NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	110-86-1
Chemical Name	Pyridine
Substance ID	R02-B-035-MHLW, MOE
Classification year (FY)	FY2020
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 FY2014 FY2017
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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 (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified."
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
6	Flammable liquids	Category 2	Danger	H225	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	It was classified in Category 2 based on a flash point of 20 deg C (closed cup) and a boiling point of 115 deg C (NFPA (14th, 2010)). Besides, it is classified in Class 3, PG II in UNRTDG (UN1282).
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
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. It was classified as "Not classified."
9	Pyrophoric liquids	Not classified	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of 482 deg C (NFPA (14th, 2010)).
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to liquid substances are not available.
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). It was classified as "Not classified."
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine. It was classified as "Not classified."
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified."
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] It was classified in Category 4 from (1) - (4). [Evidence Data] (1) LD50 for rats: 891 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004), AICIS (formerly, NICNAS) IMAP (2015), Patty (6th, 2012), GESTIS (Access on May 2020)) (2) LD50 for rats: 891-1,580 mg/kg (ACGIH (7th, 2004), NTP TR470 (2000), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2018)) (3) LD50 for rats: 1,580 mg/kg (ATSDR (1992), AICIS (formerly, NICNAS) IMAP (2015)) (4) LD50 for rats: 0.8-1.6 g/kg (800-1,600 mg/kg) (HSDB (Access on May 2020))
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	[Rationale for the Classification] It was classified in Category 4 from (1) - (3). [Evidence Data] (1) LD50 for rabbits: 1,120 mg/kg (ACGIH (7th, 2004), GESTIS (Access on May 2020)) (2) LD50 for rabbits: 1,121 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2018), AICIS (formerly, NICNAS) IMAP (2015), Patty (6th, 2012)) (3) LD50 for rabbits: 1,000 mg/kg-2,000 mg/kg (AICIS (formerly, NICNAS) IMAP (2015))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Category 4	Warning	H332	P304+P340 P261 P271 P312	[Rationale for the Classification] It was classified in Category 4 from (1) - (9). Because exposure concentrations were lower than 90% of the saturated vapor pressure concentration (27,371 ppm), a reference value in the unit of ppm was applied as a vapor with little mist. [Evidence Data] (1) LC50 for rats (nose exposure, 4 hours): 15 mg/L-18 mg/L (4,637 ppm-5,564 ppm) (AICIS (formerly, NICNAS) IMAP (2015)) (2) LC50 for rats (1 hour): 8,000-9,000 ppm (converted 4-hour equivalent value: 4,000-4,500 ppm) (NTP TR470 (2000), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2018), SCOEL (2004)) (3) LC50 for rats (1 hour): 8,000-9,020 ppm (converted 4-hour equivalent value: 4,000-4,510 ppm) (Hazard Assessment Report (CERI, NITE, 2006)) (4) LC50 for rats (1 hour): 8,800 ppm (converted 4-hour equivalent value: 4,400 ppm) (ACGIH (7th, 2004)) (5) LC50 for rats (1 hour): 9,000 ppm (converted 4-hour equivalent value: 4,500 ppm) (ACGIH (7th, 2004), Patty (6th, 2012), HSDB (Access on May 2020)) (6) LC50 for rats (1 hour): males: 9,010 ppm (converted 4-hour equivalent value: 4,505 ppm) (ATSDR (1992)) (7) LC50 for rats (1 hour): females: 9,020 ppm (converted 4-hour equivalent value: 4,510 ppm) (ATSDR (1992)) (8) LC50 for rats (4 hours): > 4,000 ppm (Hazard Assessment Report (CERI, NITE, 2006), HSDB (Access on May 2020)) (9) LC50 for rats (4 hours): 4,900 ppm (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2018), Patty (6th, 2012), HSDB (Access on May 2020)) (10) Vapor pressure of this substance: 20.8 mmHg (25 deg C) (HSDB (Access on May 2020)) (converted value for the saturated vapor pressure concentration: 27,371 ppm)
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
2	Skin corrosion/irritation	Category 1	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	[Rationale for the Classification] It was classified in Category 1 from (1) - (3). [Evidence Data] (1) This substance was corrosive to the rabbit skin, although small amounts (10 mg) applied produced only mild irritation (ACGIH (7th, 2004)). (2) In a skin irritation test in which this substance (0.5 mL) was applied to the rabbit skin for 4 hours, irreversible damage to the skin was observed, and this substance was judged as corrosive. Also, in another skin irritation test, mild to severe erythema with some necrosis was found, and cutaneous irritation index was reported to be 4.8 (maximum 8) (AICIS (formerly, NICNAS) IMAP (2015)). (3) Skin disorders and disorders in the anterior part of the eye were described as diseases due to work involving exposure to this substance in Article 35 of the Ordinance for Enforcement of the Labor Standards Act (Notification No. 33 (1996)). [Reference Data, etc.] (4) In animal tests, this substance caused slight skin irritation after open application, but strong irritation was triggered after occlusive application (GESTIS (Access on May 2020)). (5) Weak irritation was seen in a test in which 500 