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

Japanese



GENERAL INFORMATION
 
Item Information
CAS RN 173584-44-6
Chemical Name Methyl (S)-7-chloro-2,3,4a,5-tetrahydro-2-[methoxycarbonyl(4-trifluoromethoxyphenyl)carbamoyl]indeno[1,2-e][1,3,4]oxadiazine-4a-carboxylate [indoxacarb or indoxacarb M] (S:R = 75:25)
Substance ID m-nite-173584-44-6_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)  
Sample SDS by MHLW (External link)  
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 Classification not possible
-
-
- - It contains neighboring nitrogen atoms, and the oxygen balance of -153 is higher than criteria of -200. However, the classification is not possible due to no data on exothermic decomposition energy and exothermic start temperature. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2 Flammable gases Not classified (Not applicable)
-
-
- - "Solids" according to GHS definition. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3 Aerosols Not classified (Not applicable)
-
-
- - Not an aerosol product. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Oxidizing gases Not classified (Not applicable)
-
-
- - "Solids" according to GHS definition. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5 Gases under pressure Not classified (Not applicable)
-
-
- - "Solids" according to GHS definition. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6 Flammable liquids Not classified (Not applicable)
-
-
- - "Solids" according to GHS definition. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7 Flammable solids Not classified
-
-
- - It is non-flammable (ECHA (2011)). Besides, it is data on a racemic form, an S form: an R form = 50:50. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8 Self-reactive substances and mixtures Classification not possible
-
-
- - It contains neighboring nitrogen atoms, but the classification is not possible due to no data. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9 Pyrophoric liquids Not classified (Not applicable)
-
-
- - "Solids" according to GHS definition. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10 Pyrophoric solids Not classified
-
-
- - It is non-flammable (ECHA (2011)). Besides, it is data on a racemic form, an S form: an R form = 50:50. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11 Self-heating substances and mixtures Classification not possible
-
-
- - No established test method suitable for solid substances with a melting point of 140 degrees C or lower. FY2015 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)
-
-
- - Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - "Solids" according to GHS definition. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14 Oxidizing solids Not classified (Not applicable)
-
-
- - It is an organic compound which contains oxygen, fluorine, and chlorine, and the oxygen, fluorine, and chlorine are not chemically bonded to the elements other than carbon or hydrogen. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15 Organic peroxides Not classified (Not applicable)
-
-
- - It is an organic compound that does not contain bivalent -O-O- structure in the molecule. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16 Corrosive to metals Classification not possible
-
-
- - No established test method suitable for solid substances. FY2015 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 4


Warning
H302 P301+P312
P264
P270
P330
P501 		There is a reported LD50 value of > 1,500 mg/kg for both male and female rats (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2008)). Moreover, there are two reports of 1,730 mg/kg (males) and 268 mg/kg (females) (EPA Pesticide Fact Sheet (2000)), but the details are unknown. Therefore, from the data of > 1,500 mg/kg for both males and females, the substance was classified in Category 4. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Dermal) Not classified
-
-
- - From a reported LD50 value of > 5,000 mg/kg (males, females) for rats (EPA Pesticide Fact Sheet (2000)), it was classified as "Not classified." FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Gases) Not classified (Not applicable)
-
-
- - "Solids" according to GHS definition. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Vapours) Not classified (Not applicable)
-
-
- - "Solids" according to GHS definition. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Dusts and mists) Not classified
-
-
- - From a reported LC50 value (4-hour exposure) of 5.5 mg/kg for rats (Pesticide abstract (2007)), it was classified as "Not classified." Because a test substance is a solid, a reference value of dust was applied. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2 Skin corrosion/irritation Not classified
-
-
- - It is reported that in a skin irritation test using rabbits, it was not irritating (an S form: an R form = 75:25 and 79:21) (EPA Pesticide Fact Sheet (2000), Pesticide abstract (2007)). From the above, it was classified as "Not classified." Besides, there is other information that minimal to slight irritation was reported in a skin irritation test using rabbits (an S form: an R form = 50:50) (EPA Pesticide Fact Sheet (2000), Pesticide abstract (2007)). However, the information of an S form: an R form = 75:25 was used for the classification in this hazard class. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3 Serious eye damage/eye irritation Category 2A


