GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 99485-76-4 |
| Chemical Name | 1-(2-Chlorobenzyl)-3-(1-methyl-1-phenylethyl)urea [cumyluron] |
| Substance ID | H27-A-04-METI/M-004A_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) | Category 4 |
 Warning |
H302 | P301+P312 P264 P270 P330 P501 |
Two LD50 values of 2,074 mg/kg (males) and 961 mg/kg (females) for rats were reported (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2007)). Because one corresponds to "Not classified" (Category 5 in UN GHS classification), and the other corresponds to Category 4, the substance was classified in Category 4 by adopting the safe side. |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | From a reported LD50 value of > 2,000 mg/kg (males, females) for rats (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2007)), 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 > 6.21 mg/L for rats (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2007)), 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 |
- |
- | - | It is reported that in a skin irritation test using rabbits, this substance was not irritating from all irritation scores of 0 after 4-hour application of 500 mg the substance (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2007)). 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 an eye irritation test using rabbits, this substance was slightly irritating because conjunctival redness, edema, and discharge were observed after application of 100 mg the substance in a conjunctival sac but resolved after 48 hours. (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2007)) 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 sensitization reaction by the substance was not observed after induction and challenge (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2007)). 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 |
- |
- | - | Because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government, it was classified as "Classification not possible." As for in vivo, a micronucleus test in mice in oral administration was negative (Pesticide abstract (2007); Japan Crop Protection Association: Pesticide safety information, Food sanitation research Vol.49 No.6 (1999)). As for in vitro, a bacterial reverse mutation test and a chromosomal aberration test in cultured mammalian cells were positive (Pesticide abstract (2007); Food sanitation research, Vol.49 No.6 (1999)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | In a carcinogenicity test in 2-year diet administration of this substance in rats or mice, in rats, dose-related tumor lesions were not observed at the doses up to 1,600 ppm where weight gain reduction was found in both males and females (Pesticide abstract (2007)). However, in mice, a significantly increased incidence of hepatocellular adenoma was observed in both males and females at the dose of 1,200 ppm (Pesticide abstract (2007)). Although an increased incidence of hepatocellular adenoma was observed in male and female mice, it is difficult to consider that a mechanism of occurrence is through genotoxicity due to the results of genotoxicity tests. Therefore, Food Safety Commission of Japan concluded that a threshold could be set in an evaluation of this substance (Pesticide evaluation report, Food Safety Commission of Japan (2007)). From the above, from the carcinogenicity test result, an increase of liver tumor was limited to benign tumor in mice, and there is no evidence of tumor 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 | Classification not possible |
- |
- | - | In a two-generation breeding toxicity test using rats in diet administration, F0 (P) generation showed increased deaths (mortality: males 28% (7/25), females 12% (3/25)), weight gain reduction, and decreased food consumption at the dose of 3,600 ppm, and dead animals showed cholecystitis and focal necrosis of hepatocytes. Almost all animals of F1 generation at 3,600 ppm died after weaning. Therefore, after mating survived male and female animals in F0 high-dose group, a lower tendency of fertility (not significant) was suggested (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2007)). However, because general toxicity effects in parent animals were severe (over 10% mortality in both males and females), it was considered that reproductive/developmental effects in a high dose group should not be used for the classification. However, in groups of mid-dose (600 ppm) or lower, significant toxic effects of either general toxicity or reproductive/developmental toxicity were not observed in either F0, F1 parent animals or F1, F2 offspring (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2007)), and a rationale for the classification was not obtained from the breeding test result in rats. Moreover, in a teratogenicity test in pregnant rats or rabbits in gavage administration during an organogenetic period, effects by administration of test substance were not observed in maternal animals or fetuses after administered at doses up to 1,500 mg/kg/day in rats and doses up to 300 mg/kg/day in rabbits. (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2007)) As above, from the results of the two-generation breeding toxicity test in rats, and the teratogenicity test using pregnant rats or rabbits, clear findings to be a rationale for the classification were not obtained, but there is no problem in doses in the teratogenicity test result. On the other hand, findings to be a rationale for the classification could have been obtained within a range of 600 and 3,600 ppm in the two-generation toxicity test. Because there are no sufficient data for evaluation of fertility effects, the substance was classified as "Classification not possible" in this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - | No human data. As for experimental animals, it is reported that in oral administration in rats (doses corresponding to Category 2), decreased spontaneous motility, diarrhea, accelerated respiration, eyelid ptosis, and pathological findings of slight thymic and testicular atrophy were observed, and a part of animals died, and remaining animals recovered. The abnormality was not found in any of oral administration in mice, dermal administration in rats, and inhalation exposure in rats (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2007)). From the above, because a target organ cannot be specified, the substance was classified as "Classification not possible." |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (liver), Category 2 (haemal system, kidney) |
 Danger Warning |
H372 H373 |
P260 P264 P270 P314 P501 |
In a 52-week gavage administration toxicity test using dogs, effects on the liver (centrilobular hypertrophy of hepatocytes) were observed at 10 mg/kg/day within a range of Category 1, and in a 13-week gavage administration toxicity test using dogs, effects on the liver (a tendency to increase alkaline phosphatase activity, increased absolute and relative liver weight, centrilobular swelling of hepatocytes in the liver) were found at 30 mg/kg/day within a range of Category 2. Moreover, in a 13-week diet administration toxicity test using rats, effects on blood (decreases in hemoglobin content, mean corpuscular volume, mean corpuscular hemoglobin content, and lymphocyte ratio, increased platelet and neutrophil ratio) were observed at 600 ppm (males: 42.3 mg/kg/day, females: 46.8 mg/kg/day) within a range of Category 2, and in a 104-week diet administration toxicity test using rats, effects on blood system were observed at 200 to 1600 ppm (males: 10.8 to 90.8 mg/kg/day, females: 13.5 to 113 mg/kg/day) within a range of Category 2, and findings observed in a 1.600 ppm dose group were decreases in hematocrit, hemoglobin content, and red blood cell count, increased hematopoiesis of spleen, and effects on the liver (absolute and relative increased weight, granulomatous foci in the liver), and effects on the kidney (chronic nephrosis) (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2007)). As above, effects on the liver 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), 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. |