NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	107-05-1
Chemical Name	Allyl chloride
Substance ID	R03-B-015-MHLW, MOE
Classification year (FY)	FY2021
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	FY2009 FY2006
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.
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
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 -32 deg C (closed cup) (ICSC (2004)) and a boiling point of 45 deg C (ICSC (2004), GESTIS (Accessed Oct 2021)). Besides, it is classified in Class 3, Subsidiary Risk 6.1, PG I in UNRTDG (UN 1100).
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Type G	- -	-	-	There is a chemical group associated with self-reactive properties (ethylene group) present in the molecule, but it does not correspond to self-reactive substances and mixtures, hazards of the highest precedence, because it is classified in Class 3, Subsidiary Risk 6.1, PG I in UNRTDG (UN 1100). Therefore, it was classified in Type G.
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 390 deg C (GESTIS (Accessed Oct 2021)).
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	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).
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing chlorine (but not fluorine or oxygen) which is chemically bonded only to carbon or hydrogen.
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Category 1	Warning	H290	P234 P390 P406	Although test methods applicable to low-temperature-boiling liquids are not available and no data are available, dry allyl chloride is corrosive to aluminum, and at high temperatures, also corrosive to mild steel, cast iron, etc. It was classified in Category 1 from the information that it is highly corrosive when it absorbs moisture and it is necessary to use a corrosion resistant material (Solvents Handbook, Ohmsha Ltd. (1994)).
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.

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] Based on (1) to (4), it was classified in Category 4. [Evidence Data] (1) LD50 for rats: between 450 to 700 mg/kg (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2015), AICIS IMAP (2013), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIAR (1996)) (2) LD50 for rats: 450 mg/kg (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2013)) (3) LD50 for rats: 460 mg/kg (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2013)) (4) LD50 for rats: 700 mg/kg (ACGIH (2011))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (5), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: 2,200 mg/kg (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2015), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) (2) LD50 for rabbits: 2,066 mg/kg (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2013), ACGIH (2011)) (3) LD50 for rabbits: 2,026 mg/kg (AICIS IMAP (2013), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIAR (1996)) (4) LD50 for rats and rabbits: Approx. 2,000 mg/kg (DFG MAK (2002)) (5) LD50 for rabbits: 1,100 to 2,200 mg/kg (Risk Assessment Report (Ministry of Health, Labour and Welfare, 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 3	Danger	H331	P304+P340 P403+P233 P261 P271 P311 P321 P405 P501	[Rationale for the Classification] Based on (1) to (8), it was classified in Category 3 by adopting the category with the higher hazard. Also, since the exposure concentration was lower than 90% (437,118 ppm) of the saturated vapor pressure concentration, it was judged to be a vapor and classified based on the reference value in units of ppmV. [Evidence Data] (1) LC50 (4 hours) for rats: 1,120 to 2,624 ppm (corresponding to Category 3 to 4) (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2015)) (2) LC50 (4 hours) for rats: 1,100 to 2,600 ppm (corresponding to Category 3 to 4) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) (3) LC50 (2 hours) for rats (males): 3,500 ppm (converted 4-hour equivalent value: 2,475 ppm (7.75 mg/L), corresponding to Category 3) (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2015), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), US AEGL (2008)) (4) LC50 (2 hours) for rats (females): 3,800 ppm (converted 4-hour equivalent value: 2,687 ppm (8.41 mg/L), corresponding to Category 4) (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2015), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), US AEGL (2008)) (5) LC50 (2 hours) for rats: 11,000 mg/m3 (converted 4-hour equivalent value: 7.8 mg/L (2,473 ppm), corresponding to Category 3) (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2013), ACGIH (2011)) (6) LC50 (4 hours) for rats: 2,000 ppm (corresponding to Category 3) (ACGIH (2011)) (7) LC50 (4 hours) for rats: 3.506 mg/L (1,100 ppm, corresponding to Category 3) (DFG MAK (2002)) (8) LC50 (4 hours) for rats: 8.2 mg/L (2,600 ppm, corresponding to Category 4) (DFG MAK (2002))