mg was applied to the rabbit skin (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2018)). (6) As adverse effects in humans, irritation of the skin, eye, and upper respiratory tract was seen (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2018)). (7) In a skin irritation test with rabbits, this substance caused mild irritation (score 3 (maximum score 10)) (ATSDR (1992)). (8) This substance was reported to be a mild skin irritant and a severe eye irritant in rabbits (Patty (6th, 2012), HSDB (Access on May 2020)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] It was classified in Category 1 from (1) - (7). [Evidence Data] (1) Severe injury was produced when this substance was instilled into the eye (ACGIH (7th, 2004)). (2) Severe irritation was confirmed in an eye irritation test with rabbits in which this substance (0.1 mL) was applied (AICIS (formerly, NICNAS) IMAP (2015)). (3) This substance (90%) applied to rabbits caused severe reactions with clouding of the cornea and scarring of the conjunctiva, and permanent mild stromal opalescence and vascularization resulted (Patty (6th, 2012)). (4) In an eye irritation test with rabbits according to OECD TG 405, the mean score for the cornea at 24/48/72 hours after application was 3 in 2/3 animals (ECETOC 48 (1998)). (5) In an eye irritation test with rabbits, moderately irritative to corrosive effects were seen, and the maximum ocular irritation index was 40-86 (maximum 110). And some effects (edematous lesions and cellular infiltrations in the cornea) persisted for more than 21 days (GESTIS (Access on May 2020)). (6) This substance was classified in Category 1 in skin corrosion/irritation. (7) Skin disorders and disorders in the anterior part of the eye were described as diseases due to work involving exposure to this substance in Article 35 of the Ordinance for Enforcement of the Labor Standards Act (Notification No. 33 (1996)). [Reference Data, etc.] (8) Irritation was seen in a test in which 0.1 mL was applied to the rabbit eye (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2018)). (9) The vapor of this substance was irritating to the eye and nasal mucosa (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)). (10) In an eye irritation test with rabbits, this substance caused moderate irritation (score 7 (maximum score 10)) (ATSDR (1992), AICIS (formerly, NICNAS) IMAP (2015), Patty (6th, 2012)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] There are data in (1) - (5), but because positive and negative data were mixed, it was classified as "Classification not possible." [Reference Data, etc.] (1) This substance was not a sensitizer when tested in guinea pigs (ACGIH (7th, 2004), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2018), AICIS (formerly, NICNAS) IMAP (2015), Patty (6th, 2012), HSDB (Access on May 2020)). (2) It was reported to be positive in a mouse local lymph node assay (LLNA) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2018)). (3) In a maximization test in 24 adult volunteers in which pyridine (purity: unknown)/petrolatum was used at 50% for induction and 10% for a challenge, a weak positive reaction was seen in one (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2018)). (4) A woman who had worked as an assistant staff in a chemistry laboratory for half a year developed eczema in her fingertips and between fingers of both hands. In a patch test on various chemicals, positive reactions were found only in a Karl Fischer reagent (containing pyridine, iodine, and sulfur dioxide) (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2018)). (5) This substance causes photosensitization, and direct contact with a liquid causes chemical burns (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) As for in vivo, it is reported that it was negative in a micronucleus test and a chromosomal aberration test using mouse bone marrow cells and negative in an unscheduled DNA synthesis test in mouse hepatocytes (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ATSDR (1992), Patty (6th, 2012), IARC 119 (2019), Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004), CEBS (Access on May 2020)). (2) As for in vitro, it is reported in test systems using cultured mammalian cells that it was negative in a mouse lymphoma test, a gene mutation test, and a chromosomal aberration test and positive and negative in sister chromatid exchange tests. And it was reported to be negative in a bacterial reverse mutation test (same as the above).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] There are no clear data on carcinogenicity from exposure to this substance in humans. It was classified in Category 2 based on (1) - (3). [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified in Group 2B by IARC (IARC 119 (2019)), Group 2B by the Japan Society for Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), proposed in 2018)), A3 by ACGIH (ACGIH (7th, 2004)), and 3B in MAK (DFG) (DFG List of MAK and BAT values (2019)). (2) In carcinogenicity tests by 2-year drinking water administration of this substance to male and female F344/N rats and male Wistar rats, significant increases in the incidences of renal tubule adenoma and renal tubule adenoma or carcinoma (combined) in male F344/N rats were observed, and a significant increase in the incidence of mononuclear cell leukemia was seen in female F344/N rats. A significant increase in the incidence