GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 18854-01-8 |
| Chemical Name | O,O-Diethyl O-5-phenyl-3-isoxazolyl phosphorothioate [Isoxathion] |
| Substance ID | H28-B-065, C-144B |
| Classification year (FY) | FY2016 |
| 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 |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 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. |
| 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 |
- |
- | - | From a flash point of 210 deg C (Pesticide Manual (2006)), it was classified as "Not classified." |
| 7 | Flammable solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 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. |
| 9 | Pyrophoric liquids | Classification not possible |
- |
- | - | No data available. |
| 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 |
- |
- | - | 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)). |
| 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. |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 15 | Organic peroxides | Not applicable |
- |
- | - | No comment on the classification of Physical Hazards |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | No data available. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 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. |
| 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. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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. |
| 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." |
| 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. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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." |
| 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)). |
| 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." |
| 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. |
| 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). |
| 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). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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 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. |
| 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 (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. |
| 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. |