GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 732-11-6
Chemical Name O,O-dimethyl phthalimidomethyl S-phosphorodithioate; Phosmet
Substance ID R02-B-071-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 Not classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."
2 Flammable gases Not classified (Not applicable)
-
-
- - Solid (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)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
5 Gases under pressure Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
6 Flammable liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
7 Flammable solids Classification not possible
-
-
- - No data available. Besides, there is information that it is not combustible (RAC Background Document (2016)), and it is combustible (ICSC (2004)).
8 Self-reactive substances and mixtures Not classified (Not applicable)
-
-
- - There are no chemical groups present in the molecule associated with explosive or self-reactive properties. It was classified as "Not classified."
9 Pyrophoric liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
10 Pyrophoric solids Not classified
-
-
- - It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from information that it does not ignite below the melting point (72 deg C) (RAC Background Document (2016)).
11 Self-heating substances and mixtures Classification not possible
-
-
- - Classification is not possible because 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 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 24.4 mg/L (20 deg C) (HSDB (Access on May 2020)).
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
14 Oxidizing solids 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). However, the classification is not possible due to no data.
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
-
-
- - Classification is not possible because test methods applicable to solid substances are not available.
17 Desensitized explosives Not classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS
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
[Rationale for the Classification]
It was classified in Category 3 from (1) - (7).

[Evidence Data]
(1) LD50 for rats: 92-310 mg/kg (Canada Pesticides (2017))
(2) LD50 for rats: 92.5-164 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012))
(3) LD50 for rats: 113 mg/kg (EPA Pesticides RED (2006), EU CLP CLH (2016), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012))
(4) LD50 for rats: 121 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012))
(5) LD50 for rats: males: 135-310 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012))
(6) LD50 for rats: females: 224-369 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012))
(7) LD50 for rats: 230 mg/kg (EU CLP CLH (2016))
1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
Because the category cannot be determined from data for rats in (1), it was classified as "Not classified" from data for rabbits in (2) - (6).

[Evidence Data]
(1) LD50 for rats: > 1,000 mg/kg (CLH Report (2015), RAC Background Document (2016), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012))
(2) LD50 for rabbits: 3,160 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012))
(3) LD50 for rabbits: 3,160 - > 5,000 mg/kg (Canada Pesticides (2017))
(4) LD50 for rabbits: > 3,160 mg/kg (GESTIS (Access on May 2020))
(5) LD50 for rabbits: > 4,600 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012))
(6) LD50 for rabbits: > 5,000 mg/kg (CLH Report (2015), EPA Pesticides RED (2006), RAC Background Document (2016), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), Patty (6th, 2012))
1 Acute toxicity (Inhalation: Gases) Not classified
-
-
- - [Rationale for the Classification]
Solid (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) Category 2


Danger
H330 P304+P340
P403+P233
P260
P271
P284
P310
P320
P405
P501
[Rationale for the Classification]
It was classified in Category 2 from (1), (2).
Besides, because exposure concentrations were higher than the saturated vapor pressure concentration (8.4E-006 mg/L), a reference value in the unit of mg/L was applied as dust.

[Evidence Data]
(1) LC50 for rats (4 hours): 0.054 mg/L (GESTIS (Access on May 2020))
(2) LC50 for rats (4 hours): > 0.152 mg/L (EPA Pesticides RED (2006), RAC Background Document (2016), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012))
(3) Vapor pressure of this substance: 4.9E-007 mmHg (20-25 deg C) (HSDB (Access on May 2020)) (converted value for the saturated vapor pressure concentration: 8.4E-006 mg/L)

[Reference Data, etc.]
(4) LC50 for rats (4 hours): 1.12 mg/L (extrapolated from (6)) (RAC Background Document (2016))
(5) LC50 for rats (4 hours): 1.6 mg/L (70% wettable powder) (RAC Background Document (2016))
(6) LC50 for rats (1 hour): 2.76 mg/L (converted 4-hour equivalent value: 0.69 mg/L) (HSDB (Access on May 2020))
2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1) - (4). Because new data (1) - (4) were obtained, the classification result was changed.

[Evidence Data]
(1) In a skin irritation test with rabbits similar to OECD TG 404, no irritation reactions were seen at 24 hours after application (CLH Report (2015), RAC Background Document (2016)).
(2) In a skin irritation test with rabbits according to EPA OPPTS 870.2500, it was not irritating (EPA Pesticides RED (2006)).
(3) This substance was not irritating in a skin irritation test with rabbits (Draize test) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
(4) This substance was not a skin irritant (HSDB (Access on May 2020)).
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
[Rationale for the Classification]
It was classified in Category 2B from (1) - (4).

