GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 23184-66-9 |
| Chemical Name | N-Butoxymethyl-2-chloro-2',6'-diethylacetanilide [butachlor] |
| Substance ID | H27-A-09-METI/M-007A_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 |
- |
- | - | "Liquids" according to GHS definition. |
| 3 | Aerosols | Not applicable |
- |
- | - | Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 5 | Gases under pressure | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 6 | Flammable liquids | Not classified |
- |
- | - | From a flash point of > 135 degrees C (closed cup) (The pesticide manual (2006)), it was classified as "Not classified." |
| 7 | Flammable solids | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 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 classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures because it is stable to heat up to 150 degrees C (Pesticide abstract II-2, Pesticide handbook (2005)). |
| 10 | Pyrophoric solids | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | No established test method suitable for liquid substances. |
| 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 |
- |
- | - | 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. |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 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 |
- |
- | - | Due to no data, the classification is not possible. |
| 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 |
There are 4 reported LD50 values of 1,740 mg/kg, 2,000 mg/kg (HSDB (Access on October 2015)), 2,620 mg/kg (males), and 3,050 mg/kg (females) for rats (Pesticide abstract (2012); Pesticide evaluation report, Food Safety Commission of Japan (2011)). Because 2 each correspond to Category 4 and "Not classified" (Category 5 in UN GHS classification), it was classified in Category 4 to which the smallest LD50 value corresponds. |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | From reported LD50 values of 13,000 mg/kg for rabbits (Pesticide abstract (2012); Pesticide evaluation report, Food Safety Commission of Japan (2011)) and > 13,000 mg/kg (HSDB (Access on October 2015)), it was classified as "Not classified." |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Category 4 |
Warning |
H332 | P304+P340 P261 P271 P312 |
There are 2 reported LC50 values (4 hours) for rats of > 3.34 mg/L (Pesticide abstract (2012); Pesticide evaluation report, Food Safety Commission of Japan (2011)) and > 5.3 mg/L (Pesticide abstract (2012); Pesticide evaluation report, Food Safety Commission of Japan (2011)). One corresponds to "Not classified," and from the other of > 3.34 mg/L, the classification is not possible because the category cannot be determined. Therefore, the substance is classified as "Not classified," but by keeping on the safe side, the substance was classified in Category 4 to which the smallest LC50 value corresponds. Besides, a reference value of mists was applied because the LC50 values are higher than 90% of the saturated vapour pressure concentration (0.00003 mg/L). |
| 2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | The classification is not possible due to lack of data. Besides, it is reported that in a skin irritation test using rabbits, edema and erythema were observed after 24-hour or 72-hour application of 0.5 mL this substance (Pesticide abstract (2012); Pesticide evaluation report, Food Safety Commission of Japan (2011)). However, it was not used for the classification due to the report by a 24-hour application. |
| 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, conjunctival congestion and conjunctival edema were observed after application of 0.1 mL undiluted this substance but resolved within three days (Pesticide abstract (2012); Pesticide evaluation report, Food Safety Commission of Japan (2011)). 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 | Category 1 |
Warning |
H317 | P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501 |
It is reported that in a Buehler test using guinea pigs, a clear sensitizing reaction was observed in half of the animals after induction and challenge, and all of them showed a clear reaction after the second challenge (Pesticide abstract (2012); Pesticide evaluation report, Food Safety Commission of Japan (2011)). From the above, the substance was classified in Category 1. |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | As for in vivo, a dominant lethal test in mice, a micronucleus test in mouse bone marrow cells, a chromosomal aberration test in rat bone marrow cells, and an unscheduled DNA synthesis test in rat hepatocytes were negative, and as for in vitro, a bacterial reverse mutation test, a gene mutation test and a chromosomal aberration test in cultured mammalian cells were negative (Pesticide abstract (2012); Pesticide evaluation report, Food Safety Commission of Japan (2011)). Therefore, the substance was classified as "Classification not possible" in accordance with Guidance. |
