NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	134074-64-9
Chemical Name	{2-[3-(4-Chlorophenyl)propyl]-2,4,4-trimethyl-1,3-oxazolidin-3-yl}(1H-imidazol-1-yl)methanone; Oxpoconazole
Substance ID	R02-A-083-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)	- -	-	-	Although a melting point is unknown, from a boiling point of 924 deg C (literature), it is liquid or solid in GHS definition. Therefore, it was classified as "Not classified (Not applicable)."
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Although a melting point is unknown, from a boiling point of 924 deg C (literature), it is liquid or solid in GHS definition. Therefore, it was classified as "Not classified (Not applicable)."
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Although a melting point is unknown, from a boiling point of 924 deg C (literature), it is liquid or solid in GHS definition. Therefore, it was classified as "Not classified (Not applicable)."
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition) [Reference Data] If it is handled as liquid, from information on a flash point of 512.9 deg C (test method: unknown) (MOLBASE Encyclopedia (Accessed Dec. 2020)), it is estimated to exceed 93 deg C also in the prescribed closed-cup method. Therefore, it is classified as "Not classified."
7	Flammable solids	Classification not possible	- -	-	-	No data available. Besides, there is information that it is combustible (MOLBASE Encyclopedia (Accessed Dec. 2020)). [Reference Data] If it is handled as liquid, it is classified as "Not classified (Not applicable)."
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) [Reference Data] If it is handled as liquid, the classification is not possible due to no data.
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available. [Reference Data] If it is handled as liquid, it is classified as "Not classified (Not applicable)."
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available. [Reference Data] If it is handled as liquid, 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)	- -	-	-	Liquid or solid (GHS definition) [Reference Data] If it is handled as liquid, 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)	- -	-	-	The substance is an organic compound containing chlorine and oxygen (but not fluorine) which are chemically bonded only to carbon or hydrogen. [Reference Data] If it is handled as liquid, it is liquid in 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	- -	-	-	Test methods applicable to solid substances are not available. [Reference Data] If it is handled as liquid, the classification is not possible due to no data.
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 mice (males): 1,770 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)) (2) LD50 for mice (females): 1,510 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) Oxpoconazole fumarate (CAS RN 174212-12-5), consisting of 2 molecules of this substance and one molecule of fumaric acid, was classified as "Not classified" for this hazard class (GHS classification in FY 2020).
1	Acute toxicity (Inhalation: Gases)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
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 not possible due to lack of data. [Reference Data, etc.] (1) Oxpoconazole fumarate (CAS RN 174212-12-5), consisting of 2 molecules of this substance and one molecule of fumaric acid, was classified as "Classification not possible " for this hazard class (GHS classification in FY 2020).
2	Skin corrosion/irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) Oxpoconazole fumarate (CAS RN 174212-12-5), consisting of 2 molecules of this substance and one molecule of fumaric acid, was classified as "Not classified" for this hazard class (GHS classification in FY 2020).
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) Oxpoconazole fumarate (CAS RN 174212-12-5), consisting of 2 molecules of this substance and one molecule of fumaric acid, was classified as "Not classified" for this hazard class (GHS classification in FY 2020).
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] The classification is not possible due to no data on this substance. However, based on data on oxpoconazole fumarate (CAS RN 174212-12-5), consisting of 2 molecules of this substance and one molecule of fumaric acid, this substance was classified as "Not classified." [Evidence Data] (1) Oxpoconazole fumarate (CAS RN 174212-12-5), consisting of 2 molecules of this substance and one molecule of fumaric acid, was classified as "Not classified" for this hazard class (GHS classification in FY 2020).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Only the data of (1) was available on this substance, and it could be classified as "Classification not possible." However, based on the data of (2) and (3) on oxpoconazole fumarate (CAS RN 174212-12-5) comprising two molecules of this substance and one molecule of fumaric acid, it was classified as "Not classified." [Evidence Data] (1) In a bacterial reverse mutation test, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). (2) In a micronucleus test using the bone marrow cells of mice (intraperitoneal injection, 2 days) for oxpoconazole fumarate comprising two molecules of this substance and one molecule of fumaric acid, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). (3) In an in vitro mammalian cell (CHL) chromosome aberration test for oxpoconazole fumarate comprising two molecules of this substance and one molecule of fumaric acid, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] This substance could be classified as "Classification not possible" due to lack of data. However, it was classified as "Not classified" based on the data of oxpoconazole fumarate (CAS RN 174212-12-5) comprising two molecules of this substance and one molecule of fumaric acid. [Evidence Data] (1) In a two-year chronic toxicity/carcinogenicity study for oxpoconazole fumarate comprising two molecules of this substance and one molecule of fumaric acid 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 for oxpoconazole fumarate containing this substance and fumarate in the ratio of 2:1 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] There was no data available on this substance, and it could be classified as "Classification not possible." However, in the test for oxpoconazole fumarate (CAS RN 174212-12-5) comprising two molecules of this substance and one molecule of fumaric acid, at doses where minor maternal toxicity was observed, an increase in the embryo or fetal mortality was observed in pups. Therefore, it was classified in Category 2. [Evidence Data] (1) In a developmental toxicity study for oxpoconazole fumarate comprising two molecules of this substance and one molecule of fumaric acid 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 for oxpoconazole fumarate comprising two molecules of this substance and one molecule of fumaric acid 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 for oxpoconazole fumarate comprising two molecules of this substance and one molecule of fumaric acid 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	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible due to lack of data. [Reference Data, etc.] (1) Oxpoconazole fumarate (CAS RN 174212-12-5) comprising two molecules of this substance and one molecule of fumaric acid was classified in "Category 2 (nervous system)" for this hazard class in the GHS classification (GHS Classification Results in FY2020).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible due to lack of data. [Reference Data, etc.] (1) Oxpoconazole fumarate (CAS RN 174212-12-5) comprising two molecules of this substance and one molecule of fumaric acid was classified in "Category 2 (liver)" for this hazard class in the GHS classification (GHS Classification Results in FY2020).
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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