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 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2. [Evidence Data] (1) Skin contact with the liquid of this substance caused reddening of the skin, and burning sensation and pain occurred, and after several hours, strong bone pain was caused (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2015), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). (2) Prolonged skin contact might cause erythema and edema. Exposure to very small quantities of the liquid of this substance might also cause deep-seated pain (bone-ache type) around the skin contact area (SIAR (1996), ACGIH (2011)). [Reference Data, etc.] (3) As a result of soaking mouse tails in the undiluted solution of this substance for 3 to 5 hours, localized damages of the skin (reddening, swelling, necrosis of the skin in some animals) were observed (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2015), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). (4) It was reported that, in a skin irritation test with rabbits (0.01 mL of undiluted solution), slight skin irritation was observed (SIAR (1996), AICIS IMAP (2013)). (5) In the EU, it was classified in Skin Irrit. 2 (EU CLP Classification Results (Accessed Jan. 2022)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1. [Evidence Data] (1) Eye contact with this substance caused pain and severe eye irritation with corneal injury that might sometimes result in permanent impairment of vision. Vapors of this substance also irritated the eyes and the effects might be delayed (ACGIH (2011)). (2) Direct eye contact caused damage to the cornea and deep eye pain (DFG MAK (2002)). [Reference Data, etc.] (3) Exposure to this substance at 48 to 96 ppm (150 to 300 mg/m3) caused irritation of the eyes in humans and higher concentrations caused eye pain and photophobia (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2015), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), DFG MAK (2002)). (4) In a test with rats exposed to this substance at 200 ppm (640 mg/m3) for 6 hours, closure of the eyelids and redness of the conjunctiva were observed in 6/10 animals (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2015), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). (5) In the EU, it was classified in Eye Irrit. 2 (EU CLP Classification Results (Accessed Jan. 2022)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." Also, based on the new findings, the classification result was changed. [Evidence Data] (1) It was reported that, in a Local Lymph Node Assay (LLNA) (OECD TG 429, GLP) with mice (n=5/group), the stimulation index (SI values) were 0.78 (25%), 0.75 (50%), 1.97 (100%) (REACH registration dossier (Accessed Jan. 2022)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) to (3), although positive findings were obtained in the in vitro tests and negative findings were obtained in the in vivo tests, the validity of the in vivo tests was questionable and it was judged as classification not possible due to lack of data. [Reference Data, etc.] (1) As for in vivo, in a dominant lethal test with rats (inhalation exposure for 5 days (7 hours/day), 1 and 25 ppm), a chromosomal aberration test using the bone marrow cells of rats (single inhalation exposure (7 hours), 1 and 25 ppm), a micronucleus test using the bone marrow cells of rats (single inhalation exposure (7 hours), 1 and 25 ppm), and a micronucleus test using the bone marrow cells of mice (single oral administration, a single dose of 400 mg/kg), the results were all negative (IARC 125 (2020), ACGIH (2011), SIAR (1996)). (2) As for in vitro, positive results (partially negative) in a bacterial reverse mutation test, and positive or negative results in a chromosomal aberration test using the cultured mammalian cells (CHL or rat liver cells), were obtained (IARC 125 (2020), Mutagenicity Test Data of Existing Chemical Substances based on the toxicity investigation system of the Industrial Safety and Health Law (Accessed November 2021), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2013)). (3) Although no sign of mutagenicity was recorded in the in vivo test results of (1), it has been noted that the tests did not meet current guidelines with low doses (the tests should have been conducted at higher doses) and no evidence that the test substance reached the target cells (AICIS IMAP (2013), DFG MAK (2002)). (4) In the EU, it was classified in Muta. 2 (EU CLP Classification Results (Accessed November 2021)).
