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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	110488-70-5
Chemical Name	3-(4-Chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-morpholinoprop-2-en-1-one; Dimethomorph
Substance ID	R02-A-082-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	Classification not possible	- -	-	-	There is a chemical group associated with self-reactive properties (ethylene group) present in the molecule, but the classification is not possible due to no data.
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	- -	-	-	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) - (3). [Evidence Data] (1) LD50 for rats (males): 4,300 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), JMPR Report (2007)) (2) LD50 for rats (females): 3,500 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), JMPR Report (2007)) (3) LD50 for rats: 3,900 mg/kg (EFSA (2006))
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, 2013))
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 toxicity information is unknown at the upper limit for Category 4 in (1). [Reference Data, etc.] (1) LC50 for rats (4 hours): > 2.39 mg/L (dust) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013))
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 = 3) (GLP, semi-occlusive, 4-hour application, 7-day observation), no skin irritation changes were seen in any animal (erythema/eschar score: 0/0/0, edema score: 0/0/0) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), 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 = 3) (GLP, 7-day observation), all the animals showed conjunctival redness and chemosis after 4 hours but recovered within 48 hours (mean corneal opacity score: 0, mean iritis score: mean conjunctival redness score: 0.2, mean chemosis score: 0) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), 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), (2). [Evidence Data] (1) It is reported that in a maximization test with guinea pigs (n = 20) (GLP, intradermal administration: 5% suspension), the positive rate was 0% (0/20) at both 24, 48 hours after the removal of patches (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). (2) It is reported that in a modified Buehler test with guinea pigs (n = 20) (GLP, topical administration: 9-time 24-hour occlusive applications of a paste of 50% of the sample in petrolatum over 20 days), the positive rate was 0% (0/20) at both 24, 48 hours after challenge exposure (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), 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 (5), it was classified as "Not classified." [Evidence Data] (1) In micronucleus tests using the mouse bone marrow cells (single oral dose, single intraperitoneal injection), two negative results (1 case in GLP, 1 case in non-GLP) were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), HSDB (Accessed Dec. 2020), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). (2) In a bacterial reverse mutation test (GLP), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). (3) In an in vitro mammalian cell (Chinese hamster lung cells (V79)) gene mutation test (GLP), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). (4) In two chromosomal aberration tests using the cultured mammalian cells (CHL and V79 cells) (both GLP), negative (-S9) and positive (+S9) results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). (5) In a chromosomal aberration test using the human lymphocytes (GLP), negative (-S9) and positive (+S9) results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)).
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, the EPA classified this substance in NL (Not Likely to be Carcinogenic to Humans) (EPA Annual Cancer Report (2019)). (2) In carcinogenicity studies with rats and mice dosed by feeding, no evidence of carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009), JMPR Report (2007)). [Reference Data, etc.] (3) The EPA classified this substance as NL based on lack of evidence of carcinogenicity in rats and mice and no evidence of mutagenicity (US Federal Register vol. 80, No. 168 (2015)).
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1B. In (1), a reduction in gestation length in parental animals, a decrease in AGD, etc. in pups were observed at dose levels causing mild maternal toxicity. In consideration of the effects of the reduced gestation length and the delayed onset of puberty in pups, the RAC judged that the classification as Repr. 1B was appropriate. [Evidence Data] (1) It was reported that in a one-generation reproduction toxicity study with rats dosed by feeding (OECD TG 443, GLP), a decrease in body weight, reduced body weight gain, a reduction in food consumption, etc. in parental animals and reductioned AGD, deceases in seminal vesicle and prostate weight (males) in pups were observed at 800 ppm; and a reduction of gestation length in addition to the findings at 800 ppm in parental animals, and a decrease in preweaning pup body weight and a delay in preputial separation in addition to the findings at 800 ppm in pups were observed at 1,600 ppm (CLH Report (2018)). (2) It was reported that in a developmental toxicity study with rats dosed by gavage (GLP, days 6-15 of gestation), reduced body weight gain and a reduction in food consumption in parental animals and a slight increase in post-implantation fetal mortality in pups were observed at 160 mg/kg/day. It was reported that no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). [Reference Data, etc.] (3) In the CLH Report, it was proposed that this substance should be classified as Repr. 1B because the reduction of gestation length in (1) was a significant effect on sexual function and fertility, and based on the developmental effects (reduced AGD, delayed onset of puberty, reduced pup weight, and decreases in seminal vesicle and prostate weight) that were not considered to be secondary to maternal toxicity, it should be also classified as Repr. 1B for developmental toxicity (CLH Report (2018)). (4) With respect to the proposition of (3), the RAC considered that the delayed onset of puberty (preputial separation, vaginal opening) should be included in the effects on sexual function and fertility, and the reduction of gestation length, delayed onset of puberty in pups, and marked effects on the reproductive organs in males were observed at dose levels causing mild or moderate maternal toxicity, therefore, the classification as Repr. 1B was appropriate. On the other hand, the RAC gave the opinion that the classification for developmental toxicity could not be justified because the reduced AGD was attributable to the lower birth weight due to the reduction of gestation length (RAC Opinion (2019).
