NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	75-01-4
Chemical Name	Vinyl chloride
Substance ID	m-nite-75-01-4_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Flammable gases	Category 1	Danger	H220	P210 P377 P381 P403	Classified into Category 1 since lower explosive limit is 3.6 vol% in ICSC (2000). The substance containing stabilizers is classified into Division 2.1 in UNRTDG (UN1086).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Oxidizing gases	Not classified	- -	-	-	Combustible gas	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Gases under pressure	Low pressure liquefied gas	Warning	H280	P410+P403	The substance is classified as "Low pressure liquefied gas" since critical temperature is 151.5 degC (HSDB (2005)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Self-heating substances and mixtures	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to gaseous substances are not available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Not classified	- -	-	-	Based on a LD50 value of >4000 mg/kg bw for rats (SIDS (access on May 2009)), the substance was classified into "Not classified" in JIS Classification (correspond to Category 5 or "Not classified" in GHS classification).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	Based on LC50 values of 152,880 ppm/2h (4-hour equivalence: 108,102 ppm), 200,000 - 250,000 ppm/2h (4-hour equivalence: 141,421 - 176,777 ppm) (SIDS (access on May 2009)) and 150,000 ppm/2h (4-hour equivalence: 106,066 ppm) (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 75 (2005)) for rats, the substance was classified as "Not classified".	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	Erythema and second-degree burns were reported in a worker after accidental exposure to liquid vinyl chloride. He recovered without sequelae (EHC 215 (1999)). Based on the report, the substance was classified into Category 2.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	Based on positive results from in vivo mouse micronucleus tests (Initial Risk Assessment Report (NITE, CERI, NEDO) (2005)) and monitoring analysis of human peripheral lymphoma chromosome (ATSDR (2006)) (in vivo somatic cell mutagenicity tests), the substance was classified into Category 2. As relevant information, there are reports of negative results in a mouse dominant lethal test and spot test (in vivo heritable mutagenicity tests) (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 75 (2005)) and positive results in a sister chromatid exchange test and a DNA damage test (in vivo genotoxicity tests) (Initial Risk Assessment Report (NITE, CERI, NEDO) (2005)). From in vitro mutagenicity tests, there are reports of positive chromosomal aberration tests using rat bone marrow and Chinese hamster V79 cells, and negative and positive Ames tests (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 75 (2005)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Carcinogenicity	Category 1A	Danger	H350	P308+P313 P201 P202 P280 P405 P501	Based on the classifications of "Group 1" in IARC (IARC suppl. 7 (1987)), "A1" in ACGIH (2001) (ACGIH-TLV (2005)), "A" in EPA (2000) (IRIS (2005)), "K" in NTP (NTP RoC (11th, 2005)) and "2" in Japan Society For Occupational Health (JSOH) (Recommendations for allowable concentrations (2004)), the substance was classified into Category 1A. Carcinogenic activity was evaluated in inhalation and oral tests in rats (30 - 52 weeks) and inhalation tests in mice and guinea pigs (30 - 52 weeks). Significantly increased incidences of tumors in various organs (angiosarcoma in the liver, nephroblastoma), fibrosarcoma in the mammary gland, pulmonary adenoma and adenocarcinoma) are reported (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 75 (2005), IARC vol. 19 (1979)). Increased incidences of liver cancer and angiosarcoma following occupational exposure is reported in epidemiological tests (Initial Risk Assessment Report (NITE, CERI, NEDO) (2005)). Increased incidences of cancer in the brain and central nervous system and lung cancer are also reported (Initial Risk Assessment Report (NITE, CERI, NEDO) (2005)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	Male rats were mated once following a 11 week exposure to the substance. A reduction in male fertility was observed based on the decreased ratio of pregnant to mated females (EHC 215 (1999)). The number of resorbed fetuses was significantly increased in rats exposed during day 1 - 9 of gestation (SIDS (access on May 2009)). Based on these data, the substance was classified into Category 2. In humans, it was reported that exposure of the substance caused male reproductive dysfunction (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 75 (2005)). In an epidemiological test for congenital malformations, the rate of malformations for the three communities having PCV production plants was significantly higher than that in control areas. The greatest excess included malformations of the CNS, cleft lip and palate, and club foot (SIDS (access on May 2009)). However, the result was not used as the basis for the determination of classification since there is a report that the test data are not sufficient for a clear evaluation of human reproductive toxicity (EHC 215 (1999)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system), Category 3 (narcotic effects)	Danger Warning	H370 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	Volunteers inhaling 8,000 or 20,000 ppm of the substance for 3 minutes complained of nausea, dizziness, and headache (ACGIH (2001)). Exposure of workers to a 2.5% concentration of the substance for 3 minutes caused dizziness and disorientation (EHC215 (1999)). In workers who were occupationally exposed to vinyl chloride (compensation cases in Japan), poisoning symptoms, including dizziness, photophobia, vomiting and disorientation were observed following acute exposure, and severe arrhythmia, collapse, unconsciousness and sometimes death were observed following acute, high dose exposure (July 29, 1976, Kihatu No. 556). Based on the data, the substance was classified into Category 1 (central nervous system). There is a report that the main symptoms after a single exposure are narcotic effects (DFGOT vol. 5 (1993)). In inhalation tests with rats, mice, guinea pigs and dogs, deep narcosis is reported (EHC215 (1999)). Based on the data, the substance was classified into Category 3 (narcotic effects).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver, nervous system, blood vessels, blood, respiratory organs, testis, bone)	Danger	H372	P260 P264 P270 P314 P501	There are a number of case reports describing adverse effects following occupational exposure to vinyl chloride (Initial Risk Assessment Report (NITE, CERI, NEDO) (2005), IARC vol. 19 (1979)). Identification of the target organs and classification of the substance according to the adverse effects reported in occupationally exposed workers are as follows; Category 1 (liver) based on hepatic dysfunction, swelling of the liver, hepatic fibrosis and portal hypertension (Initial Risk Assessment Report (NITE, CERI, NEDO) (2005)); Category 1 (nervous system) based on neuropathy including polyneuropathy, cerebral and extrapyramidal motor neuron disorder, neurasthenia and depressive symptom (Initial Risk Assessment Report (NITE, CERI, NEDO) (2005)); Category 1 (blood vessel) based on Raynaud's phenomenon or Raynaud's disease (IARC vol. 19 (1979)); Category 1 (blood) based on thrombocytopenia, anemia, leukopenia and splenomegaly (IARC vol. 19 (1979)); Category 1 (respiratory tract) based on increase in death by pulmonary emphysema, respiratory failure and pulmonary fibrosis (Initial Risk Assessment Report (NITE, CERI, NEDO) (2005)); and Category 1 (bone) based on acro-osteolysis in the limbs and bone disorder (Initial Risk Assessment Report (NITE, CERI, NEDO) (2005)). As for animals, disorder in seminiferous tubules in the testis was observed in a dose-dependent manner in 3, 6 and 12-month inhalation (0.026 mg/L/6h: 10 ppm/6h) tests in rats (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 75 (2005)). Since these findings were observed at dose levels within the guidance value range for Category 1, the substance was classified into Category 1 (testis).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Aspiration hazard	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Not classified	- -	-	-	Classified into Not classified from its 96h-LC50 = 210 mg/L for fish (Zebrafish) (SIDS, 2001)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	No reliable chronic toxicity data available. Classified into Not classified since its 96h-LC50 = 120 mg/L for fish (Zebrafish) (SIDS, 2001) and it is not non-water soluble (Water solubility = 11000 mg/L, PHYSPROP Database, 2009).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）

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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