Item | Information |
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CAS RN | 120068-37-3 |
Chemical Name | 5-Amino-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-3-cyano-4-[(trifluoromethyl)sulfinyl]pyrazole; Fipronil |
Substance ID | m-nite-120068-37-3_v1 |
Download of Excel format | Excel file |
Item | Information |
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Guidance used for the classification (External link) | To Guidance List |
UN GHS document (External link) | To UN GHS document |
FAQ(GHS classification results by the Japanese Government) | To FAQ |
List of Information Sources (Excel file) | List of Information Sources |
List of Definitions/Abbreviations | Definitions/Abbreviations |
Sample Label by MHLW (External link) | MHLW Website (in Japanese Only) |
Sample SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
OECD/eChemPortal (External link) | To OECD/eChemPortal (External link) |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
1 | Explosives | Classification not possible |
- |
- | - | There is a chemical group associated with explosive properties (neighboring nitrogen atoms) present in the molecule, but the classification is not possible due to no data. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
6 | Flammable liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
7 | Flammable solids | Classification not possible |
- |
- | - | No data available. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
8 | Self-reactive substances and mixtures | Classification not possible |
- |
- | - | There are neighboring nitrogen atoms, a chemical group associated with explosive properties, and an S=O bond, a chemical group associated with self-reactive properties, present in the molecule, but the classification is not possible due to no data. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
9 | Pyrophoric liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
10 | Pyrophoric solids | Classification not possible |
- |
- | - | No data available. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | No data available. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
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). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
14 | Oxidizing solids | Classification not possible |
- |
- | - | The substance is an organic compound containing fluorine, chlorine, and oxygen, and the oxygen is chemically bonded to an element (S) other than carbon or hydrogen. However, the classification is not possible due to no data. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
16 | Corrosive to metals | Classification not possible |
- |
- | - | Classification is not possible because test methods applicable to solid substances are not available. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
17 | Desensitized explosives | Not classified |
- |
- | - | It was classified as "Not classified" because it is not desensitized by wetting, dilution, etc. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Category 3 |
Danger |
H301 | P301+P310 P264 P270 P321 P330 P405 P501 |
[Rationale for the Classification] Based on (1)-(3), it was classified in Category 3. [Evidence Data] (1) LD50 for rats: male: 92 mg/kg, female: 103 mg/kg (JMPR (1997), Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission, 2016), HSDB (Access on September 2019)) (2) LD50 for rats: 100 mg/kg (HSDB (Access on September 2019)) (3) LD50 for rats: 97 mg/kg (HSDB (Access on September 2019)) |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Dermal) | Category 3 |
Danger |
H311 | P302+P352 P361+P364 P280 P312 P321 P405 P501 |
[Rationale for the Classification] Based on (1)-(3), it was classified in Category 3. The category was changed from the previous classification by using new information sources. [Evidence Data] (1) LD50 for rabbits: 354 mg/kg (JMPR (1997)) (2) LD50 for rabbits: male: 445 mg/kg, female: 354 mg/kg (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission, 2016), HSDB (Access on September 2019)) (3) LD50 for rats: >2,000 mg/kg (JMPR (1997), Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission, 2016), HSDB (Access on September 2019)) |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Inhalation: Gases) | Not classified (Not applicable) |
- |
- | - | [Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)." |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Inhalation: Dusts and mists) | Category 2 |
Danger |
H330 | P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501 |
[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2. The category was changed from the previous classification by using new information sources. [Evidence Data] (1) LC50 for rats (dusts, 4 hours): 0.682 mg/L (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015), HSDB (Access on September 2019)) (2) LC50 for rats (dusts, 4 hours): male: 0.36 mg/L, female: 0.42 mg/L (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015), HSDB (Access on September 2019)) [Reference Data, etc.] (3) LC50 for rats (exposure period is unknown): 0.36 mg/L (JMPR (1997)) |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
2 | Skin corrosion/irritation | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1)-(3), it was classified as "Not classified." [Evidence Data] (1) In a skin irritation test with rabbits in which this substance was moistened with water and applied, it was not irritating (JMPR (1997), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). (2) Skin and eye irritation tests with rabbits were conducted, and no signs of skin irritation or eye irritation were observed (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission, 2016)). (3) In a skin irritation test with rabbits in which this substance was moistened with corn oil and applied for 4 hours, mild erythema (score of 1-2) and transient mild edema were observed, however, the edema disappeared within 7 days (JMPR (1997), HSDB (Access on September 2019)). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
