GHS Classification Result （Revision of the past classification result）

Chemical Name：Diacetone alcohol
CAS：123-42-2

Result：
ID: 21B3035
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government （March, 2009）

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 4 - Warning H227: Combustible liquid 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.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P501: Dispose of contents/container to ... 		Classified into Category 4 since flash point 66 degC (reagent grade) (Merck (14th, 2006)) (closed-cup) is >60 degC and <=93 degC. (Data are available that industrial diacetone alcohol contains acetone and flash point is 8 degC. Therefore, the substance is classified into Class 3, PG II or III in UNRTDG. Commercial product having such low flash point is classified into Category 2).
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 - - - - Auto-ignition point is 603 degC (Solvents Handbook, Ohmsha Ltd. (1997)) and 623 degC (Ullmanns (E) (6th, 2003)) exceeding 70 degC.
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, C, 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 - - - - Based on a LD50 value of 4000 mg/kg for rats (SIDS (2000)), the substance was classified into "Not classified" in JIS Classification (correspond to Category 5 in GHS classification).
1 Acute toxicity （Dermal） Not classified - - - - Based on LD50 values of 13630 mg/kg (SIDS (2000)) and 14.5 mL/kg (13500 mg/kg) (PATTY (5th, 2001)) for rabbits, the substance was classified as "Not classified".
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Liquid (GHS definition)
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - Classification not possible due to lack of data. Although a LC0 value was >1500 ppm/8h (2121 ppm/4h) (PATTY (5th, 2001)), determination of category is impossible. Since saturated vapour pressure concentration was 2257 ppm, the classification criteria for gas (ppm) was adopted.
1 Acute toxicity （Inhalation: Dusts and mists） Classification not possible - - - - No data available.
2 Skin corrosion/irritation Category 2 Warning H315: Causes skin irritation P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P332+P313: If skin irritation occurs: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment （see ... on this label）.
P362: Take off contaminated clothing and wash before reuse. 		Based on results of "mild irritation" to "moderately irritating" in rabbit tests (PATTY (5th, 2001), SIDS (2000)), the substance was classified into Category 2.
3 Serious eye damage/eye irritation Category 2A Warning H319: Causes serious 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.
P280: Wear protective gloves/protective clothing/eye protection/face protection. 		Based on results of "moderate or highly irritating" in a rabbit test (SIDS (2000)) and "significant eye irritation and transient corneal damage" in another rabbit test (PATTY (5th, 2001)), the substance was classified into Category 2A. As relevant information, the substance is classified into Xi; R36 in EU classification.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
5 Germ cell mutagenicity Classification not possible - - - - Classification not possible due to lack of data from in vivo mutagenicity tests. From in vitro mutagenicity tests, there are reports of negative Ames tests (SIDS (2000), NTP DB (access on Apr. 2009)) and a negative Chinese hamster lung cell (CHL/IU) chromosomal aberration test (PATTY (5th, 2001)).
6 Carcinogenicity Classification not possible - - - - No data available.
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging 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 ... 		In a combined repeat oral dose and reproductive/developmental toxicity screening test in rats, a decrease in body weight gain was noted during the premating period in females of the 1000 mg/kg group. In this dose group, there was a tendency for decrease of reproductive parameters including fertility index, number of implantations and implantation index. There was also a tendency for decrease of developmental parameters such as total number of pups born, delivery index, live birth index, number of pups alive and viability index on day 4 of lactation (SIDS (2000)). Based on the data, the substance was classified into Category 2.
8 Specific target organ toxicity - Single exposure Category 2 (blood, liver), Category 3 (narcotic effects, respiratory tract irritation) Warning H371: May cause damage to organs (blood, liver)
H336: May cause drowsiness or dizziness (narcotic effects, respiratory tract irritation) 		P309+P311: IF exposed or if you feel unwell: 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.
P405: Store locked up.
P501: Dispose of contents/container to ...
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. 		In rats, a hemolytic action persisted for several days after a single 2 mL/kg (1860 mg/kg) administration by gavage. The liver showed increased numbers of lymphocytes, followed by cloudy swelling, vacuolization, and granulation of the cytoplasm (ACGIH (2001)). Since the dose level is within the guidance value range for Category 2, the substance was classified into Category 2 (blood system, liver). Inhalation exposure of mice, rats, rabbits, and cats for 1 to 3-hour produced somnolence after a period of restlessness and excitability (ACGIH (2001)). The substance is primarily a narcotic and anticonvulsant (ACGIH (2001)). The primary systemic effect is a narcotic effect (PATTY (5th, 2001)). Based on these reports, the substance was classified into Category 3 (narcotic effects). In a human test, vapour exposure at 100 ppm for 15 minutes produced nose and throat irritation in most subjects. In another test, humans exposed to 400 ppm for 15 minutes experienced pulmonary discomfort, nose and throat irritation (PATTY (5th, 2001)). Based on the data, the substance was classified into Category 3 (respiratory tract irritation). There is a report of the development of a nephrotic syndrome in a 59-year-old man 40 days after a 3-day exposure to diacetone alcohol and ethanol paint solvents. In this case, renal biopsy gave evidence of a proliferative glomerulonephritis (PATTY (5th, 2001)). This data was not used as the basis of classification since the effect was reported only in one case and it was induced by exposure to a mixture of solvents and there is no report for association with the substance exposure.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - In an oral repeat dose and reproductive/developmental toxicity test in rats ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (access on April 2009)), increased deposition of hyaline droplets in the proximal tubular epithelium was observed at a dose level of 100 mg/kg (90-day equivalence: approximately 50 mg/kg/day) which is within the guidance value range. However, the lesion is likely to be a male rat specific lesion. There are reports of a rat 10-day oral test and a rabbit 30-day oral test (PATTY (5th, 2001)), however these tests were conducted in an earlier time (in 1928 - 1948) and there are no detailed data. In a 6-week inhalation test in rats (SIDS (2000)), effects were observed at dose levels exceeding the guidance value range. Effects at dose level near the cut-off value are not clear, therefore classification was not possible due to lack of sufficient data.
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） Not classified - - - - Classified into Not classified from its 96h-LC50 >100 mg/L for fish (Oryzias latipes) (Test for the Ecological Effect of Chemical Substances (Ministry of the Environment), 1996, etc), 48h-EC50 >1000 mg/L for Crustacea (Daphnia magna) (Test for the Ecological Effect of Chemical Substances (Ministry of the Environment), 1996, etc) and 72h-ErC50 >1000 mg/L for algae (Pseudokirchneriella subcapitata) (Test for the Ecological Effect of Chemical Substances (Ministry of the Environment), 1996).
11 Hazardous to the aquatic environment （Long-term） Not classified - - - - Classified into Not classified since its acute toxicity is Not classified and it is not non-water soluble (Water solubility = 1000000 mg/L (PHYSPROP Database, 2009).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


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）

To GHS Information