NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	301-12-2
Chemical Name	O,O-Dimethyl S-[2-(ethylsulfinyl)ethyl] phosphorothioate (Oxydemeton-methyl)
Substance ID	m-nite-301-12-2_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecules.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Not classified	- -	-	-	It was classified as "Not classified" from a flash point of 110 deg C (unknown test methods) (GESTIS (Accessed Aug. 2018)).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Pyrophoric liquids	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
12	Substances and mixtures which, in contact with water, emit flammable gases	Classification not possible	- -	-	-	The chemical structure of the substance contains a metalloid (P). Since there is no test data available, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
13	Oxidizing liquids	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 2	Danger	H300	P301+P310 P264 P270 P321 P330 P405 P501	Its rat LD50 = 30 - 75 mg/kg (JMPR 102 (1967)) or LD50 = 50 mg/kg (HSDB (2004)) represents that the substance is classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Category 2	Danger	H310	P302+P352 P361+P364 P262 P264 P270 P280 P310 P321 P405 P501	Since two of the following: its rat LD50 = 1350 mg/kg (HSDB (2004)), its rat (female) LD50 = 112 mg/kg (technical grade) (HSDB (2004)), its rat LD50 = 130 mg/kg (Pesticide manual (1994)): represents that the substance is classified into Category 2, and it is rated R24 in the EU classification (EU-Annex 1 (accessed in August 2008)), the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Dusts and mists)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	Its rat LC50 = 1.5 mg/L/h (HSDB (2004)) may be converted to its rat LC50 = 0.35 mg/L/4h and represents that the substance is classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Not classified	- -	-	-	Since it is documented that in a skin irritation test using rabbits, no erythema or edema was observed for up to 72 hours (JMPR 699 (1984)), the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	It is documented that in a test using rabbits, slight conjunctival reddening for up to 24 hours and slight conjunctival swelling at 1 hour were observed in the eyes of five out six exposed rabbits for five minutes, and all other readings in all rabbits were zero for up to seven days (JMPR 699 (1984)). However, since there is no other information available, and due to a lack of data, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	A Chinese hamster chromosomal aberration test using bone marrow cells receiving single-dose oral gavage administration (in vivo mutagenicity test using somatic cells) yielded negative results (HSDB (2004)), while mouse chromosomal aberration tests using bone marrow cells receiving intraperitoneal administration (in vivo mutagenicity test using somatic cells) induced chromatid breaks and gaps (no exchange type abberration was reported) (all from HSDB (2004)). The negative results by oral administration were obtained with the single-dose of 40 mg/kg and with a doubtful methodology, while positive results by IP administration (1 - 3 mg/kg) contained chromatid gaps and their evaluation is difficult. It is documented that a mouse dominant lethal test with intraperitoneal administration (4.5 mg/kg) yielded negative results, a rat dominant lethal test with oral administration (0.15 - 5 mg/kg) showed negative results, and a mouse oral administration test (28 - 80 mg/kg) induced micronuclei, chromosomal aberrations, and abnormal sperm heads. Based on the above results, the effects on germ cells can be denied, but the effects on somatic cells cannot be determined, therefore, the substance was classified into Category 2. As relevant information, an in vitro mutagenicity test, an Ames test, a chromosomal aberration test using human lymphcytes, a mouse lymphoma assay, and a chromosomal aberration test using the CHO cell line (HSDB (2004)) yielded positive results.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Classification not possible	- -	-	-	21-month oral administration tests using mice found the substance not carcinogenic (HSDB, 2004). However, since no carcinogenicity studies using animal species other than mice have been reported, the substance was classified into the "Classification not possible" category due to insufficient data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	A rat developmental toxicity test with oral administration during the organogenetic period did not indicate developmental toxicity (JMPR 1004 (2002)), and another rat oral administration test during the organogenetic period showed fetal hypoplasia and dysplasia of the testes, which are considered to be caused by parental toxicities (JMPR 699 (1984)). While, a male rat reproductive toxicity test by oral gavage yielded reduced female pregnancy rates (JMPR 1004 (2002)), a two-generation reproduction study in rats indicated vacuolation of the corpus of the epididymis, decreased corpus luteum, and reduced litter size (JMPR 1004 (2002)), and a rat three-generation reproduction test showed a reduced number of pregnancies and a reduced number of young per litter in all generations (JMPR 102 (1967)). Therefore, the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	A rat oral administration test at a single dose of 2.5 - 50 mg/kg by gavage showed at all doses, reductions in plasma, erythrocyte, and brain cholinestrase activity, and at the time of peak effect, the reduction was 55 - 61%, and at the doses of 10 mg/kg or higher, toxic symptoms caused by cholinestrase inhibition were seen (JMPR 1004 (2002)). A human test orally exposed at 0.0125 - 2 mg/kg did not show symptoms of anti-cholinestrase toxicity; however, at doses of 1 mg/kg and higher, reductions in plasma and erythrocyte cholinestrase activity were seen, and at the maximum, they reduced to that of approximately 70% of the control group (JMPR (2002)). Also, case reports have been made, and in a case, a woman attempted to commit suicide by ingesting half a bottle (12 g), and admitted to the hospital, experienced signs including miosis, hyperreflex, muscular fasciculations, and coma, and her plasma cholinestrase level fell to 10% of the normal level (HSDB (2004)). As described above, cholinestrase inhibition and nervous symptoms based on the inhibition was seen in rats at doses equivalent to the guidance value of Category 1, and also in humans, not only cholinestrase inhibition but also cholinergic signs in accident cases have been reported, and therefore, the substance was classified into Category 1 (nervous system).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system)	Danger	H372	P260 P264 P270 P314 P501	In a rat neurotoxicity test with gavage administration for 15 days (doses; 2.5, 10, 50 mg/kg), at a dose equivalent to the guidance value of Category 1, indicated tremors, ataxic gait, decreased number of rearings, pinpoint pupils, decreased body temperature, and decreased motor activity were observed, and inhibition of brain cholinestrase activity was found (HSDB (2004)). Furthermore, in a neurotoxicity test using rats with oral administration for 13-weeks (doses: 0.062, 0.62, and 5.4 mg/kg for males; 0.074, 0.75, and 6.6 mg/kg for females), at the dose equivalent to the guidance value of Category 1, tremors, aggressive behavior, decreased hindlimb grip strength, a decrease in body temperature, and inhibition of plasma, erythrocyte, and brain cholinesterase activities were observed (HSDB (2004)). In addition, in a 21-month oral administration test using mice (JMPR 1004 (2002)), in a 21-day oral administration test using rats (JMPR 102 (1967)), in a 6-month oral administration test using rats (HSDB (2004)), and in a 14-day oral administration test by gavage using rats (HSDB (2004)), at a dose equivalent to the guidance value of Category 1, inhibition of erythrocyte and brain cholinestrase activities were observed, and also in human volunteers, inhibition of plasma and erythrocyte cholinestrase activities were observed (HSDB (2004)). Therefore, the substance was classified into Category 1 (nervous system).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 1	Warning	H400	P273 P391 P501	Based on its 48h-LC50 = 0.24 mg/L for crustaceans (Daphinia magna) (HSDB (2004)), the substance was classified into Category 1.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Since its preexisting classification for acute toxicity is Category 1, and it is expected not to be rapidly degradable (SRC, BioWin V4.10), the substance was classified into Category 1.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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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