Item | Information |
---|---|
CAS RN | 224049-04-1 |
Chemical Name | 3,4-Dichloro-N-(2-cyanophenyl)isothiazole-5-carboxamide; Isotianil |
Substance ID | R02-A-043-METI |
Classification year (FY) | FY2020 |
Ministry who conducted the classification | Ministry of Economy, Trade and Industry (METI) |
New/Revised | New |
Classification result in other fiscal year | |
Download of Excel format | Excel file |
Item | Information |
---|---|
Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
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 classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. |
2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) |
3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. |
4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) |
5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) |
6 | Flammable liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) |
7 | Flammable solids | Classification not possible |
- |
- | - | No data available. |
8 | Self-reactive substances and mixtures | Not classified (Not applicable) |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. |
9 | Pyrophoric liquids | Not classified (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 classified (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 classified (Not applicable) |
- |
- | - | Solid (GHS definition) |
14 | Oxidizing solids | Not classified (Not applicable) |
- |
- | - | The substance is an organic compound containing chlorine and oxygen (but not fluorine) which are chemically bonded only to carbon or hydrogen. |
15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule. |
16 | Corrosive to metals | Classification not possible |
- |
- | - | Classification is not possible because test methods applicable to solid substances are not available. |
17 | Desensitized explosives | Not classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats (females): > 2,000 mg/kg (OECD TG 423, GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)) |
1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (OECD TG 402, GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)) |
1 | Acute toxicity (Inhalation: Gases) | Not classified |
- |
- | - | [Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified." |
1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | [Rationale for the Classification] The classification is not possible because effects are unknown near the upper limit for Category 4 in (1). [Evidence Data] (1) LC50 for rats (4 hours): > 4.75 mg/L (no dead animals at a measured concentration of 4.75 mg/L) (OECD TG 403, GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)) |
2 | Skin corrosion/irritation | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) It is reported that in a skin irritation test with rabbits (n = 3) (OECD TG 404, GLP, semi-occlusive, 4-hour application, 72-hour observation), no irritation changes were seen (erythema/eschar score: 0/0/0, edema score: 0/0/0) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), REACH registration dossier (Accessed Sep. 2020), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). |
3 | Serious eye damage/eye irritation | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) It is reported that in an eye irritation test with rabbits (n = 3) (OECD TG 405, GLP, 72-hour observation), irritation changes in the conjunctiva were observed after 1 hour but disappeared within 24 hours (corneal opacity score: 0/0/0, iritis score: 0/0/0, conjunctival redness score: 0/0/0, chemosis score: 0/0/0) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), REACH registration dossier (Accessed Sep. 2020), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
4 | Skin sensitization | Category 1B |
Warning |
H317 | P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501 |
[Rationale for the Classification] It was classified in Category 1B from (1). [Evidence Data] (1) It is reported that in a maximization test with guinea pigs (n = 20) (OECD TG 406, GLP, intradermal administration: 5% solution), a positive rate was 50% (10/20) at both 24, 48 hours after a challenge (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), REACH registration dossier (Accessed Sep. 2020), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). |
5 | Germ cell mutagenicity | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified." [Evidence Data] (1) In a micronucleus test using the bone marrow cells of mice (GLP, two oral administrations), negative results were obtained (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). (2) In a bacterial reverse mutation test (OECD TG471, GLP), negative results were obtained (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009), REACH registration dossier (Accessed Sep. 2020)). (3) In a mammalian cell gene mutation test (OECD TG476, GLP), negative results were obtained (REACH registration dossier (Accessed Sep. 2020)). (4) In an in vitro chromosomal aberration test (OECD TG473, GLP), negative results were obtained (REACH registration dossier (Accessed Sep. 2020)). |
6 | Carcinogenicity | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) As for the classification results by domestic and international organizations, EPA classified this substance in NL (Not Likely to be Carcinogenic to Humans) (US Federal Register, vol. 84, No. 212 (2019)). (2) In a 2-year carcinogenicity study with rats (dosed by feeding), no increase in the incidence frequency of neoplastic lesions associated with the sample administration was observed. The carcinogenicity was not observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009), REACH registration dossier (Accessed Sep. 2020)). (3) In an 18-month carcinogenicity study with mice (dosed by feeding), an increase in the incidence of hepatic mass was observed in males at or above the mid-dose, but it was determined that, histopathologically, there was no increase in hepatic tumors. There was no increase in the incidence frequency of neoplastic lesions associated with the sample administration, and carcinogenicity was not observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). |
