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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	122548-33-8
Chemical Name	Imidazo[1,2-a]pyridine-3-sulfonamide, 2-chloro-N-[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-; 1-(2-Chloroimidazo[1,2-a]pyridin-3-ylsulfonyl)-3-(4,6-dimethoxypyrimidin-2-yl)urea; Imazosulfuron
Substance ID	R02-A-069-METI
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)
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	- -	-	-	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).
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Classification not possible	- -	-	-	The substance is an organic compound containing chlorine and oxygen (but not fluorine), and the oxygen is chemically bonded to the element other than carbon or hydrogen (S). However, the classification is not possible due to no data.
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	- -	-	-	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: > 5,000 mg/kg (Japanese Journal of Pesticide Science Vol. 2 No. 3 (Pesticide Science Society of Japan, 2005))
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 (Japanese Journal of Pesticide Science Vol. 2 No. 3 (Pesticide Science Society of Japan, 2005))
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): > 2.4 mg/L (Japanese Journal of Pesticide Science Vol. 2 No. 3 (Pesticide Science Society of Japan, 2005))
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) (4-hour application, 72-hour observation), no anomalies such as erythema and edema were observed in any animal (Japanese Journal of Pesticide Science Vol. 2 No. 3 (Pesticide Science Society of Japan, 2005)).
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), slight conjunctival redness and edema were found at 1 hour after application in both 3 in the washed eye group and 6 in the unwashed eye group, but all of these disappeared by 48 hours (Japanese Journal of Pesticide Science Vol. 2 No. 3 (Pesticide Science Society of Japan, 2005)).
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" from (1). [Evidence Data] (1) It is reported that in a Buehler test with guinea pigs (n = 15) (topical administration: 25% formulation), slight erythema was observed in 1 animal at 24, 48 hours after the removal of the sample but was considered to be due to irritation of the sample, and a sensitization rate was 0% (Japanese Journal of Pesticide Science Vol. 2 No. 3 (Pesticide Science Society of Japan, 2005)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (6), it was classified as "Not classified." [Evidence Data] (1) In a micronucleus test using the bone marrow cells from mice (dosed by gavage), negative results were reported (HSDB (Accessed Oct. 2020)). (2) In a bacterial reverse mutation test, negative results were reported (Japanese Journal of Pesticide Science Vol. 3, No. 2 (Pesticide Science Society of Japan, 2005)). (3) In a chromosomal aberration test using the Chinese hamster fibroblasts (CHL), negative results were reported (Japanese Journal of Pesticide Science Vol. 3, No. 2 (Pesticide Science Society of Japan, 2005)). (4) In a gene mutation test using the mouse lymphoma cell, negative results were reported (HSDB (Accessed Oct. 2020)). (5) In a chromosomal aberration test using the CHL, positive (+S9) and negative (-S9) results were reported (HSDB (Accessed Oct. 2020). (6) Based on available genotoxicity studies, this substance was not considered to be genotoxic (EFSA (2017)).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) As for the classification results by domestic and international organizations, EPA classified this substance in NL (Not Likely to be Carcinogenic to Humans) (EPA Annual Cancer Report (2018): Classification in 2009). (2) In carcinogenicity studies with rats (for 24 months) and mice (for 18 months) dosed by feeding, no evidence of carcinogenicity was observed up to the highest dose level tested (males/females: 1,123/1,554 mg/kg/day (rats), 7,848/10,303 mg/kg/day (mice)) (US Federal Register vol. 75, No. 24 (2010), EFSA (2017), (Japanese Journal of Pesticide Science Vol. 3, No. 2 (Pesticide Science Society of Japan, 2005), HSDB (Accessed Oct. 2020)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) to (2), it was classified in Category 2. [Evidence Data] (1) It was reported that in a two-generation reproduction toxicity study with rats dosed by feeding, at 10,000 ppm, reduced body weight gain, a decrease in food consumption, etc. were observed in F0 and F1 parental animals; and a decrease in viability, growth inhibition and smaller body sizes were observed in pups (Japanese Journal of Pesticide Science Vol. 3, No. 2 (Pesticide Science Society of Japan, 2005), HSDB (Accessed Oct. 2020), US Federal Register (2010)). (2) With respect to developmental toxicity studies with rats and rabbits, the EFSA evaluation indicated different views. No