of interstitial cell adenoma of the testis was found in Wistar rats (males) (NTP TR470 (2000), IARC 119 (2019), ACGIH (7th, 2004)). From the above, it was concluded that there was some evidence of carcinogenicity of this substance in male F344/N rats, and there was equivocal evidence in female F344/N rats and male Wistar rats (NTP TR470 (2000)). (3) In a carcinogenicity test by 2-year drinking water administration of this substance to male and female mice, significant increases in the incidences of hepatocellular adenoma, hepatocellular carcinoma, and hepatoblastoma were observed in both males and females (NTP TR470 (2000), IARC 119 (2019), ACGIH (7th, 2004)). From the above, it was concluded that there was clear evidence of carcinogenicity of this substance in both males and females (NTP TR470 (2000)). [Reference Data, etc.] (4) In workers in a manufacturing plant in which this substance was used as a starting material, a slight excess in the mortality from lung cancer was observed, but there was no significant difference, and it was considered that there was no relationship with exposure to specific chemical substance such as this substance (IARC 119 (2019)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 2. Since the new data was obtained, the classification result was changed from the previous classification. [Evidence Data] (1) It was reported that in a reproduction/developmental toxicity screening test by oral administration to rats (OECD TG 421), at a dose of toxicity in parent animals (an increase in liver weight), a decrease in the number of live pups per litter on days 1 to 4 of lactation was observed (REACH registration dossier (Access on June 2020)). [Reference Data, etc.] (2) In a 13-week test with rats or mice dosed by drinking water, longer estrous cycle was observed in female rats at a high dose (1,000 ppm: 90 mg/kg/day equivalent), and a decrease in sperm motility was observed in mice at or above 250 ppm (50 mg/kg/day equivalent) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), NTP TR470 (2000)).
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system), Category 3 (respiratory tract irritation, narcotic effects)	Danger Warning	H370 H335 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	[Rationale for the Classification] Based on (1) to (7), it was classified in Category 1 (central nervous system) and Category 3 (respiratory tract irritation, narcotic effects). [Evidence Data] (1) Inhalation was the primary route of exposure to this substance, and symptoms due to slight effects on the central nervous system occurred at about 32 mg/m3. It was reported that workers who were exposed to 400 mg/m3 for 4 hours a day for 1 to 2 weeks exhibited symptoms of headaches, dizziness, insomnia, nausea, and anorexia (Environmental Risk Assessment for Chemical Substances Vol. 3 (Ministry of the Environment, 2004)). (2) In a case report on healthy adults, symptoms that developed following the exposure to pyridine vapors (exposure concentration and duration were unknown) included transient headaches, dizziness, lethargy, and tachycardia and tachypnea (ATSDR (1992), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2018)). (3) A woman who cleaned up spilled pyridine for 15 to 20 minutes exhibited speech impediment and diffuse cortical disorder from 10 hours to 3 days after the exposure (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2018)). (4) Acute inhalation exposure affected the central nervous system (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), AICIS (previous NICNAS) IMAP (2015)). (5) As for this substance, Article 35 of the Ordinance for Enforcement of the Labor Standards Act described subjective symptoms such as headaches, dizziness, and emesis, skin disorders, disorders in the anterior part of the eye, or respiratory tract disorders (Ministry of Labour Notification No. 33). (6) In a case of oral overexposure of rats, hypoactivity, muscular weakness, dyspnea, sedation, ruffled fur, and death occurred (ACGIH (7th, 2004)). (7) In a case of inhalation overexposure of rats, lacrimation, rhinitis, inactivity, hyperpnea, sedation, dyspnea, and death occurred (ACGIH (7th, 2004)). [Reference Data, etc.] (8) In an oral administration of 1.85 to 2.46 mL of this substance to humans, slight anorexia, nausea, fatigue, and depressive symptoms developed. In a high dose administration, severe emesis, diarrhea, delirium, and high fever developed, and one person died due to hepatic failure and renal failure in 40 hours after the ingestion of this substance. In this death case, edema of the lung and bronchitis were also confirmed, but bronchitis was considered to be a secondary effect of inhalation of vomit (Environmental Risk Assessment for Chemical Substances Vol. 3 (Ministry of the Environment, 2004), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2018)). (9) In a case of a 29-year-old man who accidentally ingested a half cup (about 125 mL) of this substance, he died after 43 hours, and congestion of the epiglottis, trachea, bronchi, lungs, esophagus, and stomach was observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol. 3 (Ministry of the Environment, 2004), ATSDR (1992), NTP TR470 (2000), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2018), AICIS (previous NICNAS) IMAP (2015)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (central nervous system, blood