GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 330-54-1
Chemical Name 3-(3,4-Dichlorophenyl)-1,1-dimethylurea; Diuron
Substance ID R02-B-066-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 Not classified
-
-
- - It was classified as "Not classified" from information that it is not combustible (HSDB (Access on May 2020)).
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 Not classified
-
-
- - It was classified as "Not classified" from information that it is not combustible (HSDB (Access on May 2020)).
11 Self-heating substances and mixtures Not classified
-
-
- - It was classified as "Not classified" from information that it is not combustible (HSDB (Access on May 2020)).
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 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."
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) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1) - (5).

[Evidence Data]
(1) LD50 for rats: males: 3,400 mg/kg (ACGIH (7th, 2001), HSDB (Access on May 2020))
(2) LD50 for rats: females: 4,150 mg/kg (REACH registration dossier (Access on September 2020))
(3) LD50 for rats: males: 4,721 mg/kg, females: > 5,000 mg/kg (EPA Pesticides RED (2003))
(4) LD50 for rats: 4,780 mg/kg (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 9 (Japan Crop Protection Association, 1991))
(5) LD50 for rats: males: 4,990 mg/kg, females: 5,060 mg/kg (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 8 (Japan Crop Protection Association, 1991))

[Reference Data, etc.]
(6) LD50 for rats: 1,017 mg/kg (HSDB (Access on May 2020))
(7) LD50 for rats: 1,020 mg/kg (GESTIS (Access on May 2020))
1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1) - (3).

[Evidence Data]
(1) LD50 for rats: > 2,000 mg/kg (EPA Pesticides RED (2003), Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 8 (Japan Crop Protection Association, 1991))
(2) LD50 for rats: > 5,000 mg/kg (GESTIS (Access on May 2020))
(3) LD50 for rats: > 7,000 mg/kg (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 9 (Japan Crop Protection Association, 1991))
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) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2).
Besides, because exposure concentrations were higher than the saturated vapor pressure concentration (1.0E-007 mg/L), a reference value in the unit of mg/L was applied as dust.

[Evidence Data]
(1) LC50 for rats (4 hours): > 5.05 mg/L (REACH registration dossier (Access on September 2020))
(2) LC50 for rats (4 hours): > 7.1 mg/L (EPA Pesticides RED (2003))
(3) Vapor pressure of this substance: 8.25E-009 mmHg (25 deg C) (HSDB (Access on May 2020)) (converted value for the saturated vapor pressure concentration: 1.0E-007 mg/L)
2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1) - (3). The classification result was changed due to new data (1) - (3) obtained.

[Evidence Data]
(1) In a skin irritation test with rabbits according to EPA OPPTS 870.2500, all irritation reactions cleared by 72 hours (EPA Pesticides RED (2003)).
(2) In an irritation test on the forearms of human volunteers, no irritation was seen (GESTIS (Access on May 2020)).
(3) In a skin irritation test with rabbits according to OECD TG 404, the mean score at 24/48/72 hours after application was all 0 (REACH registration dossier (Access on September 2020)).

[Reference Data, etc.]
(4) This substance may irritate the skin and eye in humans (ACGIH (7th, 2001), HSDB (Access on May 2020)).
(5) In a skin irritation test with rabbits by 24-hour application, it was irritating (GESTIS (Access on May 2020)).
(6) In a skin irritation test in which 50% paste (0.05 g) of this substance was applied to the guinea pig skin, it was slightly irritating (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 8 (Japan Crop Protection Association, 1991)).
3 Serious eye damage/eye irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2). The classification result was changed due to new data (1), (2) obtained.

[Evidence Data]
(1) In an eye irritation test with rabbits according to EPA OPPTS 870.2400, all irritation reactions cleared by 48 hours (EPA Pesticides RED (2003)).
(2) In an eye irritation test with rabbits according to OECD TG 405, the mean score at 24/48/72 hours after application was all 0 (REACH registration dossier (Access on September 2020)).

[Reference Data, etc.]
(3) This substance may irritate the skin and eye in humans (ACGIH (7th, 2001), HSDB (Access on May 2020)).
(4) In an eye irritation test with rabbits, it was irritating (GESTIS (Access on May 2020)).
(5) The wettable powder of this substance may irritate the eyes (HSDB (Access on May 2020)).
(6) The 80% wettable powder of this substance was slightly irritating in an eye irritation test with rabbits (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 8 (Japan Crop Protection Association, 1991)).
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) - (4).

