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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	84496-56-0
Chemical Name	2-(2,4-Dichloro-3-methylphenoxy)-N-phenylpropanamide; Clomeprop
Substance ID	R02-A-045-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	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing chlorine and oxygen (but not fluorine), which are chemically bonded only to carbon or hydrogen.
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	- -	-	-	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.

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 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats: > 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009))
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] The classification is not possible because effects are unknown at a dose near the upper limit for Category 4 in (1). [Evidence Data] (1) LC50 for rats (4 hours): > 1.5 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009))
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) (24-hour application, 14-day observation), no skin irritation changes were seen after applications to the normal skin area and the skin area with the horny layer detached (erythema/eschar score: 0/0/0/0/0/0, edema score: 0/0/0/0/0/0) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)).
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), 5 out of 6 animals in the unwashed eye group showed conjunctival redness, but the effect disappeared in all the animals within 72 hours (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)).
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 maximization test with guinea pigs (n = 20) (GLP, intradermal administration: 1.0% suspension), a positive rate was 0% (0/20) at both 24, 48 hours after a challenge (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified." [Evidence Data] (1) In a micronucleus test using the bone marrow cells of mice (GLP, oral administrations), negative results were obtained (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009), Japanese Journal of Pesticide Science Vol. 16, No. 1 (Pesticide Science Society of Japan, 1991)). (2) In a bacterial reverse mutation test (GLP), negative results were obtained (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009), Japanese Journal of Pesticide Science Vol. 16, No. 1 (Pesticide Science Society of Japan, 1991)). (3) In a mammalian cell chromosome aberration test (GLP), false-positive results (negative for structural aberrations, an increase in the polyploid cells) in the S9(-) system and negative results in the S9(+) system were obtained (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009), Japan Crop Protection Association (1991)). (4) In an in vitro chromosomal aberration test, it was false-positive with a slight increase in numerical aberrations by the high-concentration treatment in the S9(-) system. However, it was negative in the S9(+) system, and it was negative in the micronucleus test with mice that were tested at a dose exceeding the limit dose, and comprehensively assessing the above, it was considered not to have genotoxicity that might become a problem for a living body (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." In (2), an increase in a malignant tumor was not observed in male mice, and the possible effect of the administration was low. The evidence of carcinogenicity was not observed in male and female rats, and female mice. [Evidence Data] (1) In a 2-year combined chronic toxicity/carcinogenicity study with rats, no treatment-related increase in the incidence of neoplastic lesions was observed and no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009), Japan Crop Protection Association (1991)). (2) In a 2-year combined chronic toxicity/carcinogenicity study with mice, a significant increase in the incidence frequency of hemangioendothelioma of the liver was observed in the male group at the maximum dose, but an increase of hemangiosarcoma, which was a malignant tumor, was not observed, therefore, the possibility of the effect of the administration of this substance was considered to be low (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009), Japan Crop Protection Association (1991)).
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 three-generation reproduction toxicity study with rats dosed by feeding (GLP), at 750 ppm, general toxic effects (an increase in water consumption, changes in the weight and tissues of the kidney and spleen, inhibition of body weight gain, etc.), and an extension of the gestation period (P and F1 female) were observed in parent animals, and a decrease in the number of newborns was observed in F1 offspring. It was reported that the decrease in the number of newborns that was observed in F1 offspring, was not observed in F2 offspring (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009), Japan Crop Protection Association (1991)). (2) It was reported that in a developmental toxicity study with rats dosed by gavage (GLP, days 6-15 of gestation), at 64 mg/kg/day, inhibition of body weight gain, a decrease in food consumption, an increase in water consumption, and hemorrhage in the uterus were observed in parent animals, and low body weight was observed in fetuses, but teratogenicity was not observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009), Japan Crop Protection Association (1991)). (3) It was reported that in a developmental toxicity study with rabbits dosed by gavage (GLP, days 6-19 of gestation), at 300 mg/kg/day, a low value of the fetus weight was observed in offspring, but teratogenicity was not observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009), Japan Crop Protection Association (1991)).
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] Based on (1), the gastrointestinal tract was considered to be the target, but it was not considered to be the target organ because the symptoms were considered to be derived from mucosal irritation. Based on (2), shallow breathing and an increase in secretory responses were considered to be the effects of respiratory tract irritation, and it was classified in Category 3 (respiratory tract irritation). [Evidence Data] (1) In an acute oral toxicity test with rats, piloerection, diarrhea, loose stool, etc. were observed as symptoms in both males and females; and in females, anemia was observed, death occurred, and hemorrhage in the intestinal tract was observed by necropsy. It was reported that dead female animals were observed when the dose was 1,751 mg/kg or above (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (2) It was reported that in an acute inhalation (dust) toxicity test with rats (4 hours), at 1.5 mg/L (within the range for Category 2), death was not observed, and shallow breathing, inhibition of behavior, and an increase in secretory responses were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). [Reference Data, etc.] (3) It was reported that in an acute oral toxicity test with mice, at 1,000 to 5,000 mg/kg, neither death nor appearance of symptoms was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (4) It was reported that in acute dermal toxicity tests with rats and mice, at 1,000 to 5,000 mg/kg, neither death nor appearance of symptoms was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (blood system, liver, kidney)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1) to (4), the target organs were considered to be the blood system (anemia), liver, and kidney, and since the effects were mostly observed at a dose of Category 2, it was classified in Category 2 (blood system, liver, kidney). [Evidence Data] (1) It was reported that in a 90-day oral toxicity test with rats dosed by feeding, at 250 to 1250 ppm (17.9 to 90.7 mg/kg/day (male), 19.9 to 99.5 mg/kg/day (female), within the range for Category 2), effects on the hematology (decreases in red blood cell count, Hb, Ht, and MCHC), hypertrophy of hepatocytes, an increase in urinary volume and a decrease in urinary specific gravity, and effects on the spleen (increases in absolute and relative weight, congestion of the splenic sinus) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (2) In a 90-day oral toxicity test with mice dosed by feeding, at 500 ppm (84.2 mg/kg/day (male), 114 mg/kg/day (female), within the range for Category 2 to in the range corresponding to “Not classified”), decreases in Hb and Ht were observed in females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (3) It was reported that in a 2-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding, at 90 ppm (3.22 mg/kg/day (male), 4.53 mg/kg/day (female), within the range for Category 1), slight effects on the liver (centrilobular hypertrophy of hepatocytes), and effects on the kidney (pigment deposit in renal cortical tubular epithelial cells) were observed in males; and at 500 ppm (18.3 mg/kg/day (male), 25.7 mg/kg/day (female), within the range for Category 2), effects on the hematology (decreases in RBC, Hb, and Ht (PCV)), the liver function related enzymes (increases in ALP, AST/ALT), and the kidney (a decrease in urinary volume, an increase in urea) were observed in males and females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (4) It was reported that in a 2-year combined chronic toxicity/carcinogenicity study with mice dosed by feeding, at 500 ppm (66 mg/kg/day (male), 101 mg/kg/day (female), within the range for Category 2), effects on the kidney (increases in absolute and relative weight, tubular dilation, calcification) were observed as non-neoplastic lesions mainly in males (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). [Reference Data, etc.] (5) It was reported that in a 1-year oral toxicity test with dogs (GLP), effects were not observed within the dose range for Category 1 and Category 2, and at 200 mg/kg/day (in the range corresponding to "Not classified"), effects on the liver (liver congestion, degeneration, acidophilic change, single cell necrosis, and cellular infiltration (one case), etc.) were observed mainly in females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
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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