GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 139920-32-4 |
| Chemical Name | (RS)-2-Cyano-N-[(R)-1-(2,4-dichlorophenyl)ethyl]-3,3-dimethylbutyramide [diclocymet] |
| Substance ID | H27-A-05-METI/M-005A_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 | Not applicable |
- |
- | - | There are no chemical groups present in the molecule associated with explosive properties. |
| 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 | Not applicable |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. |
| 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 | 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 (males, females) for rats (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008); Japan Crop Protection Association: Pesticide safety information (Access on November 2015)), it was classified as "Not classified." |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | From a reported LD50 value of > 2,000 mg/kg (males, females) for rats (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008); Japan Crop Protection Association: Pesticide safety information (Access on November 2015)), 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) | Classification not possible |
- |
- | - | The classification is not possible due to lack of data. Besides, an LC50 value (4 hours) of > 1.18 mg/L (males, females) for rats was reported (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008); Japan Crop Protection Association: Pesticide safety information (Access on November 2015)), but the category cannot be determined only by this data. Because a test substance is a solid, a reference value of dust was applied. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | It is reported that in a skin irritation test using rabbits, local reactions such as erythema and edema were not observed after application of this substance, and a primary irritation index on the Draize criteria was 0 (Pesticide abstract (2007); 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 | Category 2B |
Warning |
H320 | P305+P351+P338 P337+P313 P264 |
It is reported that in a primary eye irritation test using rabbits, this substance was slightly irritating because conjunctival erythema and edema, corneal opacity, and iris congestion were observed after application of 100 mg the substance but resolved after 72 hours. (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2008)) From the above, the substance was classified in Category 2B. |
| 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 sensitizing reaction by the substance was not observed after induction and challenge (Pesticide abstract (2007); 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 classified as "Not classified." |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | As for in vivo, a micronucleus test in mouse bone marrow cells after oral administration was negative (Pesticide abstract (2008)). As for in vitro, a bacterial reverse mutation test and a chromosomal aberration test in cultured mammalian cells were negative (Pesticide abstract (2008); Japan Crop Protection Association: Pesticide safety information (Access on November 2015); Food sanitation research, Vol.54 No.1 (2004)). Therefore, the substance was classified as "Classification not possible" in accordance with Guidance. |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | In a carcinogenicity test in diet administration of this substance for 2 years in rats, or 1.5 years in mice, in rats, tumor lesions related to administration of test substance were not observed at the doses up to 2,000 ppm where weight gain reduction tendency and high liver weight were found in males and females (Pesticide abstract (2008); Food Safety Commission of Japan (2008)). On the other hand, in mice, increased hepatocellular adenoma was observed in males at 50 ppm or higher (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)). Although an incidence of hepatocellular adenoma increased in male mice at 50 ppm or higher, it is difficult to consider that a mechanism of tumor occurrence is through genotoxicity, taking into account negatives in all genotoxicity tests and test results on a mechanism of benign liver tumors. Therefore, Food Safety Commission of Japan concluded that a threshold could be set in an assessment of this substance (Pesticide evaluation report, Food Safety Commission of Japan (2008)). As above, an increase of liver tumor was limited to a benign liver tumor in mice, and there is no evidence of carcinogenicity in rats. Moreover, there is no carcinogenicity classification result by the international organization. Therefore, the substance was classified as "Classification not possible" due to lack of data. |
| 7 | Reproductive toxicity | Not classified |
- |
- | - | In a two-generation breeding toxicity test using rats in diet administration, effects on fertility were not observed in parent animals at the doses up to 2,000 ppm where effects on the liver (increased liver weight, centrilobular hypertrophy of hepatocytes) were found in F0, F1 parent animals. However, pups of both F1 and F2 generations showed weight gain reduction during a late nursing period at 200 ppm or higher (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)). On the other hand, in a teratogenicity test in pregnant rats or rabbits in gavage administration during an organogenetic period, maternal animals of both species showed weight gain reduction after administration at doses of 1,000 mg/kg/day for rats and 300 mg/kg/day for rabbits. However, fetuses did not show abnormality related to administration of test substance (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)). From the above, except slight growth suppression found in offspring during a nursing period (not used as a rationale for the classification due to slight effects) at the doses where general toxicity effects occurred in parent animals in the two-generation breeding toxicity test in rats, there are no findings showing reproductive/developmental toxicity for this substance. Therefore, it was classified as "Not classified" in this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Not classified |
- |
- | - | There are no human data. As for experimental animals, only decreased spontaneous motility in rats and mice in oral administration (a dose above Category 2) and decreased reaction to external stimuli in rats in inhalation exposure (a dose corresponding to Category 1) were observed as findings. (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)) However, because an abnormality in signs and necropsy findings was not observed in any test even after administration up to the limit dose (or maximum possible concentration), the substance was classified as "Not classified." |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (liver) |
 Danger |
H372 | P260 P264 P270 P314 P501 |
In a 78-week diet administration toxicity test using mice, effects on the liver (increases of mass, enlarged and discolored regions in the liver, increased eosinophilic variant foci of hepatocytes) were observed at 50 to 500 ppm within a range of Category 1 (males: 8.4 to 86 mg/kg/day, females: 9.9 to 108 mg/kg/day). Moreover, in a 104-week diet administration toxicity test using rats, effects on the liver (centrilobular hypertrophy of hepatocytes) were found at 500 ppm within a range of Category 2 (males: 26.0 mg/kg/day, females: 33.9 mg/kg/day). (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)) Therefore, the substance was classified in Category 1 (liver). |
| 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. |