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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	13071-79-9
Chemical Name	Terbufos
Substance ID	H27-A-006, C-006A_P
Classification year (FY)	FY2015
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)	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 present in the molecule associated with explosive properties.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	"Liquids" according to GHS definition.
3	Aerosols	Not applicable	- -	-	-	Not an aerosol product.
4	Oxidizing gases	Not applicable	- -	-	-	"Liquids" according to GHS definition.
5	Gases under pressure	Not applicable	- -	-	-	"Liquids" according to GHS definition.
6	Flammable liquids	Category 4	- Warning	H227	P370+P378 P403+P235 P210 P280 P501	A flash point is 88 degrees C in an open-cup test (HSDB (Access on June 2015)) and it is considered that a flash point will fall between 60 and 93 degrees C also in a prescribed closed-cup test method.
7	Flammable solids	Not applicable	- -	-	-	"Liquids" according to GHS definition.
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	Classification not possible	- -	-	-	Due to no data, the classification is not possible.
10	Pyrophoric solids	Not applicable	- -	-	-	"Liquids" according to GHS definition.
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No established test method suitable for liquid substances.
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	It is estimated that it does not react vigorously with water from water solubility data measured (water solubility: 5.07 mg/L (25 degrees C), HSDB (Access on June 2015)).
13	Oxidizing liquids	Classification not possible	- -	-	-	It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is chemically bonded to the element other than carbon or hydrogen (P). However, the classification is not possible due to no data.
14	Oxidizing solids	Not applicable	- -	-	-	"Liquids" according to GHS definition.
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	- -	-	-	Due to no data, the classification is not possible.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 1	Danger	H300	P301+P310 P264 P270 P321 P330 P405 P501	There are 8 reported LD50 values for rats of 1.6 to 4.5 mg/kg (male), 1.3 to 9.0 mg/kg (female) (ACGIH (7th, 2002), EPA Pesticide (1997)), 1.4 mg/kg (female) (fasted), 3.2 mg/kg (male) (fasted), 1.6 mg/kg (male, female) (fasted) (JMPR (2003)), about 1.5 mg/kg (EPA Pesticide (2006)), 4.5 mg/kg (male) (non-fasted) and 9.0 mg/kg (female) (non-fasted) (JMPR (2003)). Because five of them correspond to Category 1 and one corresponds to Category 2, the substance was classified in Category 1 to which most of the data correspond. Besides, two were not counted in due to being summary data.
1	Acute toxicity (Dermal)	Category 1	Danger	H310	P302+P352 P361+P364 P262 P264 P270 P280 P310 P321 P405 P501	Based on reported LD50 values for rats of 0.97 mg/kg and 7.4 mg/kg, and 9.8 mg/kg (JMPR (1990)) and LD50 values for rabbits of 0.81 mg/kg (male), 0.93 mg/kg (female) (EPA Pesticide (2006), JMPR (2003)), 1.0 mg/kg (male), 1.1 mg/kg (male) (JMPR (2003)), 0.8 to 1.1 mg/kg (male), 0.93 mg/kg (female) (PATTY (6th, 2012), ACGIH (7th, 2002), EPA Pesticide (1997)), it was classified in Category 1.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	"Liquids" according to GHS definition.
1	Acute toxicity (Inhalation: Vapours)	Category 1	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	Based on reported LC50 values (4 hours) (whole body) of 0.0012 mg/L (female) and 0.0061 mg/L (male) for rats (JMPR (2003)), it was classified in Category 1. Besides, one LC50 value is lower, and the other is higher than the saturated vapour pressure concentration (0.42 ppm). However, a reference value in the unit of ppm was applied from the information of administration with vapour (JMPR (2003)).
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	The classification is not possible due to lack of data. Besides, it is described that all animals died within 24 hours in a primary dermal irritation test in which 0.5 mL of this substance was applied to rabbits. (PATTY (6th, 2012), JMPR (2003), ACGIH (7th, 2002))
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	The classification is not possible due to lack of data. Besides, it is described in ACGIH (7th, 2002)) that all animals died within 24 hours in a primary eye irritation test in which 0.5 mL or 0.1 mL of this substance was applied to rabbits. (PATTY (6th, 2012), JMPR (2003), ACGIH (7th, 2002))
4	Respiratory sensitization	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.
4	Skin sensitization	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	As for in vivo, it is reported that a dominant lethal test by oral administration in rats was positive at the highest dose (0.4 mg/kg) (EPA Pesticide (1997)), however, a clear conclusion is not shown in the report. In JMPR (2003), this test is considered to be "Inconclusive." Besides, it is reported that a chromosomal aberration test using bone marrow cells after intraperitoneal administration in rats was negative (EPA Pesticide (1997), JMPR (2003)). As for in vitro, it is reported that a bacterial reverse mutation test, a gene mutation test using CHO cell strain, and a chromosomal aberration test using cultured mammalian cells were negative (NTP DB (Access on June 2015), EPA Pesticide (1997), JMPR (2003)). Due to unknown details in a positive result of the in vivo dominant lethal test, the substance was classified as "Classification not possible" in accordance with the guidance.
6	Carcinogenicity	Classification not possible	- -	-	-	There is no carcinogenicity information in humans. As for experimental animals, it is described that the evidence of carcinogenicity was not found even at the dose where apparent adverse effects (increased mortality (rats, mice), reduced weight gain (mice), and cholinesterase inhibition (rats)) were observed in diet administrations for two years to rats and for 18 months to mice (ACGIH (7th, 2002), PATTY (6th, 2012), EPA Pesticide (1997)). ACGIH classified the substance in A4 (ACGIH (7th, 2002)). From the above, taking the ACGIH's position into account, the substance was classified as "Classification not possible" in carcinogenicity.
