NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	108-05-4
Chemical Name	Vinyl acetate
Substance ID	R01-B-087
Classification year (FY)	FY2019
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	FY2018 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 (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	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2	Flammable gases	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
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 -8 deg C (closed cup) and a boiling point of 72 deg C (NFPA (2010)). Besides, stabilized one is classified in Class 3, PG II in UNRTDG (UN1301).
7	Flammable solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
8	Self-reactive substances and mixtures	Type G	- -	-	-	There is an unsaturated bond, a chemical group associated with self-reactive properties, present in the molecule, but stabilized one is classified in Class 3, PG II in UNRTDG (UN1301) and is not applicable to self-reactive substances and mixtures, hazards of the highest precedence, therefore it was classified as Type G. Besides, a pure substance and one with less amount of a stabilizer may correspond to Type A to F.
9	Pyrophoric liquids	*	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of 402 deg C (NFPA (2010)).
10	Pyrophoric solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
11	Self-heating substances and mixtures	*	- -	-	-	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	*	- -	-	-	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 (Not applicable)."
13	Oxidizing liquids	*	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
15	Organic peroxides	*	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	No data available.
17	Desensitized explosives	*	- -	-	-	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)	*	- -	-	-	[Rationale for the Classification] Based on (1)-(4), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: 2,920 mg/kg (ACGIH (7th, 2018), ATSDR (1992), PATTY (6th,2012), HSDB (Access on September 2019)) (2) LD50 for rats: 3,470 mg/kg (ACGIH (7th, 2018), ATSDR (1992), DFGOT vol.21 (2005), EU-RAR (2008)) (3) LD50 for rats: 2,900 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003)) (4) LD50 for rats: 1,600-3,480 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005))
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Based on (1)-(4), it was classified as "Not classified." [Evidence Data] (1) LD50 for rabbits: 8.0 mL/kg (7,440 mg/kg) (ACGIH (7th, 2018), ATSDR (1992), DFGOT vol.21 (2005), EU-RAR (2008)) (2) LD50 for rabbits: 2,335 mg/kg (PATTY (6th, 2012), HSDB (Access on September 2019)) (3) LD50 for rabbits: 2.5 mL/kg (2,325 mg/kg) (ACGIH (7th, 2018), ATSDR (1992)) (4) LD50 for rabbits: 2,335-7,470 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005))
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Vapours)	Category 4	Warning	H332	P304+P340 P261 P271 P312	[Rationale for the Classification] Based on (1)-(5), it was classified in Category 4. Besides, since the LC50 values were lower than 90% of the saturated vapour pressure concentration (118,693 ppm), the reference value in units of ppm was applied as a vapour with little mist. [Evidence Data] (1) LC50 (4 hours) for rats: 3,680 ppm (ACGIH (7th, 2018), ATSDR (1992), PATTY (6th,2012), HSDB (Access on September 2019)) (2) LC50 (4 hours) for rats: 4,490 ppm (ACGIH (7th, 2018), ATSDR (1992)) (3) LC50 (4 hours) for rats: 15.8 mg/L (4,487.3 ppm), 14.1 mg/L (4,004.5 ppm) (EU-RAR (2008)) (4) LC50 (4 hours) for rats: 3,200-4,490 ppm (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)) (5) LC50 (4 hours) for rats: 11,400 mg/m3 (3,237.7 ppm) (Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003))
1	Acute toxicity (Inhalation: Dusts and mists)	*	- -	-	-	[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)-(4), the human case was given priority and it was classified in Category 2. [Evidence Data] (1) In a case with workers, irritation was observed by exposure to this substance, and continued exposure caused blistering (ATSDR (1992), HSDB (Access on September 2019)). (2) Slight edema was observed in rabbits following the application of 0.5 mL of this substance (ATSDR (1992)). (3) Mild irritative effects were observed in a skin irritation test with rabbits (EU-RAR (2008), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), PATTY (6th, 2012)). (4) This substance is irritating to the mucous membranes and skin and it has a skin defatting effect at high concentrations (Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003)). [Reference Data, etc.] (5) In a skin irritation test with rabbits according to OECD TG 404, the mean scores for 24/48/72 hours were all <0.67, and after 72 hours, all reactions disappeared (REACH registration dossier (Access on October 2019)). (6) In a skin irritation test with rabbits, slight erythema was observed after exposure of the skin to this substance (amount unknown) for 5-15 minutes, and slight erythema and slight edema were observed on Day 1 after exposure for 20 hours (DFGOT vol.21 (2005)). (7) In a Draize skin test, the application of 0.5 mL of this substance to rabbits caused edema (grade 4) and subdermal hemorrhage 4, 24 and 72 hours after the application (DFGOT vol.21 (2005)). (8) In a test in which 8 mL/kg of this substance was applied to rabbits for 24 hours, 2 of 4 rabbits died within 2 days and these animals were found to have necrosis at the site of application (DFGOT vol.21 (2005)).
