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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	2104-64-5
Chemical Name	O-Ethyl O-4-nitrophenyl phenyl phosphonothioate [EPN]
Substance ID	H29-B-046
Classification year (FY)	FY2017
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)
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	- -	-	-	Although there is a chemical group associated with explosive properties (nitro group) in the molecule, and the calculated oxygen balance of -153 is above the criteria, -200, the classification is not possible due to no data on onset temperature and decomposition energy.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Solid (GHS definition).
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Solid (GHS definition).
5	Gases under pressure	Not applicable	- -	-	-	Solid (GHS definition).
6	Flammable liquids	Not applicable	- -	-	-	Solid (GHS definition).
7	Flammable solids	Classification not possible	- -	-	-	It is described that it is combustible (ICSC (J) (2008)), but the classification is not possible due to no data.
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with explosive properties (nitro group) in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	Not applicable	- -	-	-	Solid (GHS definition).
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	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 is estimated that it does not react vigorously with water from the measurement result of water solubility of 3.11 mg/L (20-25 deg C) (HSDB (Access on June 2017)).
13	Oxidizing liquids	Not applicable	- -	-	-	Solid (GHS definition).
14	Oxidizing solids	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. However, the classification is not possible due to no data.
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule
16	Corrosive to metals	Classification not possible	- -	-	-	It is a substance with a melting point of 55 deg C or lower, 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 2	Danger	H300	P301+P310 P264 P270 P321 P330 P405 P501	Based on reports of LD50 values for rats of 7.7 mg/kg (female), 36 mg/kg (male) (ACGIH (7th, 2003)), 24 mg/kg (female), and 36 mg/kg (male) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)), it was classified in Category 2.
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	There are two reports of LD50 values of 533 mg/kg (female), 2,850 mg/kg (male) for rats (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)), and they correspond to Category 3 or "Not classified" (Category 5 in UN GHS classification) respectively. It was classified in Category 3 by adopting the category with higher hazard.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Dusts and mists)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	Based on reports of LC50 values of 0.121 mg/L (female) and 0.315 mg/L (male) in a 4-hour inhalation exposure test with rats by 45% emulsion aerosol (the numerical values are the converted value equivalent to the concentration of the active ingredient) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)), it was classified in Category 2. The data from Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005) used in the previous classification was not adopted because the original source was RTECS which is the information source listed in List 3, and the details are unknown. The category was changed due to the use of the new information source.
2	Skin corrosion/irritation	Not classified	- -	-	-	Since there is a report that in a skin irritation test with rabbits, as a result of applications of this substance itself, a 45% emulsion, and a 1.5% powder, slight irritation or no irritation was found (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)), it was classified as "Not classified" (Category 3 in UN GHS classification).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	Based on a report that in an eye irritation test with rabbits, eye irritation was observed by the application of this substance itself and the 45% emulsion, and very slight eye irritation was observed by the application of the 1.5% powder, and the animals recovered within the observation period of 7 days in all cases (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)), it was classified in Category 2B.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	Based on reports in a skin sensitization test with guinea pigs that no sensitization was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)) and that no sensitization was observed in application of this substance itself, but moderate sensitization was observed by application of the 45% emulsion and the 1.5% powder (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)), it was classified as "Classification not possible." The category was revised based on the information obtained in this investigation.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The substance was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, a micronucleus test with mouse bone marrow cells was negative (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)), and as for in vitro, bacterial reverse mutation tests, a mouse lymphoma test and a chromosomal aberration test with mammalian cultured cells were positive or negative (ACGIH (7th, 2003), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), HSDB (Access on June 2017)).
6	Carcinogenicity	Classification not possible	- -	-	-	In a carcinogenicity test in which rats were dosed by feeding at up to 75 ppm for 2 years and mice were dosed by feeding at up to 125 ppm for 18 months, no increase in the incidence of neoplastic lesions associated with the dose was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)). In addition, neither in a test in which rats were dosed by feeding at up to 225 ppm (female) nor up to 450 ppm (male) for 2 years, evidence of carcinogenicity was observed (ACGIH (7th, 2003)). ACGIH classified this substance in A4 for carcinogenicity (ACGIH (7th, 2003)), and it was classified as "Classification not possible" for this hazard class.
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a two-generation study with rats dosed by feeding, suppression of body weight gain was observed at or above 15 ppm in F0 and F1 parental animals (at 75 ppm only in F1 paternal animals), and a decreased survival rate was observed at 75 ppm in F1 and F2 pups (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005)). On the other hand, in developmental toxicity tests with pregnant rats or pregnant rabbits dosed by gavage during the organogenesis period, even at the dose where symptoms such as tremors and collapse (rats) or the suppression of weight gain (rabbits) were observed in maternal animals, effects were limited to no effects (rats) or only slight effects (rabbits, lower body weight) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), Environmental Risk Assessment for Chemical Substances Vol.4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005)). In addition, in a neurodevelopmental toxicity test with pregnant rats dosed by gavage from gestational day 6 to lactational day 10, neurodevelopmental toxicity was not detected even at 4.0 mg/kg/day where tremors and suppression of weight gain were observed in maternal animals (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)). From the above, although no effects were detected in the developmental toxicity tests and the neurodevelopmental toxicity test, a decreased survival rate occurred in the pups at the dose where toxicity was observed in parental animals in the two-generation test with rats. Therefore, this substance was classified in Category 2.
