GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 88-12-0 |
| Chemical Name | N-Vinyl-2-pyrrolidone |
| Substance ID | H27-B-023/C-044B_P |
| Classification year (FY) | FY2015 |
| 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 | FY2008 FY2007 |
| 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 |
| 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 present in the molecule associated with explosive properties. |
| 2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 3 | Aerosols | Not applicable |
- |
- | - | Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 5 | Gases under pressure | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 6 | Flammable liquids | Not classified |
- |
- | - | Based on a flash point of 95 degrees C (closed cup) (HSDB (Access on June 2015)), it was classified as "Not classified." |
| 7 | Flammable solids | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 8 | Self-reactive substances and mixtures | Classification not possible |
- |
- | - | There is a chemical group present in the molecule associated with self-reactive properties (unsaturated bond (olefins)), but the classification is not possible due to no data. |
| 9 | Pyrophoric liquids | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an ignition point of 240 degrees C (HSDB (Access on June 2015)). |
| 10 | Pyrophoric solids | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | No established test method suitable for liquid substances. |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable |
- |
- | - | Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is not chemically bonded to the elements other than carbon or hydrogen. |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | It is an organic compound that does not contain bivalent -O-O- structure in the molecule. |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | Due to no data, the classification is not possible. |
| 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 |
Five LD50 values of 834-1,314 mg/kg, 1,022 mg/kg, 1,700 mg/kg, 2,500 mg/kg (EU-RAR (2003), NICNAS (2000), DFGOT vol. 5 (1993)), 1,043 mg/kg (EU-RAR (2003), NICNAS (2000)) were reported for rats. Because four correspond to Category 4, and one corresponds to "Not classified" (Category 5 in UN GHS classification), it was classified in Category 4 to which most of the data correspond. |
| 1 | Acute toxicity (Dermal) | Category 3 |
 Danger |
H311 | P302+P352 P361+P364 P280 P312 P321 P405 P501 |
Three LD50 values of 1,043-4,127 mg/kg for rats (NICNAS (2000), DFGOT vol. 5 (1993)) and > 400 mg/kg (DFGOT vol. 5 (1993)) and 560 mg/kg (NICNAS (2000), DFGOT vol. 5 (1993)) for rabbits were reported. Because one corresponds to Category 3, and the category cannot be determined from the other two data, it was classified in Category 3 to which one corresponds. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | The classification is not possible due to lack of data. Besides, it is reported that deaths were not observed after 6-8-hour inhalation to saturated vapour (0.6 mg/L) in rats (converted to a 4-hour equivalent: 0.73-0.85 mg/L (161-187 ppm)) (EU-RAR (2003)). |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Category 4 |
Warning |
H332 | P304+P340 P261 P271 P312 |
Two LC50 values of 3.07 mg/L (4 hours) (EU-RAR (2003), NICNAS (2000), DFGOT vol. 5 (1993)) and > 3.7 mg/L (6 hours) (converted to a 4-hour equivalent: > 5.55 mg/L) (DFGOT vol. 5 (1993)) were reported for rats (DFGOT vol. 5 (1993)). Because one corresponds to Category 4, and the other corresponds to "Not classified," it was classified in Category 4 to which the smaller LC50 value corresponds. Besides, a reference value of mists was applied because the LC50 values are higher than the saturated vapour pressure concentration (0.6 mg/L). |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | It was judged to be not irritating or slightly irritating because only slight erythema, slight edema, and slight scaling were observed after 20 or 24-hour application of this substance in four reports from skin irritation tests using rabbits (EU-RAR (2003), HSDB (Access on July 2015)). Moreover, it is reported that in a skin irritation test using rats, irritation was not observed after this substance was applied on about 10% of body surface at 1,043 mg/kg for 24 hours (EU-RAR (2003), DFGOT vol.5 (1993), HSDB (Access on July 2015)). On the other hand, three reports state that marked irritation was found after this substance was applied to rabbits (EU-RAR (2003)). However, because these reports are all old, in EU-RAR (2003), the substance was not classified as a skin irritant, by adopting newer reports (EU-RAR (2003)). Moreover, it is reported that after this substance was applied to six volunteers for 8 hours, slight erythema was observed in three, but the other three did not show signs (EU-RAR (2003), NICNAS (2000)). From the above results, the substance was classified as "Not classified" (Category 3 in UN GHS classification). |
| 3 | Serious eye damage/eye irritation | Category 1 |
 Danger |
H318 | P305+P351+P338 P280 P310 |