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	[Rationale for the Classification] Based on (1)-(5), the human case was given priority and it was classified in Category 2. [Evidence Data] (1) This substance is reported to cause eye and throat irritation in humans at 21.6 ppm (ACGIH (7th, 2018), HSDB (Access on September 2019)). (2) Mild irritative effects were observed in an eye irritation test with rabbits (EU-RAR (2008), PATTY (6th, 2012)). (3) This substance is irritating to the conjunctiva at high concentrations (DFGOT vol.5 (1993)). (4) Exposure to the vapor of this substance or direct exposure to this substance causes irritation of the eyes (ATSDR (1992)). (5) Instillation of this substance (1-2 drops) into the eyes of rabbits led to corneal clouding, reddening and severe edema of the conjunctiva 24 hours later, but these disappeared after 8 days (DFGOT vol.21 (2005)). [Reference Data, etc.] (6) In an eye irritation test with rabbits according to OECD TG 405, the mean scores for the cornea, iris, conjunctival reddening and chemosis at 24/48/72 hours were 0.33 for conjunctival reddening, and 0 for all others (REACH registration dossier (Access on October 2019)). (7) This substance (0.5 mL) was severely irritating when applied to the eyes of rabbits (ACGIH (7th, 2001), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) In a mouse local lymph node assay (LLNA) according to OECD TG 429, the SI values were below 3, and the test result was negative (REACH registration dossier (Access on November 2019), ACGIH (7th, 2018), EU-RAR (2008)). [Reference Data, etc.] (2) This substance showed a moderate skin sensitizing potential in a Buehler test with guinea pigs (ACGIH (7th, 2018), DFGOT vol.21 (2005), (EU-RAR (2008)), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)).
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2. [Evidence Data] (1) As for in vivo, negative results are reported for a number of micronucleus tests with mouse bone marrow, rat bone marrow and mouse spermatogonial cells after intraperitoneal administration or inhalation exposure, but a micronucleus test with rat bone marrow after intraperitoneal administration was evaluated as positive overall by means of weight of evidence. Positive results are reported for chromosomal aberration tests and sister chromatid exchange tests with rat bone marrow (ATSDR (1992), DFGOT vol.5 (1993), IARC 63 (1995), ACGIH (7th, 2001), DFGOT vol.21 (2005), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), EU-RAR (2008)). (2) As for in vitro, negative results are reported for a bacterial reverse mutation test, and positive results are reported for a chromosomal aberration test and a sister chromatid exchange test with cultured mammalian cells, and a mouse lymphoma test (ATSDR (1992), DFGOT vol.5 (1993), IARC 63 (1995), ACGIH (7th, 2001), DFGOT vol.21 (2005), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), EU-RAR (2008), PATTY (6th, 2012)). [Reference Data, etc.] (3) It is concluded in EU-RAR (2008) that the genotoxicity of this substance is unlikely to occur in human germ cells, since most of the majority of the in vivo test results were unreliable and the positive result in the most important mouse bone marrow micronucleus test was limited to these of intraperitoneal doses of high toxicity (EU-RAR (2008)). (4) In the Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), this substance was judged to be genotoxic based on the results of in vivo and in vitro studies (Hazard Assessment Report (CERI, NITE, 2005)).