developmental effect was observed in rats up to doses exceeding the limit value (1,500 mg/kg/day). On the other hand, although no maternal toxicity was observed in rabbits up to the highest dose level tested, increases in the incidence of fused skull bones and bent hyoid arch were observed in fetuses in the highest dose group. (It was concluded that the NOAELs of maternal toxicity and developmental toxicity were 125 mg/kg/day and 50 mg/kg/day, respectively). During the experts' meeting, experts agreed that based on the increased incidence of skeletal abnormalities in rabbits, this substance should be classified in Category 2 regarding developmental effect (EFSA (2017)). [Reference Data, etc.] (3) It was reported that in a developmental toxicity study with rats dosed by gavage, no teratogenicity was observed (Japan Crop Protection Association (2005), HSDB (Accessed Oct. 2020)). (4) It was reported that in a developmental toxicity study with rabbits dosed by gavage, no teratogenicity was observed (Japan Crop Protection Association (2005), HSDB (Accessed Oct. 2020), US Federal Register (2010)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] In an acute neurotoxicity test with rats of (1), effects were observed in the dose range for Category 2, but in the studies of (2) and (3), it was reported that this substance was negative for neurotoxicity. Therefore, no target organ could be identified based on (1), and classification was not possible due to lack of data. [Evidence Data] (1) It was reported that in an acute neurotoxicity test with rats, hyperreactivity to contact was observed in males at or above 500 mg/kg (within the range for Category 2) and in females at or above 1,000 mg/kg (within the range for Category 2); and reduced spontaneous activity, abnormal gait, and hunched posture were observed at 2,000 mg/kg (within the range for Category 2) but these symptoms disappeared on the following day (HSDB (Accessed Oct. 2020)). (2) The effects observed in the test of (1) could be attributed to general toxicity and were resolved by Day 2. It was reported that in other repeated dose toxicity studies, no neurotoxicity effect was observed (US Federal Register vol. 75, No. 24 (2010)). (3) It was reported that in an acute and short-term neurotoxicity test with rats, this substance did not show a neurotoxic action (EFSA (2017)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) to (4), the target organs of this substance were considered to be the eyes, liver, and thyroid, but all the effects were observed in the range corresponding to "Not classified." Therefore, it was classified as "Not classified" in the oral route. However, classification was not possible due to lack of data since there was not sufficient information available for classification in other routes. [Evidence Data] (1) In 90-day subacute oral toxicity tests with rats and mice dosed by feeding and in 90-day and one-year subacute and chronic toxicity studies with dogs orally dosed by capsules, the critical effects for the NOAEL setting were hepatocellular hypertrophy in the liver (rats and mice), an increase in thyroid weight, and alterations in thyroid tissues (dogs). The dog was the most sensitive species. Based on these results, the short-term oral NOAEL was determined to be 75 mg/kg/day in a one-year administration study with dogs (EFSA (2017)). (2) It was reported that in a one-year chronic toxicity study with dogs dosed by gavage, slight to moderate hypertrophy of the thyroid was observed at 150 mg/kg/day (in the range corresponding to "Not classified") (Japanese Journal of Pesticide Science Vol. 2, No. 3 (Pesticide Science Society of Japan, 2005)). (3) It was reported that in a two-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding, retinal atrophy and cataract in the eyes were observed at 20,000 ppm, and the NOAEL was determined to be 2,000 ppm (106.10 (males), 132.46 mg/kg/day (females)) (Japanese Journal of Pesticide Science Vol. 2, No. 3 (Pesticide Science Society of Japan, 2005)). (4) It was reported that in an 18-month carcinogenicity study with mice dosed by feeding, centrilobular hepatocyte hypertrophy due to hypermetabolism was observed at or above 450 ppm; reduced body weight gain was observed in males at or above 4,500 ppm; an increase in liver weight in males and reduced body weight gain in females were observed at 45,000 ppm; and the NOAELs were determined to be 450 ppm (72.7 mg/kg/day) in males and 4500 ppm (870.0 mg/kg/day) in females (Japanese Journal of Pesticide Science Vol. 2, No. 3 (Pesticide Science Society of Japan, 2005)).
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)	-	- -	-	-	-
11	Hazardous to the aquatic environment Long term (Chronic)	-	- -	-	-	-
12	Hazardous to the ozone layer	-	- -	-	-	-

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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