GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 149877-41-8 |
| Chemical Name | Isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinoformate [bifenazate] |
| Substance ID | H27-A-01-METI/M-001A_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 |
- |
- | - | There is a chemical group present in the molecule associated with explosive properties (hydrazine), 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 |
- |
- | - | There is a chemical group present in the molecule associated with explosive properties (hydrazine), 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 |
- |
- | - | 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 or chlorine but contains oxygen, and the oxygen is 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 (Health Canada REG2006-01 (2006), EPA Pesticide Fact Sheet (1999)), it was classified as "Not classified." |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | From a reported LD50 value of > 5,000 mg/kg for rats (Health Canada REG2006-01 (2006), EPA Pesticide Fact Sheet (1999)), 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, there is a reported LC50 value (4 hours) of > 4.4 mg/L for rats (Health Canada REG2006-01 (2006), EPA Pesticide Fact Sheet (1999)), but the category cannot be determined only from this value. Because a test substance is a solid, a reference value of dust was applied. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | It was concluded that this substance is practically not irritating from a primary irritation index (PII) of 0.1 after 4-hour semi-occlusive application of the substance in a skin irritation test using rabbits (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2012)). Besides this, it is reported to be slightly irritating (EPA Pesticide Fact Sheet (1999)) and it is written that this substance is not irritating to skin (Health Canada REG2006-01 (2006)). As above, from the detailed report from the skin irritation test using rabbits, 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, after application of 0.1 mL this substance, slight redness, edema, or discharge were observed 1 hour after application and resolved after 48 hours (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2012)). Besides, it is written that the substance is slightly irritating to eyes (EPA Pesticide Fact Sheet (1999), Health Canada REG2006-01 (2006)). 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 | Classification not possible |
- |
- | - | It is reported that the substance is slightly sensitizing because weak sensitization reaction (score 1 (maximum 3)) was observed in 2 out of 20 animals in a maximization test using guinea pigs (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2012)). A positive rate was 10% in the above report and does not meet positive in 30%, the GHS criteria. From the above, the substance was classified as "Classification not possible." |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | As for in vivo, a micronucleus test in mouse bone marrow cells after intraperitoneal administration and an unscheduled DNA synthesis test in rat liver after oral administration were negative (Pesticide evaluation report, Food Safety Commission of Japan (2012); Pesticide abstract (2007)). As for in vitro, a bacterial reverse mutation test and a mouse lymphoma test and a chromosomal aberration test in cultured mammalian cells were negative (Pesticide evaluation report, Food Safety Commission of Japan (2012); Pesticide abstract (2007)). Therefore, the substance was classified as "Classification not possible" in accordance with Guidance. |
| 6 | Carcinogenicity | Not classified |
- |
- | - | As an existing classification result by other organization, there is only NL classification (Not Likely to be Carcinogenic to Humans) by US EPA (HSDB (Access on October 2015), EPA (Chemicals Evaluated for Carcinogenic Potential dated on April 26, 2006)). In a carcinogenicity test in diet administration of this substance for 2 years to rats, or 1.5 years to mice, in a high dose group (rats: 160 to 200 ppm (corresponding to 9.7 mg/kg/day), mice: 175 to 225 ppm (corresponding to 35.1 to 35.7 mg/kg/day)), weight gain reduction and low food consumption (only males for mice) were observed during a dosing period in males and females, but an increased tumor incidence was not shown in rats. In mice, males showed twice as much incidence of hepatocellular adenoma as a control group (20% (10/50) for a 225 ppm group, 10% (5/50) for a control group). However, it is not a statistically significant increase, and it was concluded that carcinogenicity was not observed in either rats or mice (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2012); HSDB (Access on October 2015)). From the above, from the EPA carcinogenicity classification result, the substance was classified as "Not classified" in accordance with Guidance in this hazard class. |
