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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	25013-15-4
Chemical Name	Vinyl toluene
Substance ID	H30-B-011-MHLW, MOE
Classification year (FY)	FY2018
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)	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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 applicable	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Category 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	A flash point is 45-53 deg C (closed cup) (ICSC (1996) (J)).
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Not classified (when it contains a stabilizer)	- -	-	-	There is a chemical group associated with self-reactive properties (ethylene group) present in the molecule. However, because stabilized one is classified in Class 3, PG III (UN2618) in UNRTDG, it does not correspond to hazards of the highest precedence, self-reactive substances and mixtures.
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 489-515 deg C (ICSC (1996) (J)).
10	Pyrophoric solids	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 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 applicable	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1)-(5), one case corresponds to Category 4, four cases to "Not classified" (Category 5 in UN GHS classification), and one case to "Not classified." Therefore, it was classified as "Not classified" (Category 5 in UN GHS classification) with a large number of cases. The classification result was changed according to the revised GHS classification guidance for the Japanese government. [Evidence Data] (1) LD50 value for rats: 2,000 mg/kg (male) (MAK/BAT (2017)) (2) LD50 value for rats: about 4,000 mg/kg (male) (a mixture of m-, p-isomers) (MAK/BAT (2017)) (3) LD50 value for rats: 5,000 mg/kg (male) (MAK/BAT (2017)) (4) LD50 value for rats: 4,000 mg/kg (a mixture of m-, p-isomers) (ACGIH (1992), Patty (2012)) (5) LD50 values for rats: 4,900 mg/kg, 5,700 mg/kg (a mixture of m-, p-isomers) (Patty (2012))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 value for rabbits: > 4,500 mg/kg (male, female) (MAK/BAT (2017))
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	[Rationale for the Classification] Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1)-(3), it was classified as "Not classified." Besides, since the saturated vapor concentration was 1,480 ppm and the test was conducted in a range exceeding the saturated vapor concentration, it was treated as an inhalation test on the mist. [Evidence Data] (1) LC50 value for rats (4 hours): > 3,500 ppm (16.90 mg/L) (male, female) (MAK/BAT (2017)) (2) LC50 value for rats (6 hours): 1,510 ppm (7.293 mg/L, converted 4-hour equivalent value: 8.932 mg/L) (male, female) (MAK/BAT (2017)) (3) LC50 value for rats (6 hours): 1,960 ppm (9.467 mg/L, converted 4-hour equivalent value: 11.59 mg/L) (male, female) (MAK/BAT (2017))
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] Reversible irritation is indicated from data of repeated application (2) and supports (1). Data of a 24-hour application (3) shows "Not classified," but it was classified in Category 2 based on the weight of evidence. [Evidence Data] (1) There is a description that this substance is a substance generally known to irritate the human skin and to be irritating (NTP TR375 (1990), HSDB (Accessed Aug. 2018)). [Reference Data, etc.] (2) There is a report that in a test with rabbits, 10-time applications of this substance over a period of 13 days resulted in slight to moderate irritation but recovery was rapid (DFG (2017)). (3) There is a report that in a skin irritation test with rabbits, in application of this substance for 24 hours resulted in 1.5 of PII (skin primary irritation index) (ECHA registration dossier (Accessed Jul. 2018)).
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	[Rationale for the Classification] There is information indicating severe irritation (1), and information indicating slight irritation (2) and (3). However, since the exposure details in (1) are unknown, it was classified in Category 2 based on the weight of evidence. Besides, the category was changed from the previous one by the use of this newly obtained information. [Evidence Data] (1) There is a report that severe irritation to human eyes and nose was observed at or above concentrations of 400 ppm (MAK/BAT (2017), IARC 60 (1994), NTP TR375 (1990)). (2) There is a report that in an eye irritation test (isomer mixture: m-isomer: ca. 55-70%, p-isomer 30-45%) with rabbits, as a result of observation for seven days after application of this substance, slight conjunctival irritation was observed (MAK/BAT (2017)). (3) There is a report that in an eye irritation test with rabbits, as a result of observation for seven days after application of this substance, the maximum score was 1, and erythema and discharge of pus was observed, but these finally resolved (REACH registration dossier (Accessed Jul. 2018)).
