GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 174212-12-5
Chemical Name Bis({2-[3-(4-chlorophenyl)propyl]-2,4,4-trimethyl-1,3-oxazolidin-3-yl}(1H-imidazol-1-yl)methanone) fumarate; Oxpoconazole fumarate
Substance ID R02-A-084-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. Besides, there is information that it is combustible (MOLBASE Encyclopedia (Accessed Dec. 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.
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
-
-
- - 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 chlorine and oxygen (but not fluorine) 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
-
-
- - 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) Category 4


Warning
H302 P301+P312
P264
P270
P330
P501
[Rationale for the Classification]
It was classified in Category 4 from (1), (2).

[Evidence Data]
(1) LD50 for rats (males): 1,420 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019))
(2) LD50 for rats (females): 1,040 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019))
1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) LD50 for rats: > 2,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019))
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]
Classification is not possible due to lack of data because the category could not be determined from (1).

[Evidence Data]
(1) LC50 for rats (4 hours, dust): > 4.4 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019))
2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) No skin irritation was seen in a skin irritation test with rabbits (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
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, erythema, edema, and discharge in the eye conjunctiva were observed but disappeared by 72 hours (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
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) A maximization test with guinea pigs gave a negative result (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) In micronucleus tests using the bone marrow cells of mice (intraperitoneal injection, 2 days), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(2) In a chromosome aberration test using the cultured mammalian cells (CHL), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).

[Reference Data, etc.]
(3) In a bacterial reverse mutation test for oxpoconazole (CAS RN 134074-64-9) which is an active ingredient of this substance, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
6 Carcinogenicity Not classified
-
-
- - [Rationale for the Classification]
There were no classification results by domestic and international organizations. However, based on the test results of (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) In a two-year chronic toxicity/carcinogenicity study with rats dosed by feeding, no evidence of carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(2) In a 78-week carcinogenicity study with mice dosed by feeding, no evidence of carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on (1) to (3), it was classified in Category 2.

[Evidence Data]
(1) In a developmental toxicity study with rats dosed by gavage, at 100 mg/kg/day, general toxicity effects (a decrease in body weight, reduced body weight gain, a reduction in food consumption, an increase in placental weight) were observed in parental animals; and an increase in embryo or fetal mortality, lower body weight, and skeletal variations (lumbar ribs and cervical ribs) were observed in pups. It was reported that no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(2) It was reported that in a two-generation reproduction toxicity study with rats dosed by feeding, at 1,000 ppm, general toxicity effects (such as reduced body weight gain and effects on the liver and kidney) were observed in parental animals and reduced body weight gain was observed in pups, but no effect on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(3) It was reported that in a developmental toxicity study with rabbits dosed by gavage, no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
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) to (3), it was classified in Category 2 (nervous system).

[Evidence Data]
(1) It was reported that in an acute oral toxicity test with rats, recumbency, tremors, a decrease in body weight, hypoactivity and bradypnea (males), and staggering gait and salivation (females) were observed at or above 600 mg/kg (within the range for Category 2); salivation, and dyspnea and prone position (females) were observed at or above 1,000 mg/kg (within the range for Category 2); convulsions, staggering gait and prone position (males), and dyspnea (males) were observed at or above 1,500 mg/kg (within the range for Category 2); and red urine, paleness of the skin and the eyeballs were observed at 3,300 mg/kg (in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(2) It was reported that in an acute oral toxicity test with mice, hypoactivity (females) was observed at or above 300 mg/kg (within the range for Category 1); and bradypnea, staggering gait, convulsions, recumbency, hypoactivity (males), and prone position (females) were observed at or above 600 mg/kg (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(3) It was reported that in a general pharmacological test (general condition observation) with mice by intraperitoneal administration, excitatory or inhibitory symptoms for perception, motility, central excitation, posture, ataxia, muscle tone, reflex, and autonomic nerves were observed at 320 mg/kg (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
9 Specific target organ toxicity - Repeated exposure Category 2 (liver)


Warning
H373 P260
P314
P501
[Rationale for the Classification]
Based on (1) to (5), 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, hematological effects (decreases in red blood cell count, Ht, and Hb (females)) were observed at or above 300 ppm (25.7 mg/kg/day (males), 27.6 mg/kg/day (females), within the range for Category 2); and liver effects (such as an increase in weight, an increase in GGT, and hepatic lipid vacuolation (males)) were observed at 1,200 ppm (102 mg/kg/day (males), 105 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(2) It was reported that in a repeated dose 90-day oral toxicity study with mice dosed by feeding, liver effects (an increase in weight and hepatic lipid vacuolation (females)) were observed at or above 500 ppm (73.0 mg/kg/day (males), 93.0 mg/kg/day (females), within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(3) It was reported that in a repeated dose 90-day oral toxicity study with dogs dosed by gavage, liver effects (an increase in weight, an increase in ALP, centrilobular hepatocyte hypertrophy (with eosinophilic finely granular cytoplasm)) were observed at 100 mg/kg/day (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(4) It was reported that in a one-year chronic toxicity study with dogs dosed by gavage, liver effects (an increase in weight, an increase in ALP, centrilobular hepatocyte hypertrophy (with ground glass cytoplasm)) were observed at 50 mg/kg/day (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(5) It was reported that in a two-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding, hematological effects (such as decreases in hematocrit (Ht) and hemoglobin (Hb) (males)) and liver effects (centrilobular hepatocyte lipid vacuolation, basophilic altered hepatocellular foci) were observed at 400 ppm (20.2 mg/kg/day (males), 25.9 mg/kg/day (females), within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
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.

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