Item | Information |
---|---|
CAS RN | 119446-68-3 |
Chemical Name | 1-({2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-yl}methyl)-1H-1,2,4-triazole; Difenoconazole |
Substance ID | m-nite-119446-68-3_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, 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 | Not classified |
- |
- | - | It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from information that it is stable at up to 150 deg C (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2017)). | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Classification is not possible because test methods applicable to solid (melting point <= 140 deg C) substances are not 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 | 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. It was classified as "Not classified (Not applicable)." | 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 4 |
Warning |
H302 | P301+P312 P264 P270 P330 P501 |
[Rationale for the Classification] Based on (1), it was classified in Category 4. [Evidence Data] (1) LD50 for rats: 1,453 mg/kg (JMPR (2007), Risk Assessment Report (Pesticides, Food additives) (Food Safety Commission, 2019), Food Sanitation Research, Vol.46, No.5 (1996) (Japan Crop Protection Association), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2017), HSDB (Access on September 2019)) |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) LD50 for rabbits: >2,010 mg/kg (JMPR (2007), Risk Assessment Report (Pesticides, Food additives) (Food Safety Commission, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2017), HSDB (Access on September 2019)) (2) LD50 for rats: 2,010 mg/kg (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) | Classification not possible |
- |
- | - | [Rationale for the Classification] The category could not be specified based on (1). Therefore, it was classified as "Classification not possible." [Evidence Data] (1) LC50 (dust, 4 hours) for rats: > 3,300 mg/m3 (3.3 mg/L) (JMPR (2007), Risk Assessment Report (Pesticides, Food additives) (Food Safety Commission, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2017), HSDB (Access on September 2019)) |
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)-(4), it was classified as "Not classified." [Evidence Data] (1) In a skin irritation test in which the substance (0.5 g) was applied to rabbits for 4 hours, 1/6 of the animals showed very slight erythema 30 minutes after the application, but this disappeared after 24 hours. No skin reactions were observed in the other 5 animals (JMPR (2007), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2017)). (2) In a skin irritation test in which the substance (0.5 g) was applied to rabbits for 4 hours, 1/6 of the animals showed very slight erythema 30 minutes and 24 hours after removal, but it disappeared 48 hours after removal, and the other 5 animals showed no skin reaction (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2017)). (3) No irritation was observed in a skin irritation test with rabbits (Risk Assessment Report (Pesticides, Food additives) (Food Safety Commission, 2019)). (4) This substance was very slightly irritating to the skin of rabbits (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 | Category 2B |
Warning |
H320 | P305+P351+P338 P337+P313 P264 |
[Rationale for the Classification] Based on (1)-(4), it was classified in Category 2B. [Evidence Data] (1) In an eye irritation test in which this substance (0.1 g) was applied to the eyes of rabbits, the average scores for the cornea, iris, conjunctival redness and conjunctival edema at 24/48/72 hours were 0.44, 0.44, 2.0, 0.83, and all reactions had cleared by Day 4 after treatment (JMPR (2007)). (2) In an eye irritation test with this substance (0.1 g) applied to the eyes of rabbits, the mean scores for the cornea, iris, conjunctival redness and chemosis at 24/48/72 hours were 0.66, 0.1, 1.16 and 1.16 and all symptoms resolved within 7 days (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2017)). (3) Moderate irritation was observed in an eye irritation test with rabbits (Risk Assessment Report (Pesticides, Food additives) (Pesticides, Food additives) (Food Safety Commission, 2019)). (4) This substance was moderately irritating to the eyes of rabbits (HSDB (Access on September 2019)). |
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) and (2), it was classified as "Not classified." [Evidence Data] (1) In a skin sensitization test with guinea pigs (a modified Buehler method), no positive reactions were observed and it was concluded that this substance was not sensitizing (JMPR (2007), HSDB (Access on September 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2017)). (2) In a skin sensitization test with guinea pigs (guinea pig maximization test), the substance was judged as negative for sensitization (Risk Assessment Report (Pesticides, Food additives) (Food Safety Commission, 2019), Agricultural Chemicals Times supplement "Agricultural chemicals technology information" Vol.16 (1996) (Japan Crop Protection Association)). |
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, a negative result was reported in a micronucleus test with mice (JMPR (2007), Risk Assessment Report (Pesticides, Food additives) (Food Safety Commission, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2017)). (2) As for in vitro, negative results were reported in a bacterial reverse mutation test, chromosomal aberration tests with human lymphocytes, and unscheduled DNA synthesis tests and a gene mutation test with cultured mammalian cells, and a positive (S9+) result was reported in a chromosomal aberration test (same as above). [Reference Data, etc.] (3) As for in vivo, a negative result was reported in a nuclear abnormality induction test (Risk Assessment Report (Pesticides, Food additives) (Food Safety Commission, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2017)). |
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 the classification results by other organizations described in (1), it was classified in Category 2 in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified as S by EPA (Suggestive Evidence of Carcinogenicity) (EPA Annual Cancer Report (2018): classified in 2007). [Reference Data, etc.] (2) In a combined chronic toxicity/carcinogenicity study in which this substance was administered by feeding to rats for 2 years, no neoplastic lesions with increased incidence were observed after administration (Risk Assessment Report (Pesticides, Food additives) (Food Safety Commission, 2019)). (3) In a carcinogenicity test with mice in which this substance was administered by feeding for 18 months, increased incidences of hepatocellular adenomas in males and females and hepatocellular carcinomas in males were observed (Risk Assessment Report (Pesticides, Food additives) (Food Safety Commission, 2019)). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
