Latest GHS Classification Results by the Japanese Government (edited by NITE)
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 52-68-6 |
| Chemical Name | Dimethyl 2,2,2-trichloro-1-hydroxyethylphosphonate [tichlorfon or DEP] |
| Substance ID | m-nite-52-68-6_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) |
| 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 | Not classified (Not applicable) |
- |
- | - | There are no chemical groups present in the molecule associated with explosive properties. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | "Solids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not an aerosol product. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | "Solids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | "Solids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 6 | Flammable liquids | Not classified (Not applicable) |
- |
- | - | "Solids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 7 | Flammable solids | Classification not possible |
- |
- | - | The classification is not possible due to no data. Besides, there is information that it is flammable (ICSC (1997)). | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 8 | Self-reactive substances and mixtures | Classification not possible |
- |
- | - | It contains P-O (phosphites) in chemical structure, but the classification is not possible due to no data. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 9 | Pyrophoric liquids | Not classified (Not applicable) |
- |
- | - | "Solids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 10 | Pyrophoric solids | Not classified |
- |
- | - | It is practically non-flammable (HSDB (Access on June 2015)). | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | No established test method suitable for solid substances with a melting point of 140 degrees C or lower. | FY2015 | 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 is estimated that it does not react vigorously with water from water solubility data measured. Water solubility: 154 g/L (GESTIS (Access on June 2015)). | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | "Solids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 14 | Oxidizing solids | Classification not possible |
- |
- | - | It is an organic compound which does not contain fluorine but contains and oxygen and chlorine and the element (O) is chemically bonded to an element (P) other than carbon or hydrogen. However, the classification is not possible due to no data. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | It is an organic compound that does not contain bivalent -O-O- structure in the molecule. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | No established test method suitable for solid substances. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 17 | Desensitized explosives | - |
- |
- | - | - | - | - |
| 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 4 |
 Warning |
H302 | P301+P312 P264 P270 P330 P501 |
Fourteen LD50 values for rats were reported within a range of 136-866 mg/kg (PATTY (6th, 2012); Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (2010); The Pesticide Manual (Fifteenth Edition, 2009); The WHO recommended classification of pesticides by hazard and guidelines to classification (2009); EPA Pesticide (2006); ACGIH (7th, 2003); EPA Pesticide (2001); JECFA (2000); EHC 132 (1992); IARC vol. 30 (1983); IPCS, PIM G001 (Access on June 2015)). Because one among them corresponds to Category 3, and eight correspond to Category 4, it was classified in Category 4 to which most of the data correspond. Besides, five were not included in a number due to being a summarized value from multiple data. Instead of the information in Agricultural Chemical Registration Data (1998) (253 mg/kg as an LD50 value for rats), the rationale for previous classification, by adding the information with higher precedence of PATTY (6th, 2012), Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (2010), EPA Pesticide (2006), ACGIH (7th, 2003), EPA Pesticide (2001), EHC 132 (1992), IARC vol. 30 (1983), IPCS, PIM G001 (Access on June 2015), WHO recommended classification of pesticide, and Pesticide manual that were newly obtained for the search this time, the classification was revised. WHO recommended classification of pesticide, and Pesticide manual listed 250mg/kg as an oral LD50 value for rats, and classified in Category 3. However, it was not included in a number because it is a representative value of multiple data which overlap with other data. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | Three LD50 values of > 2,000 mg/kg (ACGIH (7th, 2003), EHC 132 (1992), IARC vol. 30 (1983)), 2,800 mg/kg (ACGIH (7th, 2003), EHC 132 (1992), IARC vol. 30 (1983)), and > 5,000 mg/kg (Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (2010)) were reported for rats. The category could not be determined for one, and two correspond to "Not classified" (one of them to Category 5 in UN GHS classification). A reported LD50 value of 5,000 mg/kg for rabbits (EHC 132 (1992)) corresponds to "Not classified." From the above results, it was classified as "Not classified." | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 1 | Acute toxicity (Inhalation: Gases) | Not classified (Not applicable) |
