GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 158237-07-1 |
| Chemical Name | 4-(2-Chlorophenyl)-N-cyclohexyl-N-ethyl-4,5-dihydro-5-oxo-1H-tetrazole-1-carboxamide [fentrazamide] |
| Substance ID | H27-A-03-METI/M-003A_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 |
- |
- | - | Because there is no information that a series of prescribed explosiveness tests was conducted, the classification is not possible. |
| 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 |
- |
- | - | Due to no data, the classification is not possible. |
| 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 |
- |
- | - | No established test method suitable for solid substances with a melting point of 140 degrees C or lower. |
| 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 | Not applicable |
- |
- | - | It is an organic compound which does not contain fluorine but contains oxygen and chlorine and the oxygen and the chlorine are not chemically bonded to the elements other than carbon or hydrogen. |
| 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 > 5,000 mg/kg for rats (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008); Food sanitation research, Vol.54 No.6 (2004)), it was classified as "Not classified." |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | From a reported LD50 value of > 5,000 mg/kg for rats (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)), 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 > 5.085 mg/L for rats (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)), it was classified as "Not classified." Besides, because a test substance is a solid, a reference value of dust was applied. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | In a skin irritation test using rabbits, after 4-hour semi-occlusive application of 500 mg this substance, it was judged as not irritating (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)). 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, after application of 0.1 mL this substance, it was not irritating (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)). 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 sensitizing because sensitization reaction by the substance was not observed after induction and challenge (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)). Because the above test is a GLP compliance test corresponding to OECD TG406, the substance was judged as "Not classified." |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | As for in vivo, a micronucleus test in mouse bone marrow cells after intraperitoneal administration was negative (Pesticide abstract (2008); Food sanitation research, Vol.54 No.6 (2004)), and as for in vitro, a bacterial reverse mutation test and a forward mutation test and a chromosomal aberration test in cultured mammalian cells were negative (Pesticide abstract (2008); Food sanitation research, Vol.54 No.6 (2004)). Therefore, the substance was classified as "Classification not possible" in accordance with Guidance. |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | In a carcinogenicity test in 2-year diet administration of this substance in rats or mice, carcinogenic lesions suspicious of the relationship with the administration of this substance were not observed in mice. However, in rats, transitional cell cancer (1 female) and transitional cell papilloma (2 females) of the bladder, transitional cell cancer of the urethra (1 male), and thyroid follicular adenoma (2 males) were observed. Moreover, incidences of transitional cell tumors from the bladder to urethra are small. However, at the same time, increased incidences of hyperplasia in transitional epithelium of the bladder were observed, and images of enhanced cellular proliferation were confirmed in a hyperplastic region by immunohistochemical staining (Pesticide abstract (2008)). Although urothelial tumors and thyroid follicular epithelial tumors occurred in a lower incidence in rats, considering results of various mechanism tests and no genotoxicity observed for this substance, it is difficult to consider that a mechanism of each tumor occurrence is through genotoxicity. Therefore, Food Safety Commission of Japan concluded that a threshold could be set in evaluation (Pesticide evaluation report, Food Safety Commission of Japan (2008)). From the above, from the carcinogenicity test result, it is thought that there is no evidence of carcinogenicity in mice and "equivocal" evidence of tumor incidence by the administration of this substance in rats. However, because there is no carcinogenicity classification result by other organization, the substance was classified as "Classification not possible" due to lack of data in this hazard class. |
| 7 | Reproductive toxicity | Category 2 |
 Warning |
H361 | P308+P313 P201 P202 P280 P405 P501 |
In a two-generation breeding toxicity test in diet administration of this substance in rats, at the dose (1,800 ppm) where F0 (P), or F1 parent animals showed general toxicity effects (findings in both P and F1 (inhibition of erythrocyte and brain cholinesterase activity, increased liver weight, liver cytoplasm becoming eosinophilic, hypertrophy of hepatocytes), findings only in F1 (weight gain reduction, hyperplasia of bladder epithelium, vacuolization of adrenal cortex (females))), decreased survival rate on day 4 after birth, weight gain reduction during a nursing period in F1 offspring, decreased litter size at birth and weight gain reduction during a nursing period in F2 offspring were observed, but effects on fertility were not found (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)). On the other hand, in a teratogenicity test using pregnant rats or rabbits in gavage administration during an organogenetic period, in rats, effects related to administration of test substance were not found at doses up to 1,000 mg/kg/day in either maternal animals or fetuses (Pesticide abstract (2008)). Moreover, in rabbits, a dose-dependent increased abortion at 40 mg/kg/day or higher, weight gain reduction and decreased food consumption at the highest 640 mg/kg/day dose were observed in maternal animals, but toxicity effects were not found in fetuses. (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)). From the above, because developmental effects in offspring were observed over two generations at the dose where general toxicity effects occurred in parent animals in the two-generation breeding toxicity test in rats, the substance was classified in Category 2 in accordance with Guidance in this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Not classified |
- |
- | - | There are no human data on this substance. As for experimental animals, there are data from tests in oral administration in rats and mice, dermal administration in rats, an inhalation exposure test in rats, and an oral administration neurotoxicity test in rats, an oral administration delayed neurotoxicity test in female chicken. (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2012)) However, because an abnormality in signs and necropsy findings was not observed in any test even after administration up to the limit doses (or maximum possible concentration), the substance was classified as "Not classified." |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (liver, gallbladder), Category 2 (nervous system) |
Danger Warning |
H372 H373 |
P260 P264 P270 P314 P501 |
In a 1-year diet administration toxicity test using dogs, effects on liver (increased liver weight, hypertrophy of hepatocytes, increased serum ALT/ALP) and effects on gallbladder (epithelial hyperplasia of gallbladder) were observed at 200 ppm (males: 5.4 mg/kg/day, females: 5.5 mg/kg/day) within a range of Category 1. (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)) Moreover, in a 24-month diet administration toxicity test using rats, effects on nervous system (erythrocyte cholinesterase activity inhibition (more than 20%), sciatic nerve myelin sheath degeneration) and effects on liver (centrilobular liver cytoplasm change) were observed at 1000 ppm (males: 52.7 mg/kg/day, females: 75.4 mg/kg/day) within a range of Category 2 (Pesticide evaluation report, Food Safety Commission of Japan (2008)). As above, effects on liver and gallbladder were observed within a range of Category 1, and effects on nervous system were found within a range of Category 2. Therefore, the substance was classified in Category 1 (liver, gallbladder), Category 2 (nervous system). |
| 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. |