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] It was classified in Category 1B, since based on (1) as this substance has been subject to the public announcement on guidelines in order to prevent the impairment of worker's health caused by the chemical substances decided by the Minister of Health, Labour and Welfare based on paragraph (3) of Article 28 of the Industrial Safety and Health Act, and based on (2), the evidence of carcinogenicity in experimental animals was presented. Also, based on the new information source, the classification result was changed. [Evidence Data] (1) This substance is subject to the public announcement on guidelines in order to prevent the impairment of worker's health caused by the chemical substances decided by the Minister of Health, Labour and Welfare based on paragraph (3) of Article 28 of the Industrial Safety and Health Act (public announcement on guidelines to prevent the impairment of health, No. 23 on October 10, 2012). (2) In a carcinogenicity study with rats and mice by inhalation exposure for 104 weeks (6 hours/day, 5 days/week) (rats: males and females: 25 to 100 ppm, mice: males and females: 50 to 200 ppm), a significant increasing trend and a significantly increased incidence of transitional cell carcinoma of the urinary bladder were observed in male rats. In addition, a significant positive trend in the incidence of thyroid tumors (follicular epithelium adenomas, follicular epithelium adenomas or adenocarcinomas (combined), C-cell carcinomas), pulmonary tumors (bronchiolar/alveolar adenomas, bronchiolar/alveolar adenomas or carcinomas (combined)), peritoneal mesotheliomas, keratoacanthomas of the skin, and fibroadenomas of the mammary gland were observed in males. In contrast, no significant increase in the incidence of tumors was observed in female rats. In the test with mice, a significant positive trend and a significant increase in the incidence of adenomas of the Harderian gland and bronchiolar/alveolar adenomas of the lung were observed in both males and females (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2003)). [Reference Data, etc.] (3) In a carcinogenicity study with rats and mice dosed by gavage for 78 weeks (5 days/week) (rats: males/females: 0, 57/55, 77/73 mg/kg/day, mice: males/females: 0, 172/129, 199/258 mg/kg/day), there were many cases of early death in the test with rats, and it was concluded that the test was inadequate for the evaluation of the carcinogenicity of this substance. In the test with mice, an increase in the incidence of forestomach tumor was observed in females (no statistically significant difference). The test with males was judged to be inadequate for the evaluation of the carcinogenicity of this substance (IARC 125 (2020), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2015), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2013)). (4) As for the classification results by domestic and international organizations, the IARC classified this substance in Group 3 (IARC 125 (2020)), the EPA classified it in C (Possible Human Carcinogens) (IRIS (1990)), the ACGIH classified it in A3 (ACGIH (2011)), the EU classified it in Carc. 2 (EU CLP Classification Results (Accessed Nov. 2021)), the DFG classified it in Category 3 (List of MAK and BAT values (2020)). (5) The IRIS classification in Category C was based on the forestomach tumors in female mice observed in the carcinogenicity study by administration by gavage in (2) and positive results in a variety of genetic toxicity tests, and in addition, it was based on the view in 1990 that this substance was an alkylating agent and structurally related to probable human carcinogens (IRIS (1990)). The ACGIH evaluation as A3 was based on the findings indicating that this substance was carcinogenic in mice based on neoplastic lesions of the forestomach following 78 weeks of administration by gavage and it also acted as a skin tumor initiator in mice (ACGIH (2011)). Besides, the rationale for the classification in Carc 2 by the EU was unknown.
