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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	224049-04-1
Chemical Name	3,4-Dichloro-N-(2-cyanophenyl)isothiazole-5-carboxamide; Isotianil
Substance ID	R02-A-043-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 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	- -	-	-	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 (females): > 2,000 mg/kg (OECD TG 423, GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009))
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 (OECD TG 402, GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009))
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)	Classification not possible	- -	-	-	[Rationale for the Classification] The classification is not possible because effects are unknown near the upper limit for Category 4 in (1). [Evidence Data] (1) LC50 for rats (4 hours): > 4.75 mg/L (no dead animals at a measured concentration of 4.75 mg/L) (OECD TG 403, GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009))
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 = 3) (OECD TG 404, GLP, semi-occlusive, 4-hour application, 72-hour observation), no irritation changes were seen (erythema/eschar score: 0/0/0, edema score: 0/0/0) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), REACH registration dossier (Accessed Sep. 2020), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)).
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 = 3) (OECD TG 405, GLP, 72-hour observation), irritation changes in the conjunctiva were observed after 1 hour but disappeared within 24 hours (corneal opacity score: 0/0/0, iritis score: 0/0/0, conjunctival redness score: 0/0/0, chemosis score: 0/0/0) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), REACH registration dossier (Accessed Sep. 2020), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)).
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). [Evidence Data] (1) It is reported that in a maximization test with guinea pigs (n = 20) (OECD TG 406, GLP, intradermal administration: 5% solution), a positive rate was 50% (10/20) at both 24, 48 hours after a challenge (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), REACH registration dossier (Accessed Sep. 2020), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)).
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 cells of mice (GLP, two oral administrations), negative results were obtained (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). (2) In a bacterial reverse mutation test (OECD TG471, GLP), negative results were obtained (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009), REACH registration dossier (Accessed Sep. 2020)). (3) In a mammalian cell gene mutation test (OECD TG476, GLP), negative results were obtained (REACH registration dossier (Accessed Sep. 2020)). (4) In an in vitro chromosomal aberration test (OECD TG473, GLP), negative results were obtained (REACH registration dossier (Accessed Sep. 2020)).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) As for the classification results by domestic and international organizations, EPA classified this substance in NL (Not Likely to be Carcinogenic to Humans) (US Federal Register, vol. 84, No. 212 (2019)). (2) In a 2-year carcinogenicity study with rats (dosed by feeding), no increase in the incidence frequency of neoplastic lesions associated with the sample administration was observed. The carcinogenicity was not observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009), REACH registration dossier (Accessed Sep. 2020)). (3) In an 18-month carcinogenicity study with mice (dosed by feeding), an increase in the incidence of hepatic mass was observed in males at or above the mid-dose, but it was determined that, histopathologically, there was no increase in hepatic tumors. There was no increase in the incidence frequency of neoplastic lesions associated with the sample administration, and carcinogenicity was not observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)).
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 (OECD TG416, GLP), at 1,000 ppm, weight gain inhibition (P and F1 male), and a decrease in food consumption (F1 male) were observed in parent animals, and low body weight was observed in offspring, but effects on reproductive ability were not observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), REACH registration dossier (Accessed Sep. 2020), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). (2) It was reported that in a developmental toxicity study with rats dosed by gavage (GLP, days 6 to 19 of gestation), at 100 mg/kg/day, an increase or a delay in ossification was observed in offspring, but teratogenicity was not observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). (3) It was reported that in a developmental toxicity study with rabbits dosed by gavage (OECD TG414, GLP, days 6 to 27 of gestation), at 1,000 mg/kg/day, weight gain inhibition, a decrease in food consumption, a decrease in placental weight, a liver enlargement, pale in color in the liver and accentuated lobular pattern of the liver, and abortion (3 cases) were observed in parent animals, and low body weight was observed in offspring, but teratogenicity was not observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), REACH registration dossier (Accessed Sep. 2020), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)).
8	Specific target organ toxicity - Single exposure	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), in tests with rats, in any of the oral, dermal, and inhalation exposure routes, no effect was observed within the dose range for Category 1 or Category 2, and it was classified as "Not classified." [Evidence Data] (1) It was reported that in an acute oral toxicity test with rats (OECD TG 423, GLP), at 2,000 mg/kg (within the range for Category 2), neither death nor appearance of symptoms was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (2) It was reported that in an acute dermal toxicity test with rats (OECD TG 402, GLP), at 2,000 mg/kg (within the range for Category 2), neither death nor appearance of symptoms was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (3) It was reported that in an acute inhalation (dust) exposure test with rats (OECD TG 403, GLP, 4 hours), at 4.75 mg/L (within the range for Category 2), neither death nor appearance of symptoms was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2 (liver). [Evidence Data] (1) It was reported that in a 90-day oral toxicity test with dogs dosed by feeding (GLP), at or above 2,000 ppm (51.1 mg/kg/day (male), 54.4 mg/kg/day (female), within the range for Category 2), an increase in ALT, and an increase in TG (female) were observed; and at or above 8,000 ppm (107 mg/kg/day (male), 211 mg/kg/day (female), in the range corresponding to "Not classified"), effects on the liver (a liver enlargement/centrilobular hypertrophy of the hepatocytes/hepatic/bile duct proliferation/increases in ALP, GGT, etc.) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (2) It was reported that in a chronic toxicity study with dogs dosed by feeding (GLP), at or above 1,000 ppm (27.2 mg/kg/day (male), 26.9 mg/kg/day (female), within the range for Category 2), effects on the liver (increases in absolute and relative weight/centrilobular hypertrophy of the hepatocytes/bile duct proliferation/an increase in ALT, etc.) were observed in males, and an increase in ALT was observed also in one female; and at or above 5,000 ppm (107 mg/kg/day (male), 110 mg/kg/day (female), in the range corresponding to "Not classified"), wasting, diarrhea, and symptoms of the skin and eye, as well as effects on the blood/hematopoietic system, kidney, etc. were observed in both males and females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). [Reference Data, etc.] (3) It was reported that in a repeated dose 90-day oral toxicity study with rats dosed by feeding (OECD TG408, GLP), no effect was observed within the range for Category 1 or Category 2 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (4) It was reported that in a 1-year oral toxicity test with rats dosed by feeding (GLP), at or above 600 ppm (27.9 mg/kg/day (male), 37.3 mg/kg/day (female), within the range for Category 2), an increase in relative weight of the liver was observed; and at or above 6,000 ppm (291 mg/kg/day (male), 381 mg/kg/day (female), in the range corresponding to "Not classified"), effects on the blood, liver, kidney, lung, etc. were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (5) It was reported that in a carcinogenicity study with rats dosed by feeding (GLP), at or above 2,000 ppm (79.2 mg/kg/day (male), 105 mg/kg/day (female), within the range for Category 2), effects on the forestomach and kidney were observed; and at or above 6,000 ppm (242 mg/kg/day (male), 311 mg/kg/day (female), in the range corresponding to "Not classified"), effects on the liver, kidney, and lung were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (6) It was reported that in a carcinogenicity study with mice dosed by feeding (GLP), no effect was observed within the range for Category 1 or Category 2 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
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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