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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	149961-52-4
Chemical Name	(2E)-2-[2-[(2,5-dimethylphenoxy)methyl]phenyl]-2-methoxyimino-N-methylacetamide (synonym: dimoxystrobin)
Substance ID	R03-A-004-MHLW, MOE
Classification year (FY)	FY2021
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)
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. Besides, there is information that it is combustible (GESTIS (Accessed Sep. 2021)).
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	- -	-	-	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).
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
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.
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] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 (GLP) for rats: > 5,000 mg/kg (CLH Report (2019), EFSA (2005))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (CLH Report (2019), EFSA (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)	Category 4	Warning	H332	P304+P340 P261 P271 P312	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 4. [Evidence Data] (1) LC50 (4 hours, dust) for rats (males): 1.9 mg/L (CLH Report (2019)) (2) LC50 (4 hours, dust) for rats (females): 1.3 mg/L (CLH Report (2019), EFSA (2005))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) It was reported that, in an acute dermal irritation/corrosion test (OECD TG 404, GLP, semiocclusive, 4-hour application, observation for 9 days) with rabbits (n=6), the observed effects were resolved within 8 days (erythema and scab score: 0/0/0/0.7/1/2, edema score: 0/0/0/0/0/0) (ECHA RAC Opinion (2020), CLH Report (2019), EFSA (2005)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) It was reported that, in an acute eye irritation/corrosion test (OECD TG 405, GLP, observation for 72 hours) with rabbits (n=6), the observed effects were resolved within 72 hours (corneal opacity score: 0/0/0/0/0/0, iritis score: 0/0/0/0.3/0/0, conjunctival redness score: 0/0.3/0.7/1.7/0.7/0.3, chemosis score: 0/0/0/0.7/0/0) (ECHA RAC Opinion (2020), CLH Report (2019), EFSA (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] Based on (1), it was classified as "Not classified." [Evidence Data] (1) It was reported that, in a Maximization test (OECD TG 406, GLP, intracutaneous injection: 5% solution) with guinea pigs (n=20), no skin reactions were observed (ECHA RAC Opinion (2020), CLH Report (2019), EFSA (2005)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) The data from four in vitro studies and one in vivo study (chromosome aberration) have been evaluated, and no evidence of genotoxicity of this substance was observed (EFSA (2005)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2. [Evidence Data] (1) In two carcinogenicity studies with rats by 2-year administration, only thickening of the duodenal mucosa was observed in a high-dose group, and no increased incidence of tumor was observed (EFSA (2005)). (2) In a carcinogenicity study with mice by 18-month administration, an increased incidence of adenoma and adenomacarcinoma and focal hyperplasia, which was interpreted as a pre-neoplastic lesion, were observed in the duodenum at the top dose (EFSA (2005)). [Reference Data, etc.] (3) As for the carcinogenicity classification result, the EU classified it in Carc. 2 (EU-CLP Classification Results (Accessed Sep. 2021)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) and (2), cardiomegaly, anemia, yellowish liver discoloration, hypoplasia of the thymus, etc. were observed in offspring at or above a dose at which no clear general toxic effects were observed in parental animals, and therefore, it was classified in Category 2. [Evidence Data] (1) It was reported that, in a two-generation reproduction toxicity study (OECD TG 416, GLP) with rats dosed by feeding, at the dose (150 ppm) at which no general toxic effects were observed in F0 and F1 parental animals, a decrease in thymus weight, yellowish liver discoloration, and cardiomegaly (at weaning) were observed in F1 offspring; and at 500 and 1,200 ppm, impaired body weight and body weight gain, and reduced food consumption were observed in F0 and/or F1 parental animals, a decrease in the number of liveborn pups, an increase in the number of stillborn pups, an increase in the number of fetal resorptions, hypoplasia of the thymus, etc. were observed in F1 offspring, and delays in development landmarks were observed in F2 offspring. Besides, it was reported that there were no effects on fertility of parental animals (CLH Report (2019), ECHA RAC (Background Doc.) (2020), ECHA RAC Opinion (2020)). (2) In a one-generation reproduction toxicity study (OECD TG 415, GLP) with rats dosed by feeding, at 150 ppm, slight microcytic hypochromic anemia was observed in parental animals, and anemia and increased reticulocytes were observed in offspring; and at or above 500 ppm, reduced food consumption and microcytic hypochromic anemia were observed in parental animals, and microcytic hypochromic anemia, an increase in relative heart weight and cardiomegaly (at weaning), yellowish liver discoloration, pale kidneys, etc. were observed in offspring. Besides, it was reported that there were no effects on fertility of parental animals (CLH Report (2019), ECHA RAC (Background Doc.) (2020), ECHA RAC Opinion (2020)). [Reference Data, etc.] (3) It was reported that, in a prenatal developmental toxicity study with rats dosed by gavage (OECD TG 414, GLP), reduced food consumption, reduction in body weight gain, and reduction in corrected body weight gain were observed at or above 120 ppm, but no effects were observed in offspring at doses up to 300 ppm (CLH Report (2019), ECHA RAC (Background Doc.) (2020), ECHA RAC Opinion (2020)). (4) It was reported that, in two prenatal developmental toxicity studies (OECD TG 414, GLP) with rabbits dosed by gavage, at doses (75 to 100 mg/kg/day) at which severe toxicity including death occurred in dams, abortion, reduced gravid uterus weight, increased resorption rate, and increased post implantation loss were observed, and an increase in skeletal malformation (fused sternebrae), etc. were observed in viable fetuses, but many were considered to be effects of maternal toxicity (CLH Report (2019), ECHA RAC (Background Doc.) (2020), ECHA RAC Opinion (2020)).