7 | Reproductive toxicity | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) It was reported that in a two-generation reproduction toxicity study with rats dosed by feeding (OECD TG416, GLP), at 1,000 ppm, weight gain inhibition (P and F1 male), and a decrease in food consumption (F1 male) were observed in parent animals, and low body weight was observed in offspring, but effects on reproductive ability were not observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), REACH registration dossier (Accessed Sep. 2020), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). (2) It was reported that in a developmental toxicity study with rats dosed by gavage (GLP, days 6 to 19 of gestation), at 100 mg/kg/day, an increase or a delay in ossification was observed in offspring, but teratogenicity was not observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). (3) It was reported that in a developmental toxicity study with rabbits dosed by gavage (OECD TG414, GLP, days 6 to 27 of gestation), at 1,000 mg/kg/day, weight gain inhibition, a decrease in food consumption, a decrease in placental weight, a liver enlargement, pale in color in the liver and accentuated lobular pattern of the liver, and abortion (3 cases) were observed in parent animals, and low body weight was observed in offspring, but teratogenicity was not observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), REACH registration dossier (Accessed Sep. 2020), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). |
8 | Specific target organ toxicity - Single exposure | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1) to (3), in tests with rats, in any of the oral, dermal, and inhalation exposure routes, no effect was observed within the dose range for Category 1 or Category 2, and it was classified as "Not classified." [Evidence Data] (1) It was reported that in an acute oral toxicity test with rats (OECD TG 423, GLP), at 2,000 mg/kg (within the range for Category 2), neither death nor appearance of symptoms was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (2) It was reported that in an acute dermal toxicity test with rats (OECD TG 402, GLP), at 2,000 mg/kg (within the range for Category 2), neither death nor appearance of symptoms was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (3) It was reported that in an acute inhalation (dust) exposure test with rats (OECD TG 403, GLP, 4 hours), at 4.75 mg/L (within the range for Category 2), neither death nor appearance of symptoms was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). |
9 | Specific target organ toxicity - Repeated exposure | Category 2 (liver) |
Warning |
H373 | P260 P314 P501 |
[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2 (liver). [Evidence Data] (1) It was reported that in a 90-day oral toxicity test with dogs dosed by feeding (GLP), at or above 2,000 ppm (51.1 mg/kg/day (male), 54.4 mg/kg/day (female), within the range for Category 2), an increase in ALT, and an increase in TG (female) were observed; and at or above 8,000 ppm (107 mg/kg/day (male), 211 mg/kg/day (female), in the range corresponding to "Not classified"), effects on the liver (a liver enlargement/centrilobular hypertrophy of the hepatocytes/hepatic/bile duct proliferation/increases in ALP, GGT, etc.) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (2) It was reported that in a chronic toxicity study with dogs dosed by feeding (GLP), at or above 1,000 ppm (27.2 mg/kg/day (male), 26.9 mg/kg/day (female), within the range for Category 2), effects on the liver (increases in absolute and relative weight/centrilobular hypertrophy of the hepatocytes/bile duct proliferation/an increase in ALT, etc.) were observed in males, and an increase in ALT was observed also in one female; and at or above 5,000 ppm (107 mg/kg/day (male), 110 mg/kg/day (female), in the range corresponding to "Not classified"), wasting, diarrhea, and symptoms of the skin and eye, as well as effects on the blood/hematopoietic system, kidney, etc. were observed in both males and females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). [Reference Data, etc.] (3) It was reported that in a repeated dose 90-day oral toxicity study with rats dosed by feeding (OECD TG408, GLP), no effect was observed within the range for Category 1 or Category 2 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (4) It was reported that in a 1-year oral toxicity test with rats dosed by feeding (GLP), at or above 600 ppm (27.9 mg/kg/day (male), 37.3 mg/kg/day (female), within the range for Category 2), an increase in relative weight of the liver was observed; and at or above 6,000 ppm (291 mg/kg/day (male), 381 mg/kg/day (female), in the range corresponding to "Not classified"), effects on the blood, liver, kidney, lung, etc. were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (5) It was reported that in a carcinogenicity study with rats dosed by feeding (GLP), at or above 2,000 ppm (79.2 mg/kg/day (male), 105 mg/kg/day (female), within the range for Category 2), effects on the forestomach and kidney were observed; and at or above 6,000 ppm (242 mg/kg/day (male), 311 mg/kg/day (female), in the range corresponding to "Not classified"), effects on the liver, kidney, and lung were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (6) It was reported that in a carcinogenicity study with mice dosed by feeding (GLP), no effect was observed within the range for Category 1 or Category 2 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). |
10 | Aspiration hazard | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
11 | Hazardous to the aquatic environment Short term (Acute) | - |
- |
- | - | - |
11 | Hazardous to the aquatic environment Long term (Chronic) | - |
- |
- | - | - |
12 | Hazardous to the ozone layer | - |
- |
- | - | - |
|