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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	36335-67-8
Chemical Name	O-Ethyl O-(6-nitro-m-tolyl) sec-butylphosphoramidothioate; Butamifos
Substance ID	R02-B-089-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	Classification not possible	- -	-	-	There is a chemical group associated with explosive properties (nitro group) present in the molecule, and the calculated oxygen balance is -156, higher than the criteria: -200, but the classification is not possible due to no data.
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	Not classified	- -	-	-	It was classified as "Not classified" from a flash point of around 192 deg C (Sumitomo Chemical 1984-I, Japan Crop Protection Association (1984)).
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with explosive properties (nitro group) present in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	Not classified	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from information that it is stable to heat at up to 150 deg C (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)).
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 6.19 mg/L (25 deg C) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)).
13	Oxidizing liquids	Classification not possible	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine), which is chemically bonded to elements other than carbon or hydrogen (N, 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	Classification not possible	- -	-	-	There is a chemical group associated with explosive properties (nitro group) present in the molecule, but the classification is not possible due to no data.

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) - (3). [Evidence Data] (1) LD50 for rats: females: 630 mg/kg, males: 790 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)) (2) LD50 for rats: 630-1,070 mg/kg (Food sanitation research Vol. 47, No. 2 (Japan Crop Protection Association, 1997)) (3) LD50 for rats: females: 845 mg/kg, males: 1,070 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats: > 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009))
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)	Classification not possible	- -	-	-	[Rationale for the Classification] The category could not be specified from (1), and it was classified as "Classification not possible." Because an exposure concentration was higher than the saturated vapor pressure concentration (0.011 mg/L), a reference value in the unit of mg/L was applied as mist. [Evidence Data] (1) LC50 for rats (4 hours): > 1.2 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)) (2) Vapor pressure of this substance: 6.3E-004 mmHg (27 deg C) (Japan Crop Protection Association (1984)) (converted value for the saturated vapor pressure concentration: 0.011 mg/L)
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) No irritation was observed in a skin irritation test with rabbits (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) No irritation was observed in an eye irritation test with rabbits (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)).
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] It was presumed that it was classified as "Not classified" based on data in (1) in the previous classification, but because a Draize test was not registered as OECD TG, it was classified as "Classification not possible." [Reference Data, etc.] (1) It was reported to be negative in a skin sensitization test with guinea pigs (Draize test) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) As for in vivo, it was reported to be negative in a micronucleus test with mouse bone marrow cells (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), Food sanitation research Vol. 47, No. 2 (Japan Crop Protection Association, 1997), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). (2) As for in vitro, it was reported to be negative in a bacterial reverse mutation test. On the other hand, it is reported that it did not induce chromosomal aberrations in cultured mammalian cells but increased polyploidy cells, although at a low frequency (same as the above).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] There were no classification results by domestic and international organizations. There was no available report in humans. It was classified as "Not classified" from (1), (2). [Evidence Data] (1) In combined chronic toxicity/carcinogenicity tests by diet administration of this substance to male and female rats for 2 years or 2 years and 1 month, no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (2) In a carcinogenicity test by 16-month diet administration of this substance to male and female mice, no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