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) to (3), although there were also reports suggesting developmental effects, they were minor effects and the reports were considered to be inadequate as the rationale for the classification. In addition, there was no information regarding the effects on fertility. Based on the above, it was classified as classification not possible due to lack of data. Also, based on the new information source, the classification result was reviewed. [Evidence Data] (1) It was reported that, in a developmental toxicity study by inhalation exposure with female rats (days 6 to 15 of gestation), at the high dose (300 ppm) at which maternal toxicity (reduced body weight gain, increased liver and kidney weight) was observed, minor developmental effects (delayed ossification of sterna and vertebral centra) were observed in fetuses (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2015), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2013), AICIS IMAP (2013), ACGIH (2011), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIAR (2003)). (2) It was reported that, in a developmental toxicity study by inhalation exposure with female rabbits (days 6 to 18 of gestation), at the high dose (300 ppm) at which maternal toxicity (reduced body weight gain, increased liver weight) was observed, the number of resorbed embryos increased but it was within the range for spontaneous incidence, and there was no increased incidence of anomalies or variations (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2015), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2013), AICIS IMAP (2013), ACGIH (2011), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIAR (2003)). (3) It was reported that, in a developmental toxicity study with female mice dosed by gavage (days 7 to 14 of gestation), at a dose of 500 mg/kg/day, 75% of dams developed symptoms (such as loose stool, tachypnea, apathy, prostration), resulting in death. In 2 of 7 surviving dams, fetal resorptions, a reduction of fertility rate (71.4%, controls: 94.7%), and an increase in stillborn pups were observed, while in liveborn pups, an increase in mortality by postnatal day 3 was observed. It was reported in the Initial Risk Assessment (NITE, CERI, NEDO, 2008) that these effects were considered to be attributed to maternal toxicity due to high-dose administration (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2015), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2013), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIAR (2003)).
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs), Category 2 (nervous system, cardiovascular system, liver, kidney), Category 3 (narcotic effects)	Danger Warning	H370 H371 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	[Rationale for the Classification] Based on the findings of human in (1) and (2), it was classified in Category 1 (respiratory organs) because effects on the respiratory organs of human were observed. Based on the animal test data (3) to (5), it was classified in Category 2 (nervous system, cardiovascular system, liver, kidney) because effects on the nervous system, cardiovascular system, liver, and kidney were observed within the dose range for Category 2. Based on the animal test data (5), it was classified in Category 3 (narcotic effects). Therefore, it was classified in Category 1 (respiratory organs), Category 2 (nervous system, cardiovascular system, liver, kidney) and Category 3 (narcotic effects). Based on the new findings, the classification result was reviewed. [Evidence Data] (1) It was irritating to the respiratory tract. It was reported that this substance was irritating to the skin and caused irritation to the nasal mucosa at 25 ppm (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2015), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). (2) This substance is irritating to the eyes, skin, and respiratory tract and might have an effect on the central nervous system. Inhalation can cause coughing, sore throat, headache, dizziness, weakness, difficulty in breathing, vomiting, and lapse of consciousness. Contact with the skin can cause reddening, burning sensation, and pain, and getting it into the eyes can cause reddening, pain, and blurred vision. Inhalation of high-concentration vapor can cause pulmonary edema (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2013)). (3) It was reported that, in rats, mice, and rabbits, the oral LD50 values were in the range from 300 to 700 mg/kg (within the range for Category 2) and the symptoms of toxicity observed were hypoactivity, lethargy, and symptoms of peripheral neuropathy (paralysis of the hind limbs, tremor, spasms in some animals). It was also reported that death was attributed to respiratory failure, and in addition to irritation of the mucous membranes of the gastrointestinal tract, histological examination revealed damage in the liver and kidneys (DFG MAK (2002)). (4) It was reported that the inhalation (vapor) LC50 values in rats were 3,506 mg/m3 and 8,200 mg/m3 (approx. 1,100 ppm and approx. 2,600 ppm, within the range for Category 2), the LC50 in mice was 3,130 mg/m3 (approx. 