system, liver, kidney)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1) and (2), effects on the liver, kidney, central nervous system were observed in humans, and based on (3) to (5), effects on the blood system and liver within the range for Category 1, and effects on kidney within the range for Category 2 were observed in experimental animals. Therefore, it was classified in Category 1 (central nervous system, blood system, liver, kidney). [Evidence Data] (1) In a case in which this substance was used as a drug for treating epilepsy, 5 epilepsy patients who were orally administered with doses of 1.85 to 2.46 mL per day for about 1 month exhibited anorexia, nausea, emesis, pains and a sense of fullness in the abdomen, headaches, stupor, fatigue, and depressive state during the administration period. It was reported that, in two of them, a decrease in serum total protein, azotemia, albuminaturia, etc. were observed, and dysfunctions of the liver and kidney were exhibited (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). (2) It was reported that in a case of occupational exposure, workers who inhaled pyridine vapors of a concentration of about 125 ppm (405 mg/m3) for 4 hours a day for 1 to 2 weeks exhibited nausea, dizziness, headaches, insomnia, nervous erethism, lumbar and abdominal discomfort with frequent urination, and anorexia (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). (3) In a 13-week test with rats dosed by drinking water, at or above 50 ppm (5 mg/kg/day, within the range for Category 1), decreases in hemoglobin, erythrocyte counts, and hematocrit values were observed; at or above 100 ppm (10 mg/kg/day, within the range for Category 1), an increase in liver weight was observed; at or above 250 ppm (25 mg/kg/day, within the range for Category 2), pigmentation of the liver was observed; at or above 500 ppm (55 mg/kg/day, within the range for Category 2), an increase in bile acid, chronic inflammation and pigmentation of the liver, and hypertrophy and degeneration of the centrilobular hepatocytes were observed; and at 1,000 ppm (90 mg/kg/day, within the range for Category 2), death, increases in ALT and SDH, and longer estrous cycle were observed. In males, at or above 500 ppm, protein cast, chronic inflammation, mineralization, and regenerative renal tubules of the kidney were observed; and at 1,000 ppm, granular cast and hyaline degeneration of the kidney were observed (alpha 2mu-globulin of the kidney was positive in all rats) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). (4) In a 103 to 104-week toxicity test with rats dosed by drinking water, at or above 100 ppm (7 mg/kg/day, within the range for Category 1), bile duct hyperplasia of the liver and pigmentation of the liver were observed; at or above 200 ppm (14 mg/kg/day, within the range for Category 2), reduced body weight gain, exacerbation of chronic nephropathy, cytomegaly of the centrilobular hepatocytes of the liver, and vacuolation of the hepatocytes were observed; and at 400 ppm (33 mg/kg/day, within the range for Category 2), degeneration and necrosis of the centrilobular hepatocytes of the liver, and tubular epithelium hyperplasia of the kidney were observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). (5) In a 103-week toxicity test with rats dosed by drinking water, at or above 100 ppm (8 mg/kg/day, within the range for Category 1), reduced body weight gain, degeneration of the centrilobular hepatocytes and pigmentation of the liver were observed; at or above 200 ppm (17 mg/kg/day, within the range for Category 2), a decrease in survival rate, fibrosis of the liver, perilobular fibrosis, and interstitial cell hyperplasia of the testis were observed; and at 400 ppm (34 mg/kg/day, within the range for Category 2), necrosis of the centrilobular hepatocytes of the liver was observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)).
10	Aspiration hazard	Category 1	Danger	H304	P301+P310 P331 P405 P501	[Rationale for the Classification] It was classified in Category 1 from (1). [Evidence Data] (1) It is reported that after oral ingestion of several ounces (1 ounce = 28.35 g), a person developed severe vomiting, diarrhea, hyperpyrexia, and delirium and died, and necropsy revealed damage of the respiratory organs (pulmonary edema and tracheobronchitis), which was considered to be due to aspiration (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), HSDB (Access on August 2017)).

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment Short term (Acute)	Category 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 72-hour ErC50 = 0.10 mg/L for algae (Raphidocelis subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1995)).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	It was classified in Category 1 because it was rapidly degradable (a 4-week degradation rate by BOD: 92%, 94%, 0% (average 62%) (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1998)) and due to 72-hour NOEC = 0.010 mg/L for algae (Raphidocelis subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1995), Environmental Risk Assessment for Chemical Substances Vol. 2 (Ministry of the Environment, 2003), Environmental Risk Assessment for Chemical Substances Vol. 3 (Ministry of the Environment, 2004)).
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.
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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