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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	106917-52-6
Chemical Name	2',4-Dichloro-alpha,alpha,alpha-trifluoro-4'-nitro-m-toluenesulfonanilide; Flusulfamide
Substance ID	R01-B-075
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 nitro group, a chemical group associated with explosive properties, present in the molecule, and the calculated oxygen balance is -109, higher than the criteria: -200. However, the classification is not possible due to no data on the onset temperature and decomposition energy.
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 is an N-O bond, 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	*	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from information: it is stable at 150 deg C (Pesticide Manual (2013)).
11	Self-heating substances and mixtures	*	- -	-	-	No data 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 fluorine, chlorine, and oxygen, and the oxygen is chemically bonded to elements (S and N) 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)	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. [Evidence Data] (1) LD50 for rats: 132-180 mg/kg (Food Sanitation Research, Vol.46, No.11 (Japan Crop Protection Association, 1996)) (2) LD50 for rats: male: 180 mg/kg, female: 132 mg/kg (Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.25 (Japan Crop Protection Association, 1998))
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 (Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.25 (Japan Crop Protection Association, 1998))
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 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 2. Besides, since exposure concentrations were higher than the saturated vapor concentration (1.3*10-7 mg/L), a reference value in units of mg/L was adopted as the dust. [Evidence Data] (1) LC50 for rats (4 hours): 470 mg/m3 (0.47 mg/L) (Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.25 (Japan Crop Protection Association, 1998)).
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, in which 0.5 g of this substance was applied to the skin of rabbits for 4 hours, very slight erythema on the skin (at 30 minutes and 24 hours) was observed in 1 out of 6 animals (Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.25 (Japan Crop Protection Association, 1998)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Based on (1), it was classified in Category 1. The category was changed due to new data obtained. [Evidence Data] (1) In an eye irritation test with rabbits, changes in the cornea, iris and conjunctiva were observed, but 5 out of 6 animals recovered within 10 days, however, the remaining 1 animal did not recover after 21 days (Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.25 (Japan Crop Protection Association, 1998)).
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 a skin sensitization test (Buehler test) with guinea pigs, sensitization of this substance was not confirmed (Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.25 (Japan Crop Protection Association, 1998)).
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] There were no in vivo data, therefore, classification was not possible due to lack of data. [Evidence Data] (1) As for in vitro, there are reports that the bacterial reverse mutation tests and chromosomal aberration tests with cultured mammalian cells showed negative results (Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.25 (Japan Crop Protection Association, 1998)).
6	Carcinogenicity	*	- -	-	-	[Rationale for the Classification] There are no classification results by domestic and international organizations. There are no available reports for humans. Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) In a 104-week feeding test with rats, no tumor development was observed in females and males (Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.25 (Japan Crop Protection Association, 1998)). (2) In a 78-week feeding test with mice, no tumor development was observed in females and males (Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.25 (Japan Crop Protection Association, 1998)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) to (3), developmental effects on fetuses/pups were observed at toxic doses for parental animals, therefore it was classified in Category 2. [Evidence Data] (1) In a two-generation reproductive toxicity test with rats dosed by feeding, low body weight of pups was seen at the dose without a toxic effect in parental animals, and a decreased survival rate of pups was observed at the dose where reduced body weight gain and decreased heart weight were found in parental animals (Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.25 (Japan Crop Protection Association, 1998), Food Sanitation Research, Vol.46, No.11 (Japan Crop Protection Association, 1996)). (2) In a developmental toxicity test with maternal rats dosed on gestational Days 6-15 by gavage, low body weight, skeletal variations (lumbar rib) and microphthalmia were observed in fetuses at the doses with maternal toxicity (reduced body weight gain and decreased food consumption) (Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.25 (Japan Crop Protection Association, 1998), Food Sanitation Research, Vol.46, No.11 (Japan Crop Protection Association, 1996)). (3) In a developmental toxicity test with maternal rabbits dosed on gestational Days 6-18 by gavage, nose dysplasia, microphthalmia, holoprosencephaly and frontal bone fusion (3-5 animals) were observed in fetuses at the dose with maternal toxicity (reduced body weight gain and so on). It is described that although these effects were thought to be secondary effects due to maternal toxicity, teratogenicity of this substance was suspected at the high doses with maternal toxicity (Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.25 (Japan Crop Protection Association, 1998), Food Sanitation Research, Vol.46, No.11 (Japan Crop Protection Association, 1996)).
8	Specific target organ toxicity - Single exposure	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. It was impossible to find and confirm the agricultural chemical registration application materials which were used for the previous classification. The classification result was changed due to lack of other information sources.
9	Specific target organ toxicity - Repeated exposure	Category 1 (central nervous system, liver), Category 2 (visual organs, kidney, blood system)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1) to (3), it was classified in Category 1 (central nervous system, liver) and Category 2 (visual organs, kidney, blood system). New information sources were used and reviewed, and the classification result was changed from the previous classification. [Evidence Data] (1) In a 90-day repeated dose toxicity test by feeding with rats, increased liver weight in females and males, reduced body weight gain, increases in urine protein and gamma-GT in males, and increases in AST and total bilirubin, and vacuolation of spinal nerve pathway in the central nervous tissues in females were observed at or above 160 ppm (converted guidance value: 7.5 mg/kg/day, within the range of Category 1), and enlarged centrilobular hepatocytes and localized necrosis of the renal papillary in females and males, testicular atrophy, vacuolation of spinal nerve pathway in the central nervous tissues in males, and reduced body weight gain, decreases in erythrocyte counts, hematocrit values and hemoglobin, and increases in urea nitrogen in females were observed at 600 ppm (converted guidance value: 30 mg/kg/day, within range of Category 2) (Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.25 (Japan Crop Protection Association, 1998)). (2) In a 2-year feeding carcinogenicity study with rats, reduced body weight gain in females and males, increases in total bilirubin and liver weight in females were observed at or above 30 ppm (converted guidance value: 1.5 mg/kg/day, within the range of Category 1), and increases in ALP, gamma-GT and urea nitrogen, increased kidney weight, vacuolation of white matter within the central nervous system, neurofibrillary degeneration of the spinal cord and sciatic nerve, and retinal atrophy degeneration of the eyeballs, localized necrosis of the renal papillary, papillary calcification, acidophilic foci of hepatocytes in females and males, and increased weight of the adrenal gland and testis, enlarged centrilobular hepatocytes in males, and urine protein increases, anemia, cataract and chronic nephropathy in females were observed at 300 ppm (converted guidance value: 15 mg/kg/day, within the range of Category 2) (Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.25 (Japan Crop Protection Association, 1998)). (3) In a 12-month feeding repeated dose toxicity test with dogs, vacuolation of white matter within the central nervous system white matter in females and males at a dose of 50 ppm (converted guidance value: 1.25 mg/kg/day, within the range for Category 1) were observed (Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.25 (Japan Crop Protection Association, 1998)).
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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