| 6 | Carcinogenicity | Category 2 |
 Warning |
H351 | P308+P313 P201 P202 P280 P405 P501 |
In a 26-month carcinogenicity test using rats in an oral route (in the diet), at doses of 1,000 ppm or higher where slightly increased mortality was observed in both males and females, increased incidences of thyroid follicular epithelial adenoma and nose adenoma were found in females. Those were observed in males and females at 3,000 ppm where an increased incidence of stomach malignant tumor (carcinoid: malignant neuroendocrine cell tumor) was also found in females (Pesticide abstract (2012); Pesticide evaluation report, Food Safety Commission of Japan (2011); HSDB (Access on October 2015)). On the other hand, it is reported that in a 24-month diet administration test in mice, tumor related to administration of test substance was not observed at doses up to 2,000 ppm (Pesticide abstract (2012); Pesticide evaluation report, Food Safety Commission of Japan (2011)). Although tumor incidences of stomach, thyroid, and nose increased in rats in the carcinogenicity test, Food Safety Commission of Japan considered that a mechanism of tumor occurrence is not through genotoxicity, and a threshold can be set in an evaluation of this substance (Pesticide evaluation report, Food Safety Commission of Japan (2008)). Besides, there is no classification result by the international organization and so on. As above, different results were obtained for carcinogenicity in experimental animals between animal species of rats and mice. However, by attaching importance to the fact that tumors were found in many organs in rats, and that malignant stomach tumor was observed at a high frequency (20/80 animals) although especially in females, the substance was classified in Category 2 in this hazard class. |
| 7 | Reproductive toxicity | Not classified |
- |
- | - | In a two-generation breeding toxicity test using rats in an oral route (diet administration), weight gain reduction was observed in parent animals of F0 at 3,000 ppm and F1 at 1,000 ppm or higher, and weight gain reduction was found in both F1 offspring on day 14 of nursing or later at 1,000 ppm or above, and F2 offspring on day 4 of nursing or later at 3,000 ppm. Besides these, an abnormality was not observed in fertility of parent animals, survival rate and growth after a birth of offspring (Pesticide abstract (2012); Pesticide evaluation report, Food Safety Commission of Japan (2011)). Moreover, in a teratogenicity test in gavage administration on day 6 to 19 of gestation for pregnant rats, or day 6 to 28 of gestation for pregnant rabbits, in rats, maternal animals showed weight gain reduction at 490 mg/kg/day of the highest dose, but clear toxicity effects were not shown in fetuses (Pesticide abstract (2012); Pesticide evaluation report, Food Safety Commission of Japan (2011)). On the other hand, in rabbits, at 147 mg/kg/day and 245 mg/kg/day of the highest dose, death cases, increased abortion, decreased body weight, and increased number of dead embryos in maternal animals, low fetus weight, unossification of 5th/6th breast bone in fetuses were observed (Pesticide abstract (2012); Pesticide evaluation report, Food Safety Commission of Japan (2011)). Unossification of breast bone was attributed to delayed ossification reflecting delayed growth of fetuses as estimated from low fetus weight (Pesticide abstract (2012); Pesticide evaluation report, Food Safety Commission of Japan (2011)). Namely, it is thought that there is no clear developmental toxicity but only slight effects in fetuses even when administered up to the dose where maternal toxicity occurred in the teratogenicity test in rats and rabbits. As above, from the results of the teratogenicity test in rats and breeding toxicity test using pregnant animals, the substance was classified as "Not classified" in this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Category 3 (Respiratory tract irritation) |
Warning |
H335 | P304+P340 P403+P233 P261 P271 P312 P405 P501 |
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 rabbits, and inhalation exposure in rats (Pesticide abstract (2012); Pesticide evaluation report, Food Safety Commission of Japan (2011); Japan Crop Protection Association, Pesticide safety information, Japanese Journal of Pesticide Science, Vol.25, No.1 (1999)). Among these, because irritation to the respiratory organs was described in an acute inhalation exposure test in rats (Pesticide evaluation report, Food Safety Commission of Japan (2011)), the substance was classified in Category 3 (respiratory tract irritation). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (kidney), Category 2 (eye, thyroid, respiratory organs, liver, gallbladder, pancreas, urinary bladder) |
