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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	2312-76-7
Chemical Name	sodium 4,6-dinitro-o-cresolate
Substance ID	R02-B-006-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	Division 1.3	Danger	H203	P370+P372+P380+P373 P210 P230 P234 P240 P250 P280 P401 P501	It was classified in Division 1.3 because there is a chemical group associated with explosive properties, a nitro group, present in the molecule, and it is classified in Division 1.3 in UNRTDG (UN0234). Besides, one wetted with water of 15 mass% or more is classified in Division 4.1, Subsidiary Risk 6.1, PG I in UNRTDG (UN1348) and corresponds to desensitized explosives.
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	Classification not possible	- -	-	-	It was classified as explosives, and it is impossible to conduct the prescribed test. Therefore, the classification is not possible due to no data. Besides, it was classified in Division 1.3 for explosives and has a high risk of fire.
8	Self-reactive substances and mixtures	Not classified	- -	-	-	It was classified as "Not classified" because it was classified as explosives.
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
10	Pyrophoric solids	Classification not possible	- -	-	-	It was classified as explosives, and it is impossible to conduct the prescribed test. Therefore, the classification is not possible due to no data.
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	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."
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 (N). 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	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	Not classified	- -	-	-	A pure substance was classified as "Not classified" because it was classified as explosives. Besides, one wetted with water of 15 mass% or more is classified in Division 4.1, Subsidiary Risk 6.1, PG I in UNRTDG (UN1348) and corresponds to desensitized explosives (impossible to assign Category due to no data).

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 2	Danger	H300	P301+P310 P264 P270 P321 P330 P405 P501	[Rationale for the Classification] It was classified in Category 2 from (1). [Evidence Data] (1) LD50 for rats: 26 mg/kg (GESTIS (Access on April 2020))
1	Acute toxicity (Dermal)	Category 2	Danger	H310	P302+P352 P361+P364 P262 P264 P270 P280 P310 P321 P405 P501	[Rationale for the Classification] It was classified in Category 2 from (1). [Evidence Data] (1) LD50 for rats: 200 mg/kg (GESTIS (Access on April 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	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) No skin changes occurred in a test in which a 1.8% solution of this substance was applied to two volunteers for 30 days, and no changes to the skin were reported from occupational handling of this substance (GESTIS (Access on April 2020)).
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) In a test in which five drops of a 0.9% solution of this substance were applied to the rabbit eye, no irritation reactions occurred after contact up to 24 hours (GESTIS (Access on April 2020)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) Skin sensitization should be investigated for this substance because 4,6-dinitro-o-cresol (CAS RN 534-52-1), the free acid of this substance, is a skin sensitizer in animals.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] No data available. [Reference Data, etc.] (1) In a test by 104-week diet administration of 4,6-dinitro-o-cresol (CAS RN 534-52-1) (0.00025, 0.0015, 0.01%), the free acid of this substance, to male and female rats, there were no increased tumor incidences (Environmental Risk Assessment for Chemical Substances vol. 10 (Ministry of the Environment, 2012)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] There was no data on this substance. Based on (1), it was considered that reproductive toxicity also reflected the effects of 4,6-dinitro-o-cresol, which was a free acid, and based on the classification results of 4,6-dinitro-o-cresol (CAS RN 534-52-1), which was a free acid in (2), it was classified in Category 2. Examination was carried out based on the information of 4,6-dinitro-o-cresol, and the classification results were changed from the previous classification. [Evidence Data] (1) The systemic effects of this substance were derived from the systemic effects of 4,6-dinitro-o-cresol, which was a free acid of this substance (GESTIS (Access on April 2020)). (2) 4,6-dinitro-o-cresol was classified in Category 2 based on the results of a two-generation reproduction toxicity test with rats (GHS Classification Results in FY2020). [Reference Data, etc.] Information on 4,6-dinitro-o-cresol (CAS RN 534-52-1), which was a free acid of this substance: (3) In a two-generation reproduction toxicity study with rats dosed by feeding, no effect was observed in reproductive parameters, but a reduction in the number of litters during the lactation period was observed at a dose at which reduced body weight gain was observed in dams (EHC 220 (2000)).
