NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	87674-68-8
Chemical Name	2-Chloro-N-(2,4-dimethyl-3-thienyl)-N-(2-methoxy-1-methylethyl)acetamide; Acetamide
Substance ID	R02-A-074-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)	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Classification not possible	- -	-	-	No data available.
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
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	Classification not possible	- -	-	-	No data available.
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	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).
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.
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
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	- -	-	-	No data 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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] Because this substance is liquid, knowledge without a medium was adopted from (1) - (10), and it was classified in Category 4. [Evidence Data] (1) LD50 for rats (males): 371 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), CLH Report (2012), JMPR (2005)) (2) LD50 for rats (females): 427 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), CLH Report (2012), JMPR (2005)) (3) LD50 for rats (males): 451 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)) (4) LD50 for rats (females): 501 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)) (5) LD50 for rats (females): 500 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)) (6) LD50 for rats (males): 2,360 mg/kg (medium: PEG200) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)) (7) LD50 for rats (females): 2,100 mg/kg (medium: PEG200) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)) (8) LD50 for rats (males): 2,140 mg/kg (medium: corn oil) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)) (9) LD50 for rats (females): 1,300 mg/kg (medium: corn oil) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)) (10) LD50 for rats: 1,250 mg/kg (medium: corn oil) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from 4 test results in (1) - (4). [Evidence Data] (1) LD50 for rats: > 2,380 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)) (2) LD50 for rats (females): > 2,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)) (3) LD50 for rabbits: > 2,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)) (4) LD50 for rabbits: > 2,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017))
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 (4 hours, mist): > 6.6 mg/L (GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)) (2) LC50 for rats (4 hours, mist): > 4.99 mg/L (GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), EFSA (2005), JMPR (2005), 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) - (4). [Evidence Data] (1) It is reported that in a survey of health conditions in 3 groups of workers who engaged in manufacturing this substance, there were no cases of skin irritation from occupational exposure (JMPR (2005)). (2) It is reported that in a skin irritation test with rabbits (n = 6) (GLP, 4-hour application, 72-hour observation), erythema and edema were observed at 1 hour after the removal of patches but completely disappeared within 24 hours (erythema/eschar score: 0/0/0/0/0/0, edema score: 0/0/0/0/0/0) (JMPR (2005), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). (3) It is reported that in a skin irritation test with rabbits (n = 6) (GLP, 4-hour application, 72-hour observation), irritation reactions seen all disappeared within 72 hours, and the primary irritation index (PII) was 0.4 (erythema/eschar score: 0/0.3/0.7/0/0/0.7, edema score: 0/0/0/0/0/0) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). (4) It is reported that in a skin irritation test with rabbits (n = 6) (GLP, 4-hour application, 7-day observation), irritation reactions found all disappeared within 7 days, and the primary irritation index (PII) was 0.5 (erythema/eschar score: 0/1/0/1/1/0, edema score: 0/0/0/0.7/0/0) (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) It is reported that in an eye irritation test with rabbits (n = 6) (GLP, 72-hour observation), all the animals showed irritation reactions in the conjunctiva but fully recovered within 72 hours (corneal opacity score: 0/0/0/0/0/0, iritis score: 0/0/0/0/0/0, conjunctival redness score: 1.3/1/0.3/0.7/0.7/0.3, chemosis score: 0.3/0.7/0/0.7/0.3/0) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). (2) It is reported that in an eye irritation test with rabbits (n = 6) (GLP, 7-day observation), all the animals showed conjunctival redness after 1 hour, but effects were completely reversible within 7 days (corneal opacity score: 0/0/0/0/0/0, iritis score: 0/0/0/0/0/0, conjunctival redness score: 0.7/1/0.7/0.3/0.3/0.3, chemosis score: 0/0/0/0/0/0) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). (3) It is reported that in an eye irritation test with rabbits (n = 6) (GLP, 7-day observation), all the animals showed conjunctival redness, but effects were completely reversible within 7 days (corneal opacity score: 0/0/0/0/0/0, iritis score: 0/0/0/0/0/0, conjunctival redness score: 0.7/0.3/0.3/0.7/0.3/0.3, chemosis score: 0/0/0/0/0/0) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)).
