GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 67-64-1 |
| Chemical Name | Acetone |
| Substance ID | H26-B-006, - |
| Classification year (FY) | FY2014 |
| 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 | FY2006 |
| 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) |
| 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 associated with explosive properties present in the molecule. |
| 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 2 |
 Danger |
H225 |
P303+P361+P353
P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501 |
It was classified in Category 2 based on a flash point of -17 deg C (closed cup) and a boiling point of 56.1 deg C (SIDS (2002)). Besides, it is classified in Class 3, PG II (UN1090) in UNRTDG. |
| 7 | Flammable solids | 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 is estimated that it does not ignite at normal temperatures from an autoignition temperature of 465 deg C (SIDS (2002)). |
| 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 is an organic compound containing 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 | Not classified |
- |
- | - | Steel and aluminum may be used as a container (Hommel (1991)). |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Not classified |
- |
- | - | Based on reports of LD50 values of 5,800 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008), SIDS (2002), ACGIH (7th, 2001), EHC 207 (1998), ATSDR (1994)), 8,400 mg/kg (SIDS (2002), ACGIH (7th, 2001), EHC 207 (1998), ATSDR (1994)), 7,138 mg/kg (young adults), 6,667 mg/kg (older adults) (IRIS (2003), SIDS (2002), EHC 207 (1998), ATSDR (1994)), 9,800 mg/kg (ACGIH (7th, 2001)), 9883 mg/kg (ATSDR (1994)), 1,726-9,833 mg/kg (ATSDR (1994)) and 5,800-10,000 mg/kg (PATTY (6th, 2012)) for rats, it was classified as "Not classified." Besides, since 1,726-9,833 mg/kg and 5,800-10,000 mg/kg were aggregated data, they were not included in the number. |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | Based on reports of LD50 values of >7,400 mg/kg (SIDS (2002)), >15,700 mg/kg (SIDS (2002), ATSDR (1994)) and 20,000 mg/kg (PATTY (6th, 2012), ACGIH (7th, 2001)) for rabbits, it was classified as "Not classified." |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Not classified |
- |
- | - | Based on reports of LC50 (4 hours) of 32,000 ppm (PATTY (6th, 2012), SIDS (2002), EHC 207 (1998), ATSDR (1994)), and converted 4-hour LC50 values from 8-hour LC50 of 29,698 ppm (PATTY (6th, 2012), SIDS (2002), EHC 207 (1998), ATSDR (1994)) and 70,852 ppm (Environmental Risk Assessment for Chemical Substances Vol.6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008), SIDS (2002)) for rats, it was classified as "Not classified." Besides, since the LC50 value was lower than 90% of the saturated vapor concentration (236,920 ppm), the reference value in units of ppm was applied as a vapor without a mist. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | There is a report that in a skin irritation test in which 0.01 mL of this substance was applied to rabbits, no irritation was observed (SIDS (2002), EHC 207 (1998)), therefore, it was classified as "Not classified." |
| 3 | Serious eye damage/eye irritation | Category 2B |
Warning |
H320 |
P305+P351+P338
P337+P313 P264 |
In many eye irritation tests with rabbits, severe irritation was observed (SIDS (2002), EHC 207 (1998), ACGIH (7th, 2001)), furthermore, conjunctival edema and corneal necrosis (EHC 207 (1998)), and increased central corneal thickness (ACGIH (7th, 2001)), etc. were seen. In SIDS (2002), there is a description that this substance was not a corrosive eye irritant, because after application of this substance, destruction of the corneal epithelium occurred but did not reach the corneal stroma and was reversible within 4 to 6 days (SIDS (2002)). From the above results, it was classified in Category 2B. In addition, as human epidemiological information, there is a report that eye irritation was observed in exposure to the vapor of this substance (Environmental Risk Assessment for Chemical Substances Vol.6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008), EHC 207 (1998)). Besides, this substance was classified in "Xi; R36" in the EU DSD classification and in "Eye. Irrit. 2 H319" in the EU CLP classification. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Not classified |
- |
- | - | There are reports that a mouse ear swelling test and a maximization test with guinea pigs showed negative results, and in SIDS (2002) and EHC 207 (1998), there is a report that this substance was not a sensitizer. From the above results, it was judged as "Not classified." |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | This substance was classified as "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. As for in vivo, it was negative in micronucleus tests using erythrocytes of mice and hamsters (SIDS (2002), EHC 207 (1998), NTP DB (Access on July 2014)). As for in vitro, there was only one positive result in a chromosome aberration test without metabolic activation using cultured mammalian cells (ACGIH (7th, 2001)), but in a bacterial reverse mutation test, a gene mutation test, a chromosomal aberration test and a sister chromatid exchange test using cultured mammalian cells, all showed negative results (SIDS (2002), ACGIH (7th, 2001), EHC 207 (1998), PATTY (6th, 2012), NTP DB (Access on July 2014)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | Since it was classified in A4 by ACGIH (ACGIH (7th, 2001)) and as D by EPA (IRIS (2003)), it was classified as "Classification not possible." |
| 7 | Reproductive toxicity | Category 2 |
 Warning |
H361 |
P308+P313
P201 P202 P280 P405 P501 |
