GHS Classification Result

Chemical Name：azoxystrobin
CAS：131860-33-8

Result：
ID: 20A2326
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government （Sep, 2008）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
2 Flammable gases （including chemically unstable gases） Not applicable - - - - Solid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Solid (GHS definition)
5 Gases under pressure Not applicable - - - - Solid (GHS definition)
6 Flammable liquids Not applicable - - - - Solid (GHS definition)
7 Flammable solid Classification not possible - - - - No data available.
8 Self-reactive substances and mixtures Classification not possible - - - - It contains chemical groups associated with self-reactive properties. Due to lack of additional data, classification is not possible.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Classification not possible - - - - No data available.
11 Self-heating substances and mixtures Classification not possible - - - - No data available.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - - The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable - - - - Solid (GHS definition)
14 Oxidizing solids Not applicable - - - - The substance contains oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Not classified - - - - Based on its rat LD50 of > 5000 mg/kg (GLP-compliant) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2008, 2006)), the substance was classified into the "Not classified" category.
1 Acute toxicity （Dermal） Not classified - - - - Based on its rat LD50 of > 2000 mg/kg (GLP-compliant) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2008, 2006)), the substance was classified into the "Not classified" category using the JIS classification criteria (Category 5 or "Not classified" in the United Nations classification).
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Solid (GHS definition)
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - No data available.
1 Acute toxicity （Inhalation: Dusts and mists） Category 3 Danger H331: Toxic if inhaled P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P311: Call a POISON CENTER or doctor/physician.
P321: Specific treatment （see ... on this label）.
P405: Store locked up.
P501: Dispose of contents/container to ... 		In one study, its rat LC50 was 0.926 mg/L/4h for male and 0.698 mg/L/4h for female using dust with its average particle diameter being 1.13-1.35 micrometers (GLP-compliant) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2008, 2006)). In another study, its rat LC50 was > 4.7 mg/L/4h using dust with its average diameter being 14.6 micrometers (GLP-compliant) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2008, 2006)). Choosing the LC50 value representing higher toxicity, the substance was classified into Category 3.
2 Skin corrosion/irritation Not classified - - - - In primary skin irritation tests (GLP-compliant) using rabbits that received application of the substance for 4 hours, an average Draize score for erythema and edema was 0.4 after 24, 48, and 72 hours during the observational period; and the inflammation healed after 7 days (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2008, 2006)). Based on these results, the substance was classified into the "Not classified" category.
3 Serious eye damage/eye irritation Not classified - - - - In primary skin irritation tests using rabbits (GLP-compliant), an average Draize score was "1", 24 hours after application; after 2 days, symptoms completely healed (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2008, 2006)). Based on these results, the substance was classified into the "Not classified" category.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - In maximization tests using guinea pigs (Magnusson & Kligman) (GLP-compliant), the number of animals showing sensitization reactions was "0" 24 and 48 hours after provocation (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2008, 2006)). These results represent the "Not classified" category; however, because List 2 datasets have been used, the substance was classified into "Classification not possible".
5 Germ cell mutagenicity Not classified - - - - Based on negative results found in micronucleus tests using bone marrow cells of mice that underwent oral administration (in vivo mutagenicity tests using somatic cells) (GLP-compliant), the substance was classified into "Not classified" (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2008, 2006)). Similarly, unscheduled DNA synthesis tests using rat hepatocytes (in vivo genotoxicity tests using somatic cells) gave negative results. Regarding in vitro mutagenicity tests, both chromosomal aberration tests using human lymphocytes and gene mutation tests using mouse lymphoma cells gave positive results while Ames tests yielded negative results (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2008, 2006)).
