GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 116714-46-6 |
| Chemical Name | (RS)-1-[3-Chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)phenyl]-3-(2,6-difluorobenzoyl)urea [novaluron] |
| Substance ID | H27-A-12-METI/M-010A_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 | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures due to being stable to heat up to 200 degrees C (Pesticide abstract (2013), Pesticide Handbook (2005)). |
| 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 contains oxygen, fluorine, and chlorine, and the oxygen, fluorine, and 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 (2013); Pesticide evaluation report, Food Safety Commission of Japan (2012)), 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 (2013); Pesticide evaluation report, Food Safety Commission of Japan (2012)), 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 > 5,150 mg/m3 for rats (Pesticide abstract (2013); Pesticide evaluation report, Food Safety Commission of Japan (2012)), it was classified as "Not classified." Besides, a reference value of dust was applied because the test substance is a solid. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | It is reported that in a skin irritation test using rabbits, after 4-hour occlusive application of 500 mg this substance, no irritation change was observed (Pesticide abstract (2013)). From the above, the substance was classified as "Not classified." |
| 3 | Serious eye damage/eye irritation | Not classified |
- |
- | - | In an eye irritation test using rabbits, as a result of applying 0.1 mL (72 mg) this substance, an irritation change was not observed in cornea and iris. It is reported that this substance was not irritating to eyes because redness was found in the conjunctiva but resolved after one day, (Pesticide abstract (2013)). From the above, the substance was classified as "Not classified." Besides, it is written in HSDB (Access on October 2015) that temporary but noted injury to eyes is shown (HSDB (Access on October 2015)) and that the substance is not irritating to eyes (HSDB (Access on October 2015)), but the rabbit information having detailed description was used for the classification. |
| 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, the substance was not sensitizing due to no sensitization reaction observed after induction and challenge. (Pesticide abstract (2013); Pesticide evaluation report, Food Safety Commission of Japan (2012)). Because the above test is a GLP compliance test corresponding to OECD TG 406, the substance was classified as "Not classified." Besides, it is written in HSDB (Access on October 2015) that repeated exposure could cause allergic reaction in part of humans (HSDB (Access on October 2015)) and that the substance is not a skin sensitizer (HSDB (Access on October 2015)), but they were not used for the classification due to unknown details. |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | As for in vivo, a micronucleus test in mouse bone marrow cells was negative. As for in vitro, a bacterial reverse mutation test and a chromosomal aberration test in cultured human peripheral blood lymphocytes were negative. (Pesticide abstract (2013); Pesticide evaluation report, Food Safety Commission of Japan (2012); HSDB (Access on October 2015); EPA Pesticide Fact Sheet (2001)) Therefore, the substance was classified as "Classification not possible" in accordance with Guidance. |
| 6 | Carcinogenicity | Not classified |
- |
- | - | There is no carcinogenicity information in humans. As for experimental animals, in a carcinogenicity test in diet administration of this substance in rats for two years, or in mice for 1.5 years, non-tumor changes such as blood effects, tissue changes in spleen and liver were observed in dose groups of rats at 700 ppm or higher and mice at 450 ppm or above. However, increased incidences of tumor lesions were not observed in either males or females of rats and mice even at the doses where toxicity occurred (Pesticide abstract (2013); Pesticide evaluation report, Food Safety Commission of Japan (2012)). As existing classification result in carcinogenicity, except NL classification (Not Likely to be Carcinogenic to Humans) in 2004 by EPA (U.S. EPA Office of Pesticide Program. Chemicals Evaluated for Carcinogenic Potential. (April, 2006); HSDB (Access on October 2015)), there is no classification done by the international organization. As above, from the carcinogenicity test results in an oral route and existing classification result, the substance was classified as "Not classified" according to Guidance in this hazard class. |
| 7 | Reproductive toxicity | Not classified |
- |
