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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	111988-49-9
Chemical Name	Thiacloprid
Substance ID	R03-B-010-METI
Classification year (FY)	FY2021
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)
New/Revised	Revised
Classification result in other fiscal year	FY2018 FY2006
Download of Excel format	Excel file

REFERENCE INFORMATION

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)	MHLW Website (in Japanese Only)
Model SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	eChemPortal

PHYSICAL HAZARDS

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 (but not fluorine or oxygen) which is 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.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] Based on (1) to (7), it was classified in Category 4. [Evidence Data] (1) LD50 for rats (males): 836 mg/kg (OECD TG 401) (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018), CLH Report (2013)) (2) LD50 for rats (females): 444 mg/kg (OECD TG 401) (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018), CLH Report (2013)) (3) LD50 for rats (males): 621 mg/kg (CLH Report (2013), EPA OPP HED Risk Assessment (2003), ACGIH (2019)) (4) LD50 for rats (females): 396 mg/kg (CLH Report (2013), EPA OPP HED Risk Assessment (2003), ACGIH (2019)) (5) LD50 for rats (males): between 700 to 1,000 mg/kg (EPA OPP HED Risk Assessment (2003)) (6) LD50 for rats (females): between 300 to 500 mg/kg (EPA OPP HED Risk Assessment (2003)) (7) LD50 for rats: 396 to 836 mg/kg (JMPR Report (2006))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (OECD TG 402) (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018), JMPR Report (2006), EPA OPP HED Risk Assessment (2003))
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)	Category 4	Warning	H332	P304+P340 P261 P271 P312	[Rationale for the Classification] Based on (1) to (3), it was classified in Category 4. [Evidence Data] (1) LC50 (4 hours) for rats (females): 1.22 mg/L (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018)) (2) LC50 (4 hours) for rats (females): 1.2 mg/L (OECD TG 403) (CLH Report (2013)) (3) LC50 for rats: 1.223 to 2.535 mg/L (JMPR Report (2006)) [Reference Data, etc.] (4) LC50 (4 hours) for rats (males): > 2.54 mg/L (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018)) (5) LC50 (4 hours) for rats (males): > 2.5 mg/L (OECD TG 403) (CLH Report (2013))
2	Skin corrosion/irritation	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 skin irritation test with rabbits, no skin irritation was observed (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018)). (2) It was reported that, in an acute dermal irritation/corrosion test with rabbits (n=3) (OECD TG 404), very slight erythema was observed in all rabbits but all skin reactions resolved by 72-hours post-application (erythema/eschar score: 1/1/0, edema score: 0/0/0) (ECHA RAC Opinion (2015), CLH Report (2013)). (3) This substance was not a skin irritant in rabbits (JMPR Report (2006)).
3	Serious eye damage/eye irritation	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 an ocular mucosal irritation test with rabbits, no eye irritation was observed (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018)). (2) It was reported that, in an acute eye irritation/corrosion test with rabbits (n=3) (OECD TG 405), conjunctival redness and swelling were observed in all animals but all ocular lesions resolved by 48 hours post application (corneal opacity score: 0/0/0, iris score: 0/0/0, conjunctival redness score: 0.6/0/0, chemosis score: 0/0/0) (ECHA RAC Opinion (2015), CLH Report (2013)). (3) It was reported that, in an eye irritation test with rabbits, this substance was a slight eye irritant in rabbits (JMPR Report (2006)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	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 maximization test with guinea pigs, no skin sensitization was observed (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018)). (2) It was reported that, in a maximization test (OECD TG 406, intradermal injection: 5% solution) with guinea pigs (n=10), the positive rates in 48 and 72 hours after challenge were both 10% (1/10 cases) (ECHA RAC Opinion (2015), CLH Report (2013)). (3) It was reported that, in a maximization test with guinea pigs, this substance did not induce sensitization (ACGIH (7th, 2019), JMPR Report (2006)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) As for in vivo, in a micronucleus test using the bone marrow cells of mice (single intraperitoneal administration), negative results were reported (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018), CLH Report (2013), ACGIH (7th, 2019)). (2) As for in vitro, in a bacterial reverse mutation assay, and a gene mutation assay and a chromosome aberration assay using the cultured mammalian cells (Chinese hamster V79 cells), negative results were obtained (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018), CLH Report (2013), ACGIH (7th, 2019)). (3) From the negative results in the in vitro and in vivo studies, this substance was considered not to be genotoxic (JMPR Report (2006), Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018), EFSA (2019), ACGIH (7th, 2019)).
