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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	119168-77-3
Chemical Name	N-(4-tert-Butylbenzyl)-4-chloro-3-ethyl-1-methylpyrazole-5-carboxamide; Tebufenpyrad
Substance ID	R01-B-077
Classification year (FY)	FY2019
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2006
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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	*	- -	-	-	There is a chemical group associated with explosive properties (neighboring nitrogen atoms) present in the molecule, but the classification is not possible due to no data.
2	Flammable gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
6	Flammable liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
7	Flammable solids	*	- -	-	-	No data available.
8	Self-reactive substances and mixtures	*	- -	-	-	There are neighboring nitrogen atoms, a chemical group associated with explosive properties, present in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10	Pyrophoric solids	*	- -	-	-	No data available.
11	Self-heating substances and mixtures	*	- -	-	-	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	*	- -	-	-	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 (Not applicable)."
13	Oxidizing liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	The substance is an organic compound containing chlorine and oxygen (but not fluorine) which are chemically bonded only to carbon or hydrogen. It was classified as "Not classified (Not applicable)."
15	Organic peroxides	*	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	*	- -	-	-	It was classified as "Not classified" because it is not desensitized by wetting, dilution, etc.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 3. The category was changed from the previous classification by the use of new information sources. The findings on the safe side in GLP/TG tests were adopted. [Evidence Data] (1) LD50 for rats: female: >50 to <300 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)) (2) LD50 for rats: male: 595 mg/kg, female: 997 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), Food Sanitation Research, Vol.20, No.4 (Japan Crop Protection Association, 1995), HSDB (Access on August 2019)). [Reference Data, etc.] (3) LD50 for mice: male: 224 mg/kg, female: 210 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)).
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: >2,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), Food Sanitation Research, Vol.20, No.4 (Japan Crop Protection Association, 1995), HSDB (Access on August 2019)).
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Category 4	Warning	H332	P304+P340 P261 P271 P312	[Rationale for the Classification] Based on (1), it was classified in Category 4. [Evidence Data] (1) LC50 for rats (dust, 4 hours) : male: 2,660 mg/m3 (2.66 mg/L), female: > 3,090 mg/m3 (3.09 mg/L) (Food Sanitation Research, Vol.20, No.4 (Japan Crop Protection Association, 1995), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018))
2	Skin corrosion/irritation	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) In a skin irritation test and an eye irritation test with rabbits, this substance was not irritating (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), HSDB (Access on August 2019), Food Sanitation Research, Vol.20, No.4 (Japan Crop Protection Association, 1995)).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	[Rationale for the Classification] Based on (1), it was classified in Category 2B. [Evidence Data] (1) In an eye irritation test in which this substance (0.1 g) was instilled into the eyes of rabbits, though changes due to irritation were observed in the cornea and the conjunctiva, these disappeared 72 hours after instillation (Food Sanitation Research, Vol.20, No.4 (Japan Crop Protection Association, 1995)). [Reference Data, etc.] (2) In an eye irritation test with rabbits, this substance was not irritating (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), HSDB (Access on August 2019)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1. [Evidence Data] (1) In skin sensitization tests with guinea pigs (maximization test and Buehler test), though sensitization was observed in a maximization test, it was negative in a Buehler test (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), Food Sanitation Research, Vol.20, No.4 (Japan Crop Protection Association, 1995)). (2) This substance is sensitizing to guinea pigs (HSDB (Access on August 2019)). [Reference Data, etc.] (3) It was classified as "Skin Sens. 1B (H317)" in the EU-CLP classification (EU CLP classification (Access on August 2019)).
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) As for in vivo, there is a report that it was negative in a mouse micronucleus test (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), Food Sanitation Research, Vol.20, No.4 (Japan Crop Protection Association, 1995)). (2) As for in vitro, there are reports that it was negative in a bacterial reverse mutation test, a gene mutation test and an unscheduled DNA synthesis test with cultured mammalian cells, and positive in a part (without S9) of a chromosomal aberration test with cultured human lymphocytes, however, there is a report that it was negative in another chromosomal aberration test conducted at up to higher doses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan,2018)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on the classification results by other organizations in (1), it was classified in Category 2 in accordance with the GHS Classification Guidance for the Japanese Government. The classification result was changed from the previous classification by adding the classification results by other organizations. [Evidence Data] (1) In the classification results by domestic and international organizations, it was classified as S (Suggestive Evidence of Carcinogenicity, but not Sufficient to Assess Human Carcinogenic Potential) by EPA (EPA Annual Cancer Report (2018): classified in 2002). [Reference Data, etc.] (2) In a combined chronic toxicity/carcinogenicity test in which this substance was administered by feeding to rats for 2 years, an increased incidence of hepatocellular adenoma was observed in males. Though an increased incidence of hepatocellular adenoma was also observed in females, dose-correlation was not observed, therefore, it was considered not to be a dose-related effect (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (3) In a carcinogenicity test in which this substance was administered to mice by feeding for 18 months, no neoplastic lesions the incidence of which increased dose-dependently were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)).