3 | Serious eye damage/eye irritation | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1)-(3), it was classified as "Not classified." [Evidence Data] (1) In an eye irritation test with rabbits, no change in the cornea or the iris was observed, while mild redness and edema in the conjunctiva were observed 1 hour after application, however, these subsided within 72 hours (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). (2) Skin and eye irritation tests with rabbits were conducted, and no signs of skin irritation or eye irritation were observed (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission, 2016)). (3) It was slightly irritating in an eye irritation test with rabbits (JMPR (1997)). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
4 | Skin sensitization | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) In skin sensitization tests (2 maximization tests and a Buehler test) with guinea pigs, positive response rates were 20% and 0% in the maximization method (intradermal induction concentrations were both 5% in both), and this substance was concluded as a mild sensitizer, but it was negative in the Buehler method (JMPR (1997), Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
5 | Germ cell mutagenicity | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) As for in vivo, there is a report that it was negative in a mouse micronucleus test (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission, 2016)). (2) As for in vitro, there are reports that it was negative in a bacterial reverse mutation test, a mammalian cell gene mutation test, and a chromosomal aberration test with cultured human lymphocytes, and a report that it was positive (chromosomal aberrations were induced after 6-hour treatment only at concentrations at which the cytotoxicity was observed) in a mammalian cell chromosomal aberration test (same as the above). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
6 | Carcinogenicity | Category 2 |
Warning |
H351 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] Based on classification results by other organizations in (1), it was classified in Category 2 in accordance with the GHS Classification Guidance for the Japanese Government. The classification result was changed from the previous classification by adding classification results by other organizations [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified as C (Possible Human Carcinogen) by EPA (EPA Annual Cancer Report (2018): 1995 Classification). [Reference Data, etc.] (2) In a chronic toxicity/carcinogenicity combined study with rats administered this substance for 2 years by feeding, significant increases in thyroid follicular cell adenoma and carcinoma in males and thyroid follicular cell adenoma in females were observed (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission, 2016)). (3) In a carcinogenicity study with mice administered this substance for 78 weeks by feeding, no neoplastic lesions the incidence of which increased dose-dependently were found (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission, 2016)). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
7 | Reproductive toxicity | Category 2 |
Warning |
H361 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] Based on (1) and (2), since unambiguous effects on fertility and effects on pups (including effects on the nervous system) were observed at doses at which maternal toxicity was observed, it was classified in Category 2. [Evidence Data] (1) In a two-generation reproductive toxicity test with rats by feeding, at the highest dose, death (P male: 2/30 animals, P female: 5/30 animals, F1 male: 0/30 animals, F1 female: 2/30 animals), convulsions, decreased body weight gain, decreased food consumption, increased weights of the thyroid and liver, decreased pituitary weights, thyroid follicular epithelial hypertrophy, centriacinar fatty vacuolation in the liver, etc. were observed in parental animals, furthermore, decreased live birth index in parental animals and convulsions, decreased body weights, decreased litter size, reduced postnatal survival, reduced viability index on Day 4, etc. in the pups were observed (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission, 2016), JMPR (1997)). (2) In a developmental neurotoxicity test with female rats fed from gestational Day 6 through lactation Day 10 (51 days), at a dose at which maternal toxicity was not observed, decreased body weight and delayed preputial separation were observed in the pups, and at a dose at which maternal toxicity (reduced body weight gain, decreased food consumption) was observed, reduced viability index on Day 4, delays in pinna unfolding, incisor eruption and vaginal opening, reduced acoustic startle response (reversible), and delayed swimming development, etc. were observed in the pups. No abnormalities however were observed by the neuro histopathological examination (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission, 2016)). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
8 | Specific target organ toxicity - Single exposure | Category 1 (nervous system) |
Danger |
H370 | P308+P311 P260 P264 P270 P321 P405 P501 |
