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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	163515-14-8
Chemical Name	2-Chloro-N-(2,4-dimethylthien-3-yl)-N-[(2S)-1-methoxypropan-2-yl]acetamide; Dimethenamide-P
Substance ID	R02-A-019-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)	- -	-	-	Liquid (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)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
6	Flammable liquids	Classification not possible	- -	-	-	No data available.
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
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	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from information that it is stable at up to 170 deg C (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)).
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to liquid 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)	- -	-	-	The substance is an organic compound containing chlorine and oxygen (but not fluorine) which are chemically bonded only to carbon or hydrogen. It was classified as "Not classified."
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
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	- -	-	-	No data 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: males: 429 mg/kg, females: 531 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2005), CLH Report (2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rabbits: > 2,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2005), EU CLP CLH (2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Liquid (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)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) LC50 for rats (nose exposure, 4 hours): > 2.2 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2005), CLH Report (2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)) (2) LC50 for rats (nose exposure, 4 hours): > 5.16 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (3). [Evidence Data] (1) This substance is not irritating to the skin (EU EFSA (2018)). (2) Weak irritation was seen in a skin irritation test with rabbits on this substance (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)). (3) In a skin irritation test with rabbits by 4-hour semi-occlusive application of this substance, very slight to slight erythema was observed but disappeared by 72 hours after application (JMPR (2005), CLH Report (2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (3). [Evidence Data] (1) This substance is not irritating to the eye (EU EFSA (2018)). (2) Slight irritation was seen in an eye irritation test with rabbits on this substance (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)). (3) In an eye irritation test with rabbits on this substance, slight conjunctival redness and edema and moderate to severe discharge were observed but disappeared by 48 hours, and this substance was judged as practically non-irritant to the eye (JMPR (2005), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015), CLH Report (2012)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1B	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] It was classified in Category 1B from (1), (2). [Evidence Data] (1) This substance was positive in a skin sensitization test with guinea pigs (Buehler test) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)). (2) This substance was judged as positive (positive rate 85%) in a skin sensitization test with guinea pigs (Buehler test, application concentration 100%) (JMPR (2005), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) As for in vivo, in a micronucleus test using the bone marrow cells after intraperitoneal injection or oral administration of this substance to mice, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2005), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). (2) As for in vitro, in bacterial reverse mutation tests for this substance, it was positive partly, but it was determined to be comprehensively negative. In a chromosome aberration test and a gene mutation test using cultured mammalian cells, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2005), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). [Reference Data, etc.] (3) As for in vivo for the racemic form, in a micronucleus test using the bone marrow cells after oral administration to mice, a dominant lethal test of orally dosed rats, and an unscheduled DNA synthesis test using hepatocytes of orally dosed rats, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). (4) As for in vitro for the racemic form, in a bacterial reverse mutation test, a chromosome aberration test, and a gene mutation test using cultured mammalian cells, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2005), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) to (3), it was classified in Category 2. [Evidence Data] (1) As for the classification results by domestic and international organizations, the EPA classified this substance in C (Possible Human Carcinogen) (EPA Annual Cancer Report 2019 (Access on October 2020): Classification in 2014). (2) In a combined chronic toxicity/carcinogenicity study with rats using the racemic form (CAS RN 87674-68-8) of this substance, an increasing tendency in liver tumors was observed in males, and since the racemic body was considered to have weak carcinogenicity, the racemic form and this substance were classified in Group C (US Federal Register vol. 80, No.34 (2015)). (3) Based on the comparison of test results between this substance and the racemic form of this substance, it was considered that their kinetics and metabolisms were comparable, and their toxicity profiles and toxicity levels were also similar (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)). [Reference Data, etc.] (4) In a two-year combined chronic toxicity/carcinogenicity study of the racemic form (CAS RN 87674-68-8) of this substance to male and female rats dosed by feeding, an increasing tendency in the incidence of hepatocellular adenomas, and the combined incidence of hepatocellular adenomas or carcinomas in males, and an increasing tendency in the incidence of ovarian tubular adenomas in females were observed. However, as for liver tumors, there was no significant difference in the Fisher's test, and as for ovarian tubular adenomas, there was no significant difference in the trend test after histopathological reassessment, and therefore, these changes were considered to be not treatment-related effects (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)). (5) In a 94-week carcinogenicity study of the racemic form (CAS RN 87674-68-8) of this substance to male and female mice dosed by feeding, no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)).
