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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	8065-48-3
Chemical Name	O,O-Diethyl-ethylthioethyl thiophosphate; Demeton
Substance ID	R02-B-049-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)	- -	-	-	Liquid (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)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
6	Flammable liquids	Category 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	It was classified in Category 3 from a flash point of 45 deg C (closed cup) (HSDB (Access on May 2020)).
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
8	Self-reactive substances and mixtures	Type G	- -	-	-	There is a chemical group associated with self-reactive properties (P-O) present in the molecule, but because it is classified in Division 6.1 in UNRTDG (UN3018), and it is considered to be not applicable to self-reactive substances and mixtures, hazards of the highest precedence, it was classified in Type G.
9	Pyrophoric liquids	Not classified	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of 464 deg C (ICSC (2002)).
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to liquid 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 666 mg/L (25 deg C) (HSDB (Access on May 2020)).
13	Oxidizing liquids	Classification not possible	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine), which is chemically bonded to the element other than carbon or hydrogen (P). However, the classification is not possible due to no data.
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). 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	- -	-	-	No data 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)	Category 1	Danger	H300	P301+P310 P264 P270 P321 P330 P405 P501	*This substance, demeton (CAS RN 8065-48-3) is a mixture of demeton-O (CAS RN 298-03-3) and demeton-S (CAS RN 126-75-0) (ratio: about 2:1) (ACGIH (7th, 2002)). Therefore, as a mixture, it was classified for health hazards. [Rationale for the Classification] It was classified in Category 1 from (1) - (7). [Evidence Data] (1) LD50 for rats: 2.5 mg/kg (IPCS PIM G001 (1998)) (2) LD50 for rats: females: 2.5 mg/kg, males: 6.2 mg/kg (ACGIH (7th, 2002), MAK (DFG) vol.19 (2003)) (3) LD50 for rats: females: 3-5 mg/kg, males: 5-6 mg/kg (MAK (DFG) vol.19 (2003)) (4) LD50 for rats: females: 4 mg/kg, males: 10 mg/kg (MAK (DFG) vol.19 (2003)) (5) LD50 for rats: 8 mg/kg (ACGIH (7th, 2002)) (6) LD50 for rats: 1.7 mg/kg (GESTIS (Access on May 2020), HSDB (Access on May 2020)) (7) LD50 for rats: females: 3 mg/kg, males: 6 mg/kg (HSDB (Access on May 2020))
1	Acute toxicity (Dermal)	Category 1	Danger	H310	P302+P352 P361+P364 P262 P264 P270 P280 P310 P321 P405 P501	[Rationale for the Classification] It was classified in Category 1 from (1), (2). [Evidence Data] (1) LD50 for rats: females: 8.2 mg/kg, males: 14 mg/kg (ACGIH (7th, 2002), MAK (DFG) vol.19 (2003)) (2) LD50 for rats: 8.2 mg/kg (GESTIS (Access on May 2020), HSDB (Access on May 2020)) [Reference Data, etc.] (3) LD50 for rabbits: 24 mg/kg (GESTIS (Access on May 2020), HSDB (Access on May 2020))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Liquid (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 1	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	[Rationale for the Classification] It was classified in Category 1 from (1). Besides, because an exposure concentration was higher than the saturated vapor pressure concentration (0.0047 mg/L), a reference value in the unit of mg/L was applied as mist. [Evidence Data] (1) LC50 for rats (4 hours): 0.047 mg/L (ACGIH (7th, 2002), HSDB (Access on May 2020)) (2) Vapor pressure of this substance: 0.00034 mmHg (20 deg C) (HSDB (Access on June 2020)) (converted value for the saturated vapor pressure concentration: 0.0047 mg/L)
2	Skin corrosion/irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] It was classified in Category 2 from (1), (2). [Evidence Data] (1) As for in vivo, it was reported to be negative in a dominant lethal test with mice and positive in a chromosomal aberration test with hamster bone marrow cells (MAK (DFG) vol. 9 (2003), HSDB (Access on May 2020)). (2) As for in vitro, it was reported to be positive in a bacterial reverse mutation test and a sister chromatid exchange test with cultured mammalian cells (same as the above).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] No data available.
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible due to lack of data. Possible developmental effects of intraperitoneal administration of this substance were reported. However, since the effects were observed within the range of LD50, and the reported information was not sufficient nor common among assessment reports, the information was not adopted as the rationale for the classification, and the classification results were changed from the previous classification. [Reference Data, etc.] (1) In a test in which female mice were given a single intraperitoneal dose of this substance between days 7 and 12 of gestation, a decrease in fetal weight was observed after treatment on days 9 or later of gestation (MAK (DFG) vol.19 (2003)). The ACGIH (7th, 2002) stated that, in this test, a slight increase in mortality of pups was observed, and the IRIS (1987) stated that there was a possibility of increases in the incidence of abnormalities of the digestive tract and cleft palate. In the MAK (DFG) vol.19 (2003), however, none of these findings were described as effects. (2) In a test of intraperitoneal administration of this substance to female mice on days 7 to 9, days 8 to 10, or days 9 to 11 of gestation, at a dose at which no effect on the body weight of dams was observed, slight skeletal anomalies and lower fetal weight were observed in fetuses (MAK (DFG) vol.19 (2003)). (3) Embryo toxicity was observed in mice dosed by this substance within the range for LD50 by intraperitoneal administration (MAK (DFG) vol.19 (2003)). (4) No sufficient information on reproductive toxicity was obtained (GESTIS (Access on May 2020)).
