8	Specific target organ toxicity - Single exposure	Category 1 (blood)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	It is described that the major acute toxic effect of nitrate and nitrite poisoning is methemoglobinemia, blood is the target organ, the first symptom develop within 15 to 45 minutes after ingestion, and symptoms include vomiting, nausea, headache, dizziness, fall in blood pressure, cyanosis, stupor, and convulsions (PIM G016 (1999)). Furthermore, because there is a case report in which methemoglobinemia was observed in three patients who ate meat contaminated with excessive nitrites (JECFA 844 (1998)), it was classified in Category 1 (blood). Besides, as for an animal test, it is reported that pigs became ill after oral administration of 12.2-19.8 mg/kg of this substance and died with doses of 21.3 mg/kg or more. And clinical signs of poisoning were noted when 20% of the hemoglobin was converted to methemoglobin, and death occurred when 76-80% was converted (HSDB (2007)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In two 13-week repeated administration (drinking water) tests with rats, a significant increase in a methemoglobin level in the blood at 3,000 mg/L (300 mg/kg bw/day) and slight hypertrophy of adrenal zona glomerulosa at or above 100 mg/L (10 mg/kg bw/day) were observed as the major findings (JECFA 1057 (2003)). However, the dose where increased methemoglobin was found was above the upper limit of the guidance value range, and it is described that the biological significance of the adrenal zona glomerulosa hypertrophy is discussed (HSDB (2007)). It was classified as "Classification not possible" because data are insufficient for classification. Besides, also, in tests on sodium nitrite, elevated methemoglobin levels at or above 30 mg/kg bw/day and cyanosis and increased reticulocyte counts at or above 130 mg/kg/day were observed in a 14-week repeated oral administration (drinking water) test with rats (NTP TR 495 (2001)), and extramedullary hematopoiesis of the spleen was seen at or above 445 mg/kg/day in a 14-week repeated oral administration (drinking water) test with mice (NTP TR 495 (2001)).
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.

ENVIRONMENTAL HAZARDS

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	It was classified in Category 2 from 96-hour LC50 = 0.56-1.78 mg NO2-/L (a converted value equivalent to potassium nitrite: 1.036-3.293 mg/L) for fish (Oncorhynchus mykiss) (HSDB, 2007).
11	Hazardous to the aquatic environment (Long-term)	Category 2	-	H411	P273 P391 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 2 because the behavior of the inorganic compound is unknown in water and it was classified in Category 2 in acute toxicity.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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.

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