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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	135186-78-6
Chemical Name	7-[(4,6-Dimethoxypyrimidin-2-yl)sulfanyl]-3-methylisobenzofuran-1(3H)-one; Pyriftalid
Substance ID	R02-A-047-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	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
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	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
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	- -	-	-	No data 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 oxygen (but not fluorine or chlorine) which is 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	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.

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 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008))
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 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Liquid (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): > 5.54 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007))
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, 7-day observation), slight erythema and edema were observed from 1 hour after the removal of patches but disappeared after 7 days (mean erythema score: 1.0, mean edema score: 0.39) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
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, 72-hour observation), conjunctival irritation was seen after 1 hour and later but disappeared within 48 hours (mean corneal opacity score for all the animals: 0, mean iritis score: 0, mean conjunctival redness score: 0.39, mean chemosis score: 0) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) It is reported that in a maximization test with guinea pigs (n = 20) (GLP, intradermal administration: unknown concentration), a positive rate was 0% (0/20) at both 24, 48 hours after a challenge (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (6), it was classified as "Not classified." [Evidence Data] (1) In a micronucleus test with the bone marrow cells of mice and the hepatocytes of rats (GLP, single oral dose), negative results were obtained (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). (2) In an unscheduled DNA synthesis (UDS) test (GLP), which was carried out as an in vivo/in vitro test, negative results were obtained (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). (3) In a bacterial reverse mutation test (GLP), the substance was negative (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). (4) In a gene mutation test with the lymphoma-derived cultured cells of mice (GLP), the substance was negative (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). (5) In a chromosomal aberration test with the Chinese hamster ovary cells and human lymphocytes (GLP), the substance was negative (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). (6) In an unscheduled DNA synthesis test with the hepatocytes from rats (GLP), the substance was negative (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] There was no classification result by domestic and international organizations. However, based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) In a 2-year combined chronic toxicity/carcinogenicity study with rats (GLP, dosed by feeding), no incidence nor increase of tumors associated with the sample administration was observed at doses up to 3,000 ppm in males and up to 7,500 ppm in females. The carcinogenicity was not observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). (2) In an 18-month carcinogenicity study with mice (GLP, dosed by feeding), the incidence frequency of hepatocellular adenoma increased in females of the group dosed at or above 2,500 ppm (male/female: 337/325 mg/kg/day) compared to the control group, but since there was no statistically significant difference and no earlier onset was observed, it was not considered to be the effect of the sample administration. The carcinogenicity was not observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) It was reported that in a two-generation reproduction toxicity study with rats dosed by feeding (GLP), at 5,000 ppm, increases in absolute and relative weight of the liver and kidney, hypertrophy of the hepatocytes (centrilobular), hypertrophy of the follicular cells of the thyroid (P and F1 male/female), inhibition of body weight gain (P male/female), an increase in relative weight of the thyroid (P male), and basophilic changes of the tubules of the kidney (with tubular cast in males) (F1 male/female) were observed in parent animals; and increases in absolute/relative weight of the liver and hypertrophy of the hepatocytes (centrilobular) (F1 and F2 male/female) were observed in offspring, but no effect on reproductive ability was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). (2) It was reported that in a developmental toxicity study with rats dosed by gavage (GLP, days 6 to 15 of gestation), no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). (3) It was reported that in a developmental toxicity study with rabbits dosed by gavage (GLP, days 7 to 19 of gestation), no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
8	Specific target organ toxicity - Single exposure	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (4), in all of the oral, dermal, and/or inhalation routes, it was classified as "Not classified." [Evidence Data] (1) It was reported that in an acute oral toxicity test with rats, at 5,000 mg/kg (in the range corresponding to "Not classified"), no death nor appearance of symptoms was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). (2) It was reported that in an acute oral toxicity test with mice, at 5,000 mg/kg (in the range corresponding to "Not classified"), no death nor appearance of symptoms was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). (3) It was reported that in an acute dermal toxicity test with rats, at 2,000 mg/kg (within the range for Category 2), no death nor appearance of symptoms was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). (4) It was reported that in an acute inhalation (dust, mist) exposure test with rats (4 hours), at 5.54 mg/L (in the range corresponding to "Not classified"), there was no death, and a mild decrease in the respiration rate, smudge around the eye, and blepharospasm were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (5), histopathological changes were observed in the peripheral nerves in rats at and above the dose of Category 1, but in a long-term administration test with mice in (6), the same changes were not observed after the administration in super large amounts. Based on (1) to (4), no finding related to neurotoxicity was observed in tests with rats and dogs either, therefore, there was insufficient evidence for considering the nervous system as the target organ. Furthermore, since no target organ toxicity was observed within the dose range for Category 1 and Category 2, it was considered to be classified as "Not classified" in the oral route, however, classification was not possible since there was not sufficient information on toxicity available for classification in the other routes. [Evidence Data] (1) It was reported that in a 90-day oral toxicity test with rats dosed by feeding (GLP), at or above 3,000 ppm (242 mg/kg/day (male), 265 mg/kg/day (female), in the range corresponding to "Not classified"), effects on the liver, kidney, blood system, etc. were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). (2) It was reported that in a 90-day subacute neurotoxicity test with rats dosed by feeding (GLP), no neurotoxicity was observed at doses up to the maximum dose of 15,000 ppm (1,140 mg/kg/day (male), 1,230 mg/kg/day (female), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). (3) It was reported that in a 90-day oral toxicity test with dogs dosed by feeding (GLP), at 1,000 ppm (37.1 mg/kg/day (male), 44.6 mg/kg/day (female), within the range for Category 2), increases in absolute/relative weight of the liver were observed in males, and at 30,000 ppm (1,130 mg/kg/day (male), 1,290 mg/kg/day (female), in the range corresponding to "Not classified"), an increase in weight of the liver was observed also in females, but no histopathological change was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). (4) It was reported that in a 1-year chronic toxicity study with dogs dosed by feeding (GLP), at or above 6,000 ppm (176 mg/kg/day (male), 193 mg/kg/day (female), in the range corresponding to "Not classified"), effects on the blood, liver, and thyroid were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). (5) It was reported that in a 2-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding (GLP), at 100 ppm (4.31 mg/kg/day (male), 5.37 mg/kg/day (female), within the range for Category 1), demyelination of the sciatic nerve was observed in females; at 1,000 ppm (43.9 mg/kg/day (male), 54.3 mg/kg/day (female), within the range for Category 2), demyelination of the sciatic nerve, and minor effects on the liver (an increase in relative weight, an increase in GGT) were observed in males; and at 3,000 ppm (129 mg/kg/day (male), 163 mg/kg/day (female), in the range corresponding to "Not classified"), demyelination of the lumbar spinal nerve root, degeneration of the skeletal muscle, effects on the liver, blood system, etc. were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). (6) It was reported that in an 18-month carcinogenicity study with mice dosed by feeding (GLP), at or above 2,500 ppm (337 mg/kg/day (male), 325 mg/kg/day (female), in the range corresponding to "Not classified"), effects on the liver, kidney, and blood (female only) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 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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