Item | Information |
---|---|
CAS RN | 688046-61-9 |
Chemical Name | (5-Chloro-2-methoxy-4-methylpyridin-3-yl)(2,3,4-trimethoxy-6-methylphenyl)methanone; Pyriofenone |
Substance ID | R02-A-085-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 |
- |
- | - | Test methods applicable to solid (melting point <= 140 deg C) substances are not 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 |
- |
- | - | 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, 2018), CLH Report (2018), ECHA RAC Opinion (2019)) |
1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) LD50 for rats (males): > 2,000 mg/kg (OECD TG 402, GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), CLH Report (2018), ECHA RAC Opinion (2019)) (2) LD50 for rats (females): > 2,000 mg/kg (OECD TG 402, GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), CLH Report (2018), ECHA RAC Opinion (2019)) |
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) | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) LD50 for rats (males) (4 hours): > 5.18 mg/L (OECD TG 403, GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), CLH Report (2018), ECHA RAC Opinion (2019)) (2) LD50 for rats (females) (4 hours): > 5.18 mg/L (OECD TG 403, GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), CLH Report (2018), ECHA RAC Opinion (2019)) |
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 skin irritation reactions were seen in any animal (erythema/eschar score: 0/0/0, edema score: 0/0/0) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), ECHA RAC Opinion (2019), CLH Report (2018), JMPR (2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). |
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), slight conjunctival redness was seen in 2 animals after 24 hours but disappeared after 48 hours (corneal opacity score: 0/0/0, iritis score: 0/0/0, conjunctival redness score: 0.3/0/0.3, chemosis score: 0/0/0) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), ECHA RAC Opinion (2019), CLH Report (2018), JMPR (2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). |
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) (GLP, intradermal administration: 1% suspension), the positive rate was 35% (7/20), 45% (9/20) after 24, 48 hours (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). [Reference Data, etc.] (2) It is reported that in a local lymph node assay (LLNA) with mice (n = 5/group) (OECD TG 429, GLP), the stimulation index (SI values) was 0.78 (5%), 1.04 (10%), 0.57 (25%) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), ECHA RAC Opinion (2019), CLH Report (2018), JMPR (2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). (3) As for (2), it was pointed out in the ECHA RAC Opinion (2019) that setting 25% as a top application dose may not be considered to meet the requirement in OECD TG 429, mentioning that a 50% concentration was also used in a preliminary dose-range finding test (ECHA RAC Opinion (2019)). |
5 | Germ cell mutagenicity | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1) to (7), it was classified as "Not classified." [Evidence Data] (1) In a micronucleus test using the bone marrow cells of mice (GLP), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015), CLH Report (2018), RAC (Background Doc.) (2019)). (2) In an unscheduled DNA synthesis test using the liver of rats (GLP), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015), CLH Report (2018), RAC (Background Doc.) (2019)). (3) In a comet assay using the liver of rat (OECD TG 489, GLP), negative results were reported (CLH Report (2018), RAC (Background Doc.) (2019)). (4) In a comet assay using the liver of mice, negative results were reported (CLH Report (2018), RAC (Background Doc.) (2019)). (5) In a bacterial reverse mutation test (GLP), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). (6) In a gene mutation test using the mouse lymphoma cells (GLP), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). (7) In a chromosome aberration test using the cultured mammalian cells (CHL), positive (-S9) results were reported at the higher dose level (CLH Report (2018), RAC (Background Doc.) (2019)). |
6 | Carcinogenicity | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1) to (5), due to the negative results in male and female rats and female mice, and because it was determined that the liver tumors in male mice occurred spontaneously, 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) (EPA Annual Cancer Report (2019): Classification in 2011). (2) In a two-year carcinogenicity study with rats dosed by feeding, there was no neoplastic lesion for which the incidence increased by the administration of the test substance, and no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). (3) In a 78-week carcinogenicity study with mice dosed by feeding, a significant increase in the total incidence of hepatocellular adenoma and carcinoma was observed in males in the highest dose group of 5,400 ppm (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). (4) The EPA classified the substance in NL because there was no evidence of carcinogenicity in the carcinogenicity studies with rats and mice (EPA Pesticide Fact Sheet (2012), Federal Register vol. 84, No. 104 (2019)). (5) In male mice, the incidence of hepatocellular adenoma was 13%, 11%, and 17% at 600, 1,800, and 5,400 ppm, respectively, while it was 6% in a control group, and there was no correlation with the dose. Furthermore, the incidence of carcinoma was 4%, 6%, and 6% respectively, while it was 2% in a control group, and there was no significant difference between the control group and the administrated groups. In the total incidence of hepatocellular adenoma and carcinoma, there was a statistically significant difference in a male group at the highest dose (5,400 ppm). However, it was within the range of the background data (9.8 to 36%) of the testing laboratory (CLH Report (2018), RAC (Background Doc.) (2019)). |
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 TG 416, GLP), at a dose at which general toxic effects (effects on the liver, kidney, thyroid, and blood, etc.) were observed in P and F1 parent animals, a reduction in body weight gain (F1) and a decrease in spleen weight (F2 female) were observed in offspring, but effects on fertility were not observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015), CLH Report (2018)). (2) It was reported that in a developmental toxicity study with rats dosed by gavage (OECD TG 414, GLP, days 6-19 of gestation), at a dose at which increases in liver and cecum weight were observed in parent animals, an increase in the number of fetuses with skeletal variations was observed in offspring, but teratogenicity was not observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015), CLH Report (2018)). (3) It was reported that in a developmental toxicity study with rabbits dosed by gavage (OECD TG 414, GLP, days 6-27 of gestation), no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015), CLH Report (2018)). |
