NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	153197-14-9
Chemical Name	3-[1-(3,5-Dichlorophenyl)-1-methylethyl]-3,4-dihydro-6-methyl-5-phenyl-2H-1,3-oxazin-4-one [oxaziclomefone]
Substance ID	m-nite-153197-14-9_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)
Sample SDS by MHLW (External link)
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 present in the molecule associated with explosive properties.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	Due to no data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Classification not possible	- -	-	-	Due to no data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Due to no data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	It is an organic compound which does not contain fluorine but contains oxygen and chlorine, and the oxygen and the chlorine are not chemically bonded to the elements other than carbon or hydrogen.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	It is an organic compound that does not contain bivalent -O-O- structure in the molecule.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No established test method suitable for solid substances.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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	- -	-	-	From a reported LD50 value of > 5,000 mg/kg for rats (Japan Crop Protection Association: Pesticide safety information (Access on November 2015); Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)), it was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	From a reported LD50 value of > 2,000 mg/kg for rats (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)), it was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	From a reported LC50 value (4 hours) of > 5.54 mg/L for rats (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)), it was classified as "Not classified." Besides, because a test substance is a solid, a reference value of dust was applied.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	It is reported that in a skin irritation test using rabbits, after 4-hour application of 500 mg this substance, extremely slight erythema was observed in 1 animal after 1 hour but resolved after one day (Pesticide abstract (2008)). From the above, the substance was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	It is reported that in an eye irritation test using rabbits, after an application of 0.1 mL this substance, an irritating change was observed in conjunctiva 1 hour after application but resolved after one day (Pesticide abstract (2008)). From reversible situations, the substance was classified in Category 2B.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Not classified	- -	-	-	There are reports from a maximization test and a Buehler test using guinea pigs, and it is reported that in the maximization test, this substance was slightly sensitizing (a positive rate 25%), not meeting positive in 30%, the GHS criteria. Moreover, it is reported that in the Buehler test, the substance was negative due to no skin reaction observed in a test group (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)). Because the above two tests are GLP compliance tests corresponding to OECD TG406, the substance was judged as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	As for in vivo, a micronucleus test using mouse bone marrow cells after gavage administration was negative. As for in vitro, a bacterial reverse mutation test and a chromosomal aberration test in cultured mammalian cells were negative (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)). Therefore, the substance was classified as "Classification not possible" in accordance with Guidance.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	In a carcinogenicity test in diet administration of this substance for 2 years in rats, or 1.5 years in mice, an increased incidence of hepatocellular adenoma/cancer (rats), increased incidences of hepatocellular adenoma and hepatocellular adenoma/cancer (mice) were observed in high-dose group males of 2,500 ppm for rats and 800 ppm for mice (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)). Namely, although induction of liver tumors was found only in males of both species after administration of this substance, but taking into account no classification result conducted by the international organization, the substance was classified in Category 2 in this hazard class.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	In a two-generation breeding toxicity test using rats in an oral route (in the diet), parent animals showed effects on the liver (weight increase, centrilobular hypertrophy of hepatocytes) in groups of F0 males at 500 ppm or higher, F0 females at 2,500 ppm, and F1 males and females at 500 ppm or above, but toxic effects on fertility were not observed. Moreover, effects were not found in F1, F2 offspring except that males and females at 500 ppm or higher showed increased liver weight in necropsy at weaning (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)). On the other hand, in a teratogenicity test using pregnant rats, or rabbits, in gavage administration on day 6 to 15 of gestation for rats, and day 6 to 19 of gestation for rabbits up to maximum 1,000 mg/kg/day, maternal animals showed weight gain reduction at 1,000 mg/kg/day in both animal species, but toxic effects by administration of test substance were not observed in fetuses (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)). From the above test results, findings of toxicological concern could not be found at least in sexual function and fertility in parents, fetal toxicity, teratogenicity, and growth/development after birth. The fact that increased liver weight was observed in newborns over two generations at the doses where effects on the liver occurred in maternal animals in the two-generation breeding toxicity test in rats do not correspond to findings suggesting serious reproductive/developmental toxicity, but it could be considered to be findings suggesting the possibility that general toxicity effects occurred in newborns via maternal animals. Namely, it was judged that data are not sufficient to classify as "Not classified," and the substance was classified as "Classification not possible" in this hazard class.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Not classified	- -	-	-	There are no human data on this substance. As for experimental animals, there are test data in oral administration in rats and mice, dermal administration in rats, and inhalation exposure in rats (Pesticide abstract (2008), Pesticide evaluation report, Food Safety Commission of Japan (2008)). However, because an abnormality in signs and necropsy findings was not observed in any test even after administration up to the limit doses (or maximum possible concentration), the substance was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver, kidney)	Warning	H373	P260 P314 P501	In a 2-year chronic toxicity/carcinogenicity combined test using rats in diet administration, effects on the liver (diffuse hypertrophy of hepatocytes and so on) in males and females in groups of 500 ppm within a range Category 2 (males: 18.34 mg/kg/day, females: 22.48 mg/kg/day) or higher, diffuse fatty degeneration of hepatocytes and so on, and effects on the kidney (chronic nephrosis and so on, males) added in a 2,500 ppm dose group (males: 94.4 mg/kg/day, females: 116.7 mg/kg/day) were observed. In an 18-month carcinogenicity test using mice in diet administration, effects on the liver (centrilobular hypertrophy of hepatocytes, brown pigmentation in star cells and so on) were found in males and females in a 800 ppm dose group within a range Category 2 (males: 86.08 mg/kg/day, females: 77.40 mg/kg/day) (Pesticide abstract (2008); Food sanitation research, Vol.53 No.12 (2003); Pesticide evaluation report, Food Safety Commission of Japan (2008)). As above, effects on the liver and kidney were observed both within a range Category 2. Therefore, the substance was classified in Category 2 (liver, kidney).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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)	Classification not possible	- -	-	-	No data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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