[Rationale for the Classification] Based on (1)-(4), it was classified in Category 1 (nervous system). [Evidence Data] (1) Multiple cases in which humans who ingested this substance accidentally or intentionally developed generalized tonic-clonic seizures were reported (HSDB (Access on September 2019)). (2) In a single oral dose toxicity test with rats, piloerection, diarrhea, hunched posture and abnormal gait at or above 50 mg/kg, lethargy, decreased respiratory rate, pallor in the extremities and ptosis at or above 80 mg/kg were observed. The doses at which these effects were observed corresponded to Category 1 (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission, 2016)). (3) In a single dermal dose toxicity test with rabbits, convulsions, tremors, diarrhea, emaciation, increased locomotor activity and delayed convulsions were observed at or above 250 mg/kg (corresponding to Category 1) (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission, 2016)). (4) In a single 4-hour inhalation exposure test with rats, piloerection, hunched posture, vocalization on contact, salivation, hypothermia, tremors, convulsions and ataxia were observed at or above 0.259 mg/L (corresponding to Category 1) of the dust of this substance (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). [Reference Data, etc.] (5) There is a description that this substance is considered to exhibit an insecticidal action by inhibiting the chloride ion channel control by GABA, which is regarded as an inhibitory neurotransmitter, and inhibiting neuronal excitation in insects (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission, 2016)). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (central nervous system, thyroid, liver, kidney, blood system) |
Danger |
H372 | P260 P264 P270 P314 P501 |
[Rationale for the Classification] Based on (1)-(4), effects on the central nervous system, thyroid, liver, kidney, and blood system were observed within the range of Category 1, by oral administration to experimental animals, and based on (5), effects on the central nervous system were observed within the range of Category 1, by dermal exposure to rabbits, therefore, it was classified in Category 1 (central nervous system, thyroid, liver, kidney, blood system). The review was done by using new information sources, and the classification result was changed from the previous classification. [Evidence Data] (1) In a 90-day repeated dose toxicity test with rats by feeding, decreased hematocrit and increased liver weight, etc. at or above 30 ppm (male/female: 1.93/2.28 mg/kg/day, within the range of Category 1), and increased thyroid weight, hypertrophy of the follicular epithelium of the thyroid, hyperplasia of the thyroid follicular cells, panacinar fatty vacuolation of hepatocytes, etc. at 300 ppm (male/female: 19.9/24.0 mg/kg/day, within the range of Category 2) were observed (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission, 2016)). (2) In a 90-day repeated dose toxicity test with dogs by feeding, sacrificed in extremis (1 male animal, 3 female animals), emaciation, tremors, convulsions, head nodding, sporadic generalized spasms, facial twitching, exaggerated blink, exaggerated gag responses, depressed tactile placing response, etc. were observed at 10 mg/kg/day (within the range of Category 1) (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission, 2016)). (3) In a 2-year chronic toxicity/carcinogenicity combined test with rats by feeding, convulsions, death after persistent convulsions, decreases in erythrocyte count, decreased hematocrit value, etc. at or above 1.5 ppm (male/female: 0.059/0.078 mg/kg/day, within the range of Category 1), decreased hemoglobin concentration, elevated urine volume and urine protein, increased incidence and severity of progressive nephropathy, increased kidney weight and thyroid weight, thyroid follicular cyst and growth abnormality, etc. at or above 30 ppm (male/female: 1.27/1.61 mg/kg/day, within the range of Category 1), and overactivity, increased weights of the adrenal gland, liver and spleen, accumulations of minerals in the aorta, parathyroid hyperplasia, increased uterus weight, etc. at 300 ppm (male/female: 12.7/16.8 mg/kg/day, within the range of Category 2) were observed (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission, 2016)). (4) In a 78-week carcinogenicity test with mice by feeding, microvesicular vacuolation of centrilobular hepatocytes, etc. at or above 10 ppm (male/female: 1.18/1.23 mg/kg/day, within the range of Category 1), increased liver weight, hepatocellular hyperplasia, chronic degenerative changes in the livers, etc. at 30 ppm (male/female: 3.43/3.62 mg/kg/day, within the range of Category 1) were observed (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission, 2016)). (5) In a 21-day dermal exposure test with rabbits, locomotor hyperactivity was observed at 10 mg/kg/day (within the range of Category 1) in males and females (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission, 2016)). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
10 | Aspiration hazard | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
11 | Hazardous to the aquatic environment Short term (Acute) | Category 1 |
Warning |
H400 | P273 P391 P501 |
It was classified in Category 1 from 96-hour LC50 = 0.083 mg/L for fish (Lepomis macrochirus) (U.S.EPA: OPP Pesticide Ecotoxicity Database, 2020). | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
11 | Hazardous to the aquatic environment Long term (Chronic) | Category 1 |
Warning |
H410 | P273 P391 P501 |
It was classified in Category 1 because it is not rapidly degradable (BIOWIN), and due to 32-day NOEC = 0.00024 mg/L for fish (Cyprinodon variegatus) (U.S.EPA OPP Pesticide Ecotoxicity Database, 2020). | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | Classification not possible due to lack of data. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
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