[Evidence Data]
(1) This substance was reported to be negative in a skin sensitization test in guinea pigs (ACGIH (7th, 2001)).
(2) It was reported to be negative in a skin sensitization test in guinea pigs according to EPA OPPTS 870.2600 (EPA Pesticides RED (2003)).
(3) It was reported to be negative in a skin sensitization test in guinea pigs (maximization test) (GESTIS (Access on May 2020), REACH registration dossier (Access on September 2020)).
(4) In a skin sensitization test in guinea pigs in which 50% paste (0.05 g) of this substance was applied nine times, it was reported to be negative (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 8 (Japan Crop Protection Association, 1991)).
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 (HSDB (Access on May 2020), EPA Pesticides RED (2003)).
(2) As for in vitro, it was reported to be negative in a bacterial reverse mutation test (HSDB (Access on May 2020), Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 9 (Japan Crop Protection Association, 1991)), negative in a chromosomal aberration test with cultured mammalian cells (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 9 (Japan Crop Protection Association, 1991)), and negative in a gene mutation test (HSDB (Access on May 2020)).
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
There were reports that tumor formation was not seen in mice and rats, but based on results in experimental animals in (2) and (3) and classification results by EPA and EU CLP, it was classified in Category 2. By the study using new information sources, the classification result was changed.

[Evidence Data]
(1) As for classification results by domestic and international organizations, it was classified in A4 by ACGIH (ACGIH (7th, 2001)), K/L (known/likely to be carcinogenic to humans) by EPA (EPA Annual Cancer Report 2019 (Access on July 2020): classified in 1997), and Carc.2 in EU CLP classification (EU CLP classification (Access on May 2020)).
(2) As a result of carcinogenicity tests in rats and mice, based on increases in urinary bladder carcinoma in male and female rats, kidney carcinoma (rare tumor) in male rats, and mammary gland carcinoma in female mice, EPA classified this substance as known/likely to be carcinogenic to humans (EPA Pesticides RED (2003)).
(3) In a carcinogenicity test by 2-year diet administration of this substance to male and female rats, transitional epithelial carcinoma in the urinary bladder in males and females, papilloma in the urinary bladder, transitional epithelial papilloma and transitional epithelial carcinoma in the renal pelvis in males were observed (REACH registration dossier (Access on August 2020)).

[Reference Data, etc.]
(4) In a combined chronic toxicity/carcinogenicity test by 2-year diet administration of this substance to male and female mice, no increases in incidences of neoplastic lesions were found (REACH registration dossier (Access on August 2020)).
(5) In tests by 2-year diet administration of this substance to male and female rats and mice, no treatment-related tumor formation was observed (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 9 (Japan Crop Protection Association, 1991)).
7 Reproductive toxicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (4), it was classified as "Not classified."

[Evidence Data]
(1) In a three-generation reproductive toxicity study with rats by feeding, no effect was observed (Agricultural Chemicals Times supplement, "Agricultural chemicals technology information" No. 8 (Japan Crop Protection Association, 1991)).
(2) In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by gavage, no reproductive effects were observed even at a dose at which parental toxicity (a decrease in body weight, anemia, an increase in hemosiderosis, an increase in extramedullary hematopoiesis in the spleen, hemosiderosis in Kupffer cells in the liver, etc.) was observed (Safety Test (Ministry of Economy, Trade and Industry (METI), 2009))
(3) In a developmental toxicity study with female rats dosed by gavage on days 6 to 14 of gestation, a decrease in fetal body weight and delayed ossification (vertebra, sternum) were observed in fetuses at a dose at which maternal toxicity (a decrease in food consumption, a decrease in body weight, etc.) was observed (Agricultural Chemicals Times supplement, "Agricultural chemicals technology information" No. 8 (Japan Crop Protection Association, 1991)).
(4) In a developmental toxicity study with female rabbits dosed by gavage on days 7 to 19 of gestation, miscarriage (1 case) was observed but no effect was observed in fetuses at a dose at which maternal toxicity (reduced body weight gain, a decrease in body weight, a decrease in food consumption) was observed (Agricultural Chemicals Times supplement, "Agricultural chemicals technology information" No. 8 (Japan Crop Protection Association, 1991)).
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), it was classified in Category 3 (respiratory tract irritation).

[Evidence Data]
(1) This substance may irritate the skin, eyes, and throat (HSDB (Access on May 2020)).

