NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	114-26-1
Chemical Name	2-Isopropoxyphenyl N-methylcarbamate [Propoxur]
Substance ID	m-nite-114-26-1_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	No data available. Besides, there is the information that it is combustible under specific conditions (ICSC(J) (1994)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) present in the molecule and the oxygen is chemically bonded only to carbon or hydrogen.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	There are 6 reports of LD50 values for rats of 68 mg/kg, 94 mg/kg (EPA RED (1997)), 83 mg/kg, 86 mg/kg (ACGIH (7th, 2001)), 78.5-126 mg/kg, 89.7-196 mg/kg (ACGIH (7th, 2016)). Based on these, this substance was classified in Category 3.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	There is a report of an LD50 value for rabbits of > 2,000 mg/kg (EPA RED (1997), ACGIH (7th, 2016)). There are 2 reports that the LD50 values for rats are > 2,400 mg/kg (ACGIH (7th, 2001)) and > 5,000 mg/kg (ACGIH (7th, 2016), JMPR (1989)). Based on these, this substance was classified as "Not classified." 　The classification was revised from the previous one.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, there are 2 reported LC50 values (4 hours) for rats of > 500 mg/m3 and > 654 mg/m3 (ACGIH (7th, 2016)). However, it is not possible to specify the category from these data. The category was revised based on newly obtained information.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	Since no irritation was observed in a skin irritation test (4-hour application) using rabbits (ACGIH (7th, 2016), JMPR (1989)), this substance was classified as "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	In an eye irritation test using rabbits, slight eye irritation (redness and discharge) was observed but resolved after 48 hours (EPA RED (1997)). In addition, slight erythema of the conjunctivae in 2/3 animals was observed but resolved after 24 hours (JMPR (1989)). From the above, this substance was classified in Category 2B.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, it is reported that in a maximization test using guinea pigs, no sensitization was observed (ACGIH (7th, 2016), JMPR (1989)). Since the details of the test method etc. are unknown, this data was judged as insufficient to be used for the classification.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	As for in vivo data, a mouse dominant lethal test is negative, a chromosomal aberration test using Chinese hamster spermatogonia is negative, and there are many negative results in micronucleus tests using peripheral blood erythrocyte and bone marrow cells of mice and in chromosomal aberration tests using mouse bone marrow cells. However, in recent assessment documents, multiple positive results of chromosome damage in mouse bone marrow/peripheral blood have been reported (ACGIH (7th, 2016), JMPR (1989), EPA RED (1997)). As for in vitro data, bacterial reversion mutation tests are negative, an in vitro mammalian cell gene mutation test is negative, a micronucleus test is positive, a chromosome aberration test is positive and a sister chromatid exchange test is negative (ACGIH (7th, 2016), JMPR (1989), EPA RED (1997)). From the above information, for in vivo, it was judged that the positive results were taken into account. Besides, in the previous classification, this substance was classified in Category 1B since there was a positive result in a mouse dominant lethal test. However, since it is described in JMPR (1989) that this positive result is questionable, it was not adopted for this classification. From the above, this substance was classified in Category 2 according to the GHS classification guidance for the Japanese Government. 　With the addition of new information, the previous classification was revised.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	As for classifications by other organizations, ACGIH classified this substance as A3. This substance was classified in Category 2 for this hazard class. As for test data, it is reported that in a one-year carcinogenicity study using rats dosed by feeding, there was an increase in the incidence of urinary bladder papillomas and carcinomas; after dietary administration to mice for one year, an increase in the incidence of hepatocellular adenomas; and after inhalation exposure to rats for two years, increases in the incidences of urinary bladder papillomas, hepatocellular adenomas etc. were observed (EPA RED (1997), JMPR (1989), ACGIH (7th, 2016)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	Of two 2-generation reproductive toxicity studies using rats dosed by feeding, in one study of low doses (maximum 80 ppm (7 - 8 mg/kg/day)), no reproductive toxicity was observed, but in the other study of high doses, decreases in the number of implantation sites/dam and the number of pups/dam in F1 females