[Evidence Data]
(1) This substance caused moderate eye irritation (Canada Pesticides (2017), HSDB (Access on May 2020)).
(2) In an eye irritation test with rabbits similar to OECD TG 405, 1/3 animals showed corneal opacity, conjunctival redness and edema, and discharge but recovered by 7 days after application (CLH Report (2015), RAC Background Document (2016)).
(3) In an eye irritation test with rabbits according to EPA OPPTS 870.2400, it was a moderate irritant (EPA Pesticides RED (2006)).
(4) This substance was slightly irritating to the eye (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2). The classification result was changed due to new data in (1), (2) obtained.

[Evidence Data]
(1) This substance did not cause skin sensitization (Canada Pesticides (2017)).
(2) In a skin sensitization test with guinea pigs (modified Buehler test), 1 out of 10 animals (positive rate 10%) showed a positive response (CLH Report (2015), RAC Background Document (2016), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1) - (3).

[Evidence Data]
(1) As for in vivo, it was negative in micronucleus tests with bone marrow cells after oral or intraperitoneal administration to mice, negative in an unscheduled DNA synthesis test with hepatocytes after oral administration to rats (EU CLP CLH (2016), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), Canada Pesticides (2017)), and negative in comet assays with the liver or kidney after intraperitoneal administration to mice (EU CLP CLH (2016)). Besides, it is reported that it was positive in a chromosomal aberration test with bone marrow cells after oral administration to mice, but because the increase in chromosome aberrations observed was not dose-dependent, the test result was not considered acceptable (RAC Background Document (2016)).
(2) As for in vitro, it was reported to be positive and negative in bacterial reverse mutation tests. It was reported in test systems in cultured mammalian cells that it was positive and negative in chromosomal aberration tests, positive in a sister chromatid exchange test, positive in a gene mutation test (EU CLP CLH (2016), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), Canada Pesticides (2017)), and negative in a cell transformational test (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), Canada Pesticides (2017)).
(3) As assessment of mutagenicity of this substance, RAC concluded that the weight of evidence suggested no in vivo genotoxic potential, despite the possibility of in vitro genotoxicity (RAC Background Document (2016)), and the Food Safety Commission of Japan stated that it did not have genotoxicity that could pose a problem in vivo (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
6 Carcinogenicity Not classified
-
-
- - [Rationale for the Classification]
From (1), (2), although EPA classified it in S, it was classified as "Not classified" based on the decisions by JMPR, EU EFSA, and the Food Safety Commission of Japan.

[Evidence Data]
(1) As for classification results by domestic and international organizations, EPA classified it in S (suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential) (EPA Annual Cancer Report 2019 (Access on August 2020): classified in 1999).
(2) In chronic toxicity/carcinogenicity tests by 2-year diet administration of this substance to male and female rats and mice, no carcinogenicity was observed in male and female rats and female mice. In male mice, hepatocellular adenoma occurred, but there was no significant difference in the incidence, and JMPR concluded that there was no evidence of carcinogenicity in mice (JMPR (1994)). Because the incidence of liver tumors in mice was slightly higher than the incidence of control values in the same laboratory approximately the same time, the experts of EU EFSA did not classify the substance as carcinogenic with R40 (Limited evidence of a carcinogenic effect) (EU EFSA (2011)). The Food Safety Commission of Japan supported the decision by EU EFSA (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on (1), a reduction in mating index and fertility index, etc. were observed at a dose at which reduced body weight gain, etc. were observed in parent animals, and therefore, it was classified in Category 2.

[Evidence Data]
(1) In a two-generation reproductive study with rats dosed by feeding, a reduction in mating index and fertility index were observed at a dose at which inhibition of erythrocyte cholinesterase (ChE) activity and reduced body weight gain were observed; and reductions in the number of pups born, incidence of pups with a low body weight, and survival rate of offspring were observed at a dose at which a decrease in food consumption in parent animals, dehydration in females, and a decrease in testis weight and hepatocellular vacuolization in males were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), EU CLP CLH (2016)).

[Reference Data, etc.]
(2) In a developmental toxicity study with female rats dosed by gavage on days 7 to 16 of gestation, even at a dose at which a decrease in body weight, a decrease in food consumption, shaking, and piloerection were observed in dams, no effect was observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), EU CLP CLH (2016)).
(3) In a developmental toxicity study with female rabbits dosed by gavage on days 7 to 19 of gestation, only slight skeletal variations were observed in fetuses even at a dose at which a slight reduction in body weight gain, unsteadiness, shaking, salivation, and irregular breathing were observed in dams (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), EU CLP CLH (2016)).
(4) In a developmental toxicity study with female monkeys dosed by gavage on days 22 to 32 of gestation, no effect was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
(5) In the EU CLP classification, it was classified as Repr.2 (Access on May 2020).
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]
Based on (1) to (4), the findings of dyspnea and respiratory collapse were considered to be secondary effects due to effects on the nervous system, and therefore, it was classified in Category 1 (nervous system). A new information source was used and the classification results were changed from the previous classification.