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Based on the developmental toxicity study data of this substance (S isomer) (1), the reproduction toxicity test data of the racemic form (2) to (4), and (5), it was classified as "Not classified." [Evidence Data] (1) In a developmental toxicity study by oral administration of this substance to female rats dosed by gavage on days 6 to 15 of gestation, delayed ossification was observed in fetuses at doses at which maternal toxicity (reduced body weight gain, a reduction in food consumption, subnormal temperature, a reduction in locomotor activity, etc.) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)). (2) In a two-generation reproductive study by oral administration of the racemic form (CAS RN 87674-68-8) to rats dosed by feeding, at a dose at which toxicity in parent animals (increases in absolute and relative liver weight, etc.) was observed, reduced body weight gain was observed in offspring, but no effect on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)). (3) In a developmental toxicity study by oral administration of the racemic form to female rats dosed by gavage on days 6 to 15 of gestation, maternal toxicity (salivation, soiled abdominal fur, reduced body weight gain, increases in absolute and relative liver weight at or above 215 mg/kg/day) was observed, and in fetuses, an increase in early resorption embryos were observed at 425 mg/kg/day (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)). (4) In a developmental toxicity study by oral administration of the racemic form to female rabbits dosed by gavage on days 6 to 18 of gestation, no effect was observed in fetuses even at a dose at which maternal toxicity (miscarriage /premature delivery (2 cases) and a reduction in food consumption) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)). (5) Based on the comparison of test results between this substance and its racemic form, it was considered that their in vivo kinetics and metabolisms were comparable, and their toxicity profiles and toxicity levels were also similar (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)).
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] There was no report on acute exposure effects of this substance in humans. In experimental animals, based on (1) to (4), it was classified in Category 3 (respiratory tract irritation). [Evidence Data] (1) In an acute oral toxicity test with rats, at 350 mg/kg (within the range for Category 2), lacrimation, a reduction in food consumption, and a decrease in feces in males and females, and yellow anogenital staining, red staining on the nose, salivation, and moist rales in males were observed; at or above 400 mg/kg (within the range for Category 2), black or brown staining on the mouth and cheeks, inactivity, drowsiness and bradypnea in males, and loss of fur, yellow anogenital staining, and salivation in females were observed; and at 500 mg/kg (within the range for Category 2), black or brown staining on the nose and extremities in males and females, low body temperature in males, and inactivity in females were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2005)). (2) In an acute dermal application test with rabbits, at 2,000 mg/kg (upper limit of Category 2), there was no death, and no symptoms of clear toxic effects were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2005)). (3) In a 4-hour inhalation exposure test (exposure of the nose) with rats, at 2.2 mg/L (within the range for Category 2), labored breathing, moist rales, lacrimation, bloody tears, clear/red discharge from the nose, and dried red facial materials were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2005)). (4) In a 4-hour inhalation exposure test (exposure of the nose) with rats, at 5.16 mg/L (exceeding Category 2), hunchback position, piloerection, an increase in respiration, and a slight decrease in body weight a day after the exposure were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] There was no report on repeated exposure to this substance in humans. Based on a test in the oral route with test animals, it was considered to be classified as "Not classified" in the oral route, however, classification was not possible since there was not sufficient or no information on toxicity in other routes. [Reference Data, etc.] (1) It was reported that in a 90-day test with rats dosed by feeding, at or above 500 ppm (39 mg/kg/day, within the range for Category 2), decreases in AST and ALP activities in males were observed; at or above 1,500 ppm (118 mg/kg/day, exceeding Category 2), hepatocellular hypertrophy in males and females, and an increase in serum gamma-GTP activities and an increase in liver weight in males were observed; and at 3,000 ppm (239 mg/kg/day, exceeding Category 2), an increase in serum gamma GT activities, an increase in liver weight, and also an extension of the activated partial thromboplastin time were observed in females. However, the hepatocellular hypertrophy and the increase in liver weight were considered to be adaptive responses to exposure to this substance (JMPR (2005)). (2) It was reported that in a 90-day test with rats dosed by feeding, at or above 1,500 ppm (males/females: 110/125 mg/kg/day, exceeding Category 2 in both cases), an increase in gamma-GTP, periportal hepatocellular hypertrophy, and periportal eosinophilic inclusions were observed in males (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)). (3) In a 4-day continuous oral toxicity test with rats using the racemic form (CAS RN 87674-68-8) of this substance, an increase in liver weight and a dose-related induction of liver drug metabolizing enzymes were confirmed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)).
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 = 0.029 mg/L for algae (Raphidocelis subcapitata) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 1 because it is not rapidly degradable (BIOWIN) and due to 72-hour NOErC = 0.0096 mg/L for algae (Raphidocelis subcapitata) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 because it is not rapidly degradable (BIOWIN) and due to 96-hour LC50 = 5.7 mg/L for fish (Oncorhynchus mykiss) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). By drawing a comparison between the above results, it was classified in Category 1.
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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