NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	18854-01-8
Chemical Name	O,O-Diethyl O-5-phenyl-3-isoxazolyl phosphorothioate [Isoxathion]
Substance ID	m-nite-18854-01-8_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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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	Classification not possible	- -	-	-	It is 1,2-oxazole which contains a chemical group associated with explosive properties. Although calculated oxygen balance is -153, and it decomposes at 160 deg C (HSDB (Access on November 2016)), the classification is not possible due to no data on decomposition energy.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified	- -	-	-	From a flash point of 210 deg C (Pesticide Manual (2006)), it was classified as "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with explosive properties (1,2-oxazoles) present in the molecule, but the classification is not possible due to no data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	It contains a metalloid (P), but it is estimated that it does not react vigorously with water due to the water solubility result of 1.9 ppm (25 deg C) measured (HSDB (Access on November 2016)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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), but the classification is not possible due to no data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	No comment on the classification of Physical Hazards	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	Based on the 4 reported LD50 values for rats of 112 mg/kg (male) (Japan Crop Protection Association (Access on October 2016), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)), 256 mg/kg (male), 242 mg/kg (male) and 180 mg/kg (female) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)), this substance was classified in Category 3.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the LD50 value of > 2,000 mg/kg (male and female) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)), this substance was classified as "Not classified." 　Besides, although there is a report of > 450 mg/kg (Japan Crop Protection Association (Access on October 2016), Risk Assessment Report (pesticides) (Food Safety Commission of Japan, 2016)), it was not used for the classification since acetone was used as a medium.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Category 4	Warning	H332	P304+P340 P261 P271 P312	Based on the LC50 values (4 hours) of 4.20 mg/L (male) and 2.04 mg/L (female) (Risk Assessment Report (pesticides) (Food Safety Commission of Japan, 2016)) for rats, this substance was classified in Category 4. Besides, since the LC50 values were higher than the saturated vapor pressure level (0.0015 mg/L), the reference value of mist was applied.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	In a skin irritation test using rabbits, although details were unknown, no skin irritation was observed (Risk Assessment Report (pesticides) (Food Safety Commission of Japan, 2016), Japan Crop Protection Association (Access on October 2016)), and it is evaluated that this substance is not irritating to the skin (Risk Assessment Report (pesticides) (Food Safety Commission of Japan, 2016)). Therefore, this substance was classified as "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	Because in an eye irritation test using rabbits, slight irritation was observed (Risk Assessment Report (pesticides) (Food Safety Commission of Japan, 2016)), this substance was classified in Category 2B.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Not classified	- -	-	-	In a skin sensitization test (Maximization test) using guinea pigs, although details were unknown, no sensitization was observed (Risk Assessment Report (pesticides) (Food Safety Commission of Japan, 2016)), and it is evaluated that this substance is not sensitizing to the skin. Therefore, this substance was classified as "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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 using bone marrow cells of mice was negative (Risk Assessment Report (pesticides) (Food Safety Commission of Japan, 2016)). As for in vitro, a bacterial reverse mutation test and a mammalian cell chromosomal aberration test were negative (Risk Assessment Report (pesticides) (Food Safety Commission of Japan, 2016), Japan Crop Protection Association (Access on October 2016)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Not classified	- -	-	-	In carcinogenicity studies in which rats and mice were dosed by feeding for two years and 98 weeks respectively, no increase in the incidence of tumor related to administration of this substance was observed (Risk Assessment Report (pesticides) (Food Safety Commission of Japan, 2016)). Therefore, since carcinogenicity was negative in two species of experimental animals, this substance was classified as "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	In a 3-generation reproductive toxicity study using rats dosed by feeding, no effects were observed in either the parent animals or the pups of each generation (Risk Assessment Report (pesticides) (Food Safety Commission of Japan, 2016)). In addition, in developmental toxicity studies using pregnant rats and pregnant rabbits dosed by gavage during the organogenesis period, in rats, at the dose (20 mg/kg/day) where death (1/25 animals), a decrease in weight gain, systemic symptoms (lethargy, reddish tear, weakness, etc.), and food consumption reduction were observed in maternal animals, only slight effects (lower body weight and increased number of dwarf pups) were observed in fetuses. In the test using rabbits, no abnormality in fetuses was observed at up to the dose (1.0 mg/kg/day) where decreased weight gains were observed in maternal animals (Risk Assessment Report (pesticides) (Food Safety Commission of Japan, 2016)). As above, in the experimental animals, findings of reproductive and developmental effects that would be the evidence of classification were not found. However, this substance is a substance that is neurotoxic as repeated dose effects, and it was not classified as "Not classified" but "Classification not possible" at this time when it is not clear whether it has developmental neurotoxicity or not.