[Reference Data, etc.]
(2) This substance may irritate the eyes (ACGIH (7th, 2001)).
9 Specific target organ toxicity - Repeated exposure Category 1 (blood system), Category 2 (urinary organs)


Danger
Warning
H372
H373
P260
P264
P270
P314
P501
[Rationale for the Classification]
Based on (1) to (5), it was classified in Category 1 (blood system) and Category 2 (urinary organs). Information from new sources was added to the examination and the classification result was changed from the previous classification.

[Evidence Data]
(1) In a 13-week administration study with rats dosed with this substance by feeding, hematological toxicity (a decrease in red blood cell count, an increase in MCV, an increase in spleen weight, an increase in bone marrow hematopoiesis, and extramedullary hematopoiesis, pigmentation, or congestion in the spleen) was observed in females at 100 ppm (males/females: 6.7/8.7 mg/kg/day, within the range for Category 1); and hyperplasia of the kidney and urinary bladder mucosa in males and females, and a decrease in red blood cell count, etc. in males were observed at 250 ppm (males/females: 17/22 mg/kg/day, within the range for Category 2) (HSDB (Access on May 2020), REACH registration dossier (Access on September 2020)).
(2) In a 13-week oral administration study with rats dosed with this substance, macrocytic anemia (decreases in red blood cell count, hemoglobin concentration, and hematocrit, increases in mean copuscular volume and mean copuscular hemoglobin value) in males and females and splenomegaly in males were observed at or above 75 mg/kg/day (converted guidance value: 54 mg/kg/day, within the range for Category 2); increases in serum total bilirubin and urea concentration were observed in females at or above 250 mg/kg/day (converted guidance value: 181 mg/kg/day, exceeding Category 2); and an increase in relative liver weight in males and females, weight reduction and increases in serum total bilirubin and urea concentration in males, and an increase in AST activity and splenomegaly in females were observed at 500 mg/kg/day (converted guidance value: 361 mg/kg/day, exceeding Category 2) (HSDB (Access on May 2020)).
(3) In a one-year administration study with dogs dosed with this substance by feeding, iron-containing pigment deposits in the red pulp of the spleen were observed in males and females at or above 300 ppm (11 mg/kg/day, within the range for Category 2), and decreases in hemoglobin and red blood cell count, etc., an increase in bilirubin value, pigmentation in the proximal renal tubules and kidney, a decrease in bone marrow fat, etc. in males and females, a increase in testicular weight in males, and pigmentation in the liver Kupffer cells in females were observed at 1,800 ppm (66 mg/kg/day, within the range for Category 2) (REACH registration dossier (Access on September 2020)).
(4) It was reported that in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats orally dosed with this substance, at 20 mg/kg/day (converted guidance value: 9.3 mg/kg/day, within the range for Category 1), hemosiderosis in the spleen was observed in males and females, and in the hematological examination, anemia and an increase in splenic extramedullary hematopoiesis were observed in females; and at 100 mg/kg (47 mg/kg/day, within the range for Category 2), in the hematological examination, anemia and an increase in splenic extramedullary hematopoiesis were observed in males (Safety Test (Ministry of Economy, Trade and Industry (METI), 2009)).
(5) In an inhalation exposure test with rats exposed to aerosol of this substance for 28 days (6 hours/day, 5 days/week), at or above 37.4 mg/m3 (converted guidance value: 0.012 mg/L, within the range for Category 1), increases in liver and spleen weight and an increased incidence of dark and swollen spleen in males and females, and increases in Heinz bodies and reticulocytes, and decreases in erythrocytes and hemoglobin in females were observed; and at 268.1 mg/m3 (converted guidance value: 0.083 mg/L, within the range for Category 2), a slight reduction of thyroid function, a decrease in albumin level, etc. in males and females, and increases in Heinz bodies and reticulocytes, and decreases in erythrocytes and hemoglobin in males were observed (REACH registration dossier (Access on September 2020)).
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 = 0.025 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, 2013).
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 was not rapidly degradable (a 28-day degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1988)) and due to 35-day NOEC = 0.001 mg/L for fish (Danio rerio) (REACH registration dossier, 2020).
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 was not rapidly degradable (a 28-day degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1988)) and due to 48-hour EC50 = 1.4 mg/L for crustacea (Daphnia magna) (EU REACH CoRAP, 2016).
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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