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	This substance is an organophosphorus pesticide and shows cholinesterase inhibition (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), ACGIH (7th, 2003)). As for humans, there are reports that salivation, lacrimation, urinary and fecal incontinence, tightness in the chest, fatigue, weakness, weight loss, atrophied muscles, and optical media discoloration were observed as poisoning symptoms from this substance, and these symptoms were due to the neurological disorders, and were seen over multiple years after acute or chronic exposure (ACGIH (7th, 2001), Environmental Risk Assessment for Chemical Substances Vol.4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005)). Therefore, it was classified in Category 1 (nervous system). Besides, as for experimental animals, there are reports that in a single oral dose test with rats, a decrease in locomotor activity, lacrimation, salivation, increased urine volume, decreased blood pressure, bradypnea, decline in sensory acceptance, and a marked decrease in activity were observed at or above 5 mg/kg and in addition to these symptoms, incoordination, hunched posture, tremors, and lethargy were observed at or above 20 mg/kg corresponding to the lethal dose (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)). Although Category 3 (narcotic effect) was included in the previous classification, it was not adopted because the information source of the documents on the Agricultural Chemical Registration Application (1994) was unavailable, its details could not be confirmed, and the dose where lethargy occurred was the lethal dose according to the reports (A pesticide abstract and evaluation report Food and Agricultural Materials Inspection Center, 2008) and Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017). Therefore, the classification result was changed from the previous classification.
9	Specific target organ toxicity - Repeated exposure	Category 1 (haemal system, nervous system, liver)	Danger	H372	P260 P264 P270 P314 P501	No information on humans is available. As for experimental animals, in a 90-day repeated oral dose toxicity test with rats by feeding, inhibition of erythrocyte cholinesterase activity (20% or more) was observed at or above 25 ppm (male: 1.48 mg/kg/day, female: 1.89 mg/kg/day) within the guidance value range for Category 1, and decreases in erythrocyte count, amount of hemoglobin and hematocrit value, and blood glucose, inhibition of brain cholinesterase activity, and hemosiderin deposition in the spleen were observed at 125 ppm (male: 7.34 mg/kg/day, female: 11.6 mg/kg/day) within or near the upper limit of the guidance value range for Category 1. In a 90-day repeated oral dose toxicity test with dogs by gavage, decreases in erythrocyte count and hematocrit value, inhibition of brain and erythrocyte cholinesterase activity, pigment deposit in the Kupffer cells in the liver, etc., were observed at 3.0 mg/kg/day within the guidance value range for Category 1 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)). In a 90-day inhalation toxicity test with rats (6 hours/day, 5 days/week), inhibition of erythrocyte cholinesterase activity was observed at or above 0.0008 mg/L (converted guidance value: 0.00058 mg/L) which is within the range of Category 1, in females, and at 0.008 mg/L (converted guidance value: 0.0058 mg/L) in males (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)). In a 21-day dermal exposure toxicity test with rats, inhibition of erythrocyte cholinesterase activity was observed at or above 1.5 mg/kg/day (converted guidance value: 0.35 mg/kg/day) within the guidance value range for Category 1, inhibition of brain cholinesterase activity was observed at or above 5.0 mg/kg/day (converted guidance value: 1.2 mg/kg/day), and tremors, hunched posture, emaciation, suppression of weight gain, and multifocal hepatocyte degeneration/necrosis, etc., were observed at 15.0 mg/kg/day (converted guidance value: 3.5 mg/kg/day) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)). From the above, because the effects on the haemal system and nervous system in the oral route, the effect on the nervous system in the inhalation route, and the effects on the nervous system and liver in the dermal route were observed, and all of them were observed at the doses within the guidance value range for Category 1, it was classified in Category 1 (haemal system, nervous system, liver). The classification result was different from the previous classification by using a new information source.
10	Aspiration hazard	Classification not possible	- -	-	-	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	From 26-hour EC50 (immobile) = 0.00006 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003)), it was classified in Category 1.
11	Hazardous to the aquatic environment (Long-term)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 1 due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 3% (J-CHECK, 1983)), and 31-34-day NOEC (growth) = 0.0111 mg/L for fish (Pimephales promelas) (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003)). 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 due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 3% (J-CHECK, 1983)), and 26-hour EC50 (immobile) = 0.00006 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003)). From the above results, it was classified in Category 1.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.

NOTE:

* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government,
and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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