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system, respiratory organs)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] Based on (1) to (4), it was classified in Category 1 (nervous system, respiratory organs). A new information source was used and the classification results were changed from the previous classification. [Evidence Data] (1) After inhalation, the first effects appeared in the respiratory tract and eyes, often within minutes. The effects on the respiratory tract could be a feeling of oppression in the chest and whistling noises while breathing as a result of bronchoconstriction and excessive bronchial secretion. The effects on the eyes included miosis, unclear recognition of distant objects, and lacrimation. After oral uptake, the symptoms which developed within 15 minutes to 2 hours included loss of appetite, nausea, vomiting, cramps in the stomach area, and diarrhea (MAK (DFG) vol.19 (2003)). (2) After a man spilled 60 mL of this substance on his thigh, rinsed his thigh with water, but continued wearing the pants, he suddenly experienced nausea, vomiting, and weakness after about 9 hours. Plasma and red blood cell cholinesterase (ChE) activities were severely depressed 1.5 hours before the onset of symptoms (ACGIH (7th, 2002), HSDB (Access on May 2020)). (3) Twelve of 14 agricultural workers exposed to this substance at about 1 mg/m3 were reported to have lowered plasma ChE activity but displayed no clinical evidence of poisoning (ACGIH (7th, 2002)). (4) It was reported that no clinical effect of exposure to this substance was observed up to 6 mg/m3, although it was associated with a decrease in serum ChE activity (ACGIH (7th, 2002)). [Reference Data, etc.] (5) Organophosphorus pesticides, such as this substance, are absorbed by all routes, including inhalation, ingestion, and dermal absorption. The toxicological effects of the organophosphorus pesticides are due to the inhibition of acetylcholinesterase in the nervous system, resulting in respiratory, myocardial, and neuromuscular transmission impairment (IPCS PIM G001 (1998)). (6) This substance belongs to the group of organophosphates and is acutely toxic after inhalation, ingestion, and dermal absorption. Intoxication causes miosis, accommodation disorders, salivation, lacrimation, and obsessive-compulsive seizure, and also muscle cramps, cramps in the digestive tract, bronchoconstriction, bronchial secretion, nausea, weakness, and paralysis. In addition, it can cause respiratory depression and circulatory insufficiency. Death occurs as a result of respiratory arrest, suffocation, and heart failure (MAK (DFG) vol.19 (2003)).
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) to (5), it was classified in Category 1 (nervous system). [Evidence Data] (1) This substance is an organophosphorus pesticide. The main feature of the toxic mechanism of organophosphorus pesticides is inhibition of the esterase enzyme activity, in particular of cholinesterase (ChE) (HSDB (Access on 2020)). (2) It was reported that different doses of this substance beginning at 0.75 mg/day were given to five men by capsules for 30 days, and as a result, a dose of 7.124 mg/day (equivalent to 0.10 mg/kg/day assuming a 70-kg body weight) produced 40% inhibition of plasma ChE by day 25 and 16% inhibition of red blood cell ChE (ACGIH (7th, 2002)). (3) It was reported that in rats given the feed containing 48% of demeton-S (CAS RN 126-75-0), which was one of the components of this substance, at 0.05 to 2.6 mg/kg/day for 11 to 16 weeks, at or above 0.05 mg/kg/day (within the range for Category 1), inhibition of plasma, red blood cell, and brain ChE activity was observed (ACGIH (7th, 2002), MAK (DFG) vol.19 (2003), JMPR (1965)). (4) In rats, which were given 65 oral doses of this substance over a period of 90 days, hyperexcitability and tremors were observed at or above 0.9 mg/kg/day (converted guidance value: 0.65 mg/kg/day, within the range for Category 1), and one rat died at 1.89 mg/kg/day (converted guidance value: 1.26 mg/kg/day, within the range for Category 1)) (Same as above). (5) In dogs, which were given this substance by feeding for 24 weeks, inhibition of plasma ChE activity was observed at 0.047 mg/kg/day (within the range for Category 1) and inhibition of red blood cell ChE activity was observed at 0.149 mg/kg/day (within the range for Category 1) (Same as above).
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 = 0.014 mg/L for crustacea (Daphnia pulex) (HSDB, 2020, EPA OPP Pesticide Ecotoxicity Database, 2020).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 1 because data on rapid degradability were not obtained, and it was classified in Category 1 in acute toxicity.
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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