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	There is no reproductive toxicity information in humans. As for experimental animals, it is described that reproductive toxicity was not observed in any generations in a three-generation test with oral administration to rats. On the other hand, it is described that in a two-generation test with diet administration to rats, decreases in pregnancy rate and male fertility rate and lower body weights of the offspring were found at the dose (2.5 ppm: 0.22 to 0.24 mg/kg/day) where toxicity (plasma cholinesterase inhibition and reduced maternal weight gain during a nursing period) was observed in parent animals. (ACGIH (7th, 2002), PATTY (6th, 2012), EPA Pesticide (1997)) Besides, in a teratogenicity test with gavage administration to pregnant rats (day 6 to 15 of gestation), maternal toxicity was not observed even at the highest dose (0.2 mg/kg/day), but increases in early fetal resorptions and post-implantation losses were found. On the other hand, in a teratogenicity test with gavage administration to pregnant rabbits (day 7 to 19 of gestation), only a slight reduction in fetal body weight and an increase in resorptions were observed at the dose (0.5 mg/kg/day) where reduced weight gain was found in maternal animals. Teratogenicity was not observed in either species (ACGIH (7th, 2002), PATTY (6th, 2012), EPA Pesticide (1997)). From the above, as a whole, the effects on fertility and fetal toxicity were observed at the doses where general toxicity effects were found in parent animals, therefore, the substance was classified in Category 2.
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	This substance is an extremely toxic organophosphate pesticide/nematicide, and its principal mechanism of toxic action is the inhibition of cholinesterase activity. The inhibition resulted in rapidly occuring, but reversible, symptoms of neuromuscular stimulation (ACGIH (7th, 2010)). It is regarded that limited quantitative data were available on the cholinesterase inhibition action in humans (ACGIH (7th, 2010)). There are 25 reports of incidents related to this substance. Fourteen of them are occupational exposure accidents in which cholinergic neurotoxicity was observed and deaths occured in three of them. In one of the other incidents, three children died after taking tortillas made from corn seed contaminated with this substance. In another, one child died after accidentally eating this substance (PATTY (6th, 2012)). As for experimental animals, there are following reports: Oral administration to mice at 1.69 to 2.48 mg/kg resulted in severe signs toxicity (tremors, shallow breathing, motionless crouching, and loss of righting reflex), 90% of mice died between 2 to 9 hours after the exposure, and deaths continued until up to 70 hours. In rats, there is the report of bedding contaminated with 30 ppm this substance (the main exposure route is dermal but exposure in oral and inhalation is also conceivable). Muscle fasciculations, severe depression, exophthalmos, and ptyalism occurred as marked acute toxicity (cholinergic signs), followed by deaths. It is reported that oral administration at 0.15 to 0.9 mg/kg resulted in lethargy, salivation, lacrimation, ataxia, stupor, decreased forelimb strength, and tremors, miosis and cholinesterase inhibition were found at 0.3 to 0.9 mg/kg, and one death occured at 0.9 mg/kg (ACGIH (7th, 2010), PATTY (6th, 2012)). Other than that, it is reported that central nervous system effects such as chromodacryorrhea, piloerection, ataxia, and labored breathing were observed in rats (JMPR (2003), IPCS, PIM G001 (Access on 2015)). As above, the acute effects of this substance found in the findings in humans and experimental animals are cholinergic nervous system effects and the effects were observed at the doses corresponding to Category 1 in the findings in the animals. Therefore, the substance was classified in Category 1 (nervous system).
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system, gastrointestinal tract)	Danger	H372	P260 P264 P270 P314 P501	There is no information on human. As for experimental animals, the inhibition of cholinesterase activity was observed in a 13-week diet administration toxicity test and a 2-year diet administration test using rats, a 28-day gavage administration toxicity test and a 1-year gavage administration toxicity test using dogs, a 4-week dermal administration test using rats, and a 3-week inhalation exposure test using rats. Besides, cholinergic nervous signs were found in a 2-year diet administration test using rats, a 1-year gavage administration toxicity test using dogs, and a 3-week inhalation toxicity test using rats. The inhibition of cholinesterase activity was observed at 0.0125 mg/kg/day or higher in an oral route, at 1.5 mg/kg/day in a dermal route, and from 0.0946 mg/m3 in an inhalation route. Cholinergic nervous signs were found at 0.05 mg/kg/day in an oral route, at 4 mg/kg/day in a dermal route, and from 0.0946 mg/m3 in an inhalation route (ACGIH (7th, 2002), PATTY (6th, 2012)). All these were observed within a range of doses corresponding to Category 1. Furthermore, in a 1-year gavage administration toxicity test using dogs, decreased food consumption, reduced weight gain, depressed hematology parameters, the congestion, edema, and necrosis in the digestive tract were found in 0.24 and 0.48 mg/kg/day groups in week 6 to 8. In a 13-week diet administration toxicity test using rats, increased liver weights and increased extramedullary hematopoiesis in the liver were observed at 0.025 mg/kg/day or higher and the hyperplasia of mesenteric and mandibular lymph nodes were observed at 0.05 mg/kg/day (ACGIH (7th, 2002), PATTY (6th, 2012)). All these were found within a range of doses corresponding to Category 1. Therefore, the substance was classified in Category 1 (nervous system, digestive tract).
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	It was classified in Category 1 from 96-hour LC50 = 0.000235 mg/L (geometric average) for crustacea (Gammaridea) (ECETOC TR91, 2003).
11	Hazardous to the aquatic environment (Long-term)	Category 1	Warning	H410	P273 P391 P501	Reliable chronic toxicity data were not obtained. The substance is not rapidly degradable (BioWin) and classified in Category 1 in acute toxicity (Hazardous to the aquatic environment （Acute）), 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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