Danger Warning |
H372 H373 |
P260 P264 P270 P314 P501 |
There is no report in humans. As for experimental animals, in a 90-day diet administration toxicity test using rats, effects on the liver in males (diffuse hypertrophy of hepatocytes and so on) and effects on the bladder in females (bladder epithelial hyperplasia) were observed in groups of 1,000 ppm dose (males: 58.7 mg/kg/day, females: 62.7 mg/kg/day) within a range of Category 2 or higher (Pesticide abstract (2012); Pesticide evaluation report, Food Safety Commission of Japan (2011)). In a 1-year gavage administration toxicity test using dogs, effects on the liver in males and females (perilobular or diffuse hypertrophy of hepatocytes and so on) and effects on pancreas in females (hypertrophy of exocrine gland cells) were found in a 25 mg/kg/day dose group within a range of Category 2 (Pesticide abstract (2012); Pesticide evaluation report, Food Safety Commission of Japan (2011)). In a 24-month chronic toxicity/carcinogenicity combined test using rats in diet administration, effects on the liver (diffuse swelling of hepatocytes, increased GGT and so on), effects on the kidney (chronic nephrosis and so on), and effects on the bladder (hyperplasia of bladder mucous epithelium) in males and females and effects on the eyes in females (cataract, retinal atrophy/degeneration) were observed in a 1,000 ppm dose group (males: 37.1 mg/kg/day, females: 43.4 mg/kg/day) within a range of Category 2 (Pesticide abstract (2012); Pesticide evaluation report, Food Safety Commission of Japan (2011)). The followings was observed in a 26-month chronic toxicity/carcinogenicity combined test using rats in diet administration (Pesticide abstract (2012)): effects on the kidney in males and females (chronic nephrosis and so on) in groups of 100 ppm dose (males: 4.5mg/kg/day, females: 5.7 mg/kg/day) within a range of Category 1 or higher; effects on the thyroid in males and females (hyperplasia of follicular epithelium and so on), effects on nasal cavity in males (hyperplasia of nasal mucosa goblet cells), and effects on pancreas in females (steatosis) in groups of 1,000 ppm dose (males: 45.6 mg/kg/day, females: 58.5 mg/kg/day) within a range of Category 2 or above. In a 2-year carcinogenicity test using mice in diet administration, effects on the eyes in males and females (cataract), effects on gallbladder in males (hyperplasia of gallbladder mucosa), and effects on lung in females (hyperplasia of alveolar/bronchiolar epithelium and so on) were found in a 500 ppm dose group (males: 72.45 mg/kg/day, females: 85.62 mg/kg/day) within a range of Category 2 or higher (Pesticide abstract (2012); Pesticide evaluation report, Food Safety Commission of Japan (2011)). As above, effects on the kidney were observed from Category 1, and effects on the eye, thyroid, respiratory organs, liver, gallbladder, pancreas, and bladder were found within a range of Category 2. Therefore, the substance was classified in Category 1 (kidney), Category 2 (eye, thyroid, respiratory system, liver, gallbladder, pancreas, urinary bladder). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | The classification is not possible due to lack of data. Besides, kinematic viscosity is calculated to be 34.6 mm2/sec (25 degrees C) from numerical data (viscosity: 37 mPa.s (25 degrees C), density: 1.07 g/cm3 (25 degrees C)) listed in HSDB (Access on October 2015). |
| 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 72-hour ErC50 = 0.0033 mg/L for algae (Pseudokirchneriella subcapitata) (Ecotoxicity tests by Environment Agency, 1997; Result of the initial environmental risk assessment of chemicals, Vol. 8, Ministry of the Environment in Japan, 2010), 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), 72-hour NOEC(r) = 0.000474 mg/L for algae (Pseudokirchneriella subcapitata) (Result of the initial environmental risk assessment of chemicals, Vol. 8, (Ministry of the Environment in Japan, 2010)). 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, 96-hour LC50 = 0.28 mg/L for fish (Oryzias latipes) (Ecotoxicity tests by Environment Agency, 1997; Result of the initial environmental risk assessment of chemicals, Vol. 8, Ministry of the Environment in Japan, 2010), and 96-hour LC50 = 0.28 mg/L for fish (Pimephales promelas) (Result of the initial environmental risk assessment of chemicals, Vol. 8, (Ministry of the Environment in Japan, 2010)). 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. |