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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	23103-98-2
Chemical Name	2-(dimethylamino)-5,6-dimethylpyrimidin-4-yl dimethylcarbamate; Pirimicarb
Substance ID	R02-B-076-MHLW, MOE
Classification year (FY)	FY2020
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 (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. It was classified as "Not classified."
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified."
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
7	Flammable solids	Classification not possible	- -	-	-	No data available. Besides, there is information that it is not combustible (RAC Background Document (2014)), and it is combustible (GESTIS (Access on May 2020)).
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. It was classified as "Not classified."
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
10	Pyrophoric solids	Not classified	- -	-	-	Because it is classified in Division 6.1 in UNRTDG (UN2757), and it is considered to be not applicable to pyrophoric solid, hazards of the highest precedence, it was classified as "Not classified."
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.
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."
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. It was classified as "Not classified."
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified."
16	Corrosive to metals	Classification not possible	- -	-	-	Classification is not possible because 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. 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] It was classified in Category 3 from (1) - (5). [Evidence Data] (1) LD50 for rats: females: 68-221 mg/kg (HSDB (Access on May 2020)) (2) LD50 for rats: 100 mg/kg (GESTIS (Access on May 2020)) (3) LD50 for rats: 142 mg/kg (EHC 64 (1986)) (4) LD50 for rats: females: 142 mg/kg, males: 152 mg/kg (JMPR (2004), EU CLP CLH (2014), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)) (5) LD50 for rats: 147 mg/kg (HSDB (Access on May 2020))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). Besides, the classification result was changed from the previous classification due to the use of new information sources. [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (JMPR (2004), EU CLP CLH (2014), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)) [Reference Data, etc.] (2) LD50 for rabbits: > 500 mg/kg (EHC 64 (1986), HSDB (Access on May 2020)) (3) LD50 for rats: > 500 mg/kg (GESTIS (Access on May 2020), HSDB (Access on May 2020))
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 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	[Rationale for the Classification] It was classified in Category 2 from (1), (2). Besides, because exposure concentrations were higher than the saturated vapor pressure concentration (9.3E-005 mg/L), a reference value in the unit of mg/L was applied as dust. [Evidence Data] (1) LC50 for rats (nose exposure, 4 hours): females: 0.858 mg/L, males: 0.948 mg/L (JMPR (2004), EU CLP CLH (2014), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)) (2) LC50 for rats (6 hours): 0.3 mg/L (converted 4-hour equivalent value: 0.45 mg/L) (HSDB (Access on May 2020)) (3) Vapor pressure of this substance: 7.28E-006 mmHg (25 deg C) (HSDB (Access on May 2020)) (converted value for the saturated vapor pressure concentration: 9.3E-005 mg/L)
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). Because the previous classification was conducted based on data on a formulation, the classification result was changed based on data on the substance newly obtained. [Evidence Data] (1) In a skin irritation test in which this substance (purity 97.6%) was applied to the rabbit skin for 4 hours, very slight erythema was observed but completely disappeared by 7 days after application (JMPR (2004), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). (2) This substance was mildly irritating to the eyes of rabbits but did not irritate the skin of rabbits (HSDB (Access on May 2020)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). Because the previous classification was conducted based on data on a formulation, the classification result was changed based on data on the substance newly obtained. [Evidence Data] (1) In an eye irritation test with rabbits (Draize test) on this substance (purity 97.6%), slight conjunctival redness in 6/6 animals and chemosis in 1/6 animals were observed but disappeared 2 days after application. The maximum mean total score was 2.3 (maximum 110) at 2 hours after application, 1 at 1 day after application, and 0 at 2 days after application (JMPR (2004), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). (2) This substance was mildly irritating to the eyes of rabbits but did not irritate the skin of rabbits (HSDB (Access on May 2020)).
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). The classification result was changed because new data (1) were obtained. [Evidence Data] (1) In a skin sensitization test with guinea pigs (maximization test, intradermal administration 3%) on this substance, it was judged as positive (positive rate 47%) (JMPR (2004), EU CLP CLH (2014), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). [Reference Data, etc.] (2) It was classified in Skin Sens. 1 (H317) in EU-CLP classification (EU CLP classification (Access on August 2020)). (3) This substance did not cause a skin sensitization reaction in guinea pigs (HSDB (Access on May 2020)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) As for in vivo, it was reported to be negative in a micronucleus test in bone marrow cells after gavage administration to mice, negative in an unscheduled DNA synthesis test in hepatocytes after gavage administration to rats, and negative in a dominant lethal test by 5-day gavage administration to mice (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), EU CLP CLH (2014), JMPR (2004)). (2) As for in vitro, it was reported to be negative in a bacterial reverse mutation test, negative in a chromosomal aberration test with human lymphocytes, and positive in a gene mutation test with cultured mammalian cells (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), EU CLP CLH (2014), JMPR (2004)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] From (1) - (4), EPA classified it in L, but because no carcinogenicity was found in rats, and it was classified in Carc.2 based on (4) in EU CLP, it was classified in Category 2. An investigation was conducted by using new information sources, and the classification result was changed. [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified in L (Likely to be Carcinogenic to Humans) by EPA (EPA Annual Cancer Report 2019 (Access on August 2020): classified in 2005), and Carc.2 in EU CLP classification (EU CLP classification (Access on May 2020)). (2) In a combined chronic toxicity/carcinogenicity test by 104-week diet administration of this substance to male and female rats, no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). (3) In two carcinogenicity tests by 80-week or 96-week diet administration of this substance to male and female mice, increased incidences of pulmonary adenoma were seen in both males and females, and significant increases were observed in females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). (4) The EU stated that it was classified in Carc.2 based on the rationale for carcinogenicity classification: increased incidences of pulmonary adenoma in mice and the absence of mechanistic data to dismiss the relevance of the pulmonary adenoma for humans (CLH Report (2013)).
