GHS Classification Result (Revision of the past classification result)

Chemical Name:N,N-Dimethylformamide
CAS:68-12-2

Result:
ID: 20A2376
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 Category 3 Warning H226: Flammable liquid and vapour P303+P361+P353: IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P370+P378: In case of fire: Use ... for extinction.
P403+P235: Store in a well-ventilated place. Keep cool.
P210: Keep away from heat/sparks/open flames/hot surfaces. ? No smoking.
P233: Keep container tightly closed.
P240: Ground/bond container and receiving equipment.
P241: Use explosion-proof electrical/ventilating/lighting/.../equipment.
P242: Use only non-sparking tools.
P243: Take precautionary measures against static discharge.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P501: Dispose of contents/container to ...
Its flash point is 58degC (closed cup) (ICSC (2000)), which falls under Category 3. It is rated as Class 3 with the packing group III by the UNRTDG (UN No. 2265).
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 - - - - It does not spontaneously ignite in contact with the air at room temperature (autoignition point: 445degC (ICSC, 2000).
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 - - - - 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
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) Not classified - - - - Its rat LD50 values are 3000 mg/kg, 3920 mg/kg, 4000 mg/kg, 4320 mg/kg, 3200 mg/kg, and 7170 mg/kg (EHC 114 (1991)). Considering these reported values, the substance was classified into the "Not classified" category (Category 5 in the United Nations classification).
1 Acute toxicity (Dermal) Not classified - - - - Its rat LD50 values are 3500 mg/kg (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 1 (2002)), 5000 mg/kg, 11140 mg/kg, and 11000 mg/kg (EHC 114 (1991)). Considering these reported values, the substance was classified into the "Not classified" category (Category 5 in the United Nations classification).
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - It was classified into the "Not applicable" category since it is a liquid (GHS definition), and it is presumably not inhalable as a gas.
1 Acute toxicity (Inhalation: Vapours) Category 3 Danger H331: Toxic if inhaled P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P311: Call a POISON CENTER or doctor/physician.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
Based on the 2-hour LC50 of 9400 mg/m3 for mice (4-hour conversion: 4.7 mg/L. since this value is below 90% of the saturated vapour pressure, we determined that the tests were conducted in a vaporous state) (HSDB, 2005), the substance was classified into Category 3.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - No data available.
2 Skin corrosion/irritation Not classified - - - - Based on the documented results that the substance did not cause irritation in skin irritation tests using animals (Hazard Assessment Report (CERI NITE) No. 8 (2005)), the substance was classified into the "Not classified" category. However, the substance has been reported to be a skin irritant in cases of accidental exposure to humans.
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.
In eye irritation tests using rabbits, 75-100% solutions produced more severe irritation than more diluted solutions, and by day 14 a mild degree of conjunctival redness, moderate corneal damage with an area of severe injury, slight surface distortion, and subsurface vascularization were observed (EHC 114 (1991)). As these reports indicate serious eye-damaging potential, the substance was classified into Category 1.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - The substance was tested using a maximization technique on guinea pigs to determine skin sensitization; it did not induce any response (EHC 114 (1991)). Since only one negative result is present, the substance was classified into the "classification not possible" category due to insufficient test results available.
5 Germ cell mutagenicity Category 2 Warning H341: Suspected of causing genetic defects 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 the Hazard Assessment Report (CERI NITE, No. 8, 2005), a heritable mutagenicity test gave negative results, no in vivo germ cell mutagenicity test has been conducted, an in vivo mutagenicity tests using somatic cell gave positive results, and no in vivo germ cell genotoxicity test has been conducted.
6 Carcinogenicity Category 1B Danger H350: May cause 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 ...
In carcinogenicity tests through inhalation, an increase in frequencies of hepatic adenomas and hepatic carcinomas were observed in rats of both sexes; similarly, an increase in frequencies of hepatic adenomas and hepatic carcinomas were observed at 200 ppm and above in mice of both sexes; furthermore, particularly malignant hepatoblastomas were noted in male mice, indicating clear carcinogenic effects of the substance on both sexes of rats and mice (Ministry of Health, Labour and Welfare (Results from Carcinogenicity Studies, 2000)). Thus, incidences of malignant liver neoplasm occur, regardless of animal species and sexes. In light of these results, the Ministry of Health, Labour and Welfare issued Guidelines for Preventing Health Impairment by N,N-Dimethylformamide (Ministry of Health, Labour and Welfare Guidelines, 2005). Based on this information, the substance was classified into Category 1B. As additional background information, the substance is rated as "Group 2B" by the Japan Society for Occupational Health (1991), "Group 3" by IARC 71 (1999), "A4" by ACGIH-TLV (2001); however, these classifications did not take into account test results mentioned above.
7 Reproductive toxicity Category 1B Danger H360: May damage fertility or the unborn child 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 the Hazard Assessment Report (CERI, NITE, No. 8, 2005), the substance was associated with malformations seen in the next generation (cleft palate, exencephaly, hydrocephaly, sphenoid bone defects, fused ribs, and tail defects) at concentrations that do not cause general toxicity to parental animals.
8 Specific target organ toxicity - Single exposure Category 1 (liver), Category 2 (respiratory system) Danger
Warning
H370: Causes damage to organs (liver)
H371: May cause damage to organs (respiratory 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 ...
P309+P311: IF exposed or if you feel unwell: Call a POISON CENTER or doctor/physician.
In humans, the substance is associated with eating disorders, vomiting, and pain in the abdominal, lumbar, and femoral regions; even after these symptoms disappear, fibrosis of the liver and accumulation of histiocytes were noted (Hazard Assessment Report (CERI, NITE, No. 8, 2005)). In animal studies, thickening of alveolar wall was detected (Hazard Assessment Report (CERI, NITE, No. 8, 2005)). Based on these results, we determine that the liver and respiratory system are the target organs. Effects of exposure seen in animal studies were observed at doses that fall under Category 2 guidance values. In conclusion, the substance was classified into Category 1 for the liver and Category 2 for the respiratory system.
9 Specific target organ toxicity - Repeated exposure Category 1 (liver) Danger H372: Cause damage to organs through prolonged or repeated exposure (liver) 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 ...
In humans, liver dysfunction, signs of alcohol intolerance (IRIS (1990)), increased hepatic disorder, increased AST or ALT, focal hepatocellular necrosis, and hepatocellular fatty change in microvesicles of smooth endoplasmic reticulum were observed as the effect of the substance exposure. In animal studies, the centrilobular hepatocellular hypertrophy (NTP TOX 22 (1992)), indicative of acute hepatocellular injury, increased SGPT and SGOT activities, histopathological changes in the liver of young animals (IRIS (1990)), increased ALP activity at 100 ppm or higher, increased ALT activity at 200 ppm or higher, and single cell necrosis in the liver at 200 ppm or higher (Hazard Assessment Report (CERI, NITE, No. 8, 2005)) were reported in association with the substance exposure. In animal studies, these effects were observed at Category 2 guidance doses. In conclusion, the substance was classified into Category 1 for the liver.
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) - - - - - -
11 Hazardous to the aquatic environment (Long-term) - - - - - -


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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