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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	55-38-9
Chemical Name	O,O-Dimethyl O-(3-methyl-4-methylthiophenyl) phosphorothioate (Fenthion)
Substance ID	H30-B-001-MHLW, MOE
Classification year (FY)	FY2018
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 (FY2013 revised edition (Ver. 1.1))
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 applicable	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Not classified	- -	-	-	A flash point is 170 deg C (ICSC (J) (2018)).
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9	Pyrophoric liquids	Not classified	- -	-	-	Because it is described that it may burn but does not ignite readily (HSDB (Accessed Jun. 2018)), It is estimated that it does not ignite at normal temperatures.
10	Pyrophoric solids	Not applicable	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	Because there is a measurement result of water solubility: 2 mg/kg (20 deg C) (HSDB (Accessed Jun. 2018)), it is estimated that it does not react vigorously with water.
13	Oxidizing liquids	Classification not possible	- -	-	-	It is an organic compound which does not contain fluorine or chlorine but contains oxygen, 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.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.

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] According to (1)-(6), one case corresponds to Category 3 and five cases to Category 4. It was classified in Category 4 by adopting the category with the largest number of cases. [Evidence Data] (1) LD50 values for rats: 190-315 mg/kg bw (EHC 63 (1986), JMPR (1981), Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 1989)) (2) LD50 value for rats: 405 mg/kg (male) (EPA Pesticide (2001), Evaluation of effect for the food safety (Food Safety Commission, 2013)) (3) LD50 value for rats: 586 mg/kg (female) (EPA Pesticide (2001)) (4) LD50 value for rats: 566 mg/kg (female) (Evaluation of effect for the food safety (Food Safety Commission, 2013)) (5) LD50 value for rats: 320 mg/kg (male) (Evaluation of effect for the food safety (Food Safety Commission, 2013)) (6) LD50 value for rats: 509 mg/kg (female) (Evaluation of effect for the food safety (Food Safety Commission, 2013))
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	[Rationale for the Classification] According to (1) and (2), as for LD50 values for rats, one case corresponds to Category 4, and one case corresponds to "Not classified" (Category 5 in UN GHS classification)-"Not classified." In addition, an LD50 value for rabbits in (3) corresponds to Category 3. Therefore, the category with the higher hazard was adopted, it was classified in Category 3. The category was changed by the use of new information sources. [Evidence Data] (1) LD50 value for rats: 2,000 mg/kg (Evaluation of effect for the food safety (Food Safety Commission, 2013)) (2) LD50 value for rats: >=2,000 mg/kg (Evaluation of effect for the food safety (Food Safety Commission, 2013)) (3) LD50 value for rabbits: 963 mg/kg (EPA Pesticide (2001), ACGIH (7th, 2006))
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	[Rationale for the Classification] Liquid (GHS definition)
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] According to (1)-(4), one case corresponds to Category 2, two cases to Category 3 and one case to Category 4. Therefore, it was classified in Category 3 adopting a category with the largest number of cases. The category was changed by the use of the new information sources. Besides, there is a result of a test in which the inhalation test methods are unclear: whether the vapor or mist was used. The saturated vapor concentration is 0.04 ppm (0.456 mg/L), and the inhalation experiment is conducted at concentrations exceeding the saturation vapor pressure, therefore, it was treated as a mist inhalation test. [Evidence Data] (1) LC50 for rats (4 hours): 0.507 mg/L (male) (Evaluation of effect for the food safety (Food Safety Commission, 2013), ACGIH (7th, 2006), EPA Pesticide (2001)) (2) LC50 for rats (4 hours): 0.454 mg/L (female) (Evaluation of effect for the food safety (Food Safety Commission, 2013), ACGIH (7th, 2006), EPA Pesticide (2001)) (3) LC50 for rats (4 hours): about 1.2 mg/L (male) (Evaluation of effect for the food safety (Food Safety Commission, 2013), ACGIH (7th, 2006), Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 1989)) (4) LC50 for rats (4 hours): about 0.8 mg/L (female) (Evaluation of effect for the food safety (Food Safety Commission, 2013), ACGIH (7th, 2006), Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 1989))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] Although information (2) suggesting Category 3 in UN GHS classification is also obtained, it was classified as "Not classified" based on the weight of evidence of data (1) used for pesticides review. [Evidence Data] (1) In a skin irritation test with rabbits, it is reported that the skin primary irritation index (PII)=0 (EPA Pesticide (2001)). There is a description that this substance is not considered as a skin irritant (ACGIH (7th, 2006)). [Reference Data, etc.] (2) It is reported that slight irritation was observed in a skin irritation test with rabbits (Evaluation of effect for the food safety (Food Safety Commission, 2013)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] According to (1)-(3), it was classified as "Not classified." [Evidence Data] (1) There is a report that in an eye irritation test with rabbits, no inflammation of the cornea or the iris was observed, and eye discharge, redness and swelling were observed in the conjunctiva of all the rabbits, but this resolved after 2 days (EPA Pesticide(2001)). (2) There is a report that in an eye irritation test with rabbits, no irritation was observed (Evaluation of effect for the food safety (Food Safety Commission, 2013)). (3) There is a description that this substance is not considered as an eye irritant (ACGIH (7th, 2006)).
