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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	101-21-3
Chemical Name	Isopropyl (3-chlorophenyl)carbamate; Chlorpropham
Substance ID	R01-A-002
Classification year (FY)	FY2019
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	New
Classification result in other fiscal year
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)
Model SDS by MHLW (External link)
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 associated with explosive or self-reactive properties present in the molecule. 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	*	- -	-	-	It is a solid with a melting point of 55 deg C or lower, but the classification is not possible due to no data.
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)	*	- -	-	-	[Rationale for the Classification] Based on (1)-(4), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: 4,000 mg/kg (EPA Pesticide (1994)) (2) LD50 for male rats: 5,800 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)) (3) LD50 for female rats: 6,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)) (4) LD50 for rats: 5,000-8,000 mg/kg (JMPR (1965))
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Based on (1)-(3), it was classified as "Not classified." [Evidence Data] (1) LD50 for rabbits: > 2,000 mg/kg (HSDB (Access on May 2019)) (2) LD50 for rats: > 4,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)) (3) LD50 for rabbits: > 5,000 mg/kg (EPA Pesticide (1994))
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 4	Warning	H332	P304+P340 P261 P271 P312	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 4. [Evidence Data] (1) LC50 (4 hours, mist) for male rats: 1.98 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)) (2) LC50 (4 hours, mist) for female rats: 2.17 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014))
2	Skin corrosion/irritation	*	- -	-	-	[Rationale for the Classification] Based on (1)-(3), it was classified as "Not classified." [Evidence Data] (1) This substance was not irritating to the skin and eyes (JMPR (2005)). (2) This substance produced mild dermal and eye irritation (EPA Pesticide (1994)). (3) It is reported that it showed no irritation in a skin irritation test on the pesticide ingredient (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	[Rationale for the Classification] Based on (1)-(3), it was classified in Category 2B. [Evidence Data] (1) This substance was not irritating to the skin and eyes (JMPR (2005)). (2) This substance produced mild dermal and eye irritation (EPA Pesticide (1994)). (3) It is reported that it showed mild irritation in an eye irritation test on the pesticide ingredient (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[Rationale for the Classification] Based on (1)-(4), since there is a mixture of positive and negative results, it was classified as "Classification not possible." [Reference Data, etc.] (1) It is reported to be positive with a positive rate of 30% in a skin sensitization test (split adjuvant method) with guinea pigs (JMPR (2005)). (2) It is reported to be negative in skin sensitization tests (Buhler method, maximization method) with guinea pigs (JMPR (2005)). (3) This substance is reported to be negative in a skin sensitization test with guinea pigs (EPA Pesticide (1994)). (4) It is reported to be mildly sensitizing in a skin sensitization test of the pesticide ingredient with guinea pigs (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)).
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), since the results of all standard combination tests, including in vivo and in vitro tests, were negative, it was classified as "Not classified." [Evidence Data] (1) As for in vivo, it was negative in a bone marrow micronucleus test with mice (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (2) As for in vitro, it was negative in a bacterial reverse mutation test, a mouse lymphoma TK test, and a chromosome aberration test and an unscheduled DNA synthesis test with cultured mammalian cells (EPA Pesticide (1994), IARC 12 (1976), EHC 64 (1986), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1), the newest classification by other organizations was the EU CLP classification, which is equivalent to Category 2. Based on (2) and (3), carcinogenicity was observed in rats, therefore, it was classified in Category 2. [Evidence Data] (1) In classification results by domestic and international organizations, it was classified as Group 3 by IARC (IARC Suppl.7 (1987)), as group E (evidence of non-carcinogenicity for humans) by EPA OPP RED (Office of Pesticide Programs, Registration Eligibility Decision (1994)), and as Carc.2 by EU CLP (EU CLP classification (Access on May 2019)). (2) In a carcinogenicity study by 2-year administration of this substance (30, 100, 500, 1,000 mg/kg/day) by feeding to rats, the incidence of Leydig cell tumors increased in males at 1,000 mg/kg group. Since the SD strain used in this study did not develop Leydig cell tumors frequently, the increase observed in the 1,000 mg/kg group was judged to be administration-related (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (3) In a carcinogenicity study by 18-month administration of this substance by diet to mice, no