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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	2310-17-0
Chemical Name	O,O-Diethyl S-(6-chloro-2,3-dihydro-2-oxobenzoxazolinyl)methyl phosphorodithioate; Phosalone
Substance ID	R02-B-055-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 (2010)).
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	- -	-	-	Because it is classified in Division 6.1 in UNRTDG (UN2783), and it does not correspond to pyrophoric substances, hazards of the highest precedence, it was classified as "Not classified."
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	- -	-	-	It contains a metalloid (P), but it was classified as "Not classified" because it is estimated that it does not react vigorously with water from water solubility data of 1.4 mg/L (20 deg C) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
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 (P). 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	- -	-	-	It is a solid with a melting point of 55 deg C or lower, but 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. 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 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	[Rationale for the Classification] It was classified in Category 3 from (1) - (4). [Evidence Data] (1) LD50 for rats: 85 mg/kg (GESTIS (Access on May 2020), HSDB (Access on May 2020)) (2) LD50 for rats: males: 120-170 mg/kg (HSDB (Access on May 2020)) (3) LD50 for rats: about 150 mg/kg (JMPR (2001)) (4) LD50 for rats: females: 188 mg/kg, males: 198 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013))
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	[Rationale for the Classification] It was classified in Category 3 from (1), (2). [Evidence Data] (1) LD50 for rabbits: 1,000 mg/kg (GESTIS (Access on May 2020)) (2) LD50 for rats: females: 1,530 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014))
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)	Category 3	Danger	H331	P304+P340 P403+P233 P261 P271 P311 P321 P405 P501	[Rationale for the Classification] It was classified in Category 3 from (1), (2). Besides, the classification result was changed from the previous classification due to the use of new information sources. Because exposure concentrations were higher than the saturated vapor pressure concentration (9.0E-007 mg/L), a reference value in the unit of mg/L was applied as dust. [Evidence Data] (1) LC50 for rats (4 hours): females: 0.7 mg/L, males: 1.4 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)) (2) LC50 for rats (4 hours): females: 1.3 mg/L, males: 2.1 mg/L (JMPR (2001)) (3) Vapor pressure of this substance: 4.5E-008 mmHg (25 deg C) (HSDB (Access on May 2020)) (converted value for the saturated vapor pressure concentration: 9.0E-007 mg/L)
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] It was classified in Category 2 from (1). [Evidence Data] (1) This substance was moderately irritating to the skin and eyes (HSDB (Access on May 2020)).
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	[Rationale for the Classification] It was classified in Category 2 from (1). Because there was not sufficient information for sub-categorization, the classification result was changed. [Evidence Data] (1) This substance was moderately irritating to the skin and eyes (HSDB (Access on May 2020)). [Reference Data, etc.] (2) It is reported that in an eye irritation test in which this substance (0.06 g) was applied to rabbits (6 animals) (Draize test), moderate irritation was observed, but the mean score at 24/48/72 hours after the application was less than 1 in all animals for corneal opacity and iris, and less than 2 in all animals for conjunctival redness and edema (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
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). The classification result was changed due to new data obtained. [Evidence Data] (1) In skin sensitization tests with guinea pigs (Buehler test, Sulser & Schwarz test), both gave negative results (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)). [Reference Data, etc.] (2) It was classified in Skin Sens. 1 (H317) in EU-CLP classification (EU CLP classification (Access on July 2020)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (3). [Evidence Data] (1) As for in vivo, it was reported to be negative in a dominant lethal test with mice and a micronucleus test with mouse bone marrow cells (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)). (2) As for in vitro, it was reported to be positive and negative in bacterial reverse mutation tests, negative in a chromosomal aberration test and a micronucleus test using Chinese hamster ovary cells, and negative in an unscheduled DNA synthesis test with rat hepatocytes (same as the above). (3) It is described in the Risk Assessment Report (Food Safety Commission of Japan) that it was considered that it did not have genotoxicity that could pose a problem in vivo (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] There was no available report in humans. It was classified as "Not classified" from (1) - (3). [Evidence Data] (1) As for classification results by domestic and international organizations, EPA classified it in NL (Not Likely to be Carcinogenic to Humans) (EPA Annual Cancer Report 2019 (Access on July 2020): classified in 1999). (2) In two combined chronic toxicity/carcinogenicity tests by 2-year diet administration of this substance to male and female rats, no neoplastic lesions for which the incidences increased by the administration of this substance were observed in either test (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). (3) In