7	Reproductive toxicity	*	- -	-	-	[Rationale for the Classification] Based on (1)-(3), it was classified as "Not classified." The classification result was changed from the previous classification because data were reviewed by using new information sources. [Evidence Data] (1) In a two-generation reproductive toxicity test by feeding with rats, reduced body weight gain was observed in pups at the dose where reduced body weight gain and decreased food consumption were observed in parental animals (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (2) In a developmental toxicity test in which female rats were dosed by gavage during gestational Days 6-15, increased skeletal variations (14th ribs) were observed in fetuses at doses where maternal toxicity (reduced body weight gain, hypoactivity, etc.) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (3) In a developmental toxicity test in which female rabbits were dosed by gavage during gestational Days 6-18, though miscarriages (2/20 animals) were observed at the dose where maternal toxicity (reduced body weight gain, decreased food consumption) was observed, no effect was observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). [Reference Data, etc.] (4) In a developmental toxicity test in which female rats were dosed by gavage during gestational Days 6-15, low body weight, delayed ossification and increased number of all embryo resorptions were observed in fetuses at the dose where maternal toxicity (death or sacrificed in moribund state (4/22 animals), prone position, ataxia, tremors, etc.) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). Since severe maternal toxicity was observed, this test result was not adopted as evidence of the classification.
8	Specific target organ toxicity - Single exposure	Category 2 (respiratory organs), Category 3 (narcotic effects)	Warning	H371 H336	P308+P311 P260 P264 P270 P405 P501 P304+P340 P403+P233 P261 P271 P312	[Rationale for the Classification] There is no report of single exposure to this substance in humans. Based on information on experimental animals in (1)-(3), it was classified in Category 2 (respiratory organs), Category 3 (narcotic effects). The classification result was changed from the previous classification by the use of new information sources. [Evidence Data] (1) In a single oral dose test with rats, prone position, decreased activity, ataxia, bradypnoea and tachypnea at or above 128 mg/kg (corresponding to Category 1), and loss of consciousness at or above 320 mg/kg (corresponding to Category 2) were observed. In addition, in another single oral dose test with rats, decreased motor activity and staggering gait were observed at 300 mg/kg (upper limit of Category 1) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (2) In a test with rats by 4-hour single inhalation exposure to the dust of this substance, effects on the central nervous system (lethargy, hypersensitivity to sound or touch) and effects on the respiratory organs (reduced respiratory rate, deepening of respiration, gasping, rales) were observed. These were considered to be effects corresponding to Category 2 because dead animals appeared at or above 1.28 mg/L in females and at 2.14 mg/L or above in males (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (3) In a general pharmacological test (single oral dose), findings suggestive of effects on the central nervous system (decreased cognition and ataxia, etc. (mice), and changes in the electroencephalogram, etc. (rabbits)) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver, blood system)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1) and (2), since effects on the liver and the blood system were observed by oral dose to rats within the range of Category 1, it was classified in Category 1 (liver, blood system). The classification result was changed from the previous classification because data were reviewed by using new information sources. [Evidence Data] (1) In a 90-day repeated dose toxicity test with rats by feeding, at or above 100 ppm (male/female: 6.81/7.27 mg/kg/day, within the range of Category 1), increased weight of the liver in males and females, increased ALP in females were observed. At 400 ppm (male/female: 29.0/31.6 mg/kg/day, within the range of Category 2), decreased platelet counts and increased gamma-GT and BUN in males and females, decreased leukocyte count and increased OCT (ornithine transcarbamylase) in males, decreased values of hemoglobin and hematocrit, increased erythrocyte counts, centrilobular hypertrophy of hepatocytes, and decreased weight of the pituitary, spleen and thymus, etc. in females were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (2) In a 2-year combined chronic toxicity/carcinogenicity study with rats by feeding, at or above 150 ppm (male/female: 6.52/8.13 mg/kg/day, within the range of Category 1), reduced body weight gain, decreased MCV, increased ALP and weight of the liver, hepatocellular hypertrophy in males and females, decreased MCH in males, decreased values of hemoglobin and hematocrit, increased platelet counts, increased spherocyte counts, decreased weight of the thymus, increased weight of the ovary, microcytic hypochromic anemia, etc. in females were observed. At 300 ppm (male/female: 13.4/17.0 mg/kg/day, within the range of Category 2), focal hyperplasia of the acinar cells in the pancreas in males and females, decreased weight of the thymus, and increased weight of the testis and microcytic hypochromic anemia in males, emaciated body and prone position, decreased MCH, and increased leukocyte counts and lymphocyte counts, increased urea nitrogen, etc. in females were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). [Reference Data, etc.] (3) In a 90-day repeated dose toxicity test with dogs by gavage, vomiting, diarrhea and loose stool were observed at or above 10 mg/kg/day (within the range of Category 1) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (4) In a 1-year chronic toxicity test with dogs by gavage, at or above 6 mg/kg/day (within the range of Category 1), vomiting, diarrhea, loose stool and chronic gastritis in males and females, and erosion in the gastric pylorus in females were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)).
10	Aspiration hazard	*	- -	-	-	[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 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 96-hour LC50 = 0.0178 mg/L for fish (Oncorhynchus mykiss) (U.S.EPA: OPP Pesticide Ecotoxicity Database, 2020).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 1 because it is not rapidly degradable (BIOWIN), and it was classified in Category 1 in acute toxicity.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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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