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 in (1) and the test results, etc. in (2) to (4), it was classified in Category 2. [Evidence Data] (1) As for the classification results by domestic and international organizations, the EPA classified this substance in L (Likely To Be Carcinogenic To Humans) (EPA OPP Annual Cancer Report 2020 (Accessed June 2021): classification in 2012) and the ACGIH classified it in A3 (ACGIH (7th, 2019)), the EU classified it in Carc. 2 (EU-CLP Classification Results (Accessed June 2021)). (2) In a 2-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding, as neoplastic lesions related to the administration of the test substance, significant increases in the incidence of thyroid follicular cell adenomas in males and uterine adenocarcinomas in females were observed in the group dosed at or above 500 ppm (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018), CLH Report (2013), ACGIH (7th, 2019)). (3) In a 2-year carcinogenicity study with mice dosed by feeding, as neoplastic lesions related to the administration of the test substance, a significant increase in the incidence of luteomas in females was observed in the group dosed at or above 1,250 ppm (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018), CLH Report (2013), ACGIH (7th, 2019)). (4) In a carcinogenicity study, increases in the incidence of thyroid follicular cell adenomas in male rats, uterine adenocarcinomas in female rats, and ovarian luteomas in female mice were observed. The result of a mechanism examination test suggested that the development of uterine adenocarcinomas might have been associated with an increase in estrogen due to the aromatase activity induction effect of this substance. In addition, the mechanisms of the development of ovarian luteomas and thyroid follicular cell adenomas were not revealed, however, it was difficult to consider these mechanisms of tumor formation to be associated with genotoxicity (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018)). [Reference Data, etc.] (5) Since this substance had no genotoxic activity, the level of concern about carcinogenicity in humans was lessened. Taking the tumor profile into account, although at least some of the mechanisms were considered to be mechanisms through perturbation of sex hormones, considering that the tumorigenesis was species specific (there was no commonality in the region between rats and mice), classification in Category 2 was judged to be appropriate (CLH Report (2013)). As for the carcinogenicity induced by a nongenotoxic mode of action of this substance, the EFSA concluded that uterine and ovarian tumors might have resulted from an endocrine-mediated mode of action and thyroid tumors were considered to be a consequence of liver enzyme induction, but the extrapolation of these tumors to humans could not be ruled out (EFSA (2019)).
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) to (3), it was classified in Category 1B. Besides, in (1) to (3), at doses at which general toxicity effects (effects on the liver and thyroid, reduced body weight gain, etc.) were observed in parental animals, serious effects such as death or sacrifice in extremis resulting from dystocia in parental animals, and a decrease in viability index at birth, increased late embryo resorptions, and skeletal malformations in pups were observed. [Evidence Data] (1) In a two-generation reproduction toxicity study with rats dosed by feeding (OECD TG 416, GLP), 3 cases of death and one case of sacrifice in extremis at 300 ppm and 3 cases of sacrifice in extremis at 600 ppm were observed in parental animals, and all of the cases resulted from dystocia, which was considered to be induced by marked maternal toxicity attributed to administration. It was reported that, in surviving P and F1 parental animals, hepatocyte hypertrophy (males and females) and thyroid follicular cell hypertrophy (females) were observed at or above 300 ppm and thyroid follicular cell hypertrophy (males) was observed at 600 ppm; and in F1 and F2 pups, a decrease in viability index at birth was observed at 600 ppm (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, (2018), JMPR Report (2006), CLH Report (2013)). (2) A one-generation reproduction toxicity study with rats dosed by feeding was conducted, aimed at evaluating the reproducibility of dystocia observed in parental animals in the two-generation reproduction toxicity study in (1). As a result, no difficult parturition was observed at 300 ppm, but 6 females died or were sacrificed in extremis at 1,000 ppm, 4 rats of which died at the start of parturition or within 24 hours after the start of parturition (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, (2018), JMPR Report (2006), CLH Report (2013)). (3) It was reported that, in a developmental toxicity study with rats dosed by gavage (OECD TG 414, GLP, days 6-19 of gestation), at 50 mg/kg/day, reduced body weight gain, decreases in body weight and food consumption, and increased late embryo resorptions were observed in parental animals; and lower body weight, increases in the incidence of bone dysplasia of the limbs and skeletal variations, and delayed ossification were observed in foetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, (2018), JMPR Report (2006), CLH Report (2013)). [Reference Data, etc.] (4) It was reported that, in a developmental toxicity study with rabbits dosed by gavage (OECD TG 414, GLP, days 6-28 of gestation), at a dose at which marked general toxicity effects (abortion (2/24 cases), complete embryo resorption (3/24 cases)) were observed in parental animals, increased post-implantation embryonic mortality and delayed ossification were observed in foetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, (2018), JMPR (2006), CLH Report (2013)). (5) It was reported that, in a developmental neurotoxicity study with rats dosed by feeding (GLP, from day 0 of gestation until day 22 of lactation), at or above 300 ppm, reduced body weight gain and decreased food consumption were observed in parental animals, and reduced body weight gain (males and females), delayed preputial separation (males), and delayed vaginal patency (females) were observed in pups; and at 500 ppm, abnormal alignment of the incisors (males) was observed (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018), CLH Report (2013), JMPR Report (2006)). (6) In one-generation and two-generation reproduction toxicity studies with rats, an increased incidence of dystocia, which may lead to the death of dams and reduced pup viability index, was observed. In an experimental study of the mode of action (MoA) for dystocia, an increase in ovarian aromatase activity was observed in pregnancy and remained during lactation. Alteration of sex hormone levels was proposed as the MoA for dystocia, but a causal relationship for this MoA was not demonstrated. However, the extrapolation of these effects observed in animals to humans could not be ruled out (EFSA (2019)). (7) In the EU CLP classification, it was classified as Repr. 1B. (EU-CLP Classification Results (Accessed June 2021)).