7 | Reproductive toxicity | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1)-(3), as no clear reproductive and developmental effects were observed, this substance was classified as "Not classified." [Evidence Data] (1) In a 2-generation reproductive toxicity test with rats dosed by feeding, low body weight (F1 and F2 generations) and decreased viability index on postnatal Day 4 (observed only in F1 males, slight and no significant difference) were observed in pups at the dose at which reduced body weight gain and decreased food consumption were observed in parental animals (Risk Assessment Report (Pesticides, Food additives) (Food Safety Commission, 2019), JMPR (2007)). Besides, decreased viability index on postnatal Day 4 observed in males was found to be significantly different in a trend test (JMPR (2007)). (2) In a developmental toxicity test in which female rats were administered by gavage on Days 6-15 of gestation, a reduced trend in body weight, delayed ossification such as bifid and unilaterally ossified thoracic vertebral centres, an increase in the number of ribs accompanied by changes in the number of vertebrae (an increase in the number of thoracic vertebrae and a decrease in the number of lumbar vertebrae) were observed in fetuses at the dose at which maternal toxicity (salivation, decreased body weight gain, decreased food consumption) was observed (Risk Assessment Report (Pesticides, Food additives) (Food Safety Commission, 2019), JMPR (2007)) (3) In a developmental toxicity test with female rabbits dosed by gavage on Days 7-19 of gestation, no effects on fetuses or teratogenicity were observed at the dose at which maternal toxicity (death (1/19 animal), miscarriages (2 animals), decreased body weight gain, decreased food consumption) was observed (Risk Assessment Report (Pesticides, Food additives) (Food Safety Commission, 2019), JMPR (2007)). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
8 | Specific target organ toxicity - Single exposure | Category 2 (central nervous system) |
Warning |
H371 | P308+P311 P260 P264 P270 P405 P501 |
[Rationale for the Classification] There are no reports of a single human exposure to this substance. As for experimental animals, based on the information in (1)-(3), it was classified in Category 2 (central nervous system). The classification result was changed from the previous classification by using the new information sources. [Evidence Data] (1) In a single oral dose test with rats, hypoactivity, ataxia, hypothermia, prostration and spasms were observed at or above 1000 mg/kg (equivalent to Category 2) (JMPR (2007), Risk Assessment Report (Pesticides, Food additives) (Food Safety Commission, 2019)). (2) In a single oral dose test with mice, hypolocomotion, staggering gait and crawling gait were observed at or above 400 mg/kg (equivalent to Category 2) (Evaluation of effect for the food safety (Food Safety Commission, 2019)). In addition, in another single oral dose test with mice, reduced locomotor activity and ataxia were observed at or above 1,000 mg/kg and tonic spasms were observed at 2,000 mg/kg (upper limit of Category 2) (JMPR (2007), Risk Assessment Report (Pesticides, Food additives) (Food Safety Commission, 2019)). (3) In a 4-hour single inhalation exposure test with rats, piloerection, dyspnea, hunched posture and reduced locomotion were observed at 3.29 mg/L of the aerosol of this substance (equivalent to Category 2) (JMPR (2007), Risk Assessment Report (Pesticides, Food additives) (Food Safety Commission, 2019)). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
9 | Specific target organ toxicity - Repeated exposure | Category 2 (visual organs, liver) |
Warning |
H373 | P260 P314 P501 |
[Rationale for the Classification] Based on (1)-(5), it was classified in Category 2 (visual organs, liver). The classification result was changed from the previous classification by examination using the new information sources. [Evidence Data] (1) In a 90-day repeated dose toxicity test with rats by dietary administration, increased liver weight in males and females, and decreased erythrocyte count, decrease in hemoglobin and hematocrit, etc. in males were observed at or above 750 ppm (males/females: 50.7/65.7 mg/kg/day, within the range of Category 2) (Evaluation of effect for the food safety (Food Safety Commission, 2019)). (2) In a 90-day repeated dose toxicity test with mice by administration in the diet, centrilobular hypertrophy of hepatocytes in males and females and increased AST (only at 250 ppm), etc. in males were observed at or above 250 ppm (male/female: 34.8/37.2 mg/kg/day, within the range of Category 2) (Evaluation of effect for the food safety (Food Safety Commission, 2019)). (3) In a 28-week repeated dose toxicity test with dogs by dietary administration, lens opacity (cataract) in males and females and increased ALP, irregular pupillary margin, miosis and increased absolute liver weight (only at 3,000 ppm), etc. in females were observed at or above 3,000 ppm (male/female: 96.6/111, male: within the range of Category 2, females: exceeding Category 2) (Evaluation of effect for the food safety (Food Safety Commission, 2019)). (4) In a combined chronic toxicity/carcinogenicity study with rats by administration in the diet for 2 years, hepatocellular hypertrophy in males and females and decreased platelets, etc. in males were observed at or above 500 ppm (male/female: 24.1/32.8 mg/kg/day, within the range of Category 2) (Evaluation of effect for the food safety (Food Safety Commission, 2019)). (5) In an 18-month repeated dose toxicity test with mice by administration in the diet, an increase of SDH, hepatic single cell necrosis and hepatocellular hypertrophy in males and increased liver weight, etc. in females were observed at or above 300 ppm (males/females: 46.3/57.8 mg/kg/day, within the range of Category 2) (Evaluation of effect for the food safety (Food Safety Commission, 2019)). |
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 = 0.001329 mg/L for fish (Danio rerio) (HSDB, 2019, AQUIRE, 2020, Dong, 2013). | 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 268-day NOEC = 0.0019 mg/L for fish (Pimephales promelas) (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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