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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	125306-83-4
Chemical Name	N,N-diethyl-3-(2,4,6-trimethylphenylsulfonyl)-1H-1,2,4-triazole-1-carboxamide; Cafenstrole
Substance ID	R01-B-081
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, and an S=O bond, a chemical group associated with self-reactive 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	*	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from data: it is stable to heat and decomposes at 300 deg C (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
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 oxygen (but not fluorine or chlorine), which is chemically bonded to an element (S) other than carbon or hydrogen. However, the classification is not possible due to no data.
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)	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: >5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), Food Sanitation Research, Vol.49 No.5 (Japan Crop Protection Association, 1999))
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, 2008))
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)	*	- -	-	-	[Rationale for the Classification] Based on (1), since the category could not be identified, the classification was not possible. [Evidence Data] (1) LD50 for rats (a dust, 4 hours): >1.97 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	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) In a skin irritation test with rabbits, no irritation 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	Serious eye damage/eye irritation	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) In an eye irritation test with rabbits, transient irritation was observed, and the total scores at 1/24/48/72 hours (maximum 110) were 8.3, 2, 0, 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	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) In skin sensitization tests (a maximization test and a Buehler test) with guinea pigs, no skin reactions were observed in both tests. Therefore, this substance was determined to be 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	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), all of the standard battery tests, including in vivo and in vitro tests, were negative. Therefore, it was classified as "Not classified." [Evidence Data] (1) As for in vivo, a negative result was reported in a mouse micronucleus test (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). (2) As for in vitro, negative results were reported in bacterial reverse mutation tests and chromosomal aberration tests with cultured mammalian cells (same sources as above).
6	Carcinogenicity	*	- -	-	-	[Rationale for the Classification] There were no classification results by domestic and international organizations. There were no reports available for humans. Therefore, it was classified as "Not classified" based on (1) and (2). [Evidence Data] (1) In a 2-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding, no increases in the incidence of tumors were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). (2) In an 18-month carcinogenicity study with mice dosed by feeding, no increases in the incidence of tumors were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1), since obvious reproductive and developmental effects were observed at a dosage where parental toxicity was seen, it was classified in Category 2. [Evidence Data] (1) In a 2-generation reproductive toxicity test with rats dosed by feeding, at a dosage where parental toxicity (reduced body weight gain, decreased feed consumption, vacuolation of the jejunal villous epithelium and so on) was observed, shortening of the gestational period, decreases in the number of pups born and viable pups, decreased body weight at birth, a decrease in viability index on Day 4, and shortening of the distance from the genital tubercle to the vaginal opening and hypospadias in females, shortening of the anogenital distance in males were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)).
8	Specific target organ toxicity - Single exposure	*	- -	-	-	[Rationale for the Classification] There is no information on single exposure to this substance in humans. As for experimental animals, no target organ can be identified by oral, dermal or inhalation routes as described in (1)-(3). Therefore, it was classified as "Not classified." [Evidence Data] (1) In a single oral administration test with rats, there were no dead animals at 5,000 mg/kg (exceeding the range for Category 2), and no toxic symptoms were observed. Also, even in the necropsy, no specific changes in the main tissues or organs were 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 a single dermal administration test with rats, there were no dead animals at 2,000 mg/kg (upper limit of the range for Category 2), and no toxic symptoms were observed. Also, in the necropsy, no specific changes were observed in the main tissues or organs (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 4-hour single inhalation exposure test with rats, only mild salivation was observed at 1.97 mg/L of the dust (corresponding to the range for Category 2; described as the highest concentration of the dust possible to generate stably), and there were no dead animals. Also, in the necropsy, no specific changes were observed in the main tissues or organs (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (blood system, nervous system), Category 2 (liver, gastrointestinal tract)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1) to (3), in oral administration tests with experimental animals, effects on the blood system and nervous system at dosages within the range of Category 1, and effects on the liver and gastrointestinal tract at dosages within the range of Category 2 were observed. Therefore, it was classified in Category 1 (blood system, nervous system), Category 2 (liver, gastrointestinal tract). By considering new information sources, the classification result was changed from the previous classification. [Evidence Data] (1) In a 90-day repeated dose test with rats by feeding, at 800 ppm (male/female: 45.8/52.0 mg/kg/day, within the range for Category 2), an increase in lipid droplets in the jejunal villous epithelial cells, etc. were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). (2) In a 90-day repeated dose test by gavage with dogs, a decrease in the acetylcholinesterase activity in the erythrocytes in males at or above 10 mg/kg/day (within the range for Category 1), decreases in hemoglobin, hematocrit values and erythrocytes counts, and increased lipid droplets in the bile duct epithelial cells in males and females, and inflammatory cell infiltration in the lungs, increased alveolar macrophages in females at or above 30 mg/kg/day (within the range of Category 2), ataxia of hindlimbs and neurofibrillary degeneration (medulla oblongata, thoracic-lumbar spinal cord, dorsal root of the lumbar spinal cord, sciatic nerve, peroneal nerve) in males and females, inflammatory cell infiltration in the lungs, increased alveolar macrophages in males, and a decrease in acetylcholinesterase activity in erythrocytes in females at or above 90 mg/kg/day (within the range for Category 2) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). (3) In a one-year repeated dose test by gavage with dogs, decreases in hemoglobin, hematocrit values and erythrocytes counts at or above 10 mg/kg/day (within the range of Category 1), and increased lipid droplets in the interlobular ducts of the liver were observed at or above 30 mg/kg/day (within the range of Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)).
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)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
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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