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) It is reported that in a maximization test with guinea pigs (n = 19) (GLP, intradermal administration: 5% solution), a positive rate was 100% (19/19), 79% (15/19) at 24, 48 hours after the removal of applications (ECHA RAC Opinion (2013), CLH Report (2012), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). (2) It is reported that in a maximization test with guinea pigs (n = 19) (intradermal administration: 5% solution), a positive rate was 47% (9/19), 79% (15/19) at 24, 48 hours after the removal of patches (JMPR (2005)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (6), it was classified as "Not classified." [Evidence Data] (1) In a dominant lethal test with rats (GLP, single oral dose by gavage), 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)). (2) In two micronucleus tests with the bone marrow cells of mice (GLP, single oral dose by gavage and 2-day oral doses by gavage), 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), CLH Report (2012)). (3) In a UDS test using the rat hepatocytes (GLP, single oral dose by gavage), 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), CLH Report (2012)). (4) In a bacterial reverse mutation test (GLP), 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), CLH Report (2012)). (5) In an in vitro mammalian cell gene mutation test (GLP), 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), CLH Report (2012)). (6) In an in vitro mammalian cell (CHO) chromosome aberration test (GLP), 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), CLH Report (2012)).
6	Carcinogenicity	Not classified	- -	-	-	Based on the classification results by other organizations in (1), it corresponded to Category 2, but considering the conclusions in (2) to (4), which were newer assessments, it was classified as "Not classified." [Evidence Data] (1) As for the carcinogenicity classification results by domestic and international organizations, it was classified in Group C (Possible Human Carcinogen) by EPA (EPA Annual Cancer Report (2018): Classification in 2014). (2) In a two-year combined chronic toxicity/carcinogenicity study with rats (GLP, dosed by feeding), as neoplastic lesions, a trend toward increases in the incidence of hepatocellular adenoma and the combined incidence of hepatocellular adenoma and carcinoma in males, and an increase in the incidence of ovarian tubular adenoma in females were observed. However, since there was no significant difference in liver tumors in the Fischer exact test, and there was no significant difference in ovarian tubular adenoma in the trend test based on the histopathological reassessment results, it was considered that those neoplastic lesions were not the effects of the treatment, and it was concluded that there was no carcinogenicity (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2005)). (3) In a 94-week carcinogenicity study with mice (GLP, dosed by feeding), there was no treatment-related increase in neoplastic lesions, and carcinogenicity was not observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2005)). (4) CLH Report stated that there was no statistically significant difference in liver tumors in rats, and also in comparison with the background data (spontaneous incidence), and as for the increase in hepatocellular adenoma, the report pointed out a possibility that many more old age animals were included at necropsy based on the fact that the high-dose group had a higher survival rate than the control group. As a conclusion, it was described that classification and labelling were not required because evidence of carcinogenicity could not be established in either rats or mice (CLH Report (2012)). [Reference Data, etc.] (5) EPA classified the substance in Group C because the main target organ of this substance in the test animals was the liver, and an increase in the liver tumors of rats was weak evidence for the carcinogenicity of this substance. In the results of the quantitative assessment of carcinogenicity, which was calculated assuming that there was a threshold for carcinogenicity of rats, it was concluded that the chronic RfD would be protective of any carcinogenicity effects (US Federal Register vol. 80, No. 34 (2015)).
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) It was reported that in a two-generation reproduction toxicity study with rats dosed by feeding (GLP), at 2,000 ppm, general toxicity effects (increases in absolute and relative liver weight, reductions in body weight gain and food consumption) in parent animals, and a reduction in body weight gain in F1 and F2 offspring were observed, but no effect on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015), JMPR (2005), CLH Report (2012)). (2) In a developmental toxicity study with rats dosed by gavage (GLP, days 6-15 of gestation), a slight increase in early resorption embryo was observed in offspring at a dose at which general toxicity effects (salivation, stained abdominal fur, a reduction in body weight gain, increases in absolute and relative liver weight) were observed in parent animals. It was reported that no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015), JMPR (2005), CLH Report (2012)). (3) It was reported that in a developmental toxicity study with rabbits dosed by gavage (GLP, day 6 to 18 of gestation), no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015), JMPR (2005), CLH Report (2012)).
