GHS Classification Results by the Japanese Government

日本語で表示



GENERAL INFORMATION
Item Information
CAS RN 97886-45-8
Chemical Name 3,5-Pyridinedicarbothioic acid, 2-(difluoromethyl)-4-(2-methylpropyl)-6-(trifluoromethyl)-, 3,5-dimethyl ester; Dithiopyr
Substance ID R02-A-054-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)
-
-
- - Solid (GHS definition)
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products.
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Solid (GHS definition)
5 Gases under pressure Not classified (Not applicable)
-
-
- - Solid (GHS definition)
6 Flammable liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition)
7 Flammable solids Classification not possible
-
-
- - No data available.
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 Not classified (Not applicable)
-
-
- - Solid (GHS definition)
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).
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition)
14 Oxidizing solids Not classified (Not applicable)
-
-
- - The substance is an organic compound containing fluorine and oxygen (but not chlorine) which are chemically bonded only to carbon or hydrogen.
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
-
-
- - 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.

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).

[Evidence Data]
(1) LD50 for rats: > 5,000 mg/kg (GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008))
1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) LD50 for rats: > 5,000 mg/kg (GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008))
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).

[Evidence Data]
(1) LC50 for rats (4 hours): > 5.98 mg/L (GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007))
2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) It is reported that in a skin irritation test with rabbits (n = 6) (GLP, semi-occlusive, 4-hour application, 72-hour observation), weak erythema was observed in 1 animal by 48 hours but disappeared after 72 hours, and primary irritation index (PII) was calculated as 0.2 (maximum: 8) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
3 Serious eye damage/eye irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) It is reported that in an eye irritation test with rabbits (n = 6) (GLP, 72-hour observation), irritation changes in the conjunctiva were observed at 1-24 hours after administration (the highest point 2) but disappeared after 48 hours (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
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).

[Evidence Data]
(1) It is reported that in a Buehler test with guinea pigs (n = 10) (GLP, topical administration: undiluted substance), very slight skin irritation reactions were observed during the induction period, but no skin reactions were seen at observation after a challenge (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (5), it was classified as "Not classified."

[Evidence Data]
(1) In a micronucleus test with mouse bone marrow cells (oral administrations), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
(2) In bacterial reverse mutation tests (GLP), three negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Japan Crop Protection Association (1993)).
(3) In a mammalian cell (cells derived from Chinese hamster lung (CHL)) chromosome aberration test, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Japan Crop Protection Association (1993)).
(4) In a cell gene mutation test using Chinese hamster ovary (CHO) cells, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
(5) In an unscheduled DNA synthesis tests using rat primary cultured hepatocytes, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Japan Crop Protection Association (1993)).
6 Carcinogenicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (3), it was classified as "Not classified."

[Evidence Data]
(1) As for the classification results by domestic and international organizations, EPA classified this substance in E (EPA Annual Cancer Report 2018 (Accessed Sep. 2020): Classification in 1997).
(2) In a two-year chronic toxicity/carcinogenicity study with rats dosed by feeding, no treatment-related increase in the incidence of neoplastic lesions was observed and no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Japan Crop Protection Association (1993)).
(3) In an 18-month carcinogenicity study with mice dosed by feeding, no treatment-related increase in the incidence of neoplastic lesions was observed and no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Japan Crop Protection Association (1993)).
7 Reproductive toxicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (5), it was classified as "Not classified."

[Evidence Data]
(1) In a two-generation reproduction toxicity study (GLP) with rats dosed by feeding, at the doses where reduced body weight gain and effects on the liver, kidney and thyroid gland etc. were observed in parental animals, alterations in liver tissues were observed in pups, but no effect on fertility was observed. The incidence of liver white spots, which were observed in pups in the lower dose groups, decreased along with the growth, and liver white spots were not observed in parental animals. Therefore, it has been pointed out that they are considered to be reversible lesions (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Japan Crop Protection Association (1993)).
(2) It was reported that in a two-generation reproduction toxicity study (GLP) with rats dosed by feeding, no effect on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
(3) It was reported that in a developmental toxicity study with rats dosed by gavage (GLP, day 6 to 16 of gestation), no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
(4) It was reported that in a developmental toxicity study with rabbits dosed by gavage (day 6 to 18 of gestation), no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
(5) It was reported that in a developmental toxicity study with rabbits dosed by gavage (day 7 to 19 of gestation), no teratogenicity was observed (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
8 Specific target organ toxicity - Single exposure Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (4), it was classified as "Not classified."

