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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	39807-15-3
Chemical Name	5-tert-Butyl-3-[2,4-dichlor-5-(prop-2-yn-1-yloxy)phenyl]-1,3,4-oxadiazol-2(3H)-one; Oxadiargyl
Substance ID	R02-A-056-METI
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)
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)	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)
Model SDS by MHLW (External link)
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	Classification not possible	- -	-	-	There is a chemical group associated with explosive properties (acetylenes) present in the molecule, but the classification is not possible due to no data.
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
7	Flammable solids	Classification not possible	- -	-	-	No data available.
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with explosive properties (acetylenes) present in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.
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 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).
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing chlorine and oxygen (but not fluorine) which are chemically bonded only to carbon or hydrogen.
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.
17	Desensitized explosives	Classification not possible	- -	-	-	There is a chemical group associated with explosive properties (acetylenes) present in the molecule, but the classification is not possible due to no data.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats: > 5,000 mg/kg (GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LC50 for rats (4 hours): > 5.16 mg/L (GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) It is reported that in a skin irritation test with rabbits (n = 6) (GLP, 4-hour application, 72-hour observation), no skin irritation reactions were seen in any animal (erythema/eschar score: 0/0/0/0/0/0, edema score: 0/0/0/0/0/0) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) It is reported that in an eye irritation test with rabbits (n = 6) (GLP, 15-day observation), all the animals showed slight conjunctivitis after 24, 48 hours, but 5 animals recovered within 72 hours, and 1 recovered within 15 days (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1B	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] It was classified in Category 1B from (1), (2). [Evidence Data] (1) It is reported that in a maximization test with guinea pigs (n = 20) (GLP, intradermal administration: 5% solution), a sensitization rate was 40% (8/20) after the first challenge and 25% (5/20) after the second challenge (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)). (2) The Food Safety Commission of Japan concluded that slight sensitizing potential was observed based on (1) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified." [Evidence Data] (1) In a micronucleus test using the bone marrow from mice (oral administrations, GLP), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)). (2) In vivo/in vitro unscheduled DNA synthesis (UDS) tests using the mouse primary cultured hepatocytes (GLP), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)). (3) In a bacterial reverse mutation test (GLP), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)). (4) In a gene mutation test using the mouse lymphoma cells (GLP), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] There was no classification result by domestic and international organizations. Based on (1) and (2), it was classified in Category 2. [Evidence Data] (1) In a 2-year combined chronic toxicity/carcinogenicity study with rats by feeding (OECD TG 451, GLP), no evidence of carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)). (2) In an 18-month carcinogenicity study with mice dosed by feeding (OECD TG 453, GLP), an increase in hepatocellular tumors (mainly, hepatocellular adenomas) was observed in males at the highest dose (2,000 ppm) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)). [Reference Data, etc.] (3) To investigate the mechanism of liver tumors in mice, a hepatotoxicity test and an oxidative stress test in the primary culture of hepatocytes were conducted. As a result, the enzyme inducing activity was observed although it was lower than that in phenobarbital. It was also considered that no oxidative stress of hepatocytes was enhanced, and based on the genotoxicity test result, this substance was determined to be non-genotoxic. Therefore, it was considered that carcinogenicity of this substance to the liver was not a genotoxic mechanism (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 2. [Evidence Data] (1) It was reported that in a two-generation reproduction toxicity study with rats dosed by feeding (GLP), complete embryo resorption (2 cases) and deaths of all liveborn pups (one case) (F1 females) were observed in parental animals at 150 ppm (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)). [Reference Data, etc.] (2) It was reported that in a developmental toxicity study with rats dosed by gavage (GLP, gestation days 6 to 15), reduced body weight gain in parental animals, lower body weight in pups, and an increase in the incidence of paleness and delayed ossification of dwarfs and fetuses were observed at 320 mg/kg/day, but no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)). (3) It was reported that in a developmental toxicity study with rabbits dosed by gavage, no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)). (4) Under the EU CLP, it was classified in Repr. 2
