NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	299-84-3
Chemical Name	O,O-Dimethyl O-(2,4,5-trichlorophenyl) phosphorothioate; Ronnel
Substance ID	R02-B-050-MHLW, MOE
Classification year (FY)	FY2020
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 (FY2019 revised edition (Ver. 2.0))
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 classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified."
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
7	Flammable solids	Not classified	- -	-	-	It was classified as "Not classified" from information that it is not combustible (ICSC (1995)).
8	Self-reactive substances and mixtures	Type G	- -	-	-	There is a chemical group associated with explosive properties (P-O) present in the molecule, but because it is classified in Division 6.1 in UNRTDG (UN2783), and it is considered to be not applicable to self-reactive substances and mixtures, hazards of the highest precedence, it was classified in Type G.
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
10	Pyrophoric solids	Not classified	- -	-	-	It was classified as "Not classified" from information that it is not combustible (ICSC (1995)).
11	Self-heating substances and mixtures	Not classified	- -	-	-	It was classified as "Not classified" from information that it is not combustible (ICSC (1995)).
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	It contains a metalloid (P), but it was classified as "Not classified" because it is estimated that it does not react vigorously with water from water solubility data of 1 mg/L (20 deg C) (HSDB (Access on May 2020)).
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
14	Oxidizing solids	Classification not possible	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine), which is chemically bonded to the element other than carbon or hydrogen (P). However, the classification is not possible due to no data.
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified."
16	Corrosive to metals	Classification not possible	- -	-	-	It is a solid with a melting point of 55 deg C or lower, but the classification is not possible due to no data.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

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	[Rationale for the Classification] It was classified in Category 4 from (1) - (5). [Evidence Data] (1) LD50 for rats: 625 mg/kg (GESTIS (Access on May 2020)) (2) LD50 for rats: females: 1,250 mg/kg (ACGIH (7th, 2006), JMPR (1969)) (3) LD50 for rats: 1,740 mg/kg (IPCS PIM G001 (1998), JMPR (1969)) (4) LD50 for rats: females: > 2,000 mg/kg (JMPR (1969)) (5) LD50 for rats: males: 2,630 mg/kg (ACGIH (7th, 2006), JMPR (1969))
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	[Rationale for the Classification] It was classified in Category 4 from (1). [Evidence Data] (1) LD50 for rabbits: 1,600-2,000 mg/kg (ACGIH (7th, 2006)) [Reference Data, etc.] (2) LD50 for rabbits: 1,000 mg/kg (GESTIS (Access on May 2020), HSDB (Access on May 2020))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" (Category 3 in UN GHS classification) from (1), (2). [Evidence Data] (1) As a result of 10-time applications of this substance under a gauze bandage over 14 days, very slight hyperemia of the skin was observed (ACGIH (7th, 2006)). (2) Irritations of the throat and facial skin were occasionally reported by veterinarians who used this substance in poorly ventilated areas (HSDB (Access on May 2020)).
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	[Rationale for the Classification] There was a description of (1), but it was classified as "Classification not possible" due to lack of data. Because the details of data used in the previous classification were unknown, it was judged as insufficient data for classification, and the classification result was changed. [Reference Data, etc.] (1) In a test in which a powder (small amount) of this substance was applied to the rabbit eye, slight discomfort and transient conjunctival irritation were seen, which disappeared in 48 hours (ACGIH (7th, 2006)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) In a test in which humans (30 men, 20 women) were given three patch applications per week for 3 weeks and then challenged 2 weeks later, no sensitization was observed (ACGIH (7th, 2006)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] There was no available report in humans. From (1), (2), it was classified as "Not classified" based on ACGIH's classification. [Evidence Data] (1) As for classification results by domestic and international organizations, ACGIH classified it in A4 (ACGIH (7th, 2006)). (2) In a carcinogenicity test by 2-year diet administration of this substance to male and female rats, no carcinogenicity was observed (ACGIH (7th, 2006)).
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) and (2), the only observed maternal toxicity was a decrease in cholinesterase (ChE) activity, and severe effects (cerebellar hypoplasia, increased malformations in the cardiovascular system, a decrease in survival rate of the F1b and F2b generations) were observed in fetuses, and therefore, it was classified in Category 1B. [Evidence Data] (1) In a three-generation reproduction toxicity study with rats dosed by feeding, decreases in plasma and erythrocyte cholinesterase (ChE) activity, decreases in survival rate and lactation index of the F1b and F2b generations, and a slight decrease in average body weight were observed (JMPR (1969)). (2) In a developmental toxicity study with female rabbits given oral doses on days 6 to 18 of gestation, at a dose at which decreases in plasma and erythrocyte ChE activity (no significant difference) were observed in dams, cerebellar hypoplasia and increased malformations in the cardiovascular system were observed (ACGIH (7th, 2006)). [Reference Data, etc.] (3) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, maternal toxicity was unknown, but an incidence of extra ribs was observed in fetuses (ACGIH (7th, 2006)).