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Information on carcinogenicity in humans was limited to (6). In (1) and (2) conducted in accordance with appropriate test guidelines and GLP standards, as clear evidence of carcinogenicity including malignant tumors was found in two species of animals, therefore it was classified in Category 1B. Although there are classifications by other organization as shown in (4), in the carcinogenicity studies (1) and (2) conducted by the Ministry of Health, Labour and Welfare in accordance with the appropriate test guidelines and GLP standards, clear evidence of carcinogenicity including malignant tumors was found in two species of animals, and it was emphasized that the Ministry issued the guideline due to concerns in humans after deliberation by the hazard assessment subcommittee. [Evidence Data] (1) In a carcinogenicity study with rats (drinking water for 2 years), increased incidences of oral squamous cell carcinomas and squamous cell papilloma in treated male groups and oral and esophageal squamous cell carcinomas in treated female groups were observed (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare) (Access on September 2019)). (2) In a carcinogenicity study with mice (drinking water for 2 years), increased incidences of squamous cell carcinomas and squamous cell papilloma in the oral cavity and stomach and squamous cell carcinomas of the esophagus and larynx were observed in both sexes of the treated groups (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare) (Access on September 2019)). (3) In a 2-year inhalation exposure test with rats, squamous cell carcinoma, squamous papilloma and in-situ carcinoma in the nasal cavity were observed (IARC 63 (1995), EU-RAR (2008), ACGIH (7th, 2018), Initial Risk Assessment Report (Ministry of Health, Labour and Welfare, 2010), Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). (4) As for classification results by domestic and international organizations, it was classified in Group 2B by IARC (IARC 65 (1995)), Carc. 2 in EU CLP, 2B by the Japan Society of Occupational Health (1998 Proposal), and A3 by ACGIH (ACGIH (7th, 2018)). Besides, the classification of IARC does not include the results of (1) and (2). (5) Based on the provisions of Article 28, Paragraph 3 of the Industrial Safety and Health Law, this substance is subject to the revised guidelines for preventing health impairment of workers caused by chemical substances specified by the Ministry of Health, Labour and Welfare (Dated October 10, 2012, Public announcement on guidelines in order to prevent the impairment of a worker's health based on Industrial Safety and Health Law). [Reference Data, etc.] (6) As for carcinogenicity in humans, it is reported that in a cohort study of male workers who were exposed to 19 different chemicals including this substance between 1942 and 1973, undifferentiated large cell lung cancer was related to a slightly higher cumulative exposure to this substance (IARC 63 (1995), EU-RAR (2008), ACGIH (7th, 2018)), and that in a US nested case-control study, exposure to this substance was related to the death of men employed in two large chemical manufacturing facilities, who had died in 1940-1978 with non-Hodgkin's lymphoma, multiple myeloma, lymphocytic leukemia or nonlymphocytic leukemia (IARC 63 (1995), EU-RAR (2008), ACGIH (7th, 2018), Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003)). (7) In a multi-generation test by 78-week oral administration by drinking water to male and female mice and their F1 offspring, an increased incidence of epithelial malignant tumors in the esophagus and forestomach was observed (ACGIH (7th, 2018)). (8) In a multi-generation test by 104-week oral administration by drinking water to 3 strains of male and female rats and their F1 offspring, cancers of the oral cavity, esophagus and forestomach increased in the offspring. As for F344 rats, many deaths were observed, the administration period was 100 weeks, and increases of neoplasms were observed (ACGIH (7th, 2018)).
