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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	223580-51-6
Chemical Name	N-(3-Chloro-4-methylphenyl)-4-methyl-1,2,3-thiadiazole-5-carboxamide; Tiadinil
Substance ID	R02-A-073-METI, MOE
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)/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)	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	- -	-	-	Classification is not possible because 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	- -	-	-	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: > 6,150 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)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification is not possible due to lack of data because the category could not be determined from (1). [Evidence Data] (1) LC50 for rats (4 hours): > 2.48 mg/L (GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 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, occlusive, 4-hour application, 72-hour observation), no skin irritation changes 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, 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 = 9) (GLP, 72-hour observation), all irritation changes that were seen in both 6 in the unwashed eye group and 3 in the washed eye group disappeared within 24 hours (in 6 in the unwashed eye group: corneal opacity score: 0/0/0/0/0/0, iritis score: 0/0/0/0/0/0, conjunctival redness score: 0/0/0/0/0/0, chemosis 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, 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" because a positive rate did not reach 30% in a maximization test in (1), and a positive rate was less than 15% in a Buehler test in (2). [Evidence Data] (1) It is reported that in a maximization test with guinea pigs (n = 19) (GLP, intradermal administration: 5% solution), a positive rate was 21% (4/19) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). (2) It is reported that in a Buehler test with guinea pigs (n = 20) (GLP, topical administration: 50% solution), a positive rate was 0% (0/20) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), 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 (4), it was classified as "Not classified." [Evidence Data] (1) In a micronucleus test with the bone marrow cells of mice (GLP,single dose by oral gavage), 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, 2007)). (2) 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, 2007)). (3) In an in vitro mammalian cell (CHL) chromosome aberration test, positive results (structural aberrations) were obtained (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). (4) In the in vitro chromosomal aberration test in (3), structural chromosome aberration induction was observed in a higher dose range, but since it was negative in all other tests including an in vivo mouse micronucleus test, it was considered that there was no genotoxicity that might become a problem for a living body (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] There were no classification results by domestic and international organizations. Based on (1) and (2), it was classified in Category 2. [Evidence Data] (1) In a two-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding, no carcinogenicity was observed at doses up to 2,000 ppm (95.2/119 mg/kg/day (males and females) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). (2) In an 18-month carcinogenicity study with mice, at the maximum dose of 7,000 ppm (male/female: 1,310/1,790 mg/kg/day), an increase in the incidence frequency of hepatocellular adenoma (male: 23.3%; female: 10.0%) was observed in males and females. It was considered that the incidence frequency clearly increased compared with the incidence frequency (male: 8.2 to 9.0%; female: 0 to 1.4%) of the historical control data (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). [Reference Data, etc.] (3) Based on the mechanism test with mice, etc., it was considered that this substance had a hepatic drug metabolizing enzyme activity inducing action which was similar to phenobarbital, and had a cell proliferation ability which was similar to known non-mutagenic carcinogens. It was considered to be one of the mechanisms that caused an increase of the incidence of hepatocellular adenoma (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 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, general toxic effects (an inhibition of body weight gain, a decrease in food consumption, effects on the liver, kidney, etc.), a delay of the age in days of preputial separation (F1 male), and a delay of the age in days of vaginal opening (F1 female) were observed in parent animals; and an inhibition of body weight gain, a decrease in weight (absolute and/or relative weight) of the thymus (F1 and F2), a decrease in absolute weight of the spleen (F1), and a decrease in absolute weight of the brain (F1 female) were observed in offspring, but no effect on reproductive ability was observed. The delays of the ages in days of vaginal opening and preputial separation (treated as effects in F1 parent animals) were considered not to be effects via the sex hormone activation system because there was no change in the AGD (anogenital distance) in F2 male offspring and no effect was observed in the estrus cycle and the reproductive performance in F1 females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), 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 19 of gestation), 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, 2007)). (3) It was reported that in a developmental toxicity study with rabbits dosed by gavage (GLP, days 6 to 27 of gestation), 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, 2007)).