6 Carcinogenicity Classification not possible - - - - In 104-week carcinogenicity tests via mixed diet using mice or rats (GLP-compliant), no effects of administration on incidences of tumorigenesis were detected in either species, drawing a conclusion that the substance has no potential for oncogenicity (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2008, 2006)). These results represent the "Not classified" category, however, since they were based on List 2 datasets, the substance was classified into "Classification not possible".
7 Reproductive toxicity Classification not possible - - - - In two-generation reproduction tests using rats that underwent oral administration (GLP-compliant), no effects of administration were noted on fertility properties at the doses that showed general toxicity such as cholangitis in F0 and F1 parental animals (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2008, 2006)). Similarly, in oral administration tests conducted during the organogenetic period using rats (GLP-compliant), no signs of teratogenicity were detected at the doses that showed general toxicity in parental animals (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2008, 2006)). Also, in oral administration tests conducted during the organogenetic period using rabbits (GLP-compliant), no effects of this substance on number of embryos in the uterus, growth, survival rate, and development were noted at the doses that showed general toxicity in parental animals, as well as no effects on incidences of malformation and variation being detected (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2008, 2006)). These results represent the "Not classified" category; however, since they were obtained using List 2 datasets, the substance was classified into "Classification not possible".
8 Specific target organ toxicity - Single exposure Classification not possible - - - - In neurotoxicity tests using rats that underwent oral administration (GLP-compliant), no changes related to the central and peripheral nervous tissues were detected, and no neurobehavioral toxicity or histopathological cases were noted for both sexes in 2000 mg/kg groups (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2008, 2006)). However, since these results do not provide sufficient data, classification is not possible.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - In 90-day repeated exposure tests via mixed diet using rats (GLP-compliant), effects of the exposure on the liver such as a marked increase in GGT activity and increased liver weight were noted, and as histopathological observations, hyperplasia of the intrahepatic bile duct or bile ductule, and oval cells, and cholangitis of the extrahepatic bile duct were detected at 4000 ppm (444 mg/kg/day for male and 449 mg/kg/day for female) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2008, 2006)). In addition, in chronic toxicity / carcinogenicity joint tests using rats that underwent mixed diet administration for 104 weeks (GLP-compliant), dilatation of the common bile duct as related to administration was observed for male animals in 1500 ppm (108.6 mg/kg/d) groups that died during the experiment. With this change, an increase in incidences of bile duct epithelial hyperplasia and cholangitis in the liver were noted. The bile duct is considered as the primary target organ of this substance, and its effects were seen in males only, not females. Because cases of male mortality in 1500 ppm (108.6 mg/kg/d) groups increased during the experiment, the dose was considered to be above the maximum tolerated dose. Consequently, the dose was lowered to 750 ppm (34 mg/kg/d) for only male rats from week 53 of the experiment. Since the dose was lowered, no effects related to administration were noted (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2008, 2006)). The effects of the substance on the bile duct were detected in both studies mentioned above; however, doses tested exceeded Category 2 guidance values in 90-day repeated exposure tests, and effects of the substance were detected only in dead animals in combined 104-week chronic toxicity / carcinogenicity tests. Thus, these results were not used for classification of the substance. Moreover, only oral administration test results are available. NOAEL of 1000 mg/kg/day is documented in 21-day dermal exposure tests (Pesticide Fact Sheet (1997)), but details of the test are not provided. Furthermore, there are no data from inhalation exposure tests. Thus, classification is not possible.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Category 1 Warning H400: Very toxic to aquatic life P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Since its 96-hour LC50 = 0.056 mg/L for crustaceans (Mysidopsis bahia) (AQUIRE, 2008), the substance was classified into Category 1.
11 Hazardous to the aquatic environment （Long-term） Category 1 Warning H410: Very toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Since its classification for acute toxicity is Category 1, and it is not rapidly degradable (BIOWIN), the substance was classified into Category 1.


NOTE:
* 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.

Reference：
Reference Manual
Definitions / Abbreviations
Model Label by MHLW

 MHLW Website （in Japanese Only）
Model SDS by MHLW

 MHLW Website （in Japanese Only）

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