Warning
H319 P305+P351+P338
P337+P313
P264
P280 		It is reported that in eye irritation tests using rabbits, it was moderately irritating (an S form: an R form = 75:25) (EPA Pesticide Fact Sheet (2000)) and slightly irritating (an S form: an R form = 79:21) (Pesticide abstract (2007)). As above, from the report of moderately irritating, the substance was classified in Category 2A. Besides, there is other information that in eye irritation tests using rabbits, it was slightly irritating (an S form: an R form = 50:50) (Pesticide abstract (2007)) or not irritating (an S form: an R form = 50.6:17.2). (EPA Pesticide Fact Sheet (2000)) However, the information of an S form: an R form = 75:25 was used for the classification in this hazard class. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Respiratory sensitization Classification not possible
-
-
- - Due to lack of data, the classification is not possible. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Skin sensitization Category 1


Warning
H317 P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501 		For an isomer mixture containing this substance (an S form: an R form = 75:25, 79:21), there are multiple reports of sensitization tests using guinea pigs, all of which judged as positive (EPA Pesticide Fact Sheet (2000), Pesticide abstract (2007)). From the above, the substance was classified in Category 1. It is classified in "Skin Sens. 1B H317" in EU CLP classification (ECHA CL Inventory (Access on September 2015)). FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5 Germ cell mutagenicity Classification not possible
-
-
- - For an S form: an R form = 75:25, as for in vivo, a chromosomal aberration test (unknown animal species and so on) was negative (EPA Pesticide Fact Sheet (2000)), and as for in vitro, a bacterial reverse mutation test, a gene mutation test in cultured mammalian cells, and a chromosomal aberration test in cultured mammalian cells were negative (EPA Pesticide Fact Sheet (2000)). Therefore, the substance was classified as "Classification not possible" in accordance with Guidance. Besides, for a substance of an S form: an R form = 79:21, as for in vivo, a micronucleus test in mouse bone marrow was negative, and as for in vitro, a bacterial reverse mutation test and a chromosomal aberration test in human peripheral blood lymphocytes were negative (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2008); HSDB (Access on October 2015)). FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6 Carcinogenicity Not classified
-
-
- - There are no test data on this substance itself. However, EPA classified this substance in NL in carcinogenicity (Not Likely to be Carcinogenic to Humans) from the carcinogenicity data conducted on a racemic mixture (an R form: an S form = 50:50) (EPA Pesticide Fact Sheet (2000), HSDB (Access on October 2015)). Its rationale data are based on the results that in a carcinogenicity test in diet administration of the racemic mixture for 2 years in rats or 1.5 years in mice, weight gain reduction was observed at doses of 125 ppm or higher for male rats, 60 ppm or above for female rats, and 100 ppm or higher for both male and female mice, but tumors did not occur in any groups of male and female rats and mice (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2008); HSDB (Access on October 2015)).
As above, from the EPA's carcinogenicity classification result that used the carcinogenicity test results on the racemic mixture, this substance was classified as "Not classified" in accordance with Guidance in this hazard class. 		FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7 Reproductive toxicity Classification not possible
-
-
- - There is one teratogenicity test result on this substance itself. Namely, in a teratogenicity test in which this substance (an S form: an R form = 79:21) dissolved in polyethylene glycol (PEG) was administered by gavage to pregnant rats on day 6 to 15 of gestation, at the maximum 4.0 mg/kg/day dose, weight gain reduction and decreased food consumption in maternal animals and lower average fetus body weight and skeletal variation (wavy ribs, 2/22 mothers) in fetuses were observed (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2008), HSDB (Access on October 2015)). From this result, EPA reported that NOAELs of maternal toxicity/developmental toxicity were 2 mg/kg/day for this substance (an S form: an R form = 75:25) (EPA Pesticide Fact Sheet (2000)).
As above, although effects found in fetuses were findings that are all slight and not a target for the classification, there is no test result that assessed effects on fertility and sexual function by administration of this substance, and the substance was classified as "Classification not possible" due to lack of data in this hazard class.
Besides, for a racemic mixture (an S form: an R form = 50:50), there are data from a two-generation reproductive toxicity test using rats and a teratogenicity test using pregnant rats or rabbits, and only minimal effects such as lower body weight and delayed ossification were observed in offspring and fetuses even at the dose where toxicity occurred such as weight gain reduction and decreased food consumption in parent animals (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2008); HSDB (Access on October 2015); EPA Pesticide Fact Sheet (2000)). 		FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system), Category 3 (narcotic effects)



