NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	123-42-2
Chemical Name	Diacetone alcohol
Substance ID	m-nite-123-42-2_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecules.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Flammable liquids	Category 4	- Warning	H227	P370+P378 P210 P280 P403 P501	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).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance contains oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
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).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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".	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	Based on results of "mild irritation" to "moderately irritating" in rabbit tests (PATTY (5th, 2001), SIDS (2000)), the substance was classified into Category 2.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Specific target organ toxicity - Single exposure	Category 2 (blood, liver), Category 3 (narcotic effects, respiratory tract irritation)	Warning	H371 H336 H335	P308+P311 P260 P264 P270 P405 P501 P304+P340 P403+P233 P261 P271 P312	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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (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).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Hazardous to the aquatic environment Long term (Chronic)	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).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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