8 | Specific target organ toxicity - Single exposure | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1) to (4), 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), no effect was observed at 2,000 mg/kg (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), CLH Report (2018), ECHA RAC Opinion (2019)). (2) It was reported that in an acute neurotoxicity study with rats (GLP), no neurotoxicity was observed at 2,000 mg/kg (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (3) 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), no effect was observed except for erythema, and scabbing (sites applied with the test substance) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), CLH Report (2018), ECHA RAC Opinion (2019)). (4) It was reported that in an acute inhalation (dust) toxicity test with rats (OECD TG 403, GLP, 4 hours), at 5.18 mg/L (in the range corresponding to "Not classified"), effects were not observed except for nasal discharge (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), CLH Report (2018), ECHA RAC Opinion (2019)). |
9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - | [Rationale for the Classification] Based on (1) to (7), it was classified as "Not classified" in the oral and dermal routes. An increase in ALP and hepatocyte hypertrophy which were the findings related to the liver, and chronic nephropathy which was the finding related to the kidney, were not adopted because those organs could not be considered to be the target organs based on those effects. However, classification was not possible due to lack of data since there was not sufficient information available for classification in the inhalation route. [Evidence Data] (1) It was reported that in a 90-day oral toxicity test with rats dosed by feeding (GLP), at or above 2,500 ppm (150 mg/kg/day (male), 171 mg/kg/day (female), in the range corresponding to "Not classified"), effects on the liver and kidney (increases in absolute and relative weight) (male), effects on the cecum (increases in absolute and relative weight) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), CLH Report (2018), ECHA RAC Opinion (2019)). (2) It was reported that in a two-year carcinogenicity study with rats dosed by feeding (GLP), at or above 1,000 ppm (36.4 mg/kg/day (male), 46.5 mg/kg/day (female), within the range for Category 2), chronic nephropathy (female) was observed; and at 5,000 ppm (197 mg/kg/day (male), 245 mg/kg/day (female), in the range corresponding to "Not classified"), effects on the kidney (increases in absolute and relative weight, chronic nephropathy (male)), effects on the cecum (increases in absolute and relative weight, distention), effects on the liver (centrilobular fatty change, hypertrophy, and necrosis of hepatocytes, increases in absolute and relative weight (female), focal congestion (female)), black contents in the large intestine (male), and sinus dilation of the mesenteric lymph node were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), CLH Report (2018), ECHA RAC Opinion (2019)). (3) It was reported that in a one-year oral toxicity test with rats dosed by feeding (GLP), at or above 1,000 ppm (42.9 mg/kg/day (male), 53.5 mg/kg/day (female), within the range for Category 2), an increase in GGT (female) was observed; and at 5,000 ppm (226 mg/kg/day (male), 275 mg/kg/day (female), in the range corresponding to "Not classified"), effects on the blood (decreases in Ht, Hb, and RBC, decreases in MCV, MCH, and MCHC (male), a decrease in reticulocyte count (female)), an increase in PLT, an extension of APTT, increases in TP, Alb, and Glob, effects on the cecum (distention, increases in absolute and relative weight), effects on the liver (increases in absolute and relative weight, centrilobular hypertrophy of hepatocytes (male)), effects on the kidney (increases in absolute and relative weight), effects on the epididymis (increases in absolute and relative weight) (male), increased hematopoiesis of the bone marrow (male), tubular basophilic change (male), soiled fur of the vulva (female), an increase in rearing (female), a decrease in A/G ratio (female), an increase in T.Chol (female), an increase in ketone bodies in urine (female), an increase in relative heart weight (female), and an increase in lipofuscin deposition on tubular epithelium (female) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), CLH Report (2018), ECHA RAC Opinion (2019)). (4) It was reported that in a 90-day oral toxicity test with dogs dosed by feeding (GLP), at or above 3,000 ppm (90.3 mg/kg/day (male), 89.8 mg/kg/day (female), within the range for Category 2), an increase in ALP (female) was observed; at 15,000 ppm (475 mg/kg/day (female), in the range corresponding to "Not classified"), an increase in PLT (female), and centrilobular hypertrophy of hepatocytes (female) were observed; and at 25,000 ppm (776 mg/kg/day (male), in the range corresponding to "Not classified"), effects on the liver (increases in absolute and relative weight, centrilobular hypertrophy of hepatocytes) (male) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), CLH Report (2018), ECHA RAC Opinion (2019)). (5) It was reported that in a one-year oral toxicity test with dogs dosed by feeding (GLP), at or above 3,000 ppm (83.5 mg/kg/day (male), 85.2 mg/kg/day (female), within the range for Category 2), an increase in ALP, and an increase in GGT (female) were observed; at 15,000 ppm (448 mg/kg/day (female), in the range corresponding to "Not classified"), an increase in relative liver weight was observed; and at 25,000 ppm (701 mg/kg/day (male), in the range corresponding to "Not classified"), effects on the liver (increases in absolute and relative weight) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), CLH Report (2018), ECHA RAC Opinion (2019)). (6) It was reported that in a 78-week carcinogenicity study with mice dosed by feeding (GLP), at or above 600 ppm (77.6 mg/kg/day (male), within the range for Category 2), centrilobular hepatocyte hypertrophy (male) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), CLH Report (2018), ECHA RAC Opinion (2019)). (7) It was reported that in a 28-day dermal toxicity test with rats (GLP), no effect was observed at 1,000 mg/kg/day (in the range corresponding to “Not classified”) (CLH Report (2018), ECHA RAC Opinion (2019)). |
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 | - |
- |
- | - | - |
|