In an eye irritation test using rabbits, redness (score 1.9), conjunctivitis (score 2.2), iritis (score 1), and corneal opacity (score 1.8) were observed after 0.1 mL of this substance was applied, and signs tended to become worse without a recovery. Therefore, it was judged to be severely irritating (EU-RAR (2003)). Moreover, in the other reports using rabbits, it is reported that slight to severe conjunctivitis, edema, and corneal opacity were found after application of undiluted this substance, and reversibility was not seen during the 8-day observation period (EU-RAR (2003), DFGOT vol.5 (1993)). Besides, this substance is classified in "Eye Dam. 1 H318" in EU CLP classification (ECHA CL inventory (Access on September 2015)). From the above results, it was classified in Category 1. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | The classification is not possible due to lack of data. Besides, it is written in EU-RAR (2003) that this substance will not cause respiratory tract sensitization at least by the immune system because it is not a skin sensitizer and does not bind to proteins (EU-RAR (2003)). |
| 4 | Skin sensitization | Not classified |
- |
- | - | It is reported that in a Buehler test using guinea pigs, this substance (purity 99.7%) is not sensitizing (EU-RAR (2003), HSDB (Access on July 2015)). Because this test had no vehicle control group but an untreated control group, and as a positive control group, a positive result was obtained in a Buehler test using alfa-hexylcinnamaldehyde conducted within six months of this test, it is judged in EU-RAR that there is no problem in the sensitivity of this test. From the above, it was classified as "Not classified." |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | Because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government, it was classified as "Classification not possible." As for in vivo, a micronucleus test in mouse bone marrow cells and a DNA-binding test in rat liver were negative (EU-RAR (2003), NICNAS (2000), ACGIH (7th, 2003), DFGOT vol. 5 (1993)). As for in vitro, a bacterial reverse mutation test, a gene mutation test, a chromosomal aberration test, and an unscheduled DNA synthesis test in cultured mammalian cells were negative (EU-RAR (2003), NICNAS (2000), ACGIH (7th, 2003), DFGOT vol. 5 (1993)). |
| 6 | Carcinogenicity | Category 2 |
 Warning |
H351 | P308+P313 P201 P202 P280 P405 P501 |
After rats (10 females) had been in 3-month inhalation exposure to vapour of this substance at a concentration of 45 ppm followed by leaving without treatment for a 21-month period and necropsy, liver tumors were visually observed in four out of survived six animals, and two of them showed hepatocellular carcinoma (EU-RAR (2003), ACGIH (7th, 2003)). Moreover, in a test in male and female rats in 2-year inhalation exposure to vapour of this substance (containing Kerobit (antioxidant: 3 ppm) as a stabilizer) at 5, 10, or 20 ppm, increased incidences were observed for hepatocellular carcinoma and nasal cavity adenoma or adenocarcinoma at 5 ppm or higher, and for laryngeal squamous epithelial carcinoma at 20 ppm (EU-RAR (2003), ACGIH (7th, 2003)). There is no carcinogenicity information in humans, but from the test results using experimental animals mentioned above, ACGIH classified in A3 (ACGIH (7th, 2003)). Besides, EU classified in Carc. 2 in CLP classification (ECHA CL Inventory (Access on June 2015)) by claiming that liver tumor formation in rats is applicable to humans (EU RAR (2003)). Therefore, the substance was classified in Category 2 in this hazard class in accordance with Classification Guidance. Besides, because IARC did not conduct re-assessment after the Group 3 classification in 1999 (IARC vol. 71 (1999)), the classification results of newer years were followed. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | There is no reproductive effect information in humans. As for experimental animals, in a report from a developmental toxicity test in pregnant rats in inhalation exposure to vapour of this substance during an organogenetic period (day 6-19 of gestation), lower weight, increased incidence of delayed ossification and wavy ribs were observed in fetuses at the dose (20 ppm: 92 mg/m3) with noted maternal toxicity (weight gain decreased by 68% than a control group), and skeletal effects are thought to be secondary effects of maternal toxicity (EU RAR (2003)). It is thought that this substance does not cause serious developmental effects in an inhalation route, but due to no test results to evaluate sexual function and fertility, the classification is not possible due to lack of data. |
| 8 | Specific target organ toxicity - Single exposure | Category 2 (central nervous system, respiratory organs, liver) |
Warning |
H371 | P308+P311 P260 P264 P270 P405 P501 |