7	Reproductive toxicity	*	- -	-	-	[Rationale for the Classification] Based on (1)-(3), there were differences in the evaluation of reproductive toxicity among assessment documents, on considering all the circumstances, it was classified as "Classification not possible." The classification result was changed from the previous classification because the data were reviewed. [Evidence Data] (1) In a two-generation reproductive toxicity test with rats dosed by drinking water, at doses in which palatability-induced decreases in water intake and consequent reduced body weight in parental animals were caused, slight reduction in pregnancy rate and reduced body weight gain in offspring were observed. Besides, from the result of cross mating, it is considered that the decrease in pregnancy rate was related to male reproductive performance and was rather attributable to poor mating than to impaired fertility, but there were no changes in the testis on histopathological examinations (EU-RAR (2008)). Besides, there is a remark on the results of a test seemingly identical to the above test in ATSDR (1992) that the difference observed in the reduction in pregnancy rate was not statistically significant and the pregnancy incidence was within the reported range of historical controls. Also, it is described that the reduction of the body weight gain in the pups may be attributed to the growth retardation observed in the dams and thus is most likely not a direct toxic effect. (2) No effects were observed in a developmental toxicity test in which female rats were dosed by drinking water from Day 6 to Day 15 of gestation (EU-RAR (2008)). (3) In a developmental toxicity test in which female rats were exposed by inhalation from Day 6 to Day 15 of gestation, a reduction in body weight gain in dams and decreases in body weight and crown-rump length, and delayed ossification in fetuses were observed at 1,000 ppm (EU-RAR (2008)).
8	Specific target organ toxicity - Single exposure	Category 3 (narcotic effects, respiratory tract irritation)	Warning	H336 H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] Based on (1), (2), it was classified in Category 3 (narcotic effects, respiratory tract irritation). [Evidence Data] (1) In an inhalation test with human volunteers exposed to 72 ppm of this substance for 30 minutes, it is reported that all 4 subjects complained of irritation of the mucous membranes of the throat (ATSDR (1992), ACGIH (7th, 2018)). (2) It is described that this substance is irritating to the mucous membranes and skin, and at high concentrations, it has skin defatting and narcotic effects (Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003)). [Reference Data, etc.] (3) It is reported that in a single oral administration test with rats, the LD50 value was approximately 3,500 mg/kg (exceeding the range of Category 2), and symptoms of local irritation and central nervous system disorders (diarrhea, shortness of breath, tremors, apathy) were observed (EU-RAR (2008), GESTIS (Access on September 2019)). (4) It is reported that in a single inhalation exposure test with rabbits at 7 to 142 ppm of this substance for 40 minutes, depression of the central nervous system was observed in the 71 ppm group and central nervous system enhancement was observed in the 142 ppm group (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), ACGIH (7th, 2018)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (respiratory organs)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1) and (2), since effects on the respiratory organs were observed at the dose of Category 2 in the inhalation of exposure to experimental animals, it was classified in Category 2 (respiratory organs). (1) A 2-year inhalation toxicity test with mice showed atrophy of the olfactory epithelium and atrophy of the mucos-secreting gland in the nasal cavity at and above 200 ppm (converted guidance value: 0.7 mg/L, within the range of Category 2), detachment or squamous transformation of the bronchial epithelium and aggregation of pigmented macrophages were observed in the lung at 600 ppm (converted guidance value: 2.1 mg/L, exceeding the range of Category 2) (ACGIH (7th, 2018), EU-RAR (2008), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). (2) As a result of the 2-year inhalation toxicity test with rats, squamous metaplasia and atrophy of the olfactory epithelium of the nasal cavity and basal cell hyperplasia were observed at and above 200 ppm (converted guidance value: 0.7 mg/L, within the range of Category 2), and bronchial epithelial detachment or squamous formation, pigment-phagocytic macrophage aggregation in the lungs, etc. were observed at 600 ppm (converted guidance value: 2.1 mg/L, over the range of Category 2) (same as above). [Reference Data, etc.] (3) Ongoing deterioration of the heart muscles, arrhythmias, decreased electrocardiographic amplitude, myocardial dystrophies, fainting, chest pain and a sensation of dying are reported in factory workers exposed to this substance (PATTY (6th, 2012)), but this report was considered to be an occupational exposure to multiple substances and the concentration of vinyl acetate was not described (Acute exposure guideline levels for selected airborne chemicals, vol 14 (National Research Council, 2013)).
10	Aspiration hazard	*	- -	-	-	[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	It was classified in Category 2 from 96-hour LC50 = 2.4 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2001)).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	It was classified in Category 3 because it was rapidly degradable (a 28-day degradation rate by BOD = 82, 98, 89% (Official Bulletin of Ministry of International Trade and Industry, 1988)), and due to 72-hour NOEC = 0.2 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2001)).
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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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