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] Information (1) and (2) indicating that this substance is not skin sensitizing is also obtained, but it was classified as "Classification not possible" since not enough evidence to judge as "Not classified" was obtained. [Reference Data, etc.] (1) There is a report that in a skin sensitization test (Maximization test) with guinea pigs, this substance was not skin sensitizing (Evaluation of effect for the food safety (Food Safety Commission, 2013), EPA Pesticide (2001)). (2) There is a description that this substance is not considered as a skin sensitizer (ACGIH (7th, 2006)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] According to (1) and (2), it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) As for in vivo, there are reports that a dominant lethal test with mice, a micronucleus test and a chromosomal aberration test with mouse bone marrow, and an unscheduled DNA synthesis test with rat hepatocytes were negative (ACGIH (7th, 2006), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (2) As for in vitro, bacterial reverse mutation tests, an unscheduled DNA synthesis test with human fibroblasts, and a chromosomal aberration test and a forward mutation test with cultured mammalian cells were negative, and an unscheduled DNA synthesis test with rat hepatocyte was positive (ACGIH (7th, 2006), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] As for carcinogenicity, there are no available reports on humans. Based on test results on experimental animals in (1)-(5) and classification results by other organizations, it was classified as "Classification not possible." [Evidence Data] (1) In a 2-year carcinogenicity test with rats dosed by feeding (10, 20 ppm), no significantly high incidence of tumors was observed in either males or females compared with the control group (NTP TR 103 (1979), ACGIH (7th, 2006)). (2) In a 2-year carcinogenicity test with mice dosed by feeding (10, 20 ppm), no significantly high incidence of tumors was observed in females. But incidences of nonepithelial malignant tumors, fibrosarcoma and rhabdomyosarcoma of the integumentary system were significantly high (NTP TR 103 (1979), ACGIH (7th, 2006)). (3) As for results of (1) and (2), the US National Cancer Institute concluded that the substance was not carcinogenic for male and female rats and female mice, but carcinogenic for male mice was equivocal (NTP TR 103 (1979), ACGIH (7th, 2006)). (4) In a 2-year combined chronic toxicity/carcinogenicity test with rats dosed by feeding (0, 5, 20, 100 ppm) or a 2-year carcinogenicity test with mice dosed by feeding (0, 0.1, 1, 5, 25 ppm), no carcinogenicity was observed in either rats or mice (ACGIH (7th, 2006), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (5) As for classification results by domestic and international organizations, it was classified in A4 by ACGIH (ACGIH (7th, 2006)) and as Group E since 1996 by EPA (EPA OPP Annual Cancer Report (Accessed Jun. 2018)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] According to (1), since a decrease in fertility index was observed at a dose in which general toxicity was observed in parental animals in a two-generation reproduction test with rats, it was classified in Category 2. [Evidence Data] (1) In a two-generation reproduction study with rats dosed by feeding, findings that decreases in body weight gain and fertility index in F0 and F1 maternal animals and low body weight in F1 pups were observed at 100 ppm (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010)). [Reference Data, etc.] (2) In a three-generation reproduction study with rats dosed by feeding, decreased body weight gain was observed at the high dose (75 ppm) in F0 female and male parental animals and F1 male parental animals, but no effect on parental animal fertility and pups in any generation was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010)). (3) In a developmental toxicity test with rats dosed by gavage on gestational day 6-15, decreased body weight gain, salivation, lacrimation, tremor, and hypoactivity were observed in maternal animals at 18 mg/kg/day, but no developmental effects were found in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (4) In a developmental toxicity test with rabbits dosed by gavage on gestational day 7-27, severe toxic effects such as deaths, abortion, prone position, dyspnea and decreased body weight gain were observed in maternal animals at 18 mg/kg/day, but only low weight as a slight effect was observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)).
