GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 114-26-1
Chemical Name 2-Isopropoxyphenyl N-methylcarbamate [Propoxur]
Substance ID H28-B-040, C-053B
Classification year (FY) FY2016
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 Not applicable
-
-
- -  There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- -  Solid (GHS definition).
3 Aerosols Not applicable
-
-
- -  Not aerosol products.
4 Oxidizing gases Not applicable
-
-
- -  Solid (GHS definition).
5 Gases under pressure Not applicable
-
-
- -  Solid (GHS definition).
6 Flammable liquids Not applicable
-
-
- -  Solid (GHS definition).
7 Flammable solids Classification not possible
-
-
- -  No data available. Besides, there is the information that it is combustible under specific conditions (ICSC(J) (1994)).
8 Self-reactive substances and mixtures Not applicable
-
-
- -  There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids 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 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 applicable
-
-
- -  Solid (GHS definition).
14 Oxidizing solids 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.
15 Organic peroxides 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.

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
 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.
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.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- -  Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- -  Solid (GHS definition)
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.
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."
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.
4 Respiratory sensitization Classification not possible
-
-
- -  Classification not possible due to lack of data.
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.
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.
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)).
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.
8 Specific target organ toxicity - Single exposure Category 1 (nervous system, circulatory organ 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).
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).
10 Aspiration hazard Classification not possible
-
-
- -  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 (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.
11 Hazardous to the aquatic environment (Long-term) 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.
12 Hazardous to the ozone layer Classification not possible
-
-
- -  No data available.


NOTE:
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government,
and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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