[Evidence Data]
(1) It was reported that in an acute oral toxicity test (GLP) with rats, death (1 case) with hydrothorax was observed at 5,000 mg/kg (in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
(2) It was reported that in an acute oral toxicity test (GLP) with mice, no symptom nor death was observed at 5,000 mg/kg (in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
(3) It was reported that in an acute dermal toxicity test (GLP) with rats, no symptom nor death was observed at 5,000 mg/kg (in the range corresponding to “Not classified”) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
(4) It was reported that in an acute (dust) inhalation toxicity test with rats (GLP), no symptom nor death was observed at 5.98 mg/L (in the range corresponding to “Not classified”) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
9 Specific target organ toxicity - Repeated exposure Category 1 (liver), Category 2 (kidney)


Danger
Warning
H372
H373
P260
P264
P270
P314
P501
[Rationale for the Classification]
Based on (1) to (4), the target organs were considered to be the liver and the kidney. Liver effects were observed in the dose range for Category 1, and kidney effects were observed in the dose range for Category 2. Therefore, it was classified in Category 1 (liver) and Category 2 (kidney).

[Evidence Data]
(1) It was reported that in a repeated dose 90-day oral toxicity study with rats dosed by feeding (GLP), liver effects (an increase in weight, diffuse hepatocellular swelling (females)) were observed at or above 100 ppm (6.03 mg/kg/day (males), 6.62 mg/kg/day (females), within the range for Category 1); and kidney effects (focal tubular atrophy, increases in urine specific gravity and protein), thyroid effects (an increase in weight, hypertrophy of follicular cells), liver effects (swelling, diffuse hepatocellular swelling (males)), hematological effects (decreases in Hb and Ht (males)), and hypertrophy of adrenocortical cells (females) were observed at or above 1,000 ppm (60.6 mg/kg/day (males), 67.0 mg/kg/day (females), within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Japan Crop Protection Association (1993)).
(2) It was reported that in a repeated dose 90-day oral toxicity study with dogs dosed by gavage (GLP), darker color of the liver and pigmentation of Kupffer cells and in the biliary canaliculi were observed at or above 10 mg/kg/day (within the range for Category 1); and increases in AST and ALP, a decrease in Alb, increases in absolute and relative liver weight, cholestasis, a decrease in T.Chol (males), an increase in relative kidney weight (females) were observed at 30 mg/kg/day (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Japan Crop Protection Association (1993)).
(3) It was reported that in a one-year combined chronic toxicity/carcinogenicity study with dogs dosed by gavage (GLP), brown pigmentation (bile pigment) of the liver was observed at or above 5 mg/kg/day (within the range for Category 1); and liver effects (increases in absolute and relative liver weight, hepatomegaly, darker color of the liver, an increase in ALP), gallbladder effects (distension, an increase in mucoidal secretion in the gallbladder), and brown pigment deposition in the kidneys were observed at 25 mg/kg/day (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Japan Crop Protection Association (1993)).
(4) It was reported that in a two-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding (GLP), liver effects (an increase in relative weight and spongiform cysts (males), bile duct proliferation and an increase in ALT (females)) and kidney effects (an increase in relative weight and chronic nephropathy (males), an increase in urinary protein (females)) were observed at or above 100 ppm (3.63 mg/kg/day (males), 4.33 mg/kg/day (females), within the range for Category 1); and liver effects (such as focal hepatocellular necrosis, an increase in AST), kidney effects (such as an increase in BUN, chronic nephropathy (females)) were observed at 300 ppm (11.06 mg/kg/day (males), 13.20 mg/kg/day (females), within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Japan Crop Protection Association (1993)).

[Reference Data, etc.]
(5) It was reported that in a repeated dose 90-day oral toxicity study with mice dosed by feeding (GLP), liver effects (darker color, diffuse hepatocellular swelling) were observed at or above 100 ppm (11.8 mg/kg/day (males), 14.2 mg/kg/day (females), within the range for Category 2); and liver effects (such as hepatomegaly, hepatocyte vacuolation, bile duct proliferation, increases in ALT/AST/ALP) were observed at or above 1,000 ppm (116 mg/kg/day (males), 153 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Japan Crop Protection Association (1993)).
(6) It was reported that in an 18-month combined chronic toxicity/carcinogenicity study with mice dosed by feeding (GLP), liver effects (an increase in weight, darker color, swelling, centrilobular and diffuse hepatocyte hypertrophy, brown pigment deposition) and adrenal effects (an increase in weight, cortical cytoplasm hypertrophy, brown pigment deposition on the cortico-medullary junction) were observed at 300 ppm (32.17 mg/kg/day (males), 38.41 mg/kg/day (females), within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Japan Crop Protection Association (1993)).
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