GHS Classification Result

Chemical Name:1-vinyl-2-pyrrolidone
CAS:88-12-0

Result:
ID: 20A2014
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government (Sep, 2008)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
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 Not classified - - - - Since its flash point is 95degC (closed cup method) (Ullmanns (2003)), the substance was classified into "Not classified".
7 Flammable solid Not applicable - - - - Liquid (GHS definition)
8 Self-reactive substances and mixtures Not applicable - - - - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Not classified - - - - Since its autoignition point is 240degC (Ullmanns (2003), HSDB (2005)), the substance was classified into "Not classified".
10 Pyrophoric solids Not applicable - - - - Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible - - - - No data 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, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable - - - - The substance contains oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
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 Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ...
Among documented rat LD 50 values of 1022mg/kg, 1700mg/kg, 2500mg/kg, 1040mg/kg, and 830-1310mg/kg (EU-RAR (2003)), all values but 2500mg/kg were within the range of Category 4. Thus, the substance was classified into Category 4.
1 Acute toxicity (Dermal) Category 3 Danger H311: Toxic in contact with skin P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P322: Specific treatment (see ... on this label).
P361: Remove/Take off immediately all contaminated clothing.
P363: Wash contaminated clothing before reuse.
P405: Store locked up.
P501: Dispose of contents/container to ...
Of the rat LD50 values of 1043-4127mg/kg (EU-RAR (2003)) and the rabbit LD50 of 560mg/kg (EU-RAR (2003)), the smaller LD50 value for the rabbit was used for the basis to classify the substance into Category 3.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - Tests have been documented in which rats were exposed to a saturated vapour (0.6mg/L) for 6-8 hours (EU-RAR (2003)). However, these tests did not provide LC50 values. Thus, the substance was classified into "Classification not possible".
1 Acute toxicity (Inhalation: Dusts and mists) Category 4 Warning H332: Harmful if inhaled P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
Since its 4-hour exposure LC50 = 3.07mg/L in rats (EU-RAR (2003)), the substance was classified into Category 4.
2 Skin corrosion/irritation Not classified - - - - The substance has been classified into Category 3 based on the United Nations' GHS classification, referring to results of three skin irritation tests that showed that the substance causes slight irritation in rabbits (EU-RAR (2003)). On the other hand, the substance was classified into "Not classified" according to the GHS Classification Guidance for the Japanese Government (Sep. 5, 2008 ver.), which was used as a basis to classify the substance into "Not classified".
3 Serious eye damage/eye irritation Category 1 Danger H318: Causes serious eye damage P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician.
The substance was classified into Category 1 since Draize tests using rabbits resulted in mild to marked chemosis of the conjunctiva, edemas, and corneal clouding, followed by scarring in 8 days after the application, and the symptoms worsened over time without recovery. In addition, the EU has classified the substance into R41.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Not classified - - - - Based on the description that the substance did not cause skin sensitization in Buehler tests (EU-RAR (2003)), it was classified into "Not classified".
5 Germ cell mutagenicity Not classified - - - - The substance was classified into "Not classified" since bone-marrow micronucleus tests performing oral administration to mice (in vivo mutagenicity tests using somatic cells) yielded negative results (EU-RAR (2003)). In addition, reverse mutation tests using bacteria, mutation tests using cultured mammalian cells, and chromosomal aberration tests using human lymphocytes (all of which are in vitro mutagenicity tests) all yielded negative results (EU-RAR (2003)).
6 Carcinogenicity Category 2 Warning H351: Suspected of causing cancer P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
According to 2-year carcinogenicity studies in which rats were exposed to the substance via inhalation (18 month exposure period + 6 month recovery period), increased occurrence of hepatoma, adenoma in nasal cavities, adenocarcinoma, and squamous carcinomas of the larynx were observed. The substance was first classified into Group 3 by IARC (IARC 71 (1999)), and was later classified into A3 by ACGIH (ACGIH (2007)) and 3 by the EU (EU-Annex 1 (accessed in May 2008)). Based on the information, the substance was classified into Category 2. In addition, DFG classified it into Category 2 (MAK/BAT (2007)).
7 Reproductive toxicity Classification not possible - - - - In developmental toxicity studies in which rats were exposed via inhalation during the gestational period, including the organogenetic period, no clear cases of developmental toxicity were observed other than skeletal mutation such as incomplete ossification of supraoccipital or hyoid bones (indicating maturational delay) and wavy ribs (indicative of maternal toxicity) at the doses that caused weight loss in maternal animals (EU-RAR (2003)). Despite these data, the substance was classified into "Classification not possible" since the developmental toxicity studies included only one animal species and due to lack of reproductive toxicity data.
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system) Danger H370: Causes damage to organs (central nervous system) P307+P311: IF exposed: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
In oral route or inhalation studies using rats and mice, symptoms of the central nervous system, such as lethargy, hypopnea, narcosis, coma, motor ataxia, loss of righting reflex, convulsions, spasm, and trembling, have been observed at the proximity of the lethal administration dose (EU-RAR (2003)). At sub-lethal doses, tachypnea, ataxia and coma were observed in rats that underwent inhalation exposure at 0.8mg/L for 4 hours, the concentration equivalent to Category 1 guidance values (EU-RAR (2003)). In the rat oral route tests applying the minimal dose of 834mg/kg, lethargy, decreased respiration, hunched posture, and increased salivation were observed (EU-RAR (2003)). From these, the substance was classified into Category 1 (central nervous system).
9 Specific target organ toxicity - Repeated exposure Category 1 (respiratory tract, liver, blood) Danger H372: Cause damage to organs through prolonged or repeated exposure (respiratory tract, liver, blood) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
Symptoms such as atrophy of olfactory epithelium; hyperplasia of larynx, respiratory tracts and olfactory epithelium; lymphocytic hyperplasia around the bronchia; and inflammation of the nasal mucous membranes were observed at >= 0.023mg/L in the following repeated inhalation exposure studies: 7-week rat study (0.023-0.207mg/L/6h), 3-24 month rat study (0.023-0.092mg/L/6h), 3-month rat study (0.023-0.553mg/L/6h), 4-week rat study (0.075-0.300mg/L/4h), and 7-week mouse study (0.023-0.207mg/L). As liver symptoms, weight gain, discoloration and lobule clearing, accompanied with fatty infiltration, centrilobular necrobiosis and spongiform hepatitis were observed at >= 0.023-0.207mg/L, and in 4-week oral route exposure studies with rats, cellular infiltration was recorded at >= 30mg/kg/day. Furthermore, changes in blood indices, red blood cell malformation, and increased blood platelets that indicate signs of anemia are reported at >= 0.069mg/L. Overall, adverse effects on respiratory tracts, liver, and blood were observed at the doses equivalent to the Category 1 guidance values, and thus the substance was classified into Category 1 (respiratory tract, liver, blood).
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Category 3 - - H402: Harmful to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
Since its 48-hour EC50 = 45mg/L for crustaceans (Daphnia sp.) (EU RAR, 2003), the substance was classified into Category 3.
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Its classification for acute toxicity is Category 3, it is rapidly degradable (DOC degradability: 100%, (EU RAR, 2003)), and its potential for bioaccumulation is estimated to be low (log Kow = 0.37, PHYSPROP). Based on the information, the substance was classified into "Not classified".


NOTE:
* 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.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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