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) to (4), it was classified in Category 1 (nervous system) because effects on the nervous system were observed in humans and animals. [Evidence Data] (1) In one death case after intentional ingestion of a preparation (100 mL) containing 21.7% of this substance, nausea, vomiting, and agitation were initially observed and tonic-clonic seizures occurred within 2 hours of ingestion. Tachycardia and hypertension were also presented early and the patient died of cardiac arrest within 36 hours. It was reported that these symptoms were consistent with the pharmacological action of this substance (nicotinic acetylcholine receptor stimulation) and this death was attributable to thiacloprid intoxication (ACGIH (2019)). (2) There was a report of acute thiacloprid poisoning in a 23-year-old man who deliberately ingested this substance, with status epilepticus, respiratory paralysis, rhabdomyolysis, metabolic acidosis, and acute kidney injury, and ultimately giving rise to refractory shock and death (HSDB in PubChem (Accessed June 2021)). (3) It was reported that, in an acute neurotoxicity test with rats, lower motor activity and locomotor activity were observed (females) at or above 11 mg/kg (within the range for Category 1); ptosis was observed (males) at or above 22 mg/kg (within the range for Category 1); and tremors, lower approaching response, and enlarged pupils (females) were observed at or above 53 mg/kg (within the range for Category 1) (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018)). (4) It was reported that, in an acute inhalation (dust) exposure test with rats, bradypnea, dyspnea, rales, prostration, chromodacryorrhea, tremor, reduced motility, apathy, ungroomed hair, hypothermia, and piloerection were observed at or above 0.48 mg/L (within the range for Category 1). Also, it was concluded that the respiratory symptoms observed in this test were non-specific effects in an inhalation exposure test and they were not signs of respiratory tract irritation (CLH Report (2013), ACGIH (2019)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver, thyroid)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1) to (4), it was classified in Category 2 (liver, thyroid) since liver effects (eosinophilic/clear mixed-type altered hepatocellular foci, etc.) and thyroid effects (hypertrophy of follicular cells, pigmentation, etc.) were observed within the dose range for Category 2. Also, the nervous system effects observed in (1) were caused by the abrupt ingestion of a large amount of this substance in the test, and the effects on the male reproductive organs were observed in the test with dogs in (2) but no effects were observed in a long-term test with dogs at the same dose levels. Therefore, they were not adopted as target organs. In addition, the effects on the visual organs and skeletal muscle observed in (4) were judged not to be specific effects of this substance based on (5) and they were not adopted as target organs. Based on the new information, the classification results were changed. [Evidence Data] (1) It was reported that, in a 4-week subacute inhalation (dust) exposure test with rats (6 hours/day, 5 days/week, GLP), at 0.1 mg/L and 0.2 mg/L (converted guidance values: 0.022 to 0.044 mg/L, within the range for Category 2), decreased body weight, bradypnea, decreased motility, muscle relaxation, rales, salivation, mydriasis, tremor, reduced muscle tonus and light reflex, and hypothermia were observed during exposure, and increases in absolute and relative lung weight (males), liver effects (hepatocyte hypertrophy, increased ALT (females)), and thyroid effects (follicular cell hypertrophy) were observed at the end of exposure (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018)). (2) It was reported that, in a repeated dose 15-week oral toxicity study with dogs dosed by feeding, at 1,000 ppm and 2,000 ppm (34.9 to 68.0 mg/kg/day (males), 34.7 to 65.3 mg/kg/day (females), within the range for Category 2), reproductive organ effects (increases in absolute and relative prostate weight, enlarged prostate/increased secretory ability, testicular spermatid degeneration/increased Leydig cells, epididymal spermatid degeneration) were observed in males, but no adverse effects were observed in females (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018), CLH Report (2013)). (3) In a 2-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding (GLP), liver effects (hepatocellular hyaline droplet degeneration, hypertrophy of centrilobular hepatocytes, eosinophilic/clear mixed-type altered hepatocellular foci, etc.), thyroid effects (hypertrophy of follicular cells, colloid degeneration, pigmentation, hyperplasia of follicular cells (females), increased TSH (females)), and retinal atrophy (females) were observed at 50 ppm (2.5 mg/kg/day (males), 3.3 mg/kg/day (females), within the range for Category 1); hyperplasia of the uterine glands and lens degeneration were observed at 500 ppm (25.2 mg/kg/day (males), 33.5 mg/kg/day (females), within the range for Category 2); and nervous system effects (sciatic nerve degeneration, spinal radiculoneuropathy (females)), skeletal muscle effects (atrophy/degeneration/mononuclear cell infiltration (females)) were observed at 1,000 ppm (51.7 mg/kg/day (males), 69.1 mg/kg/day (females), within the range for Category 2). Also, the hyperplasia of the uterine glands showed no statistically significant difference but it was judged as an effect of administration of the test substance (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018), CLH Report (2013)). (4) It was reported that, in a 2-year carcinogenicity study with mice dosed by feeding (OECD TG 451, GLP), at 1,250 ppm (234 mg/kg/day (males), 475 mg/kg/day (females), in the range corresponding to "Not classified"), liver effects (hepatocellular hypertrophy, fatty changes, hepatocellular necrosis, etc.) and effects on the blood /lymphatic system (increased leukocyte count, vacuolation of mesenteric/submandibular lymph nodes) were observed, and in females, adrenal gland effects (increased weight, expansion of the vacuolated region in X-zone) and ovary effects (increased eosinophilic luteinized cells) were observed (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018), CLH Report (2013)). (5) It was considered that, in the findings observed in the study with rats in (3), the increases in the incidence of lens (fiber) degeneration (at or above 500 ppm) and retinal atrophy (at or above 50 ppm) in females were not treatment-related when compared with the data for historical controls, rather they were considered to be effects of the lower survival rate of females in the control group. In addition, the increases in the incidence of degenerative changes in the nervous system and skeletal muscles in females at or above 500 ppm were considered to reach statistical significance owing to the relatively high survival rate in the highest-dose group compared with the control group, supposedly resulting in an increased incidence of age-related changes (JMPR (2006)). [Reference Data, etc.] (6) It was reported that, in a 90-day oral toxicity study with rats dosed by feeding (GLP), at or above 400 ppm (28.6 mg/kg/day (males), 35.6 mg/kg/day (females), within the range for Category 2), liver drug-metabolizing enzyme activities (ECOD, EROD (females), EH, GST, UDPGT) were observed, and increased TP, hepatocellular hypertrophy, and hepatocellular cytoplasmic changes (fine granular or vesicular structure) were observed in males; and at 1,600 ppm (123 mg/kg/day (males), 161 mg/kg/day (females)), increased macrophage activity in the spleen was observed, and increased T3 and T4, and increased mitogen (LPS) irritation cells were observed in males, and liver effects similar to those in males were observed in females (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018), CLH Report (2013)). (7) It was reported that, in a repeated dose 90-day oral toxicity study with mice dosed by feeding (OECD TG 408, GLP), at 50 ppm (19.9 mg/kg/day (males), 27.2 mg/kg/day (females), within the range for Category 2), an expanding tendency of the vacuolated region in the adrenal X-zone (females) was observed; and at 250 ppm (103 mg/kg/day (males), 139 mg/kg/day (females), in the range corresponding to "Not classified"), liver effects (increases in absolute and relative weight, centrilobular/diffuse hepatocyte hypertrophy) and ovary effects (decreased eosinophilic corpora lutea, an increase of interstitial glands) were observed (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018), CLH Report (2013)). (8) It was reported that, in a 90-day subacute neurotoxicity test with rats dosed by feeding (GLP), at 1,600 ppm (101 mg/kg/day (males), 115 mg/kg/day (females), in the range corresponding to "Not classified"), reduced body weight gain and decreased food consumption were observed but neurotoxicity was not observed (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018), CLH Report (2013)). (9) It was reported that, in a 4-week subacute dermal toxicity study with rats (6 hours/day, 5 days/week, OECD 410, GLP), liver effects (increases in absolute/relative weight, centrilobular hepatocyte hypertrophy) and thyroid effects (hypertrophy of thyroid follicular cells) were observed at 1,000 mg/kg/day (converted guidance value: 222.2 mg/kg/day, in the range corresponding to "Not classified") (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018), CLH Report (2013)). (10) It was reported that, in a one-year chronic toxicity study with dogs dosed by feeding (OECD TG 452), increased liver weight and ground glass-like changes of hepatocytes were observed at 1,000 ppm (34.4 mg/kg/day (males), 33.8 mg/kg/day (females), within the range for Category 2) (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018), CLH Report (2013)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS

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	-	- -	-	-	-

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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