7	Reproductive toxicity	Additional category for effects on or via lactation	- -	-	-	[Rationale for the Classification] Based on (1), a decrease in the number of live pups during the lactation period was observed at a dose at which no parental toxicity was observed. However, based on (1) to (3), other effects on fertility, at birth, or on fetuses, were not observed, and therefore, it was classified in "additional category: effects on or via lactation." [Evidence Data] (1) In a three-generation reproductive study with rats dosed by feeding, a decrease in the number of live pups (on days 12 and 21 of lactation of P, F1 and F2 generations) during the lactation period was observed at a dose (the maximum dose of 300 ppm (males: 24.37 mg/kg/day; females: 31.60 mg/kg/day) at which no parental toxicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). (2) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, maternal toxicity (reduced body weight gain, 1 animal showed rale, dyspnea, and salivation) was observed at the maximum dose of 125 mg/kg/day, but no effect was observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (3) In a developmental toxicity study with female rabbits dosed by gavage on days 6 to 18 of gestation, maternal toxicity (death and reduced body weight gain) was observed at the maximum dose of 80 mg/kg/day, but no effect was observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
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] There was no report on acute exposure to this substance in humans. In experimental animals, based on (1) to (4), it was classified in Category 1 (nervous system). New information sources were used and the classification results were changed from the previous classification. [Evidence Data] (1) In an acute neurotoxicity test by an oral administration to rats (0, 10, 70, 500 mg/kg), a decrease in righting reflex and diarrhea in males, and abnormal gait (toe walking) in females were observed at or above 70 mg/kg (within the range for Category 1); and abnormal gait (toe walking), soiling with urine, and a decrease in locomotor activity in males, and a decrease in righting reflex, diarrhea, and soiling with urine in females were observed at 500 mg/kg (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (2) In an acute oral toxicity test with rats, a decrease in locomotor activity, respiratory distress, piloerection, urination, irritability, salivation, lacrimation, exophthalmos, muscular spasms, and limb or systemic ataxia were observed at 385 mg/kg (within the range for Category 2); and in another test, lacrimation, salivation, reddish tear, tremor, ataxic gait, exophthalmos, incontinence of urine, and deep breathing were observed at 500 mg/kg (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (3) In an acute dermal application test with rats, at 5,000 mg/kg (exceeding Category 2), tremor was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (4) In a 4-hour acute inhalation exposure test with rats, a decrease in locomotor activity, irregular breathing, deep breathing (only at 1,200 mg/m3), salivation, lacrimation, nasal discharge, and incontinence of urine were observed at or above 147 mg/m3 (within the range for Category 1) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). [Reference Data, etc.] (5) Toxic symptoms by an oral administration to test animals were symptoms of excitement of the central or peripheral nervous system (such as irritability, salivation, and muscle spasms), and limb or systemic ataxia (Sumitomo Chemical Co., Ltd. 1984-I (Japan Crop Protection Association, 1984)).
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 (4), it was classified in Category 1 (nervous system). As a result of examination using the new information, the classification results were changed from the previous classification. [Evidence Data] (1) It was reported that, as a result of a 90-day test with mice dosed by feeding, inhibition of brain and erythrocyte cholinesterase (ChE) activity in males and females, and increases in phospholipid and total cholesterol in females were observed at or above 250 ppm (37.5 mg/kg/day, within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (2) As a result of a 90-day subacute neurotoxicity test with rats dosed by feeding, inhibition of brain and erythrocyte ChE activity was observed at or above 100 ppm (5 mg/kg/day, within the range for Category 1), and toe walking, an increase in contact reaction, upward bending of the backbone, reduced body weight gain, and a decrease in feed efficiency in males and females, and increased activity and depressed trunk in females were observed at or above 1,000 ppm (50 mg/kg/day, within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (3) As a result of a 2-year chronic toxicity study by an oral administration to dogs, inhibition of brain ChE activity in males, and inhibition of brain and erythrocyte ChE activity in females were observed at or above 12.5 mg/kg/day (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (4) As a result of a 2-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding, inhibition of erythrocyte ChE activity in males and females was observed at or above 80 ppm (4 mg/kg/day, within the range for Category 1); and inhibition of brain ChE activity in males and females, and decreases in erythrocyte count, hemoglobin, hematocrit levels, and MCV in females were observed at 300 ppm (15 mg/kg/day, within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
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 72-hour ErC50 = 0.033 mg/L for algae (Raphidocelis subcapitata) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)).
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 1 because it is not rapidly degradable (BIOWIN) and due to 72-hour NOErC = 0.01 mg/L for algae (Raphidocelis subcapitata) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 because it is not rapidly degradable (BIOWIN) and due to 48-hour EC50 = 1.9 mg/L for crustacea (Daphnia magna) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). 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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