1,000 ppm, within the range for Category 2), and the experimental animals were narcotized and histopathological examination revealed pulmonary edema and congestion of the liver and kidneys (DFG MAK (2002)). (5) It was reported that acute toxicity symptoms observed by oral administration to rats were edema and inflammation of the gastrointestinal mucosa, degeneration of cardiomyocytes, hepatocytes and renal tubular cells, congestion and bleeding of the digestive tract, and damages of kidney and liver tissues, and the LD50 values were in the range between 450 to 700 mg/kg (within the range for Category 2). In an observation of general conditions, hypoactivity, lethargy, paralysis of the hind limbs, tremors, convulsions, etc. were observed, and disorder of the respiratory organs was reported to be the cause of death. In mice exposed to a high dose (7,300 ppm), narcotism appeared in a short time and the mice died of disorder of the respiratory organs. In rats and guinea pigs exposed by inhalation, delayed respiratory mucous membrane irritation and narcotism were observed (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2015), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system, respiratory organs, kidney), Category 2 (blood system)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1) and (2), it was suggested that the effects on the nervous system and liver were caused by exposure to this substance in humans. Based on (3) to (7), in experimental animals, effects on the respiratory organs and kidney were observed within the range for Category 1, and effects on the nervous system and the blood system were observed but no effects on the liver were observed within the range for Category 2. Therefore, it was classified in Category 1 (nervous system, respiratory organs, kidney), and Category 2 (blood system). Besides, since the findings on the heart and liver adopted for the previous classification referred to the literature that was not included in the list, they were not adopted for classification. Based on the new findings, the classification result was reviewed. [Evidence Data] (1) It was reported that, in 45 male workers and 15 female workers exposed to vapor of this substance at the concentrations of 1 to 113 ppm (3 to 350 mg/m3) for 16 months at a synthesis plant, no changes in general conditions were observed during the initial one month, but in 33 % of the subjects surveyed (control group: 23 people without liver damage), garlic-like mouth odor and body odor were observed, and very rarely, headache and nausea were observed during the exposure period. It was reported that, although they were not diagnosed as exposure-related organ disorders, hepatocyte damages including reversible changes in the activity of serum ALT, AST, and LDH (which are enzymes localized in liver cytoplasm) and mitochondria enzymes, gamma-GDH and SDH were observed (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2015), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2013)). (2) In 26 women exposed to this substance at 1 to 2,100 ppm for 2.5 months to 6 years at a manufacturing plant of sodium allylsulfonate, lacrimation and irritation to the mucosa were reported from the early stage of the exposure period. In a questionnaire survey, 24 women complained of adynamia of the four limbs, and in addition, there were complains such as cramp pain and paresthesia of the distal extremities. Furthermore, in an examination of peripheral nerves, dysalgesia was observed in 17 women, and in other examinations, tactile abnormalities, reduced vibratory sense, muscle weakness, loss of Achilles reflex, etc. were observed. Also, in an electroneuromyography, abnormalities were also observed. It was reported that, as a result of comprehensive judgment based on all these results, they were diagnosed as chronic polyneuropathy caused by chronic exposure to this substance (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2015), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2013)). (3) It was reported that, in a repeated dose 13-week inhalation (vapor) exposure test with rats (6 hours/day, 5 days/week), tissue changes in the nasal cavity (increased incidence of eosinophilic changes of the olfactory epithelium) were observed at 25 and 50 ppm (converted guidance value: 18.0, 36.1 ppm, within the range for Category 1) and effects on the nasal cavity (necrosis of the olfactory epithelium (males)), the lungs (chloasma, bronchial pneumonia, deposition of foreign material, increased lung weight (males)), the kidney (increased weight (at or above 50 ppm in males), nuclear enlargement of proximal convoluted tubules, increased eosinophilic bodies/eosinophilic droplets), and the blood (mild anemia) were observed at 100 and 200 ppm (converted guidance value: 72.2 and 144 ppm, within the range for Category 2) (Results from preliminary Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2000)). (4) It was reported that, in a repeated dose 13-week inhalation (vapor) exposure test with mice (6 hours/day, 5 days/week), effects on the nasal cavity (increased incidences of eosinophilic changes of the respiratory epithelium and the nasopharynx (females)), the blood (mild anemia), the spleen (increased incidence/severity of hemosiderosis), and the forestomach (hyperplasia of the forestomach (females, 50 ppm or above), erosion) were observed at doses up to 200 ppm (converted guidance value: 144 ppm, within the range for Category 2) (Results from preliminary Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2000)). (5) It was reported that, in a 34-week neurotoxicity study by inhalation (vapor) exposure with rats (males) (8 hours/day, 5 days/week), at 100 ppm (converted guidance value: approx. 