were observed at 2,500 ppm (228 - 239 mg/kg/day), where a decrease in red blood cell acetylcholinesterase activity (males: at 100 ppm or above), body weight reductions (at 500 ppm or above) and urothelial hyperplasia were observed in F0 and F1 parental animals. In addition, reduced body weights at birth were observed in F1 and F2 pups at 2,500 ppm (EPA RED (1997), ACGIH (7th, 2016)). On the other hand, in a developmental toxicity study using pregnant rats or rabbits dosed by gavage administration during the organogenesis period, even at the dose where more than 10% of the dams died (rats: 3/25 deaths at 27 mg/kg/day, rabbits: 3/16 deaths at 30 mg/kg/day), no developmental effects including malformations were observed other than slight fetal toxicity (a slight increase in post-implantation loss) observed in rabbits (EPA RED (1997), ACGIH (7th, 2016)). 　From the above, this substance was classified in Category 2 for this hazard class, since, in a 2-generation study using rats, reproductive and developmental effects (decrease in the number of implantation sites per dam, reduced body weights at birth, etc.) were observed at the dose with parental toxicity.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system, circulatory system), Category 3 (narcotic effects)	Danger Warning	H370 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	This substance is a cholinesterase inhibitor. As for humans, it is described that accidental or intentional ingestion of this substance causes tachycardia, pinpoint pupils, coma, and pulmonary edema (ACGIH (7th, 2016). In addition, in a single oral dose study on volunteers, a decrease in the erythrocyte cholinesterase activity, an increase in pulse rate and in blood pressure, nausea, vomiting and profuse sweating were reported (ACGIH (7th, 2016), EHC 64 (1986)). Moreover, in a case of spray workers and residents exposed by inhalation to this substance sprayed for malaria control, lethargy, sweating, nausea, headaches, tachycardia, emesis and vertigo are reported ((ACGIH (7th, 2016)). As for experimental animals, in single oral dose acute toxicity studies using rats, decreases in cholinesterase activity in the plasma, erythrocytes and brain, convulsions, muscle spasm, dyspnoea and salivation were observed (JMPR (1989)). From the above, this substance was classified in Category 1 (nervous system, circulatory organ system) and Category 3 (narcotic effects).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 2 (nervous system)	Warning	H373	P260 P314 P501	There is no relevant information on humans. 　As for experimental animals, in a 16-week repeated dose toxicity study using rats by dietary administration, histopathological changes in the liver and depression of cholinesterase activity in the brain are reported at 1,000 ppm (converted guidance value: 50 mg/kg/day), which is equivalent to Category 2 (JMPR (1973)). In addition, it is reported that in a 4 or 8-week inhalation study using rats, cholinergic symptoms were observed at 139.6 mg/m3 (converted guidance value: 0.03 mg/L (20-day exposure), 0.06 mg/L (40-day exposure)), which is equivalent to Category 2 (JMPR (1989)). It is reported that in a 13-week repeated dose toxicity study using monkeys by gavage administration, effects on the nervous system (cholinergic symptoms) were observed at 40 mg/kg/day, which is equivalent to Category 2 (JMPR (1989), ACGIH (7th, 2016)). Moreover, in a 2-year repeated dose toxicity study using rats by dietary administration, hyperplasia of the urinary bladder is reported at 1,000 ppm (converted guidance value: 50 mg/kg/day), which is equivalent to Category 2 (JMPR (1989)). As for this hyperplasia of the urinary bladder, there is species specificity and it has been confirmed that the effect is not observed in mice, guinea pigs and rhesus monkeys. In addition, it has been confirmed that differences occur depending on the diet (JMPR (1989)). Therefore, the urinary bladder was not adopted as the target organ. Moreover, as for the finding in the liver, it was not adopted as evidence for the classification since the details of the histopathological changes are unknown and no histopathological findings have been reported in the other studies. 　Therefore, this substance was classified in Category 2 (nervous system).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 1	Warning	H400	P273 P391 P501	From EC/LC50 (unknown time) = 0.011 ppm for crustacea (Daphnia magna) (U.S.EPA: RED, 1997), it was classified in Category 1.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Reliable chronic toxicity data were not obtained. Due to being not rapidly degradable (a degradation rate by BOD (NH3): 1%, 9%, 6% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2002)), and acute toxicity Category 1, it was classified in Category 1.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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