GHS Classification Result （Revision of the past classification result）

Chemical Name：N,N-Dimethylacetamide
CAS：127-19-5

Result：
ID: 1-213
Classifier: Ministry of Economy, Trade and Industry （METI）, 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 - - - - - -
2 Flammable gases （including chemically unstable gases） - - - - - -
3 Aerosols - - - - - -
4 Oxidizing gases - - - - - -
5 Gases under pressure - - - - - -
6 Flammable liquids - - - - - -
7 Flammable solids - - - - - -
8 Self-reactive substances and mixtures - - - - - -
9 Pyrophoric liquids - - - - - -
10 Pyrophoric solids - - - - - -
11 Self-heating substances and mixtures - - - - - -
12 Substances and mixtures which, in contact with water, emit flammable gases - - - - - -
13 Oxidizing liquids - - - - - -
14 Oxidizing solids - - - - - -
15 Organic peroxides - - - - - -
16 Corrosive to metals - - - - - -

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Not classified - - - - There is a description of LD50 value 3,000-6,000 mg/kg of the oral administration test employing a rat (SIDS (2001)). Since there is a description that "This summarizes nine test results. Many of tests are of LD50 value >5,000 mg/kg" (SIDS (2001))" and also in Patty (5th, 2001), there is a description that "acute toxicity is weak", it was classified into "Not classified".
1 Acute toxicity （Dermal） Not classified - - - - Although LD50 value 2,100-3,600 mg/kg of the dermal administration test employing a rabbit (SIDS (2001)) was equivalent to the U.N. GHS acute toxicity Category 5, it fell under unadopted category in Japan and was classified into "Not classified". In addition, EU classification is Xn; R20/21 (EU-Annex I), and is equivalent to Category 3-4.
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Since it was a solid by the definition of GHS and inhalation in gas was not assumed, it was classified into "Not applicable".
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 ... 		It is written that LC50 value of 1-hour inhalation exposure tests employing rats is 8.81 mg/L (SIDS (2001)). When a vapor standard is applied from saturated vapor pressure level at 25degC with 2631.58 ppm (9.38 mg/L), 4-hour equivalent LC50 value is 4.41 mg/L, and it was classified into Category 3. In addition, EU classification is Xn; R20/21 (EU-Annex I), and is equivalent to Category 3-4.
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. 		Saturated vapor pressure level at 25degC is 2631.58 ppm (9.38 mg/L). Since LC50 value with 10.01 mg/L (SIDS (2001)) of the 1-hour inhalation exposure test employing rats is larger than saturated vapor pressure level, 4-hour equivalent LC50 value is 2.50 mg/L when applying the mist standard, and it was classified into Category 4. In addition, EU classification is Xn; R20/21 (EU-Annex I), and is equivalent to Category 3-4.
2 Skin corrosion/irritation Not classified - - - - Since SIDS (2001) has concluded to be "slightly irritant" based on the descriptions, "not irritating with undeluted liquid" in the skin irritation test with rabbits, "irritating " in the skin irritation test with guinea pig and "slightly irritating" in the skin irritation test with mouse, it was classified into "Not classified".
3 Serious eye damage/eye irritation Category 2B - Warning H320: Causes eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling. 		From a description of "It has mild and reversible stimulus when the non-diluted solution was dropped."(SIDS (2001)) in the eye irritation test employing rabbits, it was classified into Category 2B.
4 Respiratory sensitization Classification not possible - - - - Classification is not possible since there is no data.
4 Skin sensitization Not classified - - - - It was classified into "Not classified" since there are descriptions of "no sensitizing potential" in the skin sensitization test employing guinea pig (SIDS (2001), Patty (5th, 2001)) and "not a skin sensitiser" as a conclusion in SIDS (2001).
5 Germ cell mutagenicity Not classified - - - - It has been described that it is "negative" (SIDS (2001)) in the productive cell in vivo heritable mutagenicity test (dominant lethal test employing a rat (one case of inhalation exposure, one case of dermal administration)), respectively. Moreover, there is also a statement that "the significant increase in a chromosome aberration was not found."(SIDS (2001)) in a body cell in vivo mutagenicity test (chromosome aberration test employing a peripheral human lymphocyte). As mentioned above, it was classified into "Not classified".
6 Carcinogenicity Not classified - - - - Since it was classified into A4 by ACGIH-TLV/BEL (2005), it was classified into "Not classified" according to guidance. In addition, SIDS (2001) has a description of 5 examinations in SIDS (2001): the 52-week forcible oral administration examination which employed rats, the 24-month oral administration examination using rats, the two-year inhalation exposure test using rats, the 18-month inhalation exposure test using mice, and the six-week dermal administration test using hamsters; and all of them are negative.
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 ... 		There are reports that in a reproductive toxicity study (GLP) with gavage oral administration in rats (gestation period of 7-21days) "increased embryo mortality, decreased average fetal weight and increased fetal malformation were observed at doses at which toxic effects such as decreased weight gain and feed intake manifest themselves in mother animals. Most of the malformations were seen in the head (otocephaly, atresia of anterior nare, micrognathia and cerebral ventricular enlargement) and the cardiovascular system (heart defects such as defects in the lung artery and aorta, and ventricular septal defects)" (SIDS (2001)), and that in a reproductive toxicity study (GLP) with inhalation exposure in rabbits (gestation period of 7-19 days) "a significant increase in fetal mutation (retarded ossification) was observed at doses at which there are toxic effects on mother animals" (SIDS (2001)). For the reasons stated above, it was classified as Category 1B. The EU classification is Repr. Cat. 2; R61 (EU-Annex I), which is equivalent to Category 1.
8 Specific target organ toxicity - Single exposure Category 3 （Narcotic effects） Warning H336: May cause drowsiness or dizziness (narcotic effects) 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.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P405: Store locked up.
P501: Dispose of contents/container to ... 		For animals, there is a description of "The degeneration of heart, liver, and kidney was seen at the concentration below the lethal dose" in the single dose test where calculates the dermal lethal dose of rabbits (SIDS (2005)). However, since the details are unknown in non-public data and the dose cannot be specified, it is not adopted. In humans, there is a description of "Giddiness, lethargy, and debility were seen."(ACGIH (7th, 2001)). As mentioned above, it was classified into Category 3 (Narcotic effects).
9 Specific target organ toxicity - Repeated exposure Category 1 (liver), Category 2 (respiratory system) Danger
Warning 		H372: Cause damage to organs through prolonged or repeated exposure (liver)
H373: May cause damage to organs through prolonged or repeated exposure (respiratory system) 		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 ... 		As for animals, in the 6-month inhalation exposure test in rats, "lung irritation, decreased weight gain, significant dose-dependent nasal and upper Respiratory tract irritation and damage in liver (degeneration of hepatocyte)" (SIDS (2001)) were observed within the limits of the guidance value of Category 2. In the 2-year inhalation exposure test in rats, "an increase in liver weight, hepatic cystic degeneration, hepatic peliosis, lipofuscin/hemosiderin accumulation in Kupffer cells" (SIDS (2001)) were observed within the limits of the guidance value of Category 2. Moreover, in human testing, among 41 workers who have skin or inhalation exposure for 2 to 10 years "19 workers experienced liver dysfunction. Abnormality in bronchus, upper airway, stomach and nervous system were frequently reported" (SIDS (2001), ACGIH (7th, 2001)). Therefore, it is classified into Category 1 (liver) and Category 2 (respiratory systems).
10 Aspiration hazard Classification not possible - - - - Classification not possible due to lack of data.

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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