- |
- | - | "Solids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 1 | Acute toxicity (Inhalation: Vapours) | Not classified (Not applicable) |
- |
- | - | "Solids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Category 3 |
 Danger |
H331 | P304+P340 P403+P233 P261 P271 P311 P321 P405 P501 |
Four LC50 values (4 hours) of 0.533 mg/L (EPA Pesticide (2006), ACGIH (7th, 2003), EHC 132 (1992)), > 1.3 mg/L (ACGIH (7th, 2003)), 0.533-1.3 mg/L (PATTY (6th, 2012), Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (2010)), and > 2.3 mg/L (The Pesticide Manual (Fifteenth Edition, 2009)) were reported for rats. Because the category could not be determined for two, and one is a summarized value of multiple data, on the basis of 0.533 mg/L, it was classified in Category 3. Besides, a reference value of mist/dust was applied because the LC50 value is higher than the saturated vapour pressure concentration (1.08x10-4 mg/L). By adding PATTY (6th, 2012), Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (2010), The Pesticide Manual (Fifteenth Edition, 2009), EPA Pesticide (2006), ACGIH (7th, 2003), EHC 132 (1992) that take precedence and were newly obtained for the search this time, the Category was revised. | FY2015 | 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, no irritation was reported after 24-hour application of this substance to the normal and damaged skin (EHC 132 (1992)), and no irritation was reported after 4-hour application of this substance (EHC 132 (1992)). From the above results, it was judged to be "Not classified." | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 3 | Serious eye damage/eye irritation | Category 2A |
Warning |
H319 | P305+P351+P338 P337+P313 P264 P280 |
It is reported in an eye irritation test using rabbits that moderate irritation was observed 24 hours or 5 minutes after application with this substance, and this substance was moderately irritating to eyes (EHC 132 (1992), PATTY (6th, 2001), ACGIH (7th, 2003)). Therefore, it was classified in Category 2A. Agricultural Chemical Registration Data for the previous classification could not be confirmed. From classification based on published documents, the Category was revised. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 4 | Skin sensitization | Category 1 |
Warning |
H317 | P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501 |
In 2 reports from skin sensitization tests using guinea pigs (a maximization test and an open epicutaneous test), it is reported that it was sensitizing (EHC 132 (1992)). Moreover, it is written that this substance is a moderate sensitizer (ACGIH (7th, 2003), EPA Pestiside (2006)). From the above, it was classified in Category 1. Besides, this substance is classified in "Skin Sens. 1 H317" in EU CLP classification (ECHA CL Inventory (Access on September 2015)). | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 5 | Germ cell mutagenicity | Category 1B |
 Danger |
H340 | P308+P313 P201 P202 P280 P405 P501 |
As for in vivo, a dominant lethal test in mice gave positive and negative results (EHC 132 (1992), ACGIH (7th, 2003)), and a chromosomal aberration test in mouse reproductive cells (testicular cells) had positive and negative results (EHC 132 (1992)). A micronucleus test in mouse bone marrow cells was negative (EHC 132 (1992), NTP DB (Access on July 2015)), and a chromosomal aberration test in bone marrow cells of mice and hamsters gave positive and negative results. (EHC 132 (1992), ACGIH (7th, 2003), Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (2010)). Moreover, a sister chromatid exchange test in mouse bone marrow cells was positive (ACGIH (7th, 2003)), and a DNA damage (DNA adduct formation) test in mouse liver was positive (ACGIH (7th, 2003)). As for in vitro, a bacterial reverse mutation test, a chromosomal aberration test, a sister chromatid exchange test in human lymphocytes and cultured mammalian cells, a mouse lymphoma test in cultured mammalian cells, an unscheduled DNA synthesis test in human cells (epithelial cells, fibroblasts) and rat hepatocytes showed positive results. (EHC 132 (1992), EPA Pesticide (2001), ACGIH (7th, 2003), NTP DB (Access on July 2015), Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (2010)) From the above, it was classified in Category 1B. Besides, the previous classification was conducted using Agricultural Chemical Registration Data. |
FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | As the existing classification for this substance, it is classified in Group 3 by IARC (IARC vol. 30 Suppl. 7 (1987)), A4 by ACGIH (ACGIH (7th, 2003)). As test data, in a combined chronic toxicity/carcinogenicity test in rats or mice in 2-year diet administration, increased incidences of alveolar/bronchiolar adenomas or carcinomas in both rats and mice and hepatocellular adenomas in mice were observed (EPA Pesticide (2001), ACGIH (7th, 2003)). However, the EPA OPP (Office of Pesticide Program) Peer Review Committee of the US judged that either tumor is not the effect by dosing test substance due to no statistical significance and lacking consistency in dose relationship (EPA Pesticide (2001), ACGIH (7th, 2003)). From the above, it was classified as "Classification not possible" in accordance with the Classification Guidance revised after the previous classification. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 7 | Reproductive toxicity | Category 1B |
Danger |
H360 | P308+P313 P201 P202 P280 P405 P501 |
There is no information on reproductive effects in humans. As for experimental animals, results were reported from a three-generation reproductive toxicity test and a two-generation reproductive toxicity test using rats in diet administration. In the three-generation test, decreased litter size and decreased body weight of offspring at the dose of 1,000 ppm (about 50 mg/kg/day) or higher, and a decreased pregnancy rate, dwarf pups, and deaths of all pups by weaning at 3,000 ppm (about 150 mg/kg/day) were observed (ACGIH (7th, 2003), Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (2010)). In the two-generation test, lower body weight and dilated renal pelvis were found in F1 offspring at the dose where male and female parent animals of F0 and F1 generations in a high-dose group (1,750 ppm) showed general toxicity effects such as chronic pneumonia in the lung, mineralization/hydronephrosis in the kidney (F1 generation only) (EPA Pesticide (2001), ACGIH (7th, 2003)). On the other hand, for developmental toxicity, in a test in rats or rabbits in diet or gavage administration during an organogenetic period, only delayed ossification was observed in fetuses in rats even in a high-dose group (500 ppm), and only lower body weight and delayed ossification were found in fetuses in rabbits even at the dose where abortion occurred in maternal animals (EPA Pesticide (2001), ACGIH (7th, 2003), Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (2010)). However, it is written that in gavage administration in pregnant rats in an organogenetic period or oral administration in pregnant hamsters and mice in an organogenetic period, deaths of fetuses, malformations (increased incidences of malformed fetuses and cleft palate) occurred at the doses of 300-600 mg/kg/day. As for dose relationship of maternal toxicity and developmental toxicity, it is written that teratogenicity was observed at the dose where cholinergic signs occurred in a test using pregnant rats, but maternal toxicity was not mentioned in tests in other animal species (ACGIH (7th, 2003)). Furthermore, in a test in pregnant hamsters in gavage administration on day 42-44 of gestation, maternal animals showed clinical signs at 100 mg/kg/day or higher, and decreased cerebellum weight was found in offspring (newborns immediately after natural birth, or fetuses removed around on day 64 of gestation). Because day 42-44 of gestation is regarded as the most sensitive period to cerebellum formation, WHO attached importance to these findings as the information that shows inhibition of brain development and brain hypoplasia by this substance (JECFA (2003)). As above, at the doses where general toxicity effects were found mainly in parent animals, decreased fertility in parent animals, fetal toxicity, malformations, impaired cerebellum development, and development disorder after birth in fetuses or newborns were observed. Especially by taking into account findings showing serious reproductive toxicity effects such as malformations and impaired central nervous system development, it was judged that classification in Category 1B in this hazard class is appropriate. |
FY2015 | 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 |
