GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 181587-01-9 |
| Chemical Name | 5-Amino-1-(2,6-dichloro-4-trifluoromethylphenyl)-4-ethylsulfinyl-1H-pyrazole-3-carbonitrile [ethiprole] |
| Substance ID | H27-A-11-METI/M-009A_P |
| Classification year (FY) | FY2015 |
| Ministry who conducted the classification | Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE) |
| New/Revised | New |
| Classification result in other fiscal year | |
| 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) | |
| 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 contains neighboring nitrogen atoms (pyrazole ring), but the classification is not possible due to no data. |
| 2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 3 | Aerosols | Not applicable |
- |
- | - | Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 5 | Gases under pressure | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 6 | Flammable liquids | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 7 | Flammable solids | Classification not possible |
- |
- | - | Due to no data, the classification is not possible. |
| 8 | Self-reactive substances and mixtures | Classification not possible |
- |
- | - | It contains neighboring nitrogen atoms (pyrazole ring), but the classification is not possible due to no data. |
| 9 | Pyrophoric liquids | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 10 | Pyrophoric solids | Classification not possible |
- |
- | - | Due to no data, the classification is not possible. |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Due to no data, the classification is not possible. |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable |
- |
- | - | Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 14 | Oxidizing solids | Classification not possible |
- |
- | - | It is an organic compound which contains fluorine, oxygen, and chlorine, and the oxygen is chemically bonded to the elements (S) other than carbon or hydrogen, but the classification is not possible due to no data. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | It is an organic compound that does not contain bivalent -O-O- structure in the molecule. |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | No established test method suitable for solid substances. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Not classified |
- |
- | - | From a reported LD50 value of > 7,080 mg/kg for rats (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014)), it was classified as "Not classified." |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | From a reported LD50 value of > 2,000 mg/kg for rats (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014)), it was classified as "Not classified." |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Not classified |
- |
- | - | From a reported LC50 value (4 hours) of > 5.21 mg/L for rats (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014)), it was classified as "Not classified." Besides, a reference value of dust was applied because test substance is a solid. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | It is reported that in a skin irritation test using rabbits applied 500 mg this substance, it was not irritating due to no skin reaction observed during a 72-hour observation period (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014)). From the above, the substance was classified as "Not classified." |
| 3 | Serious eye damage/eye irritation | Not classified |
- |
- | - | It is reported that in an eye irritation test using rabbits applied 100 mg this substance, it was not irritating due to no irritation reaction observed in cornea and iris during an observation period from 1 to 72 hours (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014)). From the above, the substance was classified as "Not classified." |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 4 | Skin sensitization | Not classified |
- |
- | - | It is reported that in a maximization test using guinea pigs, this substance was not a skin sensitizer due to no sensitization reaction observed after induction and challenge (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014)). Because the above test is a GLP compliance test corresponding to OECD TG 406, the substance was classified as "Not classified." |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | As for in vivo, a micronucleus test in mouse bone marrow cells and an unscheduled DNA synthesis test in rat hepatocytes were negative. As for in vitro, a bacterial reverse mutation test, a chromosomal aberration test in cultured mammalian cells and cultured human peripheral blood lymphocytes, and a gene mutation test in cultured mammalian cells were negative. (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2004); EPA Pesticide Fact Sheet (2012)) Therefore, the substance was classified as "Classification not possible" in accordance with Guidance. |
| 6 | Carcinogenicity | Category 2 |
 Warning |
H351 | P308+P313 P201 P202 P280 P405 P501 |
As for experimental animals, in a carcinogenicity test in oral administration (in the diet) of this substance in rats for two years, or in mice for 1.5 years, increases in thyroid follicular epithelial adenoma and hepatocellular adenoma were observed in male rats at the highest dose (250 ppm) although it is not significant. In mice, a slightly increased incidence of hepatocellular adenoma (6/50 animals, significant at 5%) was found in females at the highest dose (300 ppm) (Pesticide abstract (2015), EPA Pesticide Fact Sheet (2012)). Although increases of thyroid tumor in rats and liver tumor in mice were observed in the carcinogenicity test, it is difficult to consider that a mechanism of both is through genotoxicity, and Food Safety Commission of Japan concluded that a threshold could be set in the assessment. (Pesticide evaluation report, Food Safety Commission of Japan (2014)) As existing classification result by the international organization, EPA classified the substance in S (Suggestive Evidence of Carcinogenicity) (EPA Pesticide Fact Sheet (2012), EPA 2014 Annual Cancer Report (Access on January 2015)). As above, from the existing classification result, the substance was classified in Category 2 in this hazard class in accordance with Guidance. |
| 7 | Reproductive toxicity | Category 2 |
Warning |
H361 | P308+P313 P201 P202 P280 P405 P501 |
