NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	87392-12-9
Chemical Name	2-Chloro-N-(2-ethyl-6-methylphenyl)-N-[(S)-1-methoxypropan-2-yl]acetamide (synonym: S-Metolachlor)
Substance ID	R03-A-026-METI
Classification year (FY)	FY2021
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	- -	-	-	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).
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)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified" (Category 5 in UN GHS classification). [Evidence Data] (1) LD50 (S-metolachlor (containing an S isomer at 80% or higher)) for rats (males): 3,270 mg/kg (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2009)) (2) LD50 (S-metolachlor (containing an S isomer at 80% or higher)) for rats (females): 2,580 mg/kg (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2009)) (3) In this hazard class for Metolachlor (racemate, CAS RN 51218-45-2) containing this substance (S isomer), it was classified as "Not classified" (GHS Classification Results in FY2020).
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) LD50 (S-metolachlor (containing an S isomer at 80% or higher)) for rabbits: > 2,000 mg/kg (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2009)) (2) In this hazard class for Metolachlor (racemate, CAS RN 51218-45-2) containing this substance (S isomer), it was classified as "Not classified" (GHS Classification Results in FY2020).
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. [Reference Data, etc.] (1) In this hazard class for Metolachlor (racemate, CAS RN 51218-45-2) containing this substance (S isomer), it was classified as "Classification not possible" (GHS Classification Results in FY2020).
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) LC50 (S-metolachlor (containing an S isomer at 80% or higher), 4 hours) for rats: > 2.91 mg/L (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2009)) (2) In this hazard class for Metolachlor (racemate, CAS RN 51218-45-2) containing this substance (S isomer), it was judged as classification not possible (GHS Classification Results in FY2020).
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) It was reported that, as for S-metolachlor (containing an S isomer at 80% or higher), in a skin irritation test with rabbits (NZW), slight irritation was observed (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2009)). (2) In this hazard class for Metolachlor (racemate, CAS RN 51218-45-2) containing this substance (S isomer), it was classified as "Not classified" (GHS Classification Results in FY2020).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) It was reported that, as for S-metolachlor (containing an S isomer at 80% or higher), in an eye irritation test with rabbits (NZW), slight irritation was observed (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2009)). (2) In this hazard class for Metolachlor (racemate, CAS RN 51218-45-2) containing this substance (S isomer), it was classified as "Not classified" (GHS Classification Results in FY2020).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) In this hazard class for Metolachlor (racemate, CAS RN 51218-45-2) containing this substance (S isomer), it was judged as classification not possible (GHS Classification Results in FY2020).
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1. [Evidence Data] (1) It was reported that, as for S-metolachlor (containing an S isomer at 80% or higher), in a skin sensitization test by the maximization method with guinea pigs, results were positive (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2009)). (2) In this hazard class for Metolachlor (racemate, CAS RN 51218-45-2) containing this substance (S isomer), it was classified in Category 1 (GHS Classification Results in FY2020).
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 S-metolachlor (containing an S isomer at 80% or higher), results were negative in an in vivo micronucleus test, and there were no data in an in vitro test, but for metolachlor of a racemate, results were negative in an in vivo micronucleus test, and results were negative in a reverse mutation test and an in vitro UDS assay, and therefore, the Food Safety Commission of Japan considered that S-metolachlor had no significant genotoxicity to living organisms (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2009)). (2) In this hazard class for Metolachlor (racemate, CAS RN 51218-45-2) containing this substance (S isomer), it was classified as "Not classified" (GHS Classification Results in FY2020).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) As for the classification results by domestic and international organizations, there were no classification results for this substance, but as for the racemate and S-metolachlor (containing an S isomer at 80% or higher), the EPA classified these substances in NL (Not Likely to be Carcinogenic to Humans) (EPA Annual Cancer Report 2018 (Accessed Oct. 2020): classification in 2017). (2) For the S isomer, a carcinogenicity study was not conducted, but based on the comparison between the test results on the racemate and those on the S-metolachlor, it was considered that both had similar dynamics and metabolism, and their toxicological profile and the degree of toxicity were almost the same (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2009)). (3) The EPA initially classified this substance in Group C (possible human carcinogen) based on the increased incidence of liver tumors observed in female rats, but in the re-assessment in 2017, the EPA substantially adopted the findings by the mode of action analysis, clarified that the liver tumors caused in rats were due to cell proliferation by the activation of CAR (constitutive androstane receptor), and concluded that the findings were an extension of hepatocyte toxicity. Therefore, since hepatocellular proliferation did not occur in the regulation range of the chronic RfD (reference dose), the carcinogenicity classification of metolachlor (racemate)/S-metolachlor was changed to NL (US Federal Register Vol. 83, No. 55 (2018)). (4) In this hazard class for Metolachlor (racemate, CAS RN 51218-45-2) containing this substance (S isomer), it was classified as "Classification not possible" (GHS Classification Results in FY2020).
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified." [Evidence Data] (1) Based on the comparison between the test results on the racemate and those on the S-metolachlor (containing an S isomer at 80% or higher), it was considered that both had similar dynamics and metabolism, and their toxicological profile and the degree of toxicity were almost the same (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2009)). (2) In a developmental toxicity study with rats dosed by gavage (days 6-15 of gestation) using S-metolachlor (containing an S isomer at 80% or higher) as the test substance, no developmental effects were observed in fetuses even at a dose at which maternal toxicity (reduced body weight gain, a decrease in food consumption, discomfort) were observed (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2009)). (3) In a developmental toxicity study with rabbits dosed by gavage (days 7-19 of gestation) using S-metolachlor (containing an S isomer at 80% or higher) as the test substance, in a group at a high dose at which maternal toxicity (reduced body weight, a decrease in food consumption) was significant, malformations were observed in fetuses from 1 litter, but were considered to be spontaneous or secondary effects of maternal toxicity. Decreased feces, no-excretion, or loose stool were observed in dams even at a middle dose, but no effects were observed in fetuses (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2009)). (4) In this hazard class for Metolachlor (racemate, CAS RN 51218-45-2) containing this substance (S isomer), it was classified as "Not classified" (GHS Classification Results in FY2020).
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1 (central nervous system). [Evidence Data] (1) As for S-metolachlor (containing an S isomer at 80% or higher), in an acute oral toxicity test with rats and mice, effects on the central nervous system (decreases in exploratory behavior/locomotor activity/pain response/somersault reflex, mydriasis, tonic convulsions, etc.) were observed at doses for Category 1 (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2009)). (2) In this hazard class for Metolachlor (racemate, CAS RN 51218-45-2) containing this substance (S isomer), it was classified in Category 1 (central nervous system) (GHS Classification Results in FY2020).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) In a 28-day feeding administration test using S-metolachlor (containing an S isomer at 80% or higher) as the test substance, effects on the liver (increased relative weight, centrilobular hepatocyte hypertrophy, increased GGT (males only), etc.) were observed similarly as metolachlor (racemate, CAS RN 51218-45-2) at or above 3,000 ppm (within the range for Category 2) (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2009)). (2) In a 90-day oral toxicity test with rats and dogs dosed by feeding using S-metolachlor (containing an S isomer at 80% or higher) as the test substance, no clear organ toxicity was observed within the dose range for Category 1 and Category 2 (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2009)). (3) In this hazard class for Metolachlor (racemate, CAS RN 51218-45-2) containing this substance (S isomer), it was classified as "Classification not possible" (GHS Classification Results in FY2020).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) In this hazard class for Metolachlor (racemate, CAS RN: 51218-45-2) containing this substance (S-isomer), it was classified as "Classification not possible" (GHS Classification Results in FY2020).

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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