[Evidence Data]
(1) In humans, acute exposure to this substance sometimes caused pinpoint pupils, blurred vision, headache, dizziness, muscle spasms, profound weakness, vomiting, diarrhea, abdominal pain, seizures, coma, and hypertension. Chest pain, hypotension, and dyspnea followed by respiratory collapse were also observed in some cases (HSDB (Access on May 2020)).
(2) In animal studies, acute symptoms due to this substance showed typical parasympathetic stimulation-like symptoms which were generally observed for cholinesterase (ChE) inhibitory agents. Toxic signs appeared rapidly, and symptoms such as tremor, salivation, mastication behavior, exophthalmos, bloody exudate in the eye, nose, or mouth, dyspnea, diarrhea, convulsions, and death were generally observed within 30 minutes after administration. Toxic symptoms and signs were transient, and generally disappeared rapidly within 24 to 72 hours after administration (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
(3) The above toxic symptoms were considered to occur within the range for Category 1 because, in an oral administration to rats, the LD50 values were 92.5 to 369 mg/kg, and most of them were 300 mg/kg or less (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
(4) In an acute neurotoxicity test with rats dosed by gavage, inhibition of erythrocyte ChE activity was 70% or above, and inhibition of brain ChE activity was 60% or above in a 22.5 mg/kg group (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).

[Reference Data, etc.]
(5) The symptoms of organophosphate poisoning were divided into the following three groups. Muscarinic manifestations (increased bronchial secretion, excessive sweating, salivation, lachrymation, pinpoint pupils, bronchoconstriction, abdominal cramps (vomiting and diarrhea), bradycardia), nicotinic manifestations (fasciculation of fine muscles, tachycardia), or central nervous system manifestations (headache, dizziness, restlessness, anxiety, mental confusion, convulsions, coma, depression of the respiratory center) occurred. Mild poisoning might include muscarinic and nicotinic signs only, and severe cases always showed central nervous system involvement. The clinical picture was dominated by respiratory failure, sometimes leading to pulmonary edema due to the combination of symptoms (EHC 63 (1986)).
9 Specific target organ toxicity - Repeated exposure Category 1 (nervous system), Category 2 (liver)


Danger
Warning
H372
H373
P260
P264
P270
P314
P501
[Rationale for the Classification]
Based on (1), it was reported that effects on the nervous system were observed in humans. Based on (2) to (4), it was reported that effects on the nervous system at doses within the range for Category 1 and the liver at doses within the range for Category 2 were observed in experimental animals. Therefore, it was classified in Category 1 (nervous system) and Category 2 (liver).

[Evidence Data]
(1) Multiple cases of long-term exposure due to occupational use of veterinary flea control products for animals containing this substance were reported. In these cases, erythrocyte cholinesterase (ChE) activity was within a normal range, but the symptoms of organophosphate poisoning, such as headache, dizziness, blurred vision, pinpoint pupils, shortness of breath, chest pain, tachycardia, abdominal cramps, nausea, a feeling of fatigue, and sweating, were observed (HSDB (Access on May 2020), Patty (6th, 2012)).
(2) It was reported that in a 90-day test with rats dosed by feeding, inhibition of erythrocyte and brain ChE activity was observed at 100 ppm (equivalent to 5 mg/kg/day, within the range for Category 1) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), JMPR (1994)).
(3) It was reported that in a 2-year test with rats dosed by feeding, inhibition of erythrocyte and brain ChE activities, and increased incidences and severity of fatty liver were observed at 200 ppm (males/females: equivalent to 9.4/10.9 mg/kg, within the range for Category 2 in both cases) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), JMPR (1994)).
(4) It was reported that in a 2-year test with mice dosed by feeding, convulsions, hepatocellular cytoplasmic vacuolation in males, and inhibition of brain ChE activity in females were observed at 100 ppm (equivalent to 15 mg/kg/day, within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), JMPR (1994)).
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 EC50 = 0.00211 mg/L for crustacea (Daphnia magna) (EU CLP CLH, 2016).
11 Hazardous to the aquatic environment Long term (Chronic) Category 1


Warning
H410 P273
P391
P501
It was classified in Category 1 because it was not rapidly degradable (a 28-day degradation rate in a test according to OECD TG301D 19.5% (EU CLP CLH, 2016)) and due to 21-day NOEC = 0.00078 mg/L for crustacea (Daphnia magna) (EU CLP CLH, 2016).
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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