As for experimental animals, in a two-generation breeding toxicity test using rats in oral administration (in the diet), in parent animals, both P (F0) and F1 generation showed weight gain reduction (females), effects on the liver or thyroid (increased weight, hepatocellular hypertrophy/hypertrophy of thyroid follicular epithelial cells) in both males and females, or in either males or females at a high dose (500 ppm), and increased liver weight was also observed at a middle dose (75 ppm). However, F1 and F2 offspring showed lower body weight during a nursing period, decreased organ weight (thymus, spleen, kidney, and brain) in a necropsy at weaning at a high dose (500 ppm), and F1 offspring in a high dose group showed delayed sexual maturation (delay in acquisition of preputial separation and vaginal patency) as well (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014)). As above, offspring showed findings indicating growth reduction and delayed sexual maturation at a dose where general toxicity effects were observed in parent animals. However, toxic effects on sexual function and fertility were not found in parent animals (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014); EPA Pesticide Fact Sheet (2012)). On the other hand, as a teratogenicity test, this substance was administered by gavage to pregnant rats at 3 to 30 mg/kg/day on day 6 to 20 of gestation, or to pregnant rabbits at 0.25 to 4.0 mg/kg/day on day 6 to 28 of gestation. It is written that in rats, weight gain reduction, decreased food consumption, clarified hepatic lobules in maternal animals, and skeletal variations (increased incidences of dumbbell body of the thoracic vertebra and unossification of the first metatarsal bone) in fetuses were observed at 30 mg/kg/day (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014)). In rabbits, weight gain reduction, decreased food consumption, increased incidence of abortion in maternal animals and skeletal variations (increased incidences of incomplete ossification/unossification of the first metacarpal bone, unossification of forelimb fourth and fifth middle phalanx) in fetuses were found at 2.0 mg/kg/day or higher (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014)). However, it is reported that this substance did not show teratogenicity in either rats or rabbits (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014)). Moreover, it is also written in the US EPA report that skeletal variations or incomplete ossification were observed in fetuses at doses where maternal toxicity occurred (EPA Pesticide Fact Sheet (2012)). As above, in the breeding test in rats, offspring showed lower body weight and decreased organ weight by weaning at a dose where general toxicity occurred in parent animals, and F1 offspring showed delayed sexual maturation as well. All of these findings were considered to reflect growth reduction by weaning. However, it was judged that delayed sexual maturation is a finding that should be a rationale for the classification as developmental toxicity effects. In the teratogenicity test, slight developmental effects of incomplete ossification and skeletal variations only were observed as developmental effects. From the above, because growth reduction and delayed sexual maturation were found in the next generation at a dose where toxicity occurred in parent animals in the breeding test in rats, the substance was classified in Category 2 in this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (nervous system) |
Danger |
H370 | P308+P311 P260 P264 P270 P321 P405 P501 |
There are no human data on this substance. As for experimental animals, the following was observed (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014); EPA Pesticide Fact Sheet (2012)): decreased landing foot splay and decreased spontaneous motility in oral administration (100 mg/kg, corresponding to Category 1) in rats; no abnormal findings in dermal administration (LD50 > 2,000 mg/kg) in rats; hunched posture, eyelid ptosis, decreased respiratory rate, incoordination, tremor, and lethargy in inhalation exposure (LC50 > 5.21 mg/L, above Category 2) in rats; decreased grooming, increased grip strength of forelimb and hindlimb, closed eyelids, hunched posture, decreased landing foot splay, decreased spontaneous motility at 250 mg/kg corresponding to Category 1, closed eyelids and decreased arousal level at 35 mg/kg in oral administration neurotoxicity test in rats; and convulsion in general pharmacological test in mice in oral administration (120 mg/kg, corresponding to Category 1). From the above, because this substance has neurotoxicity, it was classified in Category 1 (nervous system). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (liver, thyroid), Category 2 (haemal system, kidney) |
Danger Warning |
H372 H373 |
P260 P264 P270 P314 P501 |
There is no report in humans. As for experimental animals, in 90-day diet administration toxicity test using rats, effects on the liver (centrilobular hepatocellular hypertrophy and so on) and effects on the thyroid (hypertrophy/hyperplasia of thyroid follicular epithelial cells and so on) in males and females, and effects on blood in females (decreases in hemoglobin content and hematocrit and so on) were observed in dose groups of 500 ppm (males 30.5 mg/kg/day, females: 37.6 mg/kg/day) within a range of Category 2 or higher (Pesticide evaluation report, Food Safety Commission of Japan (2014); Pesticide abstract (2015)). In a 90-day diet administration toxicity test using dogs, effects on the liver (males: centrilobular hepatocellular hypertrophy, females: increased alkaline phosphatase activity) were observed in males in dose groups of 90 ppm (males: 3.2 mg/kg/day) or higher, and in females in a 200 ppm dose group (females: 8.5 mg/kg/day) within a range of Category 1 (Pesticide evaluation report, Food Safety Commission of Japan (2014); Pesticide abstract (2015)). In a 2-year diet administration combined chronic toxicity/carcinogenicity test using rats, the followings was observed (Pesticide evaluation report, Food Safety Commission of Japan (2014); Pesticide abstract (2015)): effects on the liver (males: fibrosis of bile duct and so on, females: hyperplasia of bile duct and so on) in males and females, and effects on the thyroid (deposit of colloidal minerals and so on) in females in dose groups of 75 ppm (males: 3.2 mg/kg/day, females: 4.4 mg/kg/day) within a range of Category 1 or higher; effects on the kidney (males: progressive chronic nephrosis, females: arteritis/periarteritis) in males and females in a 250 ppm dose group (males: 10.8 mg/kg/day, females: 14.7 mg/kg/day) within a range of Category 2. In a 18-month diet administration carcinogenicity test using mice, effects on the liver (clear cell foci of altered hepatocytes and so on) were found in males in a 300 ppm dose group (males: 50.8 mg/kg/day) within a range of Category 2 (Pesticide evaluation report, Food Safety Commission of Japan (2014); Pesticide abstract (2015)). As above, effects on the liver and thyroid were observed from Category 1, and effects on blood system and kidney were found within a range of Category 2. Therefore, the substance was classified in Category 1 (liver, thyroid), Category 2 (blood system, kidney). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Classification not possible |
- |
- | - | No data. |
| 11 | Hazardous to the aquatic environment (Long-term) | Classification not possible |
- |
- | - | No data. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data. |
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. |