133 ppm, within the range for Category 2), weakness of the four limbs was observed in 1 of 5 animals, resulting in extended landing foot spreads of the hindlimbs after week 28, and in addition, an electrophysiological examination of the nervous system of the same dose group revealed a decrease in the maximum conduction velocity of the motor nerve/sensory nerve in the tail (weeks 28 and 34), an increase in the motor distal latency (week 34), and depressed amplitude of nerve action potentials (week 34) (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2013), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ACGIH (2011), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2015)). (6) It was reported that, in a 2-year carcinogenicity study with rats by inhalation (vapor) exposure (6 hours/day, 5 days/week), effects on the nasal cavity (an increase in eosinophilic changes of the olfactory epithelium (males)) and the kidney (emergence of eosinophilic droplets in the proximal convoluted tubules, nuclear enlargement in epithelium cells of the proximal convoluted tubules, an increase in the severity of chronic nephropathy (males)) were observed at 25 and 50 ppm (within the range for Category 1), and effects on the kidney (hyperplasia of renal pelvis urothelium (males)) and Harderian gland (lymphocytic infiltration (females)) were observed at 100 ppm (within the range for Category 2) (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2003)). (7) It was reported that, in a 2-year carcinogenicity study with mice by inhalation (vapor) exposure (6 hours/day, 5 days/week), ataxic/paralytic gait and effects on the nasal cavity (eosinophilic changes of the olfactory epithelium (males)) and the urinary organs (urinary retention) were observed at 200 ppm (within the range for Category 2) (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2003)). (8) It was reported that, in a repeated dose 3-month inhalation (vapor) exposure test with rats (6 hours/day, 5 days/week), effects on the kidney (eosinophilic hyalin materials in the proximal tubular epithelium cells, localized necrosis/atrophy of the renal tubules) were observed at 250 ppm (converted guidance value: 181 ppm, within the range for Category 2) (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2013), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ACGIH (2011), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2015)). [Reference Data, etc.] (9) It was reported that, in a 3-month repeated dose inhalation (vapor) exposure test with mice (6 hours/day, 5 days/week), tissue changes in the liver (pigmentation of centrilobular hepatocytes/periportal glycogen accumulation, glycogen accumulation in the absence of degeneration/necrosis of hepatocytes around the bile duct) were observed at 250 ppm (converted guidance value: 181 ppm, within the range for Category 2) but toxicological significance of this finding was unclear (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2013), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ACGIH (2011), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2015)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.

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 2	- -	H401	P273 P501	In a test conducted in consideration of the volatility of this substance, 48-hour LC50 = 6.9 mg/L for fish (Oryzias latipes) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)) was obtained, but in the Environmental Risk Assessment for Chemical Substances (Ministry of the Environment), it is said that the reliability of this data cannot be judged and the toxicity value cannot be adopted (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2013)). On the other hand, in the Environmental Risk Assessment for Chemical Substances (Ministry of the Environment), it was reported that 14-day LC50 = 1.2 mg /L for prolonged toxicity of fish (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2013)), and therefore, it was classified in Category 2 as a tentative assessment based on expert judgment. The classification result was changed from the previous classification by reviewing information.
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Reliable chronic toxicity data were not obtained. It was classified as "Not classified" because it was rapidly degradable (a 28-day degradation rate by BOD: 62% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1986)) and due to a low bioaccumulation estimate (BCF >= 0.14-0.88, > 1.3-5.6) (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1979)).
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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