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] Although there is information that this substance is not sensitizing (1), test details are unknown, and it was classified as "Classification not possible" due to lack of data. [Reference Data, etc.] (1) There is a report that in a Maximization test (n=15 (male)) with guinea pigs, in which this substance (mixture of m-isomer and p-isomer) was applied, no skin sensitization was shown (MAK/BAT (2017), REACH registration dossier (Accessed Jul. 2018)).
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] From (1)-(3), based on the positive finding in a micronucleus test with mouse erythrocytes, it was classified in Category 2. [Evidence Data] (1) As for in vivo, it was negative in a dominant lethal test with rats (MAK/BAT (2017)). (2) As for in vivo, it was negative in a chromosomal aberration test with rat bone marrow (MAK/BAT (2017)), and it was positive in a micronucleus test with mouse erythrocytes (MAK/BAT (2017), IARC 60 (1994)). (3) As for in vitro, there are reports of it being negative in bacterial reverse mutation tests (MAK/BAT (2017), IARC 60 (1994)), of it being positive in a chromosomal aberration test and a sister chromatid exchange test with human lymphocytes, of it being weakly positive in a mammalian cell gene mutation test (MAK/BAT (2017), IARC 60 (1994)), and of it being negative in a chromosomal aberration test and a sister chromatid exchange test with cultured mammalian cells (MAK/BAT (2017)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] As for carcinogenicity, there are no available reports on humans. Based on (1)-(3), it was classified as "Classification not possible." [Evidence Data] (1) This substance (p-isomer: 96.8%, m-isomer: 3%) was administered orally to male and female rats and mice at 10, 50, 250, 500 mg/kg bw for 108 weeks, 10, 50, 250 mg/kg bw for 78 weeks, respectively. As a result, no significant increase was observed in the ratio or incidence of malignant or benign tumors (IARC 60 (1994)). (2) Male and female rats and mice were exposed by inhalation to this substance (p-isomer: 32-35%, m-isomer: 65-71%) at 100, 300 ppm for 103 weeks, 10, 25 ppm for 103 weeks, respectively. As a result, no treatment-related increase in tumor incidence was observed in either sex (IARC 60 (1994), NTP TR375 (1990)). (3) As for the classification results by domestic and international organizations, it was classified in Group 3 by IARC (IARC 60 (1994)) and A4 by ACGIH (ACGIH (7th, 2001)).
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] According to (1), increased mortality of pups is reported in the two-generation reproductive toxicity study with rats, but details such as statistical significance and general conditions of parental animals are unknown. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) In a two-generation reproductive toxicity study with rats by the oral route (feeding), in the administration of 500 mg/kg/day, decreased body weight gain was observed in parental animals, and a slight increase in mortality was observed in pups (MAK/BAT (2017)).
