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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	93-68-5
Chemical Name	Acetoacetotoluidide
Substance ID	24A6012
Classification year (FY)	FY2012
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	New
Classification result in other fiscal year
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th 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

PHYSICAL HAZARDS

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	- -	-	-	Solid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not applicable	- -	-	-	Solid (GHS definition)
7	Flammable solids	Classification not possible	- -	-	-	From a flash point of 143 deg C (SIDS (2003)), it may be combustible, but the classification is not possible due to no data in the prescribed test.
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 applicable	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 516 deg C (SIDS (2003)).
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) 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	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Not applicable	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure.
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	It was classified in Category 4 based on LD50 values for rats of 1,854 mg/kg (males) and 1,945 mg/kg (females) (OECD TG401, GLP) (JECDB (Access on May 2012)).
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Data are lacking. Besides, there is a report on an LD50 value of > 1,000 mg/kg for guinea pigs, but the category cannot be determined.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.
2	Skin corrosion/irritation	Not classified	- -	-	-	In a dermal exposure test by a 24-hour occlusive application to guinea pigs (doses: 250, 500, 1,000 mg/kg), moderate edema and slight erythema were observed after the removal of the patch, and desquamation was found one week later, but the skin appeared normal one week after the test, and it was slightly irritating (SIDS (2003)). Therefore, it was classified as "Not classified" (Category 3 in UN GHS classification).
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	In an eye irritation test with rabbits (OECD TG405), it was moderately irritating (SIDS (2003)), and in another eye irritation test in which 100 mg was applied to six rabbits, slight erythema was observed in the conjunctiva and nictitating membranes 1 hour after application, all animals recovered 24 hours later, no abnormalities were found during a 2-week observation period, and it was slightly irritating (SIDS (2003)). Therefore, it was classified in Category 2.
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Classification not possible	- -	-	-	It is reported that in a sensitization test with guinea pigs, one out of 10 animals showed strong erythema at 24 and 48 hours after application, and the result was ambiguous. However, because the test method was not the one approved by OECD, the classification is not possible due to lack of data.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The classification is not possible due to no in vivo test data. Besides, as for in vitro tests, it is reported that it was negative in an Ames test (OECD TG471, 472, GLP) and positive in a chromosomal aberration test with CHL cells (OECD TG473, GLP) (JECDB (Access on May 2012)).
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.
7	Reproductive toxicity	Classification not possible	- -	-	-	In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test by gavage administration to rats (OECD TG422, GLP), there were no effects on the fertility of paternal and maternal animals at the doses that produced general toxicity in parents, and as for the development of offspring, no changes compared with the control group were observed in the total number of pups born, live birth rate, sex ratio, and body weights, viability, and general appearance of offspring (JECDB (Access on May 2012)). However, because data on the development of offspring including teratogenicity are lacking, the classification is not possible due to lack of data.
8	Specific target organ toxicity - Single exposure	Category 2 (systemic toxicity)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	In an acute oral toxicity test with rats (doses: 819-2,500 mg/kg), reduced motor activity, prone position, flaccidity, ptosis, deep respiration, piloerection, drop in body temperature, lacrimation, and generalized pallor were observed as the main poisoning symptoms, most of these resolved in surviving animals at 1-5 days after administration, and all of them disappeared on day 13. Deaths were found in males at 1,280 mg/kg or above and females at 1,600 mg/kg or above: the symptoms mentioned above became severe, and they died of feeble respiration, petechia in the glandular stomach was found at necropsy, and histopathological examination revealed erosion of mucous membranes of the glandular stomach, but no abnormalities were seen in the glandular stomach of surviving animals (JECDB (Access on May 2012)). From the above, it was hard to specify the target organ. However, because the above symptoms and deaths were observed within the guidance value range for Category 2, it was classified in Category 2 (systemic toxicity).
9	Specific target organ toxicity - Repeated exposure	Category 2 (blood)	Warning	H373	P260 P314 P501	In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test by gavage administration to rats (doses: 8, 25, 80, 250 mg/kg/day) (OECD TG422, GLP), decreased erythrocyte count and an increase in mean corpuscular volume were observed in males at or above 80 mg/kg (converted guidance value: 40 mg/kg/day), and increases in mean corpuscular hemoglobin and reticulocyte count and a trend toward an increase in methemoglobin content were found in males at 250 mg/kg (converted guidance value: 125 mg/kg/day). Histopathological examination revealed an increase in the extent of hemosiderin deposit in the liver and spleen in males and females at or above 80 mg/kg (converted guidance value: 40 mg/kg/day) and an increase in the extent of extramedullary hematopoiesis in the spleen in the group of 250 mg/kg (converted guidance value: 125 mg/kg/day), and it is reported that repeated dose of this substance caused hemolytic anemia (JECDB (Access on May 2012)). From the above, because the symptoms occurred within the guidance value range for Category 2, it was classified in Category 2 (blood).
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment (Acute)	Not classified	- -	-	-	It was classified as "Not classified" because acute toxicity is not reported at 100 mg/L for algae, crustacea, and fish (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1998), SIDS (2005)).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" due to being not rapidly degradable (not readily degradable, a degradation rate by BOD: 17.6% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2000)), and 21-day NOEC = 16.5 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1998), SIDS (2005)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" because it corresponds to "Not classified" in acute toxicity for fish (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1998), SIDS (2005)), and it is not water-insoluble (water solubility = 6900 mg/L, PHYSPROP Database 2009) From the above results, it was classified as "Not classified."
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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.

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