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) In a two-generation reproductive study with rats dosed by feeding, reduced body weight gain, etc. were observed in parent animals and offspring, but no effect on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). (2) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, at a dose at which reduced body weight gain and a decrease in food consumption were observed in dams, low body weight, an increase in skeletal variations, etc. were observed in fetuses, but no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). (3) In a developmental toxicity study with female rabbits dosed by gavage on days 6 to 18 of gestation, even at a dose at which reduced body weight gain and a decrease in food consumption were observed in dams, no effect was observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)).
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] There was no report on single exposure to this substance in humans. Based on (1) to (3), it was classified in Category 1 (nervous system). New information was used and the classification results were changed from the previous classification. [Evidence Data] (1) It was reported that, in an oral toxicity test with rats, at or above 100 mg/kg (within the range for Category 1), salivation, wet fur, a decrease in activity, muscular spasm, wasting, irregular respiration, diarrhea, stooping position, etc. were observed (CLH Report (2013)). (2) It was reported that, in an acute neurotoxicity test with rats, by an oral administration, reduced locomotor activity was observed at or above 40 mg/kg (within the range for Category 1); and at 110 mg/kg (within the range for Category 1), inhibition of brain cholinesterase (ChE) activity was observed, and additionally in females, a decrease in landing foot splay width, and prolonged avoidance time to tail stimuli were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), JMPR (2004)). (3) It was reported that, in an inhalation exposure test with rats by nasal exposure, a decrease in body weight, a decrease in activity, tremor, wet fur, hunched posture, chromodacryorrhea, piloerection, stains around the nose, etc. were observed at or above 0.414 mg/L (aerosol, within the range for Category 1); and bradypnea, irregular breathing, and salivation were observed at or above 0.747 mg/L (aerosol, within the range for Category 1) (CLH Report (2013)). [Reference Data, etc.] (4) It was reported that, in an inhalation exposure test with rats using a 50% dispersible powder formulation of this substance, plasma and red blood cell ChE depression were observed at 20 mg/L (powder, within the range exceeding Category 2) (JMPR (1976)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (nervous system, blood system, liver, kidney)	Warning	H373	P260 P314 P501	[Rationale for the Classification] There was no report on repeated exposure to this substance in humans. Based on (1) to (4), effects on the nervous system, blood system, liver, and kidney at doses for Category 2 were observed in experimental animals. Therefore, it was classified in Category 2 (nervous system, blood system, liver, kidney). As a result of reviewing the information, the classification result was changed from the previous classification. [Evidence Data] (1) It was reported that, in a 104-week test with rats dosed by feeding, at or above 250 ppm (males/females: equivalent to 12.3/15.6 mg/kg/day, within the range for Category 2 in both sexes), increases in cholesterol and triglycerides, and renal pelvic transitional cell hyperplasia were observed, and renal pelvic vascular ectasia in males, and increases in hemoglobin concentration and hematocrit level in females were observed; and at 750 ppm (males/females: equivalent to 37.3/47.4 mg/kg/day, within the range for Category 2 in both sexes), an increase in mean corpuscular hemoglobin (MCH) was observed, and an increase in mean corpuscular volume (MCV), vacuolar degeneration of the adrenal cortex, hepatocyte hypertrophy, and clear cell foci of altered hepatocytes in males were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), EU CLP CLH (2014), JMPR (2004)). (2) It was reported that, in an 80-week test with mice dosed by feeding, at or above 200 ppm (males/females: equivalent to 26.6/37.1 mg/kg/day, within the range for Category 2 in both sexes), increases in erythrocyte count and mean corpuscular hemoglobin concentration (MCHC), and decreases in MCV and MCH were observed, and mononuclear cell infiltration of the renal pelvis was also observed in males (Same as above). (3) In a 90-day test with dogs dosed by feeding, at or above 10 mg/kg/day (within the range for Category 1), an increase in circulating erythroblasts was observed, and in females, macrocytic anemia was also observed; and at 25 mg/kg/day (within the range for Category 2), a decrease in erythrocyte ChE activity and an increase in mean erythrocyte diameter were observed, and in cases of severe anemia, extramedullary hematopoiesis was observed in the spleen and lymph node (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), CLH Report (2013), JMPR (2004)). (4) It was reported that, in a 1-year oral toxicity test with dogs, tremor, salivation, unsteady gait, sedation, irregular breathing, occasional coughing, fluid feces, decreases in albumin and total proteins, and hepatic hemosiderosis were observed in the highest dose group that received 35 mg/kg/day (within the range for Category 2) for 1 week, followed by a 2-week cessation period, and then 25 mg/kg/day (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), CLH Report (2013), JMPR (2004)).
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)	Category 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 48-hour EC50 = 0.017 mg/L for crustacea (Daphnia magna) (EU CLP CLH, 2014).
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 21-day NOEC = 0.0009 mg/L for crustacea (Daphnia magna) (EU CLP CLH, 2014).
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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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