8	Specific target organ toxicity - Single exposure	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (5), it was classified as "Not classified." [Evidence Data] (1) It was reported that in an acute oral toxicity test with rats (GLP), at 5,000 mg/kg (in the range corresponding to "Not classified"), neither death nor symptom was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)). (2) It was reported that in an acute oral toxicity test (GLP) with mice, at 5,000 mg/kg (in the range corresponding to "Not classified"), neither death nor symptom was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)). (3) It was reported that in an acute neurotoxicity test with rats by oral administration (GLP), no neurotoxicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)). (4) It was reported that in an acute dermal toxicity test with rats (GLP), at 2,000 mg/kg (within the range for Category 2), neither death nor symptom was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)). (5) It was reported that in an acute (dust) inhalation toxicity test with rats (for 4 hours, GLP), at 5.16 mg/L there was no death case and no specific effect was observed (in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1) to (5), the target organ was considered to be the liver, and effects were observed within the dosage range for Category 1, therefore, it was classified in Category 1 (liver). [Evidence Data] (1) It was reported that in a repeated dose 90-day oral toxicity study with rats dosed by feeding (GLP), an increase in serum T4 levels was observed at or above 200 ppm (13.5 mg/kg/day (males), 15.5 mg/kg/day (females), within the range for Category 2); and increases in T.Chol, TP, and Alb, an increase in TSH, increases in relative liver and kidney weight, hypertrophy and darkening of the liver, darkening of the kidney, centrilobular hepatocyte hypertrophy, and an increase in T3 (males) were observed at or above 6,000 ppm (412 mg/kg/day (males), 474 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)). (2) It was reported that in a repeated dose 90-day oral toxicity study with mice dosed by feeding (GLP), centrilobular hepatocyte hypertrophy (males) was observed at or above 200 ppm (29.1 mg/kg/day (males), 37.0 mg/kg/day (females), within the range for Category 2); and an increase in relative liver weight, deposit of brown pigments in hepatocytes, bile canaliculi, sinusoid, macrophages in sinusoid (males), and centrilobular hepatocyte hypertrophy (females) were observed at or above 2,000 ppm (290 mg/kg/day (males), 363 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)). (3) It was reported that in a one-year chronic toxicity study with dogs dosed by feeding (GLP), liver effects (an increase in ALT, deposit of pigments in bile canaliculi and Kupffer cells, centrilobular pigmentation, pigment phagocytosis of liver macrophages) were observed at or above 3 mg/kg/day (within the range for Category 1); and liver effects (interlobular fibrosis with pigmentation of liver macrophage, increases in ALP and AST) and gall bladder effects (dark-colored visous matter/puruloid matter in the gall bladder, calcinosis in the gall bladder) were observed at 10 mg/kg/day (within the range for Category 1) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)). (4) It was reported that in a two-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding (GLP), hepatocyte pigmentation (males) was observed at or above 50 ppm (2.1 mg/kg/day (males), 2.5 mg/kg/day (females), within the range for Category 1); and hematological effects (decreases in Ht, Hb, MCH, MCV and MCHC), liver effects (an increase in relative weight, centrilobular hepatocyte hypertrophy (males)) and kidney effects (an increase in relative weight, brown pigmentation in the renal tubules) were observed at or above 500 ppm (21.5 mg/kg/day (males), 25.0 mg/kg/day (females), within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)). (5) It was reported that in an 18-month combined chronic toxicity/carcinogenicity study with mice dosed by feeding (GLP), liver effects (an increase in relative weight, pigmentation in hepatic Kupffer cells) were observed at or above 200 ppm (24.3 mg/kg/day (males), 30.8 mg/kg/day (females), within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment Short term (Acute)	-	- -	-	-	-
11	Hazardous to the aquatic environment Long term (Chronic)	-	- -	-	-	-
12	Hazardous to the ozone layer	-	- -	-	-	-

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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