a carcinogenicity test by 2-year diet administration of this substance to male and female mice, no neoplastic lesions for which the incidences increased by the administration of this substance were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1), in addition to inhibition of erythrocyte cholinesterase (ChE) activity, reduced body weight gain was observed in dams, and effects on the nervous system, dyspnea, etc. were also observed as maternal toxicity in (2) and (3), and therefore, effects were considered to be severe. Effects in offspring and fetuses were considered to be severe in (1) and (2). Taking these factors into consideration, there were effects in offspring at a dose at which maternal toxicity was observed, and therefore, it was classified in Category 2. A new information source was used and the classification results were changed from the previous classification. [Evidence Data] (1) In a two-generation reproductive study with rats dosed by feeding, in parent animals, inhibition of erythrocyte ChE activity (20% or above) was observed in groups dosed at or above 50 ppm (3.6-4.3 mg/kg/day), and reduced body weight gain was observed in a group dosed at 400 ppm (29.4-36.7 mg/kg/day); and in offspring, an increase in cumulative mortality and lower body weight were observed before adjustment on postnatal day 4 in a group dosed at 400 ppm (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). (2) In a developmental toxicity study with female rats dosed by gavage on days 6-15 of gestation, at a dose (20 mg/kg/day) at which maternal toxicity (continuous mastication behavior, hypersensitivity to sounds, piloerection, dyspnea, reduced body weight gain, and a decrease in food consumption) was observed, an increase in cumulative mortality and a decrease in litter size were observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). (3) In a developmental toxicity study with female rabbits dosed by gavage on days 6-18 of gestation, at a dose (20 mg/kg/day) at which maternal toxicity (dyspnea, extensile spasms, convulsion, collapsed state, abdominal spasms, and a decrease in body weight) was observed, incomplete ossification of the phalanges was observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)).
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] Based on (1), it was reported that effects on the nervous system at doses within the range for Category 1 were observed in experimental animals. Therefore, it was classified in Category 1 (nervous system). As shown in (2), a possibility of effects on the nervous system was also indicated in humans. After a review of the information, the classification results were changed from the previous classification. [Evidence Data] (1) It was reported that in an oral toxicity test with rats, at 60 mg/kg (within the range for Category 1), tremors of the extremities and trunk, hunchback position, subnormal temperature of the extremities, unsteady gait, unsteadiness, subnormal temperature, a decrease in locomotor activity level, and inhibition of erythrocyte and brain cholinesterase (ChE) activity (20% or above) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). [Reference Data, etc.] (2) It could cause ChE inhibition in humans. Consequently, it could cause nausea, dizziness, and confusion, and at very high exposures by accidents or major spills, respiratory paralysis and death (HSDB (Access on May 2020)). (3) In the previous classification, the liver was determined to be a target organ based on the description of the HSDB, "The liver injury was not only structural but also functional. Clinical symptoms were general depression, discoordination of movements, salivation, muscle disorder, tremor, bronchospasm, paresis, paralysis, coma, etc.," but it was confirmed that the test animal species in this report was sheep (HSDB (Access on May 2020)). Therefore, the liver was excluded from target organs.
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1), it was reported that effects on the nervous system at doses within the range for Category 1 were observed in experimental animals. Therefore, it was classified in Category 1 (nervous system). As shown in (2), a possibility of effects on the nervous system was also shown in humans. [Evidence Data] (1) In a 90-day test with rats dosed by feeding, at 50 ppm (males: 3.9 mg/kg; females: 4.4 mg/kg, within the range for Category 1 in both cases), inhibition of brain and erythrocyte cholinesterase (ChE) activity was observed, and at 600 ppm (males: 45.9 mg/kg; females: 56.0 mg/kg, within the range for Category 2 in both cases), a decrease in grip strength, and a decrease in landing foot splay width were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), JMPR (2001)). [Reference Data, etc.] (2) It could cause ChE inhibition in humans. Consequently, it could cause nausea, dizziness, and confusion, and at very high exposures by accidents or major spills, respiratory paralysis and death (HSDB (Access on May 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 48-hour EC50 = 0.000739 mg/L for crustacea (Daphnia magna) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 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 2 because it is not rapidly degradable (BIOWIN) and due to 72-hour NOEC = 0.56 mg/L for algae (Desmodesmus subspicatus) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 because it is not rapidly degradable (BIOWIN) and due to 48-hour EC50 = 0.000739 mg/L for crustacea (Daphnia magna) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)). 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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