There is a report that there was no effect on miscarriage in an epidemiological survey (ATSDR (1994)). It is reported that in a teratogenicity test with rats through the inhalation route, by exposure at a high concentration (11,000 ppm (26.1 mg/L)), at which maternal toxicity (decreased body weight gain) was observed, decreased fetal body weight was observed, and no significant increase in the incidence of fetal malformations was observed, but there was an increase in the number of dams with fetuses having one or more malformations (11.5%) (control: 3.8%) (EHC 207 (1998)). In a teratogenicity test with mice through the inhalation route, decreased fetal body weight and increased late resorptions were reported by exposure at a high concentration (6,600 ppm (15.6 mg/L)) at which maternal toxicity (increased relative liver weight) was observed (EHC 207 (1998)). There is a description in EHC that further studies will be required in humans and animals. Therefore, it was classified in Category 2. |
| 8 | Specific target organ toxicity - Single exposure | Category 3 (respiratory tract irritation, narcotic effects) |
 Warning |
H335
H336 |
P304+P340
P403+P233 P261 P271 P312 P405 P501 |
In humans, as for the inhalation route, there are reports of moderate respiratory tract irritation by exposure to acetone vapor (PATTY (6th, 2012), SIDS (2002), Environmental Risk Assessment for Chemical Substances Vol.6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008)), of irritation to the throat and trachea by exposure to 100 ppm (6 hours) vapor (ACGIH (7th, 2001)), of irritation to the nose, throat, trachea by exposure at 500, 1000 ppm (EHC 207 (1998)), and of irritation of the nose, throat, trachea and lung, and central nervous system depression such as dizziness, vomiting, unsteadiness, loss of cooperative conversation, drowsiness, unconsciousness and coma, etc., by exposure at 100-12,000 ppm (2 minutes-6 hours) (ATSDR (1994), ACGIH (7th, 2001), SIDS (2002), Environmental Risk Assessment for Chemical Substances Vol.6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008)). Although most findings were transient and reversible (SIDS (2002)), a few death cases were reported (PATTY (6th, 2012)). As for the oral route, nausea and vomiting were mainly observed, and as for extremely large exposure such as an accidental ingestion, fatigue, irritation, dizziness, breathing irregularities, vomiting, progression of gastrointestinal disturbances, unconsciousness and apathy and most of all central nervous system depression and irritation were observed (Environmental Risk Assessment for Chemical Substances Vol.6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008), SIDS (2002), IRIS TR (2003)). As for experimental animals, the acute effects of exposure to acetone vapor were the same symptoms of central nervous system depression as seen in the human poisoning cases. Drowsiness, lack of coordination, loss of autonomic reflexes, coma, respiratory failure and death were reported (SIDS (2002), ACGIH (7th, 2001)). From the above, acetone showed moderate irritation to the respiratory tract and mild central nervous system depression effects, and it was classified in Category 3 (respiratory tract irritation, narcotic effects). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (central nervous system, respiratory organs, gastrointestinal tract) |
Danger |
H372 |
P260
P264 P270 P314 P501 |
In humans, there is a description of occupational exposure, that in workers exposed to 700 ppm of this substance for 3 hours/day, for 7 to 15 years, inflammation of the respiratory tract, stomach and duodenum was observed along with giddiness and loss of strength (ACGIH (7th, 2001), DFGOT vol.7 (1996)). In a re-evaluation by ATSDR Addendum (2011), it is also reported that the target organs in humans exposed to this substance were mainly the respiratory tract, gastrointestinal tract, and nervous system (ATSDR Addendum (2011)). In addition, although ATSDR Addendum (2011) listed the kidney as a target organ based on case reports of nephritis and renal failure caused by exposure to a product containing this substance (a case of one person who developed glomerulopathy and tubulointerstitial nephritis (original source report year: 2002) as a chronic poisoning case, and one case of renal failure with an unknown exposure period and a high probability of acute poisoning (original source report year: 2003)), the number of cases was small (1 to 2), therefore, it was hard to say that the evidence was sufficient to add the kidney as a target organ in this classification. On the other hand, it is described in ACGIH (7th, 2001) that effects on the hemal system (increased leukocyte and eosinophil counts, decreased neutrophil phagocytic activity) were observed by inhalation exposure with volunteers at a concentration of 500 ppm for 6 hours/day for 6 days, and it was considered as the basis for Category 2 (hemal system) in the previous classification. However, the hemal system was excluded from the target organs for the following reasons: ACGIH (7th, 2001) also describes that there was no hemal effect, it is described that it was confirmed to have no hemal effect in an epidemiological study comparing the group exposed to 600 or 1,000 ppm of this substance for more than 5 years with the control group (DFGOT vol.7 (1996)), in the hazard assessment by IRIS (2003) and ATSDR Addendum (2011), newly assessed than these, there was no description of hemal effects by human exposure. Therefore, it was classified in Category 1 (central nervous system, respiratory organs, gastrointestinal tract) based on the new knowledge in humans. Besides, in experimental animals, no clear toxic effects were observed at and lower than the dose range of Category 2 both in a 13-week drinking water study with rats and mice and in a 13-week gavage study with rats (SIDS (2002)). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, its kinematic viscosity was calculated to be 0.426 mm2/sec (20 deg C, CERI calculated value), and although there were no data of its causing chemical pneumonitis due to aspiration, it is a ketone of 13 carbons or less, therefore, it was classified corresponding to Category 2 in the UN classification standards. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | - |
- |
- | - | - |
| 11 | Hazardous to the aquatic environment (Long-term) | - |
- |
- | - | - |
| 12 | Hazardous to the ozone layer | - |
- |
- | - | - |
NOTE:
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