8	Specific target organ toxicity - Single exposure	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (5), it was considered that this substance had no specific target organ toxicity at doses up to and within the range for Category 2 and it was classified as "Not classified." [Evidence Data] (1) It was reported that in an acute oral toxicity test with rats, piloerection, hunched posture, abnormal gait, lethargy, reduced respiratory rate, ptosis, paleness of limbs, and coma-like state were observed at 3,200 mg/kg to 5,000 mg/kg (in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). (2) It was reported that in an acute oral toxicity test with mice, hypoactivity, prostration, piloerection, ataxia, and stained fur were observed at 1,500 mg/kg to 5,000 mg/kg (within the range for Category 2 and in the range corresponding to "Not classified) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). (3) It was reported that in an acute dermal toxicity test with rats, no deaths or symptoms were observed at 2,000 mg/kg (upper limit of Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). (4) It was reported that in an acute inhalation (dust) toxicity test with rats (4 hours), there was no death case, and completely closed eyelids, half-closed eyelids, abnormal respiratory pattern, abnormal posture, and stained fur were observed at 2.39 mg/L (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). (5) It was reported that in an acute neurotoxicity test with rats by oral administration, a decrease in locomotor activity and impairment of gait and rearing were observed at or above 250 mg/kg (within the range for Category 1), but they were considered to be caused by the poor general condition after the oral administration, not by direct neurotoxicity (US Federal Register vol. 80, No. 168 (2015)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (prostate)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2 (prostate). The findings on the liver (an increase in ALP, an increase in lipid droplets, an increase in the incidence of ground-glass foci of liver cells) in (1) to (3) were not considered to be target organ toxicity effects and were not adopted. [Evidence Data] (1) It was reported that in a 90-day oral toxicity test with dogs dosed by feeding (GLP), an increase in ALP and a decrease in prostate weight with fibrosis (males) were observed at 1,350 ppm (43.1 mg/kg/day (males), 43.7 mg/kg/day (females), within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013). (2) It was reported that in a one-year chronic toxicity study with dogs dosed by feeding (GLP), an increase in ALP, an increase in liver weight, an increase in hepatic lipid droplets, and a decrease in prostate weight (males) were observed at 1,350 ppm (44.6 mg/kg/day (males), 47.0 mg/kg/day (females), within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (3) It was reported that in a two-year carcinogenicity study with rats dosed by feeding (GLP), reduced body weight gain, an increase in the incidence of ground-glass foci of liver cells, increases in the incidence of dilatation of mesenteric blood vessels and arteritis (in the pancreas in particular) and other effects (males) were observed at 2,000 ppm (94.6 mg/kg/day (males), 133 mg/kg/day (females), within the range for Category 2 to in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). [Reference Data, etc.] (4) It was reported that in a 90-day oral toxicity test with rats dosed by feeding (GLP), no significant toxicity findings were observed up to the highest dose of 1,000 ppm (73 mg/kg/day (males), 82 mg/kg/day (females), within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (5) It was reported that in a two-year chronic toxicity study with rats dosed by feeding (GLP), reduced body weight gain, mild anemia, increases in the incidence of dilatation of mesenteric blood vessels and arteritis (in the pancreas in particular) and other effects (males) were observed at 2,000 ppm (99.9 mg/kg/day (males), 158 mg/kg/day (females), within the range for Category 2 to in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (6) It was reported that in a two-year carcinogenicity study with mice dosed by feeding (GLP), reduced body weight gain was observed at the highest dose of 1,000 mg/kg/day (in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)).
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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