8	Specific target organ toxicity - Single exposure	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 an acute oral toxicity test with rats (GLP), in the groups of 4,390 mg/kg and 6,150 mg/kg (in the range corresponding to "Not classified"), one male each died 1 day after the administration, and as symptoms, reddish brown secretions from the peripheral parts of the eye and nose, a decrease in locomotor activity, lying on belly, lying on side, lacrimation, soiled fur in the peripheral part of the mouth, and incontinence of urine were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)). (2) It was reported that in an acute dermal toxicity test with rats (GLP), at 2,000 mg/kg (within the range for Category 2), no symptom was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)). (3) It was reported that in an acute inhalation exposure test (dust) with rats (GLP, 4 hours), at 2.48 mg/L (within the range for Category 2), no symptom was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver, kidney)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1) to (3), it was classified in Category 2 (liver, kidney). [Evidence Data] (1) It was reported that in a 90-day oral toxicity test with dogs dosed by gavage (GLP), at 100 mg/kg/day (within the range for Category 2), effects on the liver (centrilobular hypertrophy of the hepatocytes, hyperplasia of the bile duct, brown pigment deposit of the hepatocytes (female)), effects on the kidney (hyaline droplets of the tubules and the tubular epithelium, vacuolar degeneration of the tubular epithelium, basophilic change, urine protein positive (male), uric blood positive (female)), etc. were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)). (2) It was reported that in a 1-year chronic toxicity study with dogs dosed by gavage (GLP), at 100 mg/kg/day (within the range for Category 2), effects on the liver (degeneration/necrosis of the hepatocytes, hyperplasia of the bile duct, brown pigment deposit of the hepatocytes (male)), and effects on the kidney (vacuolar degeneration of the tubular epithelium, an increase in urinary volume (male), a high value of urine specific gravity, an increase in BUN (female)), etc. were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)). (3) It was reported that in a 2-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding (GLP), at 2,000 ppm (95.2 mg/kg/day (male), 115 mg/kg/day (female), within the range for Category 2), an increase in relative weight of the liver, and an increase in sporadic vacuolar degeneration of the hepatocytes were observed in males (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)). [Reference Data, etc.] (4) It was reported that in a 90-day oral toxicity test with rats dosed by feeding (GLP), at or above 400 ppm (28.0 mg/kg/day (male), 32.8 mg/kg/day (female), within the range for Category 2), effects on the liver (increases in absolute/relative weight of the liver) were observed in females; at or above 2,000 ppm (139 mg/kg/day (male), 157 mg/kg/day (female), in the range corresponding to "Not classified"), effects on the liver (an increase in relative weight of the liver) (male), and effects on the kidney (an increase in urine protein, a decrease in urinary volume (male)), etc. were observed; and at or above 5,000 ppm (359 mg/kg/day (male), 411 mg/kg/day (female), in the range corresponding to "Not classified"), a trend of an increase in vacuolar degeneration of the hepatocytes (male), effects on the kidney (a decrease in absolute weight, an increase in relative weight (male), an increase in urinary ketone bodies, a trend of a decrease of urine specific gravity), etc. were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)). (5) It was reported that in an 18-month carcinogenicity study with mice dosed by feeding (GLP), at the maximum dose of 7,000 ppm (1,310 mg/kg/day (male), 1,790 mg/kg/day (female), in the range corresponding to "Not classified"), an increase in relative weight of the liver in males, and increases in absolute/relative weight of the liver in females were observed as non-neoplastic changes (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)).
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)	Category 2	- -	H401	P273 P501	It was classified in Category 2 from 48-hour EC50 = 1.6 mg/L for crustacea (Daphnia magna) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 2 because it is not rapidly degradable (BIOWIN), and it was classified in Category 2 in acute toxicity.
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.
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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