GHS Classification Result

Chemical Name:Ethyl acetoacetate
CAS:141-97-9

Result:
ID: 22A4065
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government (July, 2010)

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 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 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 ...
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.
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 - - - - Since its autoignition temperature is 280 degC (Hommel (1996)), it is considered that the substance does not ignite at room temperature.
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 halogen) 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 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).
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".
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Liquid (GHS definition)
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.
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.
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)).
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.
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.
4 Respiratory sensitization Classification not possible - - - - No data available.
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".
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.
6 Carcinogenicity Classification not possible - - - - No data available.
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".
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".
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".
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 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).
11 Hazardous to the aquatic environment (Long-term) 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)).
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)


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