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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	2074-50-2
Chemical Name	Paraquat-dimethylsulfate
Substance ID	R01-B-059
Classification year (FY)	FY2019
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)
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	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2	Flammable gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
6	Flammable liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
7	Flammable solids	*	- -	-	-	No data available.
8	Self-reactive substances and mixtures	*	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties. It was classified as "Not classified (Not applicable)."
9	Pyrophoric liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10	Pyrophoric solids	*	- -	-	-	No data available.
11	Self-heating substances and mixtures	*	- -	-	-	No data available.
12	Substances and mixtures which, in contact with water, emit flammable gases	*	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). It was classified as "Not classified (Not applicable)."
13	Oxidizing liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine), which is chemically bonded to an element (S) other than nitrogen, carbon, or hydrogen. However, the classification is not possible due to no data.
15	Organic peroxides	*	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	*	- -	-	-	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 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 3. [Evidence Data] (1) LD50 for rats: male: 100 mg/kg, female: 110 mg/kg (JMPR (2003))
1	Acute toxicity (Dermal)	Category 2	Danger	H310	P302+P352 P361+P364 P262 P264 P270 P280 P310 P321 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2. [Evidence Data] (1) LD50 for rats: male: 80 mg/kg, female: 90 mg/kg (JMPR (2003)) [Reference Data, etc.] (2) LD50 for rabbits: 236 mg paraquat ions/kg (converted value: 517 mg/kg) (ACGIH (7th, 2001))
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] Based on (1), it was classified in Category 2. [Evidence Data] (1) Concentrated solutions of this substance caused skin irritation but following prolonged contact can lead to necrosis and blistering (GESTIS (Access on July 2019)). [Reference Data, etc.] (2) It was classified as "Skin Irrit. 2 (H315)" in the EU CLP classification (EU CLP classification (Access on July 2019)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Based on (1), it was classified in Category 1. The category was changed due to new data obtained. [Evidence Data] (1) According to occupational experience and animal experiments, eye contact with solutions of this substance can cause not only severe irritation and inflammatory changes to the mucous membranes but also (in concentrations from 12.5% upwards) corneal opacity and necrosis (GESTIS (Access on July 2019)). [Reference Data, etc.] (2) It was classified as "Eye Irrit. 2 (H319)" in the EU CLP classification (EU CLP classification (Access on July 2019)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[Rationale for the Classification] Although there is no information on this substance itself, it was judged that classification based on the information on paraquat (CAS RN 1910-42-5) was possible. Therefore, it was classified as "Not classified." [Evidence Data] (1) In skin sensitization assays using guinea pigs, paraquat failed to induce a positive response (ACGIH (7th, 2018)). (2) In a skin sensitization test on a 33% solution of paraquat with guinea pigs (maximization method), it was judged as negative (EPA Pesticide (1997), JMPR (2003)).
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] Although there was no information on this substance itself, it was judged that classification based on the information on paraquat dichloride (CAS RN 1910-42-5) was possible. Based on (1), this substance was classified as "Not classified." [Reference Data, etc.] (1) Paraquat dichloride was classified as "Not classified" (FY 2019, GHS classification).
6	Carcinogenicity	*	- -	-	-	[Rationale for the Classification] Based on the classification results by other organizations in (1), it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) In classification results by domestic and international organizations, it was classified as A4 by ACGIH (ACGIH (7th, 2018)).
7	Reproductive toxicity	*	- -	-	-	[Rationale for the Classification] There were no data on this substance but based on the data in (1)-(5), no obvious reproductive toxicity was observed. Therefore, it was classified as "Not classified." [Evidence Data] (1) The toxicity of paraquat depends solely on its cation moiety, all salts having equivalent toxicity (ACGIH (7th, 2001)). (2) In a three-generation reproductive study by feeding diets containing paraquat dichloride (CAS RN 1910-42-5) to rats, retarded ossification, reduction in body weights and retarded opening of the vagina, etc. were noted in pups at doses showing parental animal toxicity (lung lesions) (JMPR (2003)). (3) In a developmental toxicity test by oral gavage of paraquat dichloride to female rats on Days 6-15 of gestation, reduced fetal weights and retarded ossification were noted at doses showing maternal toxicity (JMPR (2003)). (4) In a developmental toxicity test by oral gavage of this substance to female mice on Days 6-15 of gestation, neither maternal toxicity nor fetotoxicity was seen (JMPR (2003)). (5) In a two-generation reproductive toxicity study with mice by feeding diets containing paraquat, deaths and lung lesions (extensive fibrosis) were noted in both parental animals and pups (JMPR (2003)).
8	Specific target organ toxicity - Single exposure	Category 1 (lung, liver, kidney)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] Based on (1) to (4), it was classified in Category 1 (lung, liver, kidney). Though the respiratory system was judged as the target organ in the previous classification, the classification result was changed. [Evidence Data] (1) Numerous cases of poisonings with paraquat (CAS RN 4685-14-7) by oral ingestion due to accidents or suicides are reported. As symptoms, acute pulmonary edema, pulmonary fibrosis, acute renal failure (oliguria, proteinuria, etc.) and acute liver failure (jaundice, liver hypertrophy, abnormal liver function test values) occurred (ACGIH (7th, 2018), IPCS, PIM 399 (2000), JMPR (2003), EHC 39 (1984)). (2) Through the dermal route, multiple human cases with respiratory insufficiency and renal failure due to exposure to paraquat by accidents or suicides are reported (ACGIH (7th, 2018), JMPR (2003)). In one of them, interstitial pneumonia, intra-alveolar hemorrhage, renal tubular cell degeneration and cholestasis were noted at autopsy (JMPR (2003)). (3) After a single dose at 110 mg/kg (converted value equivalent to this substance: 241 mg/kg, corresponding to Category 1) of paraquat to rats, diarrhea, wheezing and irregular respiration were seen as early clinical signs, and reduced body weight, pulmonary edema, congestion and hemorrhage were noted after 5-6 days. Besides, in the other report, pulmonary fibrosis occurred by 10 days after a dose (ACGIH (7th, 2018)). (4) In ACGIH (7th, 2001), it is described that the toxicity of paraquat depends solely on its cation moiety, all salts having equivalent toxicity.
9	Specific target organ toxicity - Repeated exposure	Category 1 (lung)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Although there is no information on this substance itself, it was judged that classification based on information on paraquat dichloride (CAS RN 1910-42-5) was possible. Based on (2), it was classified in Category 1 (lung). Since it was impossible to confirm whether information on the basis for the previous classification was that of this substance, the supporting data was revised, and the classification result was changed from the previous classification. [Evidence Data] (1) The toxicity of paraquat depends solely on its cation moiety, all salts having equivalent toxicity (ACGIH (7th, 2001)). (2) Paraquat dichloride was classified in Category 1 (lung) because effects on the lung were seen within the range of Category 2 by oral administration to experimental animals and within the range of Category 1 by inhalation exposure (GHS classification result, fiscal 2019).
10	Aspiration hazard	*	- -	-	-	[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.
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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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