increased incidence of neoplastic lesions was observed after administration of this substance (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). [Reference Data, etc.] (4) Regarding the increased incidence of the Leydig cell tumors in male rats, the Food Safety Commission judged that it was impossible to deny that this substance was a carcinogen with a threshold based on existing findings (genetic toxicity and carcinogenicity) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). On the other hand, although the EU assigned it a harmonized classification as Carc. 2 based on the increased incidence of Leydig cell tumors observed in a carcinogenicity study with rats, the possibility that the mechanism of the tumor induction of the testes by endocrine disrupting action (mechanism via dopaminergic activity) was suggested (EFSA (2017)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1), no effects on fertility were observed. However, based on (2) and (3), decreased litter size and increased mortality of embryos and fetuses were reported only at doses where maternal toxicity was observed, therefore, it was classified in Category 2. [Evidence Data] (1) In 2 two-generation reproduction toxicity studies dosed by feeding with rats, no effects on fertility were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (2) In a developmental toxicity study with female rats dosed by gavage on gestational Days 6-15, reduced body weight gain (gestational Day 17) and decreased food consumption were noted in maternal animals, and decreased litter size, lower body weight and delayed ossification were observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (3) In a developmental toxicity study with female rabbits dosed by gavage on gestational Days 6-18, decreased food consumption and decreased feces in maternal animals, and increased mortality in embryos and fetuses were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)).
8	Specific target organ toxicity - Single exposure	Category 1 (blood system, respiratory organs), Category 2 (central nervous system)	Danger Warning	H370 H371	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] There were no reports of single exposure to this substance in humans. As for experimental animals, based on (1), an effect on the blood system at a dose equivalent to Category 1 and effects on the central nervous system at a dose equivalent to Category 2 were observed, and based on (2), effects on the respiratory organs at a dose equivalent to Category 1 were noted. Therefore, it was classified in Category 1 (blood system, respiratory organs), Category 2 (central nervous system). [Evidence Data] (1) In a single dose oral toxicity test with dogs, reduced activity, vomiting, a very small increase in blood methemoglobin levels, etc. at or above 125 mg/kg (equivalent to Category 1), unsteady hind gait, trembling, etc. at 625 mg/kg (equivalent to Category 2) were observed, but no dead animals were found (JMPR (2005), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (2) In a 4-hour single inhalation exposure test with rats, nose bleeding and so on (male), abnormal respiratory sound (female) and hypothermia and decreased respirations (both sexes) were observed by exposure to the aerosol of this substance at or above 0.905 mg/L (equivalent to Category 1), and dead animals were found at or above 1.68 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)). [Reference Data, etc.] (3) In a single oral dose test in rats, clinical signs such as sedation, ptosis and ataxia were observed from the minimum dose of 4,350 mg/kg (exceeding the range of Category 2), but the effects at lower doses than that were unknown (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (blood system, thyroid)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1) and (2), in an oral administration to experimental animals, effects on the blood system and thyroid were observed within the range of Category 2, therefore, it was classified in Category 2 (blood system, thyroid). [Evidence Data] (1) As a result of a 90-day test by dosing by feeding to rats at doses of 120-3,000 ppm, decreased erythrocyte counts and increased methemoglobin levels were observed at or above 600 ppm (male: 47 mg/kg/day, female: 54 mg/kg/day, equivalent to Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), EFSA (2017), JMPR (2000)). (2) As a result of a 1-year dog study dosed by feeding at 5-500 mg/kg/day, effects on the thyroid (increased organ weight, morphologically hyperfunctional images) were observed at or above 50 mg/kg/day (range of Category 2), and erythrocyte counts, hemoglobin levels and hematocrit were decreased at or above 350 mg/kg/day (exceeding the range of Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), EFSA (2017), EPA Pesticide (1994)).
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)	Category 2	- -	H401	P273 P501	It was classified in Category 2 from 48-hour EC50 = 3.7 mg/L for crustacea (Daphnia magna) (U.S. EPA: RED, 2002).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 2 because it is not rapidly degradable (BIOWIN), and it was classified in Category 2 in acute toxicity.
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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