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	There is no single exposure data of this substance in humans. As for experimental animals, in a single dose study using rats dosed by gavage, sedation, lacrimation, bloody tears, salivation, nasal discharge, incontinence of urine, suppressed body weight gain, tremor, and feeble respiration were reported at 205 mg/kg, which is equivalent to category 1 (Risk Assessment Report (pesticides) (Food Safety Commission of Japan, 2016)). In addition, in another single oral dose study using rats, hunchback position, lethargy, slanted gait, tremor, hypothermia, increased motor activity, changes in sensory response (decrease in nail pinch/tail pinch response) were reported at 100 mg/kg (Risk Assessment Report (pesticides) (Food Safety Commission of Japan, 2016)). Moreover, in a single exposure by inhalation to this substance using rats, tremor, abnormal respiration, ataxia, exophthalmos, suppressed body weight gain and decrease in food consumption were reported at 2.04 - 4.20 mg/L, which is equivalent to category 2 (Risk Assessment Report (pesticides) (Food Safety Commission of Japan, 2016)). This substance is an insecticide belonging to organophosphorus compounds, and its mechanism of action is thought to exhibit insecticidal effect by inhibiting normal neurotransmission mechanism by inhibiting cholinesterase (Risk Assessment Report (pesticides) (Food Safety Commission of Japan, 2016)). Organophosphorus insecticides are known to affect the nervous system in humans in general (IPCS, PIM G001 (1989)). From the above, this substance was classified in Category 1 (nervous system).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system)	Danger	H372	P260 P264 P270 P314 P501	There is no information used for classification in humans. 　As for experimental animals, in a 90-day repeated dose neurotoxicity study using rats dosed by feeding, inhibition of erythrocyte acetylcholinesterase activity at or above 40 ppm (male: 2.77 mg/kg/day, female: 3.0 mg/kg/day) corresponding to Category 1, and hunchback position, tremor, tip toe gait, increased startle response, exophthalmos, decreased forelimb grip strength, and inhibition of cerebral acetylcholinesterase activity at 1,000 ppm (male: 72.1 mg/kg/day, female: 88.2 mg/kg/day) corresponding to Category 2 were observed. Moreover, in several studies (90-day repeated dose toxicity study, 2-year repeated dose toxicity study, etc.) using mice, rats and dogs dosed by feeding, inhibition of erythrocyte acetylcholinesterase activity and cerebral acetylcholinesterase activity were observed at or above the doses of Category 1 (Risk Assessment Report (pesticides) (Food Safety Commission of Japan, 2016)). 　Besides, in a 90-day repeated dose toxicity study using mice dosed by feeding, hepatocellular enlargement at or above 50 ppm (male: 7.0 mg/kg/day, female: 7.8 mg/kg/day) corresponding to Category 1, and adrenal medullary hyperplasia (male) at 100 ppm (male: 13.5 mg/kg/day, female: 16.2 mg/kg/day) corresponding to Category 2 were observed. In a 2-year combined repeated dose toxicity/carcinogenicity study using rats dosed by feeding, decreased leukocyte count at 2.4 mg/kg/day or more corresponding to category 1, and decrease in erythrocyte count, hemoglobin concentration, and hematocrit value, and depressed bone marrow function at 25-35 mg/kg/day corresponding to category 2 were observed (Risk Assessment Report (pesticides) (Food Safety Commission of Japan, 2016)). 　As above, effects on the nervous system were mainly observed. Effects on the blood and bone marrow function, and effects on the liver and adrenal gland were also reported. However, they were not adopted as the evidence of the classification because these were not consistently observed, . 　Therefore, this substance was classified in Category 1 (nervous system).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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	From 48-hour EC50 = 0.00019 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2003)), it was classified in Category 1.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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 due to being not rapidly degradable (BIOWIN), and 21-day NOEC (reproduction) = 0.0001 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (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 2 due to being not rapidly degradable (BIOWIN), and 96-hour LC50 = 1.3 mg/L for fish (Oncorhynchus mykiss) (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003)). 　It was classified in Category 1 by drawing a comparison between the above results.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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