Toxicity effects of this substance are typical of organophosphate poisoning, and acute human toxicity is central nervous system signs or peripheral nerve signs by acetylcholinesterase inhibition (EHC 132 (1992), PATTY (6th, 2012)). It is reported that this substance inhibits cholinesterase of plasma, red blood cells, and the brain, but does not show delayed neurotoxicity (ACGIH (7th, 2003)). Multiple human poisoning cases by oral ingestion of this substance were reported. According to them, typical acute poisoning signs in humans were a headache, weakness, nausea, vomiting, dizziness, abdominal pain, diarrhea, confusion, excessive sweating, salivation, pinhole pupils, unconsciousness as well as dyspnea due to congestion of the lung and weakness of respiratory muscles, and reversible if it is slight. It is written that in serious cases in oral poisoning, there are muscle spasms and unconsciousness, and possibly resulting in polyneuropathy, death from respiratory failure at a later stage (EHC 132 (1992), PATTY (6th, 2012), EPA Pesticide (2006)). Besides, it is reported that this substance was used to treat human Alzheimer disease (EPA Pesticide (2001), ACGIH (7th, 2003), EHC 132 (1992)). As acute toxicity signs in rats, muscular fibrillation, salivation, lacrimation, incontinence, diarrhea, dyspnea, weakness, gasping, tonic-clonic convulsion, coma, and deaths were observed. It is reported that poisoning signs by this substance occurred rapidly, within five minutes even at the dose of LD50 (EHC 132 (1992)). Salivation, tremor, eyelid ptosis, and diarrhea were found in rats in oral administration at 100 mg/kg (a dose corresponding to Category 1) (ACGIH (7th, 2003)). From the above, because this substance has effects on nervous system, it was classified in Category 1 (nervous system). Besides, the previous classification was conducted using Agricultural Chemical Registration Data. The Category of the previous classification was revised. |
FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (nervous system, blood), Category 2 (gastrointestinal tract, liver, kidney, testis, ovary) |
Danger Warning |
H372 H373 |
P260 P264 P270 P314 P501 |
As for humans, it is reported that other than inhibition of red blood cell cholinesterase, gastrointestinal disturbance, muscle cramp, abdominal discomfort, a headache, muscle weakness, weakness, coordination difficulties, and electroencephalogram abnormalities were observed as cholinergic effects (ACGIH (7th, 2003), PATTY (6th, 2012)). As for experimental animals, in a 10-year oral administration toxicity test using monkeys, decreased body weight, anemia, cholinergic effects of miosis, muscle fasciculation, and diarrhea were observed at 5.0 mg/kg/day within a range of Category 1 (ACGIH (7th, 2003), EPA Pesticide (2001), PATTY (6th, 2012), EHC 132 (1992)). In a 13-week repeated oral administration toxicity test using rats, other than inhibition of plasma and erythrocyte cholinesterase activity at 100 ppm (6.08-6.91 mg/kg/day) within a range of Category 1, impaired aerial righting reflex, colored urine, decreased spontaneous motility, degeneration in myelin of spinal nerve cord were found at 2,500 ppm (165-189 mg/kg/day) above Category 2 (Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (2010), PATTY (6th, 2012)). In a 1-year repeated oral administration toxicity test using dogs, other than inhibition of plasma and erythrocyte cholinesterase activity at 250 ppm (6.25 mg/kg/day) within a range of Category 1, enlargement of the spleen, congestion with atrophy of white pulp region in the spleen, and foci of inflammatory cells in the liver were observed at 1,000 ppm (25 mg/kg/day) within a range of Category 2 (ACGIH (7th, 2003), PATTY (6th, 2012), EPA Pesticide (2001)). In multiple chronic toxicity tests (17 to 24 months) using rats and mice in an oral route, other than inhibition of plasma/erythrocyte/brain cholinesterase activity within a range of Category 2, in rats, colored urine, anemia, thickened duodenum, gastritis, inflammation of the lung, hepatocellular vacuolization/hyperplasia in the liver, chronic nephropathy, aspermatogenesis, and the absence of primary follicles/primitive ova in the ovary were found (ACGIH (7th, 2003), EPA Pesticide (2001), PATTY (6th, 2012), EHC 132 (1992)). Therefore, the substance was classified in Category 1 (nervous system, blood), Category 2 (digestive tract, liver, kidney, testis, ovaria). |
FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 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 EC50 = 0.18 micro g/L for crustacea (Daphnia pulex) (U.S. EPA: RED, 2001), it was classified in Category 1. | FY2015 | 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 |
Reliable chronic toxicity data were not obtained. Due to lack of rapid degradability (BioWin), and acute toxicity Category 1, it was classified in Category 1. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
NOTE:
|