NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	130000-40-7
Chemical Name	N-[2,6-dibromo-4-(trifluoromethoxy)phenyl]-2-methyl-4-(trifluoromethyl)-5-Thiazolecarboxamide; Thifluzamide
Substance ID	R02-A-024-MHLW, MOE
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/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)	MHLW Website (in Japanese Only)
Model SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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. It was classified as "Not classified."
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified."
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
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. It was classified as "Not classified."
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
10	Pyrophoric solids	Not classified	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from information that it is stable to heat at up to 150 deg C (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)).
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). It was classified as "Not classified."
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing fluorine and oxygen (but not chlorine) which are chemically bonded only to carbon or hydrogen. It was classified as "Not classified."
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified."
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. It was classified as "Not classified."

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), (2). [Evidence Data] (1) LD50 for rats: > 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)) (2) LD50 for rats: > 6,500 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rabbits: > 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014))
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): > 5.0 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) No irritation was observed in a skin irritation test with rabbits (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) In an eye irritation test with rabbits, the mean score at 24/48/72 hours after application was <= 1, and slight irritation was observed but disappeared at 72 hours after application (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)).
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 the data in (1) or (2) did not meet the criteria for Category 1B. [Evidence Data] (1) It was negative in a skin sensitization test with guinea pigs (Buehler test) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014), Agricultural Chemicals Times supplement, Agricultural chemicals technology information No. 30 (Japan Crop Protection Association, 2001)). (2) It is reported that in a skin sensitization test with guinea pigs (maximization test, intradermal administration 5%), the positive rate was 20%, and it was slightly sensitizing (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) As for in vivo, in a micronucleus test using the bone marrow cells of mice dosed by single intraperitoneal administration and a chromosomal aberration test using the bone marrow cells of rats dosed by single oral administration, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)). (2) As for in vitro, in a bacterial reverse mutation test, a gene mutation test and an unscheduled DNA synthesis test using the cultured mammalian cells, negative results were obtained (Same as above).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] There are no classification results by domestic and international organizations. There was no report available on humans. Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) In a two-year combined chronic toxicity/carcinogenicity study with male and female rats dosed by feeding, there was no neoplastic lesion for which the incidence increased by administration, and no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). (2) In an 18-month carcinogenicity study with male and female mice dosed by feeding, there was no neoplastic lesion for which the incidence increased by administration, and no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) In a two-generation reproduction study with rats dosed by feeding, centrilobular/midzonal vacuolation of hepatocytes, etc. were observed in parental animals and reduced body weight gain was observed in pups, but no effect on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). (2) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, at a dose at which alopecia, salivation, and a decrease in body weight/reduced body weight gain were observed in maternal animals, lower body weight was observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). (3) In a developmental toxicity study with female rabbits dosed by gavage on days 7 to 19 of gestation, at a dose at which maternal toxicity effects (emaciation, reduced body weight gain, and a decrease in food consumption) were observed, lower body weight was observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
8	Specific target organ toxicity - Single exposure	Not classified	- -	-	-	[Rationale for the Classification] There was no report on acute exposure effects of this substance in humans. In experimental animals, based on (1) to (4), any of the tests in the oral, dermal, and inhalation routes did not show any findings by which target organs could be identified at doses at which classification was possible, and therefore, it was classified as "Not classified." In (4), incrustation was observed, but no other symptoms of poisoning including abnormal respiratory sound were observed. Also, in the skin irritation test and the acute dermal application test with rabbits, no skin irritation was observed. Therefore, the incrustation around the nose and the eyes was considered to be due to the drying of secretion from the nose and the eyes, and it was determined that the finding could not identify the target organ. [Evidence Data] (1) In an acute oral toxicity test with rats, at or above 2,000 mg/kg (the upper limit of Category 2), stained fur around the urogenital organs, red staining around the muzzle, a decrease in locomotor activity, loose stool, diarrhea, mucous stool, loss of fur around the urogenital organs/on the hindlimbs, ataxia, secretion around the eyes, decreases in feces/urine, and a fall of body temperature were observed; and at 6,500 mg/kg (exceeding Category 2), multiple ulcers and erosion in the forestomach were observed in males (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). (2) In an acute oral toxicity test with rats, at 5,000 mg/kg (exceeding Category 2), transient colored feces and urine, a decrease in feces, poor grooming, and dark-colored face were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). (3) In an acute dermal application test with rabbits, at 5,000 mg/kg (exceeding Category 2), there was no death case, and no apparent toxicity effect was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). (4) In a four-hour inhalation exposure test with rats, at or above 4.3 mg/L (within the range for Category 2), red/brown scabs around the nose and incrustation around the eyes were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014))
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] There was no report on hazard by repeated exposure to this substance in humans. In experimental animals, based on (1) to (3), at doses for Category 1, effects on the liver were observed. Therefore, it was classified in Category 1 (liver). In (1) and (2), effects on the blood system were also observed but only in one sex. Therefore, the information was determined to be not sufficient for identifying the target organ. [Evidence Data] (1) It was reported that in a 90-day oral toxicity test with rats dosed by feeding, at or above 200 ppm (males/females: 13.4/16.9 mg/kg/day, both within the range for Category 2), centrilobular hepatocyte vacuolation was observed in males; and at or above 1,000 ppm (males/females: 67.3/82.3 mg/kg/day, both within the range for Category 2), an increase in ALP and an increase in relative liver weight in males, and decreases in hematocrit and mean corpuscular volume (MCV), an increase in mean corpuscular hemoglobin concentration (MCHC), an increase in cholesterol (Chol), increases in absolute and relative liver weight, and centrilobular hepatocyte vacuolation in females were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). (2) It was reported that in a one-year oral toxicity test with dogs dosed by capsules, at or above 100 mg/kg/day (within the range for Category 2), increases in ALP and Chol were observed, and furthermore, in males, an increase in MCHC was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). (3) It was reported that in a two-year oral administration study with rats dosed by feeding, at or above 100 ppm (males/females: 4.75/6.54 mg/kg/day, both within the range for Category 1), centrilobular fatty changes of hepatocytes was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). The Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019) indicated that centrilobular fatty changes of hepatocytes suggested hepatotoxicity. [Reference Data, etc.] (4) It was reported that in a 90-day oral toxicity test with rats dosed by feeding, at or above 5,000 ppm (males: 322 mg/kg/day, females: 382 mg/kg/day, both exceeding Category 2), a decrease in feces, increases in gamma-GT and BUN, and decreases in glucose and pyelonephritis were observed, and furthermore, in females, a death (1 case), an increase in neutrophils, an increase in ALP, an increase in inorganic phosphates, a decrease in albumin, and renal tubular enlargement/cysts were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). (5) It was reported that in a one-year oral toxicity test with dogs dosed by capsules, at 1,000 mg/kg/day (exceeding Category 2), an increase in MCV, lack of visual stimulus response, lower strength of legs/ataxic gait, abnormal posture response, and nystagmus were observed, and furthermore, an increased degree of fragmentation/degeneration of nerve fiber axons and breakdown/degeneration of myelin in the spinal cord, and spongiform degeneration of the inferior cerebellar peduncle tract were observed in males, and an increase in MCHC was observed in females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
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 = 1.4 mg/L for crustacea (Daphnia magna) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 2 because it is not rapidly degradable (BIOWIN) and due to 72-hour NOErC = 1 mg/L for algae (Raphidocelis subcapitata) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 because it is not rapidly degradable (BIOWIN) and due to 48-hour EC50 = 1.4 mg/L for crustacea (Daphnia magna) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)). From the above results, it was classified in Category 2.
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.

To GHS Information