8	Specific target organ toxicity - Single exposure	Category 2 (systemic)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2 (systemic toxicity). [Evidence Data] (1) It was reported that, in an acute oral toxicity test with rats, at 2,000 (within the range for Category 2) and 5,000 mg/kg (in the range corresponding to "Not classified"), symptoms such as poor general state, dyspnea, apathy, staggering gait, and diarrhea were observed, but animals recovered within 6 days after application (CLH Report (2019)). (2) It was reported that, in an acute inhalation (dust) exposure test with rats (4 hours), attempts to escape, irregular (accelerated and intermittent) respiration, squatting posture, piloerection, smeared fur, etc. were observed at 0.51 mg/L (within the range for Category 1) and 1.28 mg/L (within the range for Category 2) (CLH Report (2019)). [Reference Data, etc.] (3) It was reported that, in an acute dermal toxicity test with rats, no deaths or symptoms were observed at 2,000 mg/kg (within the range for Category 2) (CLH Report (2019)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (gastrointestinal tract)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2 (digestive tract) since effects on the digestive tract (thickening of the duodenal mucosa) were observed within the range for Category 2. [Evidence Data] (1) It was reported that, in a repeated dose 90-day oral toxicity study with rats dosed by feeding, thickening of the duodenal mucosa were observed at 300 ppm (21 mg/kg/day (males), 24 mg/kg/day (females), within the range for Category 2) (EFSA (2005)). (2) It was reported that, in a repeated dose long-term oral toxicity study with rats and mice (2 years for rats, 18 months for mice), thickening of the duodenal mucosa in rats, and hyperplasia of the duodenal mucosa in mice were observed (EFSA (2005)). [Reference Data, etc.] (3) 4,500 ppm (232 mg/kg/day, in the range corresponding to "Not classified") of this substance was administered to rats (males, 10 weeks of age) by feeding for up to 5 weeks or 3 weeks (19 days), and after a 2-week cessation period, changes over time in serum iron levels and blood parameters were measured in a mechanism examination test, and as a result, a decrease in serum iron levels was observed from 24 hours after the start of administration in a group dosed with this substance, and animals recovered 11 days after cessation, showing higher values than a control group. It was reported that blood tests of the treated group 30 days after administration showed marked decreases in hemoglobin, MCV, and MCH were observed, and in the group with 11-day cessation after 19-day administration, these blood parameters tended to improve but did not return to normal (CLH Report (2019)). (4) This substance reduces serum iron levels, and causes microcytic hypochromic anemia which is characterized by reduced hemoglobin, MCH, and MCV (CLH Report (2019)). (5) The duodenum is the main site for iron absorption, and it is suggested that duodenal thickening is related to decreased levels of iron in serum (EFSA (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)	Category 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 72-hour ErC50 = 0.0078 mg/L for algae (Navicula pelliculosa) (EU CLP CLH, 2019).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Sufficient data on rapid degradability were not obtained. It was classified in Category 1 from 97-day NOAEC = 0.001 mg/L for fish (Oncorhynchus mykiss) (EU CLP CLH, 2019).
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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