GHS Classification Result

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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 H27-A-10-METI/M-008A_P
Classification year (FY) FY2015
Ministry who conducted the classification Ministry of Economy, Trade and Industry (METI)/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 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.
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- - "Solids" according to GHS definition.
3 Aerosols Not applicable
-
-
- - Not an aerosol product.
4 Oxidizing gases Not applicable
-
-
- - "Solids" according to GHS definition.
5 Gases under pressure Not applicable
-
-
- - "Solids" according to GHS definition.
6 Flammable liquids Not applicable
-
-
- - "Solids" according to GHS definition.
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.
8 Self-reactive substances and mixtures Classification not possible
-
-
- - It contains neighboring nitrogen atoms, but the classification is not possible due to no data.
9 Pyrophoric liquids Not applicable
-
-
- - "Solids" according to GHS definition.
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.
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.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable
-
-
- - Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable
-
-
- - "Solids" according to GHS definition.
14 Oxidizing solids 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.
15 Organic peroxides Not applicable
-
-
- - It is an organic compound that does not contain bivalent -O-O- structure in the molecule.
16 Corrosive to metals Classification not possible
-
-
- - No established test method suitable for solid substances.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
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.
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."
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - "Solids" according to GHS definition.
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- - "Solids" according to GHS definition.
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.
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.
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.
4 Respiratory sensitization Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
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)).
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)).
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.
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)).
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).
9 Specific target organ toxicity - Repeated exposure Category 1 (haemal 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).
10 Aspiration hazard Classification not possible
-
-
- - Due to lack of data, the classification is not possible.

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 96-hour EC50 = 0.0542 ppm for crustacea (Mysidopsis bahia) (AQUIRE, 2016), it was classified in Category 1.
11 Hazardous to the aquatic environment (Long-term) 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.
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data.


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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