This substance is irritating to the respiratory tract in inhalation and oral routes (EU-RAR (2003), NICNAS (2000), IARC 71 (1999)). There are multiple data in experimental animals. In inhalation exposure, dyspnea, salivation, nasal discharge, piloerection, decreased respiratory rates, hunched posture, staggering gait, ataxia, and coma were observed in rats and mice at 3.07 mg/L (LC50) (corresponding to Category 2), and necropsy in dead animals revealed that the liver and lung are the major target organs of rats. Damage including centrilobular hepatocellular necrosis, single cell necrosis, and changes in cell nuclei in the liver, discoloration of the kidney, congestion of the lung, an increase in alkaline phosphatase and a decreased total protein level were found. The following was reported in oral administration: lacrimation, eyelid ptosis, diuresis, and loss of the righting reflex in rats at 834-1,314 mg/kg (corresponding to Category 2) (NICNAS (2000), EU-RAR (2003)); and "convulsive twitching with arching of the back" and tremors in mice at 420-1,400 mg/kg (corresponding to Category 2 or higher) (EU-RAR (2003)). Among findings mentioned above, changes in the liver and lung found in dead animals were judged to be toxicity signs by single dose because histopathological changes in the liver and lung were also observed in repeated dose. The kidney was not taken as a target organ because there were only discoloration and diuresis. There is no information in humans. From the above, because this substance shows effects on respiratory tract irritation, central nervous system, respiratory organs, and liver, the substance was classified in Category 2 (central nervous system, respiratory system, liver). By adding new information, the previous classification was revised. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (respiratory organs, liver, haemal system) |
Danger |
H372 | P260 P264 P270 P314 P501 |
There is no human information. As for experimental animals, the following was observed (NICNAS (2000)): catarrhal purulent rhinitis, atrophy of nasal olfactory epithelium, hyperplasia of nasal submucosal glandular cells, hyperplasia of nasal respiratory epithelium at 5 ppm (converted to a Guidance value equivalent: 0.0088 mg/L) or higher in a 7-week inhalation toxicity test using mice; and anemia, increases in gamma-GT and glutathione, increased platelet count, dysproteinemia, and atrophy of nasal olfactory epithelium at 15 ppm (converted to a Guidance value equivalent: 0.027 mg/L) or above, increased absolute liver weight, centrilobular hepatocellular necrosis/fatty accumulation of the liver at 45 ppm (converted to a Guidance value equivalent: 0.08 mg/L) in a 7-week inhalation toxicity test using rats. Changes in blood and blood biochemistry and histopathological changes in liver and nasal cavity similar to those in the 7-week inhalation exposure tests were also found at 15 ppm (converted to a Guidance value equivalent: 0.045 mg/L) or higher in a 3-month inhalation toxicity test using rats, and at 10 ppm (converted to a Guidance value equivalent: 0.045 mg/L) in a 6-month inhalation toxicity test using rats and mice (NICNAS (2000), EU-RAR (2003)). In a 3-month gavage administration toxicity test using rats, effects of the liver (increased liver weight, increased gamma-GT, and slight degeneration of hepatocytes) were observed at 100 mg/kg/day (converted to a 90-day equivalent: 72.2 mg/kg/day), and in a 3-month drinking water administration toxicity test using rats, dysproteinemia was found at 75 ppm (8.3 mg/kg/day) (NICNAS (2000), EU-RAR (2003)). As above, effects on the respiratory tract, liver, and blood were observed within a range of Category 1. Therefore, the substance was classified in Category 1 (respiratory system, liver, blood system). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | The classification is not possible due to lack of data. Besides, kinematic viscosity is calculated to be 1.99 mm2/sec (25 degrees C) from numerical data listed in HSDB (viscosity: 2.07 mPa*s; density (specific gravity): 1.04 (HSDB (Access on June 2015))). |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Category 3 |
- |
H402 | P273 P501 |
From 48-hour EC50 = 45 mg/L for crustacea (Daphnia magna) (EU-RAR, 2003), it was classified in Category 3. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 3 |
- |
H412 | P273 P501 |
Reliable chronic toxicity data were not obtained. Due to being not rapidly degradable (hardly degradable, a degradation rate by 28-day O2 consumption = 1% (average), a degradation rate by DOC = 3% (average), a degradation rate by HPLC = 1% (average)) (4th Chemical Substance Review meeting of Subcommittee on Chemical Substances in the Committee on Safety of Chemical Substances, Pharmaceuticals Affairs Council, Pharmaceutical Affairs and Food Sanitation Council in 2012, 118th Review Committee, 125th Subcommittee on Chemical Substances in the Environmental Health Committee of the Central Environment Council, 2012), and acute toxicity Category 3, it was classified in Category 3. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data. |
NOTE:
| * A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users. * This is a provisional English translation of classification results and is subject to revision without notice. * The responsibility for any resulting GHS labelling and SDS referenced from this site is with users. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |