GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 122-14-5 |
| Chemical Name | O,O-Dimethyl-O-(3-methyl-4-nitrophenyl) thiophosphate [Fenitrothion] |
| Substance ID | H29-B-076 |
| 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 |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Explosives | Not applicable |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. |
| 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 |
- |
- | - | Although a flash point of 157 deg C (unknown method) (GESTIS (Access on July 2017)) is from unknown method, it is judged that it will be above 93 deg C also in the proscribed closed-cup method, therefore, it was classified as "Not classified." |
| 7 | Flammable solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 8 | Self-reactive substances and mixtures | Not applicable |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. |
| 9 | Pyrophoric liquids | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 315 deg C (List of guidelines for chemical disaster prevention (1996)). |
| 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 metalloids (P), but it is estimated that it does not react vigorously with water from the measurement data of water solubility of 21 mg/L (20 deg C) (GESTIS (Access on July 2017)). |
| 13 | Oxidizing liquids | 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 (N, P). However, the classification is not possible due to no data. |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule |
| 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 4 |
 Warning |
H302 |
P301+P312
P264 P270 P330 P501 |
Based on reports of LD50 values for rats of 330 mg/kg (male), 800 mg/kg (female), 660 mg/kg (male), 1,050 mg/kg (female), 415 mg/kg (male), 860 mg/kg (female), 1,700 mg/kg (male), 1,720 mg/kg (female) (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2014)), 740 mg/kg (male) and 570 mg/kg (female) (JMPR (1970)), it was classified in Category 4. |
| 1 | Acute toxicity (Dermal) | Category 4 |
Warning |
H312 |
P302+P352
P362+P364 P280 P312 P321 P501 |
There are six reports of LD50 values of 890 mg/kg (male), 1,200 mg/kg (female), 2,700 mg/kg (male), about 5,000 mg/kg (female), 1,260 mg/kg (male) and 1,910 mg/kg (female) for rats (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2014)), 1 case corresponds to Category 3, 3 cases correspond to Category 4, and 2 cases correspond to "Not classified" (Category 5 in UN GHS classification). It was classified in Category 4 by adopting the category with the largest number of reports. |
| 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) | Classification not possible |
- |
- | - | There are reports of LC50 values of 4-hour inhalation exposure tests of > 0.186 mg/L (male and female), > 2.21 mg/L (male and female) for rats (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2014)), however, it was classified as "Classification not possible" because it was impossible to determine the category based on only these values. Besides, since the LC50 values were higher than the saturated vapor pressure concentration of 0.002 mg/L (0.178 ppm), the reference values in the unit of mg/L were applied as mist. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | Based on a report that skin irritation was not observed in a skin irritation test with rabbits (EHC 133 (1992), Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2014)), it was classified as "Not classified." The category was revised based on the information obtained in this research. |
| 3 | Serious eye damage/eye irritation | Category 2B |
Warning |
H320 |
P305+P351+P338
P337+P313 P264 |
In eye irritation tests with rabbits, there were reports as below: in the case of unwashed eyes after applying this substance, slight hyperaemia in the conjunctiva was observed 1 hour after application, but this disappeared within 48 hours, so this substance was a slight irritant (EHC 133 (1992)); slight or no eye irritation was observed (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2014)). From the above, since it was judged to be a slight irritant, it was classified in Category 2B. The category was revised based on the information obtained in this research. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, it is described that in a sensitization test by inhalation with guinea pigs, this substance is considered not to have the potential to provoke allergic asthma (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2014)), however, it was classified as "Classification not possible" because the details were unknown. Because a pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 1993) used in the previous classification was not available, the category was revised based on the information obtained in this research. |
| 4 | Skin sensitization | Category 1 |
Warning |
H317 |
P302+P352
P333+P313 P362+P364 P261 P272 P280 P321 P501 |
It is reported that in a skin sensitization test (maximization test) with guinea pigs, positive rates were 70% (both in 24 and 48 hours after challenge) in the challenge with a 5% solution of this substance, and 30% (after 24 hours) and 40% (after 48 hours) in a challenge with a 0.5% solution, and high positive rates were shown (EHC 133 (1992)). Additionally, there is a report that in a skin sensitization test (Landsteiner-Draize test) with guinea pigs, it was negative in the skin sensitization (EHC 133 (1992), Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2014)). The results from the maximization test which was more sensitive were preferentially adopted, and it was classified in Category 1. Because a pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 1993) used in the previous classification was not available, the category was revised based on the information obtained in this research. |
| 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, all were negative in dominant lethal tests, micronucleus assays, chromosomal aberration tests with rats and mice, and unscheduled DNA synthesis tests in hepatocytes of rats (EHC 133 (1992), Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2014)). As for in vitro, it was positive for Salmonella typhimurium TA 100 in bacterial reverse mutation tests, however, it was negative for other strains; it was negative in mammalian cell gene mutation tests, chromosomal aberration tests, sister chromatid exchange tests (EHC 133 (1992), Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2014)). Regarding the positive result with Salmonella typhimurium TA 100, this is estimated to be due to the nitroreductase that TA 100 has (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2014)). |
| 6 | Carcinogenicity | Not classified |
- |
- | - | In the combined chronic toxicity/carcinogenicity studies with rats or mice dosed by feeding for 2 years, and in the carcinogenicity tests with mice dosed by feeding for 18 months, a significant increase in the frequency of hepatocellular adenomas (27/50 cases versus 16/50 cases in the control group) was observed in males at 100 ppm in a 2-year test with mice dosed by feeding, but there was no dose correlation, so it was not considered to be an effect by administration. In addition, there was no increase in the frequency of neoplastic lesions in any other tests, and it was concluded as no carcinogenicity (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2014)). This substance was classified in Group E (Evidence of non-carcinogenicity for humans) for carcinogenicity by EPA (EPA Pesticide (1995)). From the above, it was classified as "Not classified." |
| 7 | Reproductive toxicity | Category 2 |
 Warning |
H361 |
P308+P313
P201 P202 P280 P405 P501 |
In a 1-generation study with mice dosed by feeding at a maximum of 60 ppm, no effect was observed both in F0 dams and F1 pups (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2014)). However, in a 2-generation study with rats dosed by feeding at a maximum of 120 ppm, as for parental animals, decreased weight gain was observed at 120 ppm in males and females of F0 and F1 excluding F1 of females (decreased weight gain at 40 ppm, loose stools and tremors at 120 ppm), and both in F1 and F2 pups, an increase in the number of dead pups, a decrease in a 4-day survival rate, and a decrease in the weaning rate were observed at 120 ppm in addition to decreased weight gain and deterioration of the general condition (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2014)). Additionally, in a 3-generation study with rats dosed by feeding at maximum 150/100 ppm (regarding F1, dose reduction from 150 ppm to 100 ppm after weaning), at high dose (150/100 ppm), decreased weight gain in F0, F1, F2 parental animals and a decreased survival rate at weaning in F1, F2, F3 pups were observed (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2014)). On the other hand, in developmental toxicity studies with pregnant rats and pregnant rabbits dosed by gavage during the organogenesis period, no development effect in fetuses was observed even at the dose where the general toxic effects (decreased weight gain, tremors etc. (rat), death, decreased weight gain, abortion (rabbit)) were observed in maternal animals (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2014), PATTY (6th, 2012), EPA Pesticide (1995)). From the above, since in the 2-generation or 3-generation studies with rats, a decreased survival rate of pups was observed at the dose where the general toxic effects were observed in the parental animals, it was classified in Category 2 for this hazard class. Besides, the classification result was changed based on the new information source after the previous classification ("Not classified"). |
| 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 organophosphorous pesticide and inhibits cholinesterase activity (JMPR (1970), Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2014)). As for humans, there are the reports as below; as poisoning symptoms, initially exhaustion, headache, weakness, confusion, vomiting, abdominal pain, excessive sweating, salivation, and pupillary constriction occur. Difficulty in breathing may be experienced, due to either congestion of the lungs or weakness of the respiratory muscles. It is reported that in severe cases, muscle spasms, unconsciousness, and convulsions may develop and death may result from respiratory failure (EHC 133 (1992)). As for experiential animals, in a single exposure study by oral, dermal and inhalation with rats, there was a report that reduction of spontaneous locomotion, irregular breathing, dyspnea, ataxia, salivation, tremors, spasms, clonic convulsion, exophthalmos, piloerection and lacrimation were observed. The effect on the nervous system in animal studies was shown at or above 50 mg/kg within the range for Category 1 (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2014)). From the above, it 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 |
No information on humans is available. As for experimental animals, in a 90-day toxicity test with rats dosed by feeding, the erythrocytes/brain-cholinesterase activity inhibition at or above 60 ppm (male: 3.05-5.88 mg/kg/day, female: 3.96-5.96 mg/kg/day) within the guidance value range for Category 1 and decreased grip strength of the forelimbs at 200 ppm (male: 10.6-18.5 mg/kg/day, female: 14.9-20.7 mg/kg/day) within the guidance value range for Category 2 were observed. Additionally, also in a 6-month toxicity test with rats dosed by feeding, and in a 2-year toxicity test with rats, dogs and monkeys dosed by feeding, the erythrocytes/brain-cholinesterase activity inhibition (more than 20%) was observed within the guidance value range for Category 1. Moreover, in a 28-day inhalation toxicity test with rats (2 hours/day, 5-6 days/week), at or above 0.015 mg/L (converted guidance value: 0.0016 mg/L) within the guidance value range for Category 1, erythrocytes/brain-cholinesterase activity inhibition (more than 20%) and decreased absolute or relative weight of the ovary were observed. In a 28-day inhalation toxicity test with mice (2 hours/day, 5-6 days/week), at or above 0.062 mg/L (converted guidance value: 0.0064 mg/L) within the guidance value range for Category 1, erythrocytes/brain-cholinesterase activity inhibition (more than 20%) was observed (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2014)). From the above, it 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 96-hour LC50 = 0.000021 mg/L for crustacea (Caridina rajadhari) (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 |
Due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 0% (J-CHECK, 1979)), and 21-day NOEC (reproduction inhibition) = 0.000009 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003), ECETOC TR91: 2003), it was classified in Category 1. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
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* 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. |