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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	330-55-2
Chemical Name	3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea; Linuron
Substance ID	R02-B-067-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	Revised
Classification result in other fiscal year	FY2006
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)	- -	-	-	Solid (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)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
7	Flammable solids	Classification not possible	- -	-	-	No data available. Besides, there is information that it is combustible (ICSC (1998)).
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 (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Classification is not possible because 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). It was classified as "Not classified."
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
14	Oxidizing solids	Classification not possible	- -	-	-	The substance is an organic compound containing chlorine and oxygen (but not fluorine), and the oxygen 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. It was classified as "Not classified."
16	Corrosive to metals	Classification not possible	- -	-	-	Classification is not possible because 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. 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) - (4). [Evidence Data] (1) LD50 for rats: 1,146 mg/kg (HSDB (Access on May 2020)) (2) LD50 for rats: 1,150 mg/kg (GESTIS (Access on May 2020)) (3) LD50 for rats: females: 1,196 mg/kg, males: 1,254 mg/kg (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 10 (Japan Crop Protection Association, 1992)) (4) LD50 for rats: 2,600 mg/kg (EPA Pesticides RED (1995))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (EPA Pesticides RED (1995), Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 10 (Japan Crop Protection Association, 1992)) (2) LD50 for rats: > 5,000 mg/kg (GESTIS (Access on May 2020))
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] From (1) - (3), it corresponded to Category 4 to "Not classified," but because the category cannot be determined from this information alone, it was classified as "Classification not possible." Besides, because exposure concentrations were higher than the saturated vapor pressure concentration (1.9E-005 mg/L), a reference value in the unit of mg/L was applied as dust. [Evidence Data] (1) LC50 for rats (4 hours): > 1.7 mg/L (EPA Pesticides RED (1995)) (2) LC50 for rats (4 hours): > 4.06 mg/L (HSDB (Access on May 2020)) (3) LC50 for rats (4 hours): 6.15 mg/L (GESTIS (Access on May 2020), Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 10 (Japan Crop Protection Association, 1992)) (4) Vapor pressure of this substance: 1.43E-006 mmHg (25 deg C) (HSDB (Access on May 2020)) (converted value for the saturated vapor pressure concentration: 1.9E-005 mg/L)
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) In a skin irritation test with rabbits on this substance (97.4%) according to EPA OPP 81-5, no irritation was observed (EPA Pesticides RED (1995)). (2) In a skin irritation test with rabbits using 7.5% and 75% suspensions of this substance in dimethylphthalate, no irritation was seen (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 10 (Japan Crop Protection Association, 1992)). [Reference Data, etc.] (3) This substance may irritate the skin and eye (HSDB (Access on May 2020)). (4) A 10% aqueous suspension of this substance caused mild to moderate irritation to the skin of guinea pigs (HSDB (Access on May 2020)). (5) In a skin irritation test with rabbits on 5% and 50% suspensions of a dry flowable formulation (50%) of this substance, no irritation was seen at 5%, and slight irritation was found at 50% (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 10 (Japan Crop Protection Association, 1992)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) In an eye irritation test with rabbits on this substance (97.4%) according to EPA OPP 81-4, slight conjunctival redness was seen at 24 hours but cleared at 72 hours (EPA Pesticides RED (1995)). [Reference Data, etc.] (2) This substance may irritate the skin and eye (HSDB (Access on May 2020)). (3) In an eye irritation test with rabbits on a dry flowable formulation (50%) of this substance, very slight irritation was observed (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 10 (Japan Crop Protection Association, 1992)).
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) In a skin sensitization test with guinea pigs on this substance (97.4%) according to EPA OPP 81-6, it was judged as negative (EPA Pesticides RED (1995)). (2) In a skin sensitization test by intradermal administration of this substance to guinea pigs, no sensitization was seen (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 10 (Japan Crop Protection Association, 1992)). [Reference Data, etc.] (3) In a skin sensitization test by intradermal administration of a dry flowable formulation (50%) of this substance to guinea pigs, no sensitization was observed (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 10 (Japan Crop Protection Association, 1992)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) As for in vivo, it was reported to be negative in a chromosomal aberration test with bone marrow cells after oral administration to rats (EPA Pesticides RED (1995), Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 10 (Japan Crop Protection Association, 1992)) and negative in a chromosomal aberration test with bone marrow cells after drinking water administration to mice (HSDB (Access on May 2020)). (2) As for in vitro, it was reported to be negative in a bacterial reverse mutation test (EPA Pesticides RED (1995), Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 10 (Japan Crop Protection Association, 1992)) and negative in a gene mutation test with cultured mammalian cells (EPA Pesticides RED (1995)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] It was classified in Category 2 from (1), (2). Besides, EPA's Category C was assessed as "Not classified" in the former GHS classification guidance for the Japanese government, but because EPA's Category C was assessed as Category 2 in the latest GHS classification guidance for the Japanese government, the classification result was changed. [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified in C (possible human carcinogen) by EPA (EPA Annual Cancer Report 2019 (Access on August 2020): classified in 2001) and Carc.2 in EU CLP classification (EU CLP classification (Access on May 2020)). (2) In carcinogenicity tests by 2-year diet administration of this substance to male and female rats and mice, a significant increase in testicular interstitial cell adenoma in rats and a significant increase in hepatocellular adenoma in female mice were observed (EPA Pesticides RED (1995)).