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system), Category 3 (Respiratory tract irritation)	Danger Warning	H370 H335	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	[Rationale for the Classification] Based on (1), there is information that respiratory tract irritation was observed in humans. And based on (2), organophosphorus pesticides, including this substance, generally inhibit cholinesterase. Therefore, it was classified in Category 1 (nervous system), Category 3 (Respiratory tract irritation). [Evidence Data] (1) Veterinarians who used this substance or other organophosphorus pesticides in poorly ventilated areas had nausea, headache, and inflammation of the throat and facial skin (ACGIH (7th, 2006), HSDB (Access on May 2020)). (2) In a single oral dose toxicity test with rats, the inhibition of plasma cholinesterase (43%) was observed at or above 250 mg/kg (within the range for Category 1) (ACGIH (7th, 2006)). [Reference Data, etc.] (3) Organophosphorus pesticides, such as this substance, are absorbed by all routes, including inhalation, ingestion, and dermal absorption. The toxicological effects of the organophosphorus pesticides are due to the inhibition of acetylcholinesterase in the nervous system, resulting in respiratory, myocardial, and neuromuscular transmission impairment (IPCS PIM G001 (1998)). (4) Exposure to organophosphorus pesticides, including this substance, in humans caused muscarinic manifestations (increased bronchial secretion, excessive sweating, salivation, lachrymation, pinpoint pupils, bronchoconstriction, abdominal cramps (vomiting and diarrhea), bradycardia), nicotinic manifestations (fasciculation of fine muscles, tachycardia), and central nervous system manifestations (headache, dizziness, restlessness, anxiety, mental confusion, convulsions, coma, depression of the respiratory center). Mild poisoning might include only muscarinic and nicotinic signs. Severe cases showed central nervous system involvement. The combination of the above-mentioned symptoms caused respiratory failure, sometimes leading to pulmonary edema (EHC 63 (1986)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1) to (5), it was classified in Category 1 (nervous system). In the test with rats in (4), findings on the kidney were reported, but they could be due to aging. Therefore, the kidney was not adopted as the target organ. [Evidence Data] (1) Organophosphorus pesticides, such as this substance, are absorbed by all routes, including inhalation, ingestion, and dermal absorption. The toxicological effects of the organophosphorus pesticides are due to the inhibition of acetylcholinesterase in the nervous system, resulting in respiratory, myocardial, and neuromuscular transmission impairment (IPCS PIM G001 (1998)). (2) In five of 21 patients with cutaneous larva migrans who were orally given 10 mg/kg/day of this substance for 5 or 10 days, nausea, weakness, blurred vision, and serpiginous ulcers were observed (ACGIH (7th, 2006)). (3) Twenty volunteers were orally given 250 mg of this substance for 3 to 7 days. As a result, 7 subjects showed side effects such as sporadic abdominal cramps, anorexia, blurred vision, diarrhea, headache, heartburn, malaise, nausea and weakness and discontinued the administration at the end of three days. In the three remaining subjects who suffered no symptoms, a decrease in erythrocyte ChE activity and a marked decrease in plasma ChE activity were observed (JMPR (1969)). (4) In a two-year oral toxicity test of this substance with rats dosed by feeding, inhibition of plasma ChE activity was observed in females at or above 1.5 mg/kg/day (within the range for Category 1); inhibition of erythrocyte and brain ChE activity in males and females and inhibition of plasma ChE activity in males were observed at or above 15 mg/kg/day (within the range for Category 2); and slight granular degeneration or cloudy swelling of parenchymal cells of the liver and cloudy swelling and vacuolation of the renal tubular epithelium were observed at 50 mg/kg/day (within the range for Category 2) (ACGIH (7th, 2006), JMPR (1969)). (5) In dogs which were given this substance by feeding for two years, inhibition of plasma ChE activity was observed at 3 mg/kg/day (within the range for Category 1) (ACGIH (7th, 2006), JMPR (1969)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] 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 Short term (Acute)	Classification not possible	- -	-	-	Classification not possible due to lack of data. The classification result was changed from the previous classification by reviewing information: 96-hour LC50 = 171 microg/L for fish (Oncorhynchus clarkii) (AQUIRE, 2003) used in the previous classification.
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Classification not possible due to lack of data. The classification result was changed from the previous classification by reviewing information: 96-hour LC50 = 171 microg/L for fish (Oncorhynchus clarkii) (AQUIRE, 2003) used in the previous classification.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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.

To GHS Information