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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	105779-78-0
Chemical Name	5-Chloro-N-{2-[4-(2-ethoxyethyl)-2,3-dimethylphenoxy]ethyl}-6-ethylpyrimidine-4-amine; Pylimidifen
Substance ID	R01-B-073
Classification year (FY)	FY2019
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	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 (FY2013 revised edition (Ver. 1.1))
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	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2	Flammable gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
6	Flammable liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
7	Flammable solids	*	- -	-	-	No data available.
8	Self-reactive substances and mixtures	*	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties. It was classified as "Not classified (Not applicable)."
9	Pyrophoric liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10	Pyrophoric solids	*	- -	-	-	No data available.
11	Self-heating substances and mixtures	*	- -	-	-	Classification is not possible because 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	*	- -	-	-	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)."
13	Oxidizing liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	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)."
15	Organic peroxides	*	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 3. [Evidence Data] (1) LD50 for rats: male: 148 mg/kg, female: 115 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), Japanese Journal of Pesticide Science vol. 24 No. 2 (Japan Crop Protection Association, 1999)) (2) LD50 for rats: 115-148 mg/kg (Food Sanitation Research vol. 48 No.11 (Japan Crop Protection Association, 1998))
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), Japanese Journal of Pesticide Science vol. 24 No. 2 (Japan Crop Protection Association, 1999))
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
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), it was classified in Category 2. [Evidence Data] (1) LC50 (4 hours) for rats: male: 0.069 mg/L, female: 0.076 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013))
2	Skin corrosion/irritation	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) No irritation was observed in a skin irritation test with rabbits (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (2) No irritation was observed in a skin irritation test in which this substance (0.5 g) was applied to rabbits (Japanese Journal of Pesticide Science vol. 24 No. 2 (Japan Crop Protection Association, 1999)).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2B. [Evidence Data] (1) Slight irritation was observed in an eye irritation test with rabbits (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (2) Transient conjunctival inflammation was observed in an eye irritation test in which this substance (46 mg) was applied to the eyes of rabbits, however, it resolved within 3 days (Japanese Journal of Pesticide Science vol. 24 No. 2 (Japan Crop Protection Association, 1999)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] Based on (1), it was classified in Category 1. [Evidence Data] (1) Moderate sensitization was observed in a skin sensitization test (maximization method) with guinea pigs (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). [Reference Data, etc.] (2) No sensitization was observed in a skin sensitization test (Buehler method) with guinea pigs (Japanese Journal of Pesticide Science vol. 24 No. 2 (Japan Crop Protection Association, 1999), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)).
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), since the results of all standard combination tests, were negative, it was classified as "Not classified." [Evidence Data] (1) As for in vivo, there was a report of a negative result in a micronucleus test with mice (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (2) As for in vitro, there were reports on negative results in a bacterial reverse mutation test and a chromosomal aberration test with cultured mammalian cells (Japanese Journal of Pesticide Science vol. 24 No. 2 (Japan Crop Protection Association, 1999), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)).
6	Carcinogenicity	*	- -	-	-	[Rationale for the Classification] There were no classification results by domestic and international organizations. There are no reports for humans available. Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) In a combined chronic toxicity/carcinogenicity study in which rats were given this substance by feeding for 2 years, a significant increase in benign pheochromocytomas of the adrenal gland was observed in males at 100 ppm. In females, the incidence of pheochromocytomas of the adrenal gland was low even in the treated groups, and there was no difference from the control group (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (2) In a carcinogenicity test in which mice were given this substance by feeding for 86 weeks, no increases in the incidence of neoplastic lesions were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)).
7	Reproductive toxicity	*	- -	-	-	[Rationale for the Classification] Based on (1)-(3), it was classified as "Not classified." [Evidence Data] (1) In a 2-generation reproductive toxicity test with rats dosed by feeding, reduced body weight gain, reduced food consumption and increased liver weight were observed in the parent animals of P and F1, and decreased spermatogenesis were observed in the F1 parental animals, but no reproductive effects were observed. Reduced body weight gain and lower body weight in the F1 and F2 pups and delayed preputial separation and delayed vaginal opening in the F1 pups were observed at the same doses where parental toxicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (2) In a developmental toxicity test with female rats dosed by gavage on gestational Days 6-15, lower body weight, delayed ossification (sternebrae) and skeletal variations (14th ribs) were observed in the fetuses at the dose where maternal toxicity (decreased body weight gain, decreased food consumption) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (3) In a developmental toxicity test with female rabbits dosed by gavage on gestational Days 6-19, delayed ossification (carpal bones, metacarpals, and phalanges) was observed in fetuses at the dose where maternal toxicity (emergency slaughter (1 out of 15-16 animals), reduced body weight gain, reduced food consumption) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)).
8	Specific target organ toxicity - Single exposure	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Target organs could not be identified from the symptoms in the oral test in (1), and the symptoms in the inhalation test in (2) were observed in the vicinity of lethal doses, and none of these were judged to be appropriate as evidence of the classification. Since the previous classification result was based on these symptoms, the classification result was changed. [Reference Data, etc.] (1) In single oral administration tests with rats and mice, inactivity and bradypnea were observed. Deaths were observed at or above 35 mg/kg (male and female) in rats and at or above 204 mg/kg (male) or 120 mg/kg (female) in mice (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (2) In a single inhalation exposure test (no description of the exposure time, but 4 hours) with rats, partial eye closure, decreased respiratory rate, exertional respiration and mouth opening during inspiration were observed. Deaths occurred at or above 0.068 mg/L (male and female) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (blood system, kidney)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1)-(3), it was classified in Category 1 (blood system, kidney). As a result of reviewing by the use of new information sources, the classification result was changed from the previous classification. Besides, the liver was not adopted as a target organ since the findings were considered to be adaptive changes. [Evidence Data] (1) In a 90-day repeated dose toxicity test with rats dosed by feeding, reduced body weight gain and decreased hemoglobin level in males and females, increased urea nitrogen and creatinine and increased kidney weight in males, and decreased erythrocyte counts, etc. in females were observed at 150 ppm (male/female: 8.74/9.43 mg/kg/day, within the range of Category 1) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (2) In a 90-day repeated dose toxicity test with mice dosed by feeding, increased liver and kidney weights were observed in females at 100 ppm (male/female: 13.4/17.7 mg/kg/day, within the range of Category 2), and at 300 ppm (male/female: 39.7/46.7 mg/kg/day, within the range of Category 2), centrilobular hepatocellular hypertrophy in males and females, increased liver weight in males, and decreased hemoglobin level and erythrocyte counts, and increased urea nitrogen, etc. in females were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (3) In a combined chronic toxicity/carcinogenicity study with rats dosed by feeding for 2 years, reduced body weight gain, increased urea nitrogen and increased epithelial brown pigmentation of the renal tubules were observed in females at 100 ppm (male/female: 3.41/4.47 mg/kg/day, within the range of Category 1) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)).
10	Aspiration hazard	*	- -	-	-	[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)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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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