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) to (3), the degree of parental toxicity and reproductive toxicity was examined, and although no malformations were observed, serious embryonic or fetal toxicity and toxicity of pups were observed. Therefore, it was classified in Category 1B. A new information source was used and the classification results were changed from the previous classification. [Evidence Data] (1) In a three-generation reproductive toxicity study with rats dosed by feeding (25, 125, 625 ppm (equivalent to 1.25, 6.25, 31.25 mg/kg/day)), decreases in fertility rate and litter size, decreases in survival rate and body weight of pups, decreases in liver and kidney weight, and hepatocyte atrophy in F2b weanlings were observed at a dose (31.25 mg/kg/day) at which parental toxicity (a decrease in body weight, reduced body weight gain, alopecia) was observed (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" Vol. 10 (Japan Crop Protection Association, 1992), EPA Pesticides RED (1995)) (2) In a developmental toxicity study with female rats dosed by feeding (50, 125, 625 ppm (equivalent to 5.0, 12.1, 49.8 mg/kg/day)) on days 6 to 15 of gestation, an increase in post-implantation embryo resorption and increases in litter size and fetal incidences of resorptions were observed at a dose (49.8 mg/kg/day) at which maternal toxicity (a decrease in food consumption, reduced body weight gain) was observed (EPA Pesticides RED (1995)). (3) In a developmental toxicity study with female rabbits dosed by gavage (0, 5, 25, 100 mg/kg/day) on days 7 to 19 of gestation, developmental effects (an increase in the number of miscarriages (5/25 cases), a decrease in the mean number of fetuses per litter, a decrease in fetal body weight, and an increased incidence of fetuses with skeletal variations of the skull) were observed at a dose (100 mg/kg/day) at which maternal toxicity (a decrease in body weight, a decrease in food consumption, decreases in absolute and relative liver weight) was observed (EPA Pesticides RED (1995)). [Reference Data, etc.] (4) In a two-generation reproductive toxicity study with rats dosed by feeding, no reproductive effects were observed (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" Vol. 10 (Japan Crop Protection Association, 1992)). (5) In a developmental toxicity study with female rats dosed by feeding on days 6 to 15 of gestation, even at a dose at which maternal toxicity (a decrease in food consumption, reduced body weight gain) was observed, no teratogenicity was observed (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" Vol. 10 (Japan Crop Protection Association, 1992)). (6) In a developmental toxicity study with female rabbits dosed by gavage on days 7 to 19 of gestation, at a dose at which maternal toxicity (reduced body weight gain, a decrease in food consumption, miscarriage, an increase in liver weight) was observed, a tendency for low body weight and the skull fontanel having an irregular shape (variation) were observed in fetuses, but no teratogenicity was observed (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" Vol. 10 (Japan Crop Protection Association, 1992)). (7) In the EU CLP classification, it was classified as Repr.1B (Classification in EU CLP (Access on May 2020)).
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] Based on (1) and (2), it was classified in Category 3 (respiratory tract irritation). A new information source was used and the classification results were changed from the previous classification. [Evidence Data] (1) Dust of this substance may cause irritation of mucous membranes of the respiratory tract (GESTIS (Access on May 2020)). (2) This substance may irritate the eyes, nose, throat, and skin (HSDB (Access on May 2020)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (blood system)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1) to (5), it was classified in Category 2 (blood system). In (3), although signs of hematological toxicity were observed within the range for Category 1, based on other animal test results as well, it was judged that clear hematological toxicity would occur at doses within the range for Category 2. [Evidence Data] (1) In a 90-day administration study with rats dosed with this substance by feeding, a decrease in red blood cell count and an increase in white blood cell count were observed at or above 400 ppm (20 mg/kg/day, within the range for Category 2), and reduced body weight gain was observed at 3,000 ppm (150 m/kg/day, exceeding Category 2) (EPA Pesticides RED (1995)). (2) In a two-year administration study with rats dosed with this substance by feeding, at 625 ppm (15.63 mg/kg/day, within the range for Category 2), reduced body weight gain, a decrease in food consumption, and an increase in hemosiderin content of the spleen were observed in males and females, and a decrease in bone marrow fat and endometrial hypoplasia associated with hemolysis were observed in females (EPA Pesticides RED (1995)). (3) In a two-year administration study with rats dosed with this substance by feeding, at or above 125 ppm (6.25 mg/kg/day, within the range for Category 1), indications of blood cell destruction and turnover (an increase in mean corpuscular volume, a decrease in red blood cell count, and a trend toward an increase in reticulocytes) were observed; and in males, an increase in testicular interstitial cell adenomas was observed (EPA Pesticides RED (1995)). (4) In a two-year administration study with mice dosed with this substance by feeding, an increase in methemoglobin in males and females and an increase in hepatocellular adenomas in males were observed at 50 ppm (12 mg/kg/day, within the range for Category 2); and a decrease in body weight, hemosiderosis in the spleen, hepatocytomegaly, hepatocellular cytoplasmic alteration, vacuolization or necrosis, and hemorrhage in males and females were observed, and an increase in hepatocellular adenomas and an increase in liver weight in females were observed at 1,500 ppm (455 mg/kg/day, exceeding Category 2) (EPA Pesticides RED (1995)). (5) In a one-year administration study with dogs dosed with this substance by feeding, hemosiderin deposition on liver Kupffer cells, slight decreases in erythrocyte count and hemoglobin and hematocrit levels, a small increase in erythropoiesis in the bone marrow, etc. were observed in males and females at 625 ppm (males/females: 18.6/16.1 mg/kg/day, within the range for Category 2) (EPA Pesticides RED (1995)).
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 = 0.035 mg/L for algae (Raphidocelis subcapitata) (Document for registration standards for agricultural chemicals set by the Minister of Environment to prevent harm to animals and plants in areas of public waters, 2017).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	It was classified in Category 1 because it was not rapidly degradable (a 4-week degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1982)) and due to 80-day NOEC < 0.042 mg/L for fish (Oncorhynchus mykiss) (EPA RED, 2002).
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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