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] According to (1)-(3), it was classified in Category 1 (nervous system). [Evidence Data] (1) There is a report that in a case of a human (41-year-old man, exposure level: unknown) who died 7 days after ingesting this substance, an inhibition of cholinesterase activity in blood and plasma was observed, and worsening cholinergic symptoms were observed coincident with rapidly increasing levels of this substance in blood (ACGIH(7th, 2006)). (2) There are descriptions that it causes an inhibition of cholinesterase activity in humans and overstimulates the nervous system causing nausea, dizziness, confusion, and that when exposed to extremely high doses such as in an accident or major spill, respiratory paralysis occurs and leads to death (EPA Pesticide(2001)). (3) There is a report that cholinergic neurotoxic symptoms such as ataxic gait, convulsions, tremors, salivation, diarrhea, hypoactivity and miosis were observed after oral administration to rats at or above 50 mg/kg (male) or at or above 75 mg/kg (female) (within the range of Category 1) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system, visual organs)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] It can be classified in Category 1 (visual organs) from (1), and it can be classified in Category 1 (nervous system) since neurological symptoms via the cholinergic nervous system were observed within the range of Category 1 from (2). Therefore, it was classified in Category 1 (nervous system, visual organs). Besides, the classification was reviewed using different information sources than the previous one, and a target organ was added. [Evidence Data] (1) There is a report that in an epidemiological study comparing 79 workers sprayed with the liquid of this substance with 100 control subjects, visual impairment, reduced visual acuity and abnormal color vision were seen in 15 workers (19% vs control 3%) in whom macular changes (hypopigmentation, irregularity of background pigmentation, decreased foveal reflex) were observed (ACGIH (7th, 2006)). (2) In a study with rats dosed by feeding for 90 days, tremors were observed at 200 ppm (corresponds to 10 mg/kg/day, within the range of Category 1) in males and females. Also, in a study with rats dosed by feeding for 16 weeks, diarrhea, salivation and lacrimation were observed at 100 ppm (corresponds to 5 mg/kg/day, within the range of Category 1) in males and females. In both studies, inhibition of cholinesterase activity in erythrocytes and the brain was observed at lower doses than those where these symptoms developed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). [Reference Data, etc.] (3) In a chronic toxicity study with rats dosed by feeding for 2 years, granulomatous pneumonia, accumulations of minerals in the stomach, chronic active dermatitis of the tails and feet, effects on the eyes (corneal degeneration, corneal vascularization, retinal atrophy (females only), retinal degeneration (females only)) and vacuolar degeneration in the nasolacrimal duct were observed in both sexes (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (4) There are descriptions that in a study in which 50 mg/kg of this substance was administered intramuscularly to rats once every 4 days for one year, effects on the retinal potential were observed, and that in a study administered to dogs for 2 years, at doses where cholinesterase activity in the plasma was depressed by about 30%, changes in optical function occurred after 13-month exposure, and morphological changes in the ciliary muscle occurred at the end of the study (EHC 63 (1986)).
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 (Acute)	Category 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 96-hour LC50 = 0.0053 mg/L for crustacea (Palaemon macrodactylus) (WHO/IPCS EHC: 1986).
11	Hazardous to the aquatic environment (Long-term)	Category 1	Warning	H410	P273 P391 P501	It was classified in Category 1 due to being not rapidly degradable, and 88-day NOEC (reproduction) = 0.0075 mg/L for fish (Oncorhynchus mykiss) (EPA AQUIRE: 2018, EPA Pesticide Ecotoxicity Database (1992)).
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.

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.

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