Danger
Warning
H370
H336 		P308+P311
P260
P264
P270
P321
P405
P501
P304+P340
P403+P233
P261
P271
P312 		There are no data on this substance, but there are experimental animal data using mixtures such as an S form/an R form = 71.3/22.0 (there are multiple compounding ratios that are slightly different depending on test data). Namely, in an acute neurotoxicity test in rats in oral administration, a transient decrease in locomotor activity at 100 mg/kg corresponding to Category 1, decreased forelimb grip strength and decreased hindlimb spread at 200 mg/kg corresponding to Category 1 were observed, and it was suggested that NOAEL of neurotoxicity is 50 mg/kg. Abnormality findings were not observed in a dermal toxicity test in rats (LD50> 5,000 mg/kg) (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2008)).
From the above, because it is thought that this substance has effects on the central nervous system and narcotic effects, it was classified in Category 1 (central nervous system), Category 3 (narcotic effects). 		FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9 Specific target organ toxicity - Repeated exposure Category 1 (blood system), Category 2 (nervous system, heart)


Danger
Warning
H372
H373 		P260
P264
P270
P314
P501 		There is no human information.
As for experimental animals, as information on this substance (an S form: an R form = 75:25), in a toxicity test in rats in 90-day diet administration of this substance (an S form: an R form = 79:21), decreases in red blood cell count, hemoglobin content, and hematocrit and so on were observed in groups of females at 50 ppm (3.78 mg/kg/day) or higher and males at 100 ppm (6.01 mg/kg/day) or above within a range of Category 1 (Pesticide evaluation report, Food Safety Commission of Japan (2008); Pesticide abstract (2007)).
Moreover, as information on a racemic form (an S form: an R form = 50:50), effects on blood system were found in rats and dogs similarly within a range of Category 1. Besides this, in an 18-month carcinogenicity test using mice in diet administration, effects on nervous system (torticollis, abnormal gait and behavior, degeneration and necrosis of brain nerve cells and so on) in males in groups of 125 to 200 ppm (22.1 mg/kg/day), and females in groups of 100 ppm (20.3 mg/kg/day) or higher, effects on heart (pleural effusion, myocardial necrosis/hemorrhage or inflammation) in males in groups of 125 to 200 ppm (22.1 mg/kg/day) were observed (Pesticide evaluation report, Food Safety Commission of Japan (2008); Pesticide abstract (2007)).
It is estimated that they are also observed for this substance (an S form: an R form = 75:25) at about 14 mg/kg/day supposed that effects on nervous system and heart found in the racemic form (an S form: an R form = 50/50) were caused by the S form, and at about 45 mg/kg/day supposed that the R form is the cause, and at about 20 mg/kg/day supposed that the S form and the R form are identical, namely within a range of Category 2 (14 to 45 mg/kg/day).
Therefore, this substance was classified in Category 1 (blood system), Category 2 (nervous system, heart).
 FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10 Aspiration hazard Classification not possible
-
-
- - Due to lack of data, the classification is not possible. FY2015 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 96-hour EC50 = 0.0542 ppm for crustacea (Mysidopsis bahia) (AQUIRE, 2016), it was classified in Category 1. FY2015 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 		If chronic toxicity data are used, then it is classified in Category 1 due to being not rapidly degradable (BIOWIN), and 32-day NOEC = 0.0169 ppm for fish (Cyprinodon variegatus) (AQUIRE, 2016).
For a trophic level for which chronic toxicity data are not obtained, acute toxicity data are not obtained either.
From the above, it was classified in Category 1. 		FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data. FY2015 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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