NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	141-97-9
Chemical Name	Ethyl acetoacetate
Substance ID	m-nite-141-97-9_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 molecule.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Category 4	- Warning	H227	P370+P378 P210 P280 P403 P501	Since its flash point reported 65 degC (closed-cup) (Ullmanns (E) (6th, 2003)) is > 60 degC and <= 93 degC, the substance corresponds to Category 4.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified	- -	-	-	Since its autoignition temperature is 280 degC (Hommel (1996)), it is considered that the substance does not ignite at room temperature.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or halogen) which is chemically bonded only to carbon or hydrogen.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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 the rat LD50 values of 3980 mg/kg bw, 12300 mg/kg bw (male) and 10800 mg/kg bw (female) (EU-RAR 13 (2002)), the substance was classified as "Not classified" in the JIS classification (corresponding to Category 5 or "Not classified" in the UN-GHS classification).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the rabbit LD50 value of > 10,300 mg/kg bw (EU-RAR 13 (2002)), the substance was classified as "Not classified".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	It was reported (EU-RAR 13 (2002)) that inhalation in rats at the saturated vapor pressure concentration (5.46 mg/L/8hrs = 7.72 mg/L/4hrs) caused no mortality. However, the category could not be specified from this result, and the classification was not possible.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	Based on rat LC50 value of > 8.99 mg/L/4 hours (IUCLID (2000)), the substance was classified as "Not classified" in the JIS classification (corresponding to Category 5 in the UN-GHS classification). Since the exposure concentration (5.995 mg/L/8 hours) was higher than the saturated vapor pressure concentration (5.46 mg/L), it was judged that the test was carried out with mist.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Not classified	- -	-	-	The substance was classified as "Not classified" based on the documented case of "not irritating" resulted from rabbit test (OECD TG 404, GLP-compliant) in which 0.5 mL of test substance was applied for 4 hours (EU-RAR 13 (2002), IUCLID (2000)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	The substance was classified as Category 2B based on the documented case of "slightly irritating" resulted from rabbit test (OECD TG 405, GLP-compliant) that instillation of 0.1 mL caused no effect to cornea, but moderate irritation of conjunctiva and slight irritation to iris. The symptoms were all reversible in 2 - 3 days.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	No positive reaction was reported in 26 volunteers in the skin sensitization test (maximization test) after the elicitation procedure (EU-RAR 13 (2002)), and no skin sensitization was shown in the maximization test using guinea pigs (IUCLID (2000)). However, in the human case, information was a merely summary of the study and it was stated in the assessment report that valid human data on sensitization was not available (EU-RAR 13 (2002)). And the latter guinea pig case was the information from the "List 2" information source designated in the GHS classification guidance for the Japanese government. Only insufficient data of humans and animals were available, thus the substance was classified as "Classification not possible".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The classification was not possible due to lack of in vivo test data. As relevant information, as for in vitro studies, negative results in the Ames test (JECFA 974 (2000), EU-RAR 13 (2002)) and the chromosome aberration test using Chinese hamster lung (CHL) cells and V79 cells (EU-RAR 13 (2002)) were reported.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	In the reproductive and developmental toxicity screening test by oral administration in rats (OECD TG 421, GLP-compliant), no adverse effects were reported on reproductive functions and fertility. Slightly decrease in the number of offspring correlating with the reduced number of implantation, increase in the rate of postimplantation loss, and slightly decrease in the live birth index and live birth index were observed at the highest dose of 1,000 mg/kg bw/day. However, because these changes were not considered to be of toxicological significance, and the extent of pre and postimplantation loss and birth indices were within the ranges of the available historical control data, the effects observed were not considered treatment-related (EU-RAR 13 (2002)). However, since data on developmental effects on the offspring containing teratogenic effects were insufficient, the substance was classified as "Classification not possible".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	The findings observed in rats administered by oral gavage were as follows: occurrence of deaths and signs such as erratic tachypnea, lethargy and severe diarrhea at 10000 mg/kg or more. Moderate to severe diarrhea at 8000 mg/kg, and moderate diarrhea at 2000 - 4000 mg/kg were noted, but no other effects were described (EU-RAR 13 (2002)). As it is, therefore, considered that no serious toxicity was caused at 2000 mg/kg, the upper limit dosage within the range of the guidance values, the classification corresponded to "Not classified" category for oral route. However, because the category could not be specified due to lack of data on other routes, the classification for specific target organ toxicity (single exposure) was concluded as "Classification not possible".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In the 4-week repeated oral dose study in rats (OECD TG 407), no treatment-related effects were found in body weight changes, food consumptions, ophthalmology, hematology, clinical chemistry, organ weights, gross and microscopic observations, except for salivation observed at the highest dose level of 1000 mg/kg/day. Consequently, the NOAEL of 1000 mg/kg/day (converted dose level as that of 90-day study: 308 mg/kg/day) was reported (EU-RAR 13 (2002)). Moreover, in the 28-day feeding study in rats, some effects caused by exposure to the test substance were seen at the highest dose level of 1000 mg/kg/day. However, the toxicological significance of them were unknown, and it was concluded that the effects observed did not represent clearly the test substance-induced adverse effects. The NOAEL of 1000 mg/kg/day (converted dose level as that of 90-day study: 311 mg/kg/day) in the study was reported (EU-RAR 13 (2002)). The NOAELs of both studies were beyond the upper limit dose of the guidance values, the classification corresponded to "Not classified" category for oral route. However, because the category could not be specified due to lack of data on other routes, the classification for specific target organ toxicity (repeated exposure) was concluded as "Classification not possible".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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 as "Not classified" since all LC50 and EC50 values exceeded 100 mg/L in acute toxicity tests for fish, crustacea and algae (EU-RAR, 2001).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Classified as "Not classified" since its acute toxicity is "Not Classified" and it is not non-water soluble (water solubility = 110 g/L (PHYSPROP Database, 2011)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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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