- | - | There is no information on reproductive effects in humans. As for experimental animals, in a two-generation breeding toxicity test using rats in an oral route (diet administration), parent animals showed increased relative kidney weight (F1males) at a middle dose (4,000 ppm) or higher, hemosiderosis in the spleen (F0, F1 males and females), centrilobular hepatocellular hypertrophy (F1 males), perilobular hepatocellular fatty degeneration (F1 females), hemosiderosis in broad ligament of uterus (F0 females) in a high dose group (12,000 ppm), but toxic effects on fertility were not observed. In offspring, in a 12,000 ppm group, a decreased number of live pups at day 14 and 21 of nursing (F1) and increased weights of liver and spleen (F1, F2) in necropsy at weaning were found. Besides, increased weights of liver or spleen were sporadically observed mainly as relatively increased weights at 1,000 ppm or higher in males and females of both F1 and F2 generations (including dose groups that did not show statistical significance). (Pesticide abstract (2013); Pesticide evaluation report, Food Safety Commission of Japan (2012)) As a teratogenicity test, doses up to 1,000 mg/kg/day were administered by gavage to pregnant rats on day 6 to 15 of gestation, or to pregnant rabbits on day 6 to 19 of gestation. In a test in rats, toxicity effects were not found in either maternal animals or fetuses even in administration up to the limit dose (Pesticide abstract (2013); Pesticide evaluation report, Food Safety Commission of Japan (2012); HSDB (Access on October 2015)). On the other hand, in a test in rabbits, weight gain reduction as maternal toxicity at 1,000 mg/kg/day and skeletal variations (increased incidence of incomplete ossification of the fifth sternebra) as effects on fetuses at 300 mg/kg/day or higher were observed respectively, but teratogenicity was not shown (Pesticide abstract (2013); Pesticide evaluation report, Food Safety Commission of Japan (2012)). As above, from the results of the breeding toxicity test and the teratogenicity test using experimental animals, effects on sexual function and fertility, and teratogenicity were not shown. In an administration to pregnant rabbits during an organogenetic period, the only thing found as fetotoxicity from the dose without toxicity in maternal animals was an increased incidence of skeletal variations, but it is hard to say that it is an apparent developmental effect that can be used as evidence for the classification. Therefore, because the findings available as evidence for classification were not shown in the results from the breeding test and the teratogenicity test, the substance was classified as "Not classified" 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, from piloerection and hunched posture in oral administration (LD50 > 5,000 mg/kg, above Category 2) in rats, no abnormal findings in dermal administration (LD50 > 2,000 mg/kg, above Category 2) in rats, and no abnormal findings in inhalation exposure (LC50 > 5.15 mg/L) in rats (Pesticide abstract (2013); Pesticide evaluation report, Food Safety Commission of Japan (2012)), an abnormality in signs and necropsy findings was not observed in any test even in administration up to the limit doses (or highest possible concentration). Therefore, the substance was classified as "Not classified." |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (haemal system) |
 Danger |
H372 | P260 P264 P270 P314 P501 |
There are no human data. As for experimental animals, in a 90-day diet administration toxicity test using rats, effects on blood system (decreased red blood cells and so on) were observed in females in dose groups of 50 ppm (females: 4.7 mg/kg/day) within in a range of Category 1 or higher (Pesticide evaluation report, Food Safety Commission of Japan (2012); Pesticide abstract (2013)). As above, effects on blood system were observed within in a range of Category 1. Besides this, effects on blood system were found within in a range of Category 2 in combined chronic toxicity/carcinogenicity test using rats, a 90-day diet administration toxicity test using mice, an 18-month diet administration toxicity test using mice, a 90-day diet administration toxicity test using dogs, and a 52-week diet administration toxicity test using dogs (Pesticide evaluation report, Food Safety Commission of Japan (2012); Pesticide abstract (2013)). Therefore, the substance was classified in Category 1 (blood 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) | Category 1 |
 Warning |
H400 | P273 P391 P501 |
From 96-hour LC50 = 0.13 ppb for crustacea (Mysidopsis bahia) (AQUIRE, 2016), it was classified in Category 1. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 1 |
Warning |
H410 | P273 P391 P501 |
If chronic toxicity data are used, then it is classified in Category 1 due to being not rapidly degradable (BioWin), and 28-day NOEC = 0.026 ppb for crustacea (Mysidopsis bahia) (AQUIRE, 2016). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 due to being not rapidly degradable (BioWin), and 96-hour LC50 = 2.0 ppb for fish (Cyprinodon variegatus) (AQUIRE, 2016). It was classified in Category 1 from the above results. |
| 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. |