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 |
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 |
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. |
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. |
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. |
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