| 7 | Reproductive toxicity | Not classified |
- |
- | - | In a two-generation breeding toxicity test in diet administration in rats, parent animals showed weight gain reduction in a high dose group (200 ppm) of F0 generation and groups of mid-dose (80 ppm) or higher of F1 generation. However, toxic effects on fertility of parent animals and growth/development after a birth of F1, F2 offspring were not found (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2012); HSDB (Access on October 2015)). Moreover, in a teratogenicity test in gavage administration of this substance in pregnant rats or rabbits during an organogenetic period (rats: day 6 to 15 of gestation, rabbits: day 7 to 19 of gestation), in rats, maternal animals showed weight gain reduction and low food consumption at 100 mg/kg/day or higher, discoloring of extremities, decreased defecation, and brown discharge from the vagina at 500 mg/kg/day, but effects of test substance administration were not observed in fetuses. Moreover, in a teratogenicity test using rabbits, toxic effects were not found up to 200 mg/kg/day of high dose in either maternal animals or fetuses. (Pesticide evaluation report, Food Safety Commission of Japan (2012); EPA Pesticide Fact Sheet (1999); HSDB (Access on October 2015)). From the above, there are no findings suggesting reproductive toxicity in results of the breeding test and the teratogenicity test using experimental animals, taking into account the evaluation result by Food Safety Commission of Japan, 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, there are test data in oral administration in rats and mice, dermal administration in rats, and inhalation exposure in rats (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 (haemal system), Category 2 (liver, adrenal gland) |
 Danger Warning |
H372 H373 |
P260 P264 P270 P314 P501 |
The following was observed in an oral route (Pesticide abstract (2007); Health Canada REG2006-01 (2006); Pesticide evaluation report, Food Safety Commission of Japan (2012); HSDB (Access on October 2015)): effects on blood system (decreased red blood cell count, decreased hemoglobin and so on), effects on liver (centrilobular hypertrophy of hepatocytes, single cell necrosis, lymphohistiocytic cellular infiltration), adrenal (vacuolization of zona fasciculata of the adrenal cortex) at 200 to 400 ppm (13.8 to 32.63 mg/kg/day) within a range of Category 2 in a 13-week diet administration toxicity test using rats; effects on liver (increased weight, centrilobular or diffuse hypertrophy of hepatocytes) at 400 to 1000 ppm (10.4 to 28.2 mg/kg/day) within a range of Category 2 in a 13-week diet administration toxicity test using dogs; effects on blood system (decreased red blood cell count, hemoglobin, and hematocrit, increased reticulocyte count, nucleated red blood cell count, and platelet count, increased leukocyte count, bone marrow hyperplasia and so on) at 400 ppm (males: 8.9, females: 10.4 mg/kg/day) almost within a range of Category 1 in a 52-week diet administration toxicity test using dogs; effects on blood system (decreased red blood cell count, hemoglobin, and hematocrit and so on) at 80-200/160 ppm (3.9 to 9.7 mg/kg/day) within a range of Category 1 in a 104-week diet administration toxicity test using rats. In a dermal route, in a 21-day dermal administration toxicity test using rats, effects on blood system (abnormal stainability and morphology of red blood cell, increased extramedullary hematopoiesis of spleen) were observed at 400 mg/kg/day (converted to a 90-day equivalent: 93 mg/kg/day) within a range of Category 2 (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2012); HSDB (Access on October 2015)). As above, effects on blood system were observed from Category 1, and effects on liver and adrenal were found within a range of Category 2. Therefore, the substance was classified in Category 1 (blood system), Category 2 (liver, adrenal). |
| 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 48-hour EC50 = 500 micro g/L for crustacea (Daphnia magna) (US EPA: Registration Review, 2012), 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 2 due to being not rapidly degradable (BIOWIN), and NOAEC (reproduction, growth) = 150 micro g/L for crustacea (Daphnia magna) (US EPA: Registration Review, 2012). 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 = 580 micro g/L for fish (Lepomis macrochirus) (US EPA: Registration Review, 2012). It was classified in Category 1 by drawing a comparison between 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. |