NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	7632-00-0
Chemical Name	Sodium nitrite
Substance ID	23B5576
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 (6.1), PG III in UNRTDG (UN1500).
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 (Hommel (1996)). However, it is a potent oxidant, and its mixture with combustibles has a risk of explosion (Chemical Substances Safety Data Book (The Chemical Substances Safety Information Workshop, 1997)).
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	- -	-	-	From water solubility of 84.8 g/100 g (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 3	Warning	H272	P370+P378 P210 P220 P221 P280 P501	It was classified in Category 3 because it is classified in Division 5.1 (Subsidiary Risk 6.1), PG III in UNRTDG (UN1500).
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)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	All four LD50 values for rats [77 mg/kg, 130 mg/kg, 150 mg/kg (the above, SIDS (2005)), 85 mg/kg (JECFA 844 (1998))] correspond to Category 3. Besides, as for health hazards, please also refer to those for potassium nitrite (CAS RN 7758-09-0), 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)	Classification not possible	- -	-	-	There is a report on LC0 of 0.0951 mg/L for rats by 4-hour exposure to dust (SIDS (2005)), but the category cannot be determined with this data alone, and the classification is not possible. Besides, there is List 3 data: an LC50 value of 0.0055 mg/L/4 hours for rats (5.5 mg/m3/4 hours) (RTECS (2004)).
2	Skin corrosion/irritation	Not classified	- -	-	-	It was classified as "Not classified" because it was assessed as not irritating in a test in which 500 mg of this substance was applied to the rabbit skin for 4 hours (OECD TG 404; GLP) (SIDS (2005)).
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	In a test in which 100 mg of this substance was applied into the conjunctival sac of six rabbits (OECD TG 405; GLP), conjunctival effects consisting of moderate redness, mild chemosis, and severe discharge were seen in all the animals but disappeared by twelve days, and it was assessed as moderately irritating (SIDS (2005)). Therefore, it was classified in Category 2A.
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Classification not possible	- -	-	-	No data available.
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	It was classified in Category 2 because all positive results were reported in in-vivo somatic cell mutagenicity tests: multiple chromosomal aberration tests with bone marrow after oral administration to rats and mice, a micronucleus test with peripheral blood after oral administration to mice, and a micronucleus test with embryonic cells after oral administration to hamsters (SIDS (2005), IARC 94 (2010)). Besides, as for other in vivo tests, it was reported to be negative in a mutual translocation test and a dominant lethal test with mice (in vivo heritable germ cell mutagenicity tests) (SIDS (2005), IUCLID (2000)) and positive in a sister chromatid exchange test with bone marrow after oral administration to mice (SIDS (2005)). As for in vitro tests, there is a report on positive results in many Ames tests and a chromosomal aberration test with cultured mammalian cells (SIDS (2005)).
6	Carcinogenicity	Classification not possible	- -	-	-	In 2-year drinking water administration carcinogenicity tests with rats and mice, there was no evidence of carcinogenicity in male and female rats and male mice, and there was equivocal evidence of carcinogenicity in female mice based on the positive trend observed in the incidences of squamous cell papilloma or carcinoma of the forestomach (NTP TR 495 (2001)). Based on the above test results, overall evaluation leads to the conclusion that nitrite ingestion did not show evident carcinogenicity (SIDS (2005)). However, IARC classified ingested nitrate or nitrite under conditions that result in endogenous nitrosation in Group 2A for carcinogenicity (IARC 94 (2010)), and it is described that nitrosating agents that arise from nitrite under acidic gastric conditions react readily with nitrosatable compounds, especially amines and amides to generate N-nitroso compounds, which are carcinogens (IARC 94 (2010)). Because it was impossible to determine the assessment for this substance, and it was classified as "Classification not possible."
7	Reproductive toxicity	Category 2, Additional category: Effects on or via lactation	Warning	H361 H362	P308+P313 P201 P202 P280 P405 P501	In a developmental toxicity test by oral administration to pregnant mice during the organogenesis period, significant decreases in implantation frequency and mean litter size and significant increases in dead fetuses and early fetal death were observed at the dose where maternal animals showed reduced weight gain (SIDS (2005)), and in a test by oral administration to rats from pregnancy to lactation, increased mortality of pups and decreased mean litter size at birth were reported (SIDS (2005)). Therefore, it was classified in Category 2. Furthermore, it is described that in another test by oral administration 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) (SIDS (2005)). Therefore, 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	Ingestion of (or exposure to) this substance causes methemoglobin formation in the blood, cyanosis is seen in some cases, and there are many case reports of persons who developed methemoglobinemia (SIDS (2005), JECFA 844 (1998), PIM G016 (1999)). Therefore, it was classified in Category 1 (blood). Besides, also in animal tests, increased methemoglobin levels in the blood were reported after oral administration of 150 mg/kg to rats or 100-300 mg/kg to mice (SIDS (2005)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (blood)	Warning	H373	P260 P314 P501	It is reported that in a 14-week repeated oral administration (drinking water) test with rats (males: 30, 55, 115, 200, 310 mg/kg bw/day, females: 40, 80, 130, 225, 345 mg/kg bw/day), cyanosis was observed in males in the groups at 200 or 310 mg/kg/day and females in the groups at or above 130 mg/kg/day, and in addition to increased reticulocyte counts, methemoglobin concentrations were elevated in almost all exposed groups, including those at doses corresponding to Category 2 (NTP TR 495 (2001)). Therefore, it was classified in Category 2 (blood). Besides, in a 14-week repeated oral administration (drinking water) test with mice (males: 90, 190, 345, 750, 990 mg/kg bw/day, females: 120, 240, 445, 840, 1230 mg/kg bw/day), extramedullary hematopoiesis of the spleen was seen in males in the groups at 750 or 990 mg/kg/day and females in the groups at or above 445 mg/kg/day as a related finding (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 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 96-hour LC50 = 0.54 mg/L for fish (Oncorhynchus mykiss) (SIDS, 2006).
11	Hazardous to the aquatic environment (Long-term)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified as "Not classified" due to data of NOEC > 1 mg/L obtained for crustacea (Penaeus monodon) and algae (Desmodesmus subspicatus) (SIDS, 2006), despite unknown behavior of the inorganic compound in water. If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 due to unknown behavior of the inorganic compound in water and 96-hour LC50 = 0.54 mg/L for fish (Oncorhynchus mykiss) (SIDS, 2006). By drawing a comparison between the above results, it was classified in Category 1.
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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