NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	133408-50-1
Chemical Name	(E)-α-methoxyimino-N-methyl-2-phenoxyphenylacetamide; (E)-Metominostrobin
Substance ID	R02-A-025-MHLW, MOE
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
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)	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	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified."
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
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. It was classified as "Not classified."
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
10	Pyrophoric solids	Not classified	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from information that it is stable to heat at up to 250 deg C (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)).
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	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	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). It was classified as "Not classified."
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
14	Oxidizing solids	Classification not possible	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine), which is chemically bonded to the element other than carbon or hydrogen (N). 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. It was classified as "Not classified."
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. It was classified as "Not classified."

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] It was classified in Category 4 from (1). [Evidence Data] (1) LD50 for rats: females: 708 mg/kg, males: 776 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011))
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 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011))
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] It was classified as "Classification not possible" because the category could not be determined from (1). [Evidence Data] (1) LC50 for rats (4 hours): > 1.88 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011))
2	Skin corrosion/irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
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 was negative in a skin sensitization test with guinea pigs (maximization test, intradermal administration 5%) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), the substance was negative in all standard combined tests including in vivo and in vitro tests, and it was classified as "Not classified." [Evidence Data] (1) As for in vivo, in a micronucleus test using the bone marrow cells of mice, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)). (2) As for in vitro, in a bacterial reverse mutation test and a mammalian cell chromosome aberration test, negative results were reported (Same as above).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] There are no classification results by domestic and international organizations. There was no report available on humans. Based on (1) and (2), carcinogenicity was observed in male rats. Therefore, it was classified in Category 2. [Evidence Data] (1) In a two-year combined chronic toxicity/carcinogenicity study with male and female rats dosed by feeding, a significant increase in the incidence of hepatocellular adenomas and large granular lymphocyte (LGL) leukemia was observed in males (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010)). (2) In an 18-month carcinogenicity study with male and female mice dosed by feeding, there was no treatment-related increase in the incidence of neoplastic lesions and no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010)). [Reference Data, etc.] (3) In the case of hepatocellular adenoma, the formation mechanism was unlikely to be a genotoxic one, and it was considered possible to set a threshold for assessment. As for LGL leukemia, it frequently occured in Fischer rats and no genotoxicity of the substance was observed. Therefore, it was considered that the developmental mechanism of LGL leukemia was not a genotoxic one. In addition, LGL leukemia rarely occured in humans and the biological characteristics of tumors in humans were greatly different from those in rats. Therefore, it was concluded that the possibility of extrapolation of the tumor increase to humans is very low (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] In (1), although no effect on fertility was observed at doses at which toxicity effects were observed in parental animals, effects on the reproductive organs, sexual cycle, etc. were observed in females. Therefore, it was classified in Category 2. [Evidence Data] (1) In a two-generation reproduction study with rats dosed by feeding, at a dose at which hyaline cast in the kidney, etc. in males, and centrilobular hepatocyte hypertrophy, atrophy of the ovary, decreased corpora lutea and secondary follicles, smaller uterine diameter, multi-stratified columnar epithelial cells in the vagina (P females), irregular sexual cycle, and delayed recurrence of estrus (at the time of weaning of F2a) in females were observed in parental animals, centrilobular hepatocyte hypertrophy, etc. were observed in pups. No effect on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010)). [Reference Data, etc.] (2) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, even at a dose at which death, salivation, reduced body weight gain, a decrease in food consumption, and an increase in corrected liver weight were observed in dams, no effect was observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010)). (3) In a developmental toxicity study with female rabbits dosed by gavage on days 6 to 18 of gestation, at a dose at which maternal toxicity effects (decreases in body weight and food consumption) were observed in dams, the increased incidence of fetuses having supernumerary ribs was observed. The supernumerary ribs were not considered to be a finding suggestive of teratogenicity (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010)).
8	Specific target organ toxicity - Single exposure	Category 2 (central nervous system), 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 was no report on acute exposure effects of this substance in humans. In experimental animals, based on (1) and (2), it was classified in Category 2 (central nervous system), and Category 3 (narcotic effects). [Evidence Data] (1) In an acute oral toxicity test with rats (No mention of the minimum dose at which effects were observed. It was assumed that effects were observed at doses that were lower than 390 mg/kg (within the range for Category 2) where at least death was observed for the first time), a reduction in locomotor activity, a reduction in muscle tonus, coma, bradypnea or labored breathing, and convulsion were observed in males and females, and hunched posture was observed in males (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)). (2) In an acute oral toxicity test with mice, at or above 1,014 mg/kg in males and 780 mg/kg in females (both within the range for Category 2), a reduction in locomotor activity, a reduction in muscle tonus, coma, and bradypnea or labored breathing were observed, and ptosis in males and convulsion in females were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)). [Reference Data, etc.] (3) In a four-hour inhalation exposure test with rats, at or above 1.8 mg/L (within the range for Category 2), slightly contaminated fur all over the body was observed in all males and females after the exposure ended (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver, kidney)	Warning	H373	P260 P314 P501	[Rationale for the Classification] There was no report on hazard by repeated exposure of humans to this substance. In experimental animals, based on (1) to (3), at doses for Category 2, effects on the liver and kidney were observed. Therefore, it was classified in Category 2 (liver, kidney). [Evidence Data] (1) It was reported that in a two-year oral toxicity study with rats dosed by feeding, at or above 350 ppm (males/females: 16.3/19.7 mg/kg/day, both within the range for Category 2), an increase in foci of altered hepatocytes in males; and glomerulosclerosis, hyaline droplets in the tubular epithelium, interstitial cell infiltration, and basophilic changes of the renal tubules in females were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)). (2) It was reported that in a one-year oral toxicity test with dogs dosed by capsules, at or above 30 mg/kg (within the range for Category 2), an increase in ALP was observed, and furthermore, ground glass-like cytoplasm in centrilobular to midzonal hepatocytes was observed in males (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010)). (3) It was reported that in an 18-month oral toxicity study with mice dosed by feeding, at or above 300 ppm (males/females: 30.54/26.90 mg/kg/day, both within the range for Category 2), hypertrophy of periportal hepatocytes was observed, and furthermore, single cell necrosis was observed in males (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)). [Reference Data, etc.] (4) It was reported that in a two-year oral toxicity study with rats dosed by feeding, at 3,500 ppm (males/females: 167.1/212.3 mg/kg/day, both exceeding Category 2), a decrease in hemoglobin, increases in platelet count and fibrin, an increase in gamma GT, increases in total cholesterol and phospholipid, darker color of the liver, granular renal surface, and centrilobular hepatocyte hypertrophy were observed, and furthermore, decreases in red blood cell count and hematocrit, increases in absolute and relative weight of the lung and spleen, white spots on the liver, hypertrophy of the spleen, spongy degeneration of the liver, focal hyperplasia of the renal tubular epithelium, renal tubular enlargement and glomerulosclerosis in males; and decreases in mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC), darker color of the kidney, and hyaline casts in the kidney in females were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)).
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)	Category 2	- -	H401	P273 P501	It was classified in Category 2 from 72-hour ErC50 = 4.08 mg/L for algae (Raphidocelis subcapitata) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 2 because it is not rapidly degradable (BIOWIN), and it was classified in Category 2 in acute toxicity.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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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