8	Specific target organ toxicity - Single exposure	Category 2 (nervous system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	[Rationale for the Classification] Based on (1) and (2), the target organ was considered to be the nervous system, and effects were observed within the dosage range for Category 2, therefore, it was classified in Category 2 (nervous system). [Evidence Data] (1) It was reported that in an acute oral toxicity test with rats (GLP), at or above 300 mg/kg (within the range for Category 1), nasal discharge (male), fecal staining (male), soft stools and decreased activity (male), and wet rales and abdominal convulsions (female) were observed; at 600 mg/kg (within the range for Category 2), hypopnea, irregular gait (female), tremor (female), irregular respiration (female), and urinary staining and prostration (female) were observed; and there were deaths in males at 300 mg/kg and in females at 600 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), CLH Report (2012), JMPR (2005)). (2) It was reported that in an acute oral toxicity test with rats (female), at or above 470 mg/kg (within the range for Category 2), inanimation, indifference, piloerection, salivation, and bradypnea were observed; and at 770 mg/kg (within the range for Category 2), tremor, lacrimation, and diarrhea were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). [Reference Data, etc.] (3) It was reported that in another acute oral toxicity test with rats (GLP), at or above 310 mg/kg (within the range for Category 2), discharge from the mouth, unkempt fur, reduced locomotor activity , and a reduction in food consumption were observed; at 620 mg/kg (within the range for Category 2), hypopnea, discharges from the nose/eye, irregular breathing, urinary staining, abdominal tightening, and eyelid closure were observed; and there were deaths in males at 310 mg/kg and in females at 620 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). (4) It was reported that in an acute inhalation (mist) toxicity test with rats, at 6.6 mg/L (in the range corresponding to "Not classified"), dyspnea, and unkempt fur were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1) to (4), the target organ was considered to be the liver, and effects were observed within the dosage range for Category 2, therefore, it was classified in Category 2 (liver). [Evidence Data] (1) It was reported that in a repeated dose 90-day oral toxicity study with rats dosed by feeding (GLP), at 1,500 ppm (98.0 mg/kg/day (male), 119 mg/kg/day (female), within the range for Category 2 or the range corresponding to "Not classified"), effects on the liver (an increase in corrected liver weight, centrilobular hypertrophy of the hepatocytes (female)) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), CLH Report (2012), JMPR (2005), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). (2) It was reported that in a repeated dose 90-day oral toxicity study with dogs dosed by feeding (GLP), at or above 750 ppm (33.6 mg/kg/day (male), 39.7 mg/kg/day (female), within the range for Category 2), an increase in relative liver weight, perilobular vacuolization of the hepatocytes, and dilatation of liver sinusoids (female) were observed; and at 2,000 ppm (89.6 mg/kg/day (male), 87.4 mg/kg/day (female), within the range for Category 2), an increase in absolute liver weight, dilatation of liver sinusoids (male), an increase in T.Chol, and an increase in ALP (female) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), CLH Report (2012), JMPR (2005), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). (3) It was reported that in a 1-year chronic toxicity study with dogs dosed by feeding (GLP), at 1,250 ppm (48.7 mg/kg/day (male), 49.3 mg/kg/day (female), within the range for Category 2), effects on the liver (an increase in corrected liver weight, enlargements of mid-zonal hepatocytes, perilobular vacuolization of the hepatocytes, an increase in ALP) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). (4) It was reported that in a 2-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding (GLP), at or above 700 ppm (36.0 mg/kg/day (male), 49.0 mg/kg/day (female), within the range for Category 2), bile duct hyperplasia (female) was observed; and at 1,500 ppm (80.0 mg/kg/day (male), 109 mg/kg/day (female), within the range for Category 2 or the range corresponding to "Not classified"), an increase in GGT, acidophilic altered hepatocellular foci (male), an increase in T.Chol, and an increase in corrected liver weight (female) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), CLH Report (2012), JMPR (2005), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)).
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.

To GHS Information