8	Specific target organ toxicity - Single exposure	Category 2 (nervous system), Category 3 (narcotic effects, respiratory tract irritation)	Warning	H371 H336 H335	P308+P311 P260 P264 P270 P405 P501 P304+P340 P403+P233 P261 P271 P312	[Rationale for the Classification] Based on (1)-(3), it was classified in Category 2 (nervous system), Category 3 (narcotic effects, respiratory tract irritation). Besides, the target organ and category were changed from the previous classification. [Evidence Data] (1) There is a report that depression of the central nervous system is observed when humans are continuously exposed by inhalation to high concentrations (NTP TR 375 (1990)). (2) There is a report that respiratory tract irritation occurred in subjects exposed to 400 ppm (ACGIH (7th, 2001), PATTY (6th, 2012)). (3) There is a report that in a test with rats exposed by inhalation at 3,500 mL/m3 (converted value: 16.9 mg/L, exceeding the range of Category 2) for 4 hours, respiratory abnormalities, discharge from the eyes, nose and ears during exposure, and muscular weakness, loss of reflexes, uncoordinated movements and tremors after exposure were observed (MAK/BAT (2017)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on the data in (1) and (2), it was classified in Category 1 (respiratory organs). The effects on the central nervous system in humans are not adopted as a target organ because these are not known to be effects by this substance. In addition, an increase in severity of nephropathy was observed in male rats in (6), but no effect on the kidneys was observed in female rats and male and female mice. Therefore, it was judged as a kidney disorder specific to male rats. Since effects on the liver observed in (3) and (4) were not observed in long-term exposure studies, they are considered to be short-term transient effects and not considered to be a target organ. Since the target organ in the previous classification was reviewed, the category was changed. [Evidence Data] (1) There is a report that in a test with mice exposed by inhalation at 10-200 ppm for 13 weeks, metaplasia of the nasal turbinates (male and female) at or above 10 ppm (converted value: 0.0343 mg/L, within the range of Category 1), and inflammation of the lung (male and female) at 160 ppm (converted value: 0.549 mg/L, within the range of Category 2) were observed (NTP TR375 (1990), ACGIH (7th, 2001)). (2) There is a report that in a test with mice exposed by inhalation at 10-25 mg/L for 2 years, at or above 10 ppm (converted value: 0.0343 mg/L, within the range of Category 1), degenerative and nonneoplastic proliferative lesions of the nasal mucosa (focal chronic active inflammation, diffuse hyperplasia of the respiratory epithelium) were observed (NTP TR375 (1990), ACGIH (7th, 2001)). [Reference Data] (3) In humans, there is a report that there are effects on the central nervous system such as depression, poor memory and electrophysiological changes by occupational exposure, but this is information on combined exposure to other substances with neurotoxicity (IARC 60 (1994)). (4) There is a report that in a test with rats exposed by inhalation at 200-1,300 ppm for 2 weeks, centrilobular hepatocellular necrosis and focal inflammatory cell infiltration of the liver (male), minimal centrilobular vacuolization of the liver (female), and dysplasia of the bronchial epithelium, chronic bronchitis, and lymphoid hyperplasia of the lungs (male, female) were observed at 1,300 ppm (converted value: 4.46 mg/L, equivalent to "Not classified") (NTP TR375 (1990)). (5) There is a report that in a test with mice exposed by inhalation at 10-200 ppm for 2 weeks, hepatocellular necrosis (male), centrilobular hepatocellular necrosis, vacuolization and inflammatory cell infiltrates in the liver (female), and hyperplasia of the epithelium of the intrapulmonary bronchi (female) were observed at 200 ppm (converted value: 0.686 mg/L, within the range of Category 2) (NTP TR375 (1990)). (6) There is a report that in a test with rats exposed by inhalation at 25-1,000 ppm for 13 weeks, dose-related increase in the severity of nephropathy (male) was observed at or above 160 ppm (converted value: 0.549 mg/L, within the range of Category 2) (NTP TR375 (1990), ACGIH (7th, 2001)). (7) There is a report that in a test with rats exposed by inhalation at 100-300 ppm for 2 years, at or above 100 ppm (converted value: 0.343 mg/L, within the range of Category 2), degenerative and nonneoplastic proliferative lesions of the nasal mucosa (respiratory epithelial metaplasia of the olfactory epithelium, diffuse hyperplasia of the respiratory epithelium with intraepithelial mucous cysts, focal erosion of the olfactory epithelium, etc.) were observed in males and females (NTP TR375 (1990), ACGIH (7th, 2001)).
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 (Acute)	Classification not possible	- -	-	-	Reliable acute toxicity data were not obtained.
11	Hazardous to the aquatic environment (Long-term)	Classification not possible	- -	-	-	No data available.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.

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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