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system, cardiovascular system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1 (central nervous system, cardiovascular system). Examination was carried out based on the information of 4,6-dinitro-o-cresol (CAS RN 534-52-1), which was a free acid, and the classification results were changed from the previous classification. [Evidence Data] (1) The systemic effects of this substance were derived from the systemic effects of 4,6-dinitro-o-cresol (CAS RN 534-52-1), which was a free acid of this substance (GESTIS (Access on April 2020)). (2) 4,6-dinitro-o-cresol (CAS RN 534-52-1) was classified in Category 1 (central nervous system, cardiovascular system) based on the information in humans (GHS Classification Results in FY2020). [Reference Data, etc.] Information on 4,6-dinitro-o-cresol (CAS RN 534-52-1), which was a free acid of this substance: (3) The symptoms of acute poisoning in humans resulted from the effect on cell metabolism, and included severe thirst, painful colic, diarrhea, and vomiting. Dyspnea, cyanosis, tachycardia, apnea, and cardiac insufficiency with angina were also reported. The initial effect on the central nervous system was usually euphoria, later the persons suffered from dizziness, a tendency to collapse, anxiety and restlessness, confusion, unconsciousness, and terminal spasms (MAK (DFG) vol.19 (2003)). (4) In a case of accidental intoxication involving a 4-year-old boy, emesis and headache were observed as the first symptoms after skin absorption, and jaundiced skin (especially on the arms), tachypnea, weak heartbeat, and severe general depression were observed. Autopsy revealed focal hemorrhages in the intestinal mucosa, capillary blood (plethora) in the brain, liver, lungs, intestinal walls, myocardium, and kidneys as well as edema of the lung and brain (ACGIH (7th, 2019)). (5) In one case of intoxication, poisoning by this substance resulted from a concentration in the air of 4.7 mg/m3. Reduction of the level to 2.5 mg/m3 eliminated the symptoms. The chief symptoms were fever, increased basal metabolic rate, rapid pulse and respiration, profuse sweating, shortness of breath, and cough (ACGIH (7th, 2019)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (central nervous system, eye, cardiovascular system, blood system, liver, kidney, skin)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1 (central nervous system, eye, cardiovascular system, blood system, liver, kidney, skin). Examination was carried out based on the information on 4,6-dinitro-o-cresol (CAS RN 534-52-1), which was a free acid, and the classification results were changed from the previous classification. [Evidence Data] (1) The systemic effects of this substance were derived from the systemic effects of 4,6-dinitro-o-cresol (CAS RN 534-52-1), which was a free acid of this substance (GESTIS (Access on April 2020)). (2) 4,6-dinitro-o-cresol (CAS RN 534-52-1) was classified in Category 1 (central nervous system, eye, cardiovascular system, blood system, liver, kidney, skin) based on the information in humans and test animals (GHS Classification Results in FY2020). [Reference Data, etc.] Data as the basis for classification of 4,6-dinitro-o-cresol: (1) Chronic toxic symptoms in humans were headache, weakness, anorexia, and marked weight loss. Later, degenerative changes developed in the heart muscle, liver, and kidneys, and neuritis, leukopenia, Heinz bodies, and methemoglobinemia progressed. Agranulocytosis and severe toxic dermatitis were sometimes observed as well. Liver damage was the primary effect after oral ingestion of this substance (MAK (DFG) vol. 19 (2003)). (2) There were reports of a case of a pearly swollen cataract in the left eye of a woman who ingested this substance for 3 years, and a case of punctate lenticular opacity in the right eye after diagnosis of cataract, which eventually led to blindness (ATSDR (2018)).
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)	Category 1	Warning	H400	P273 P391 P501	Because this substance is a sodium salt, it rapidly generates 4,6-dinitro-o-cresol (CAS RN 534-52-1) in water. This substance was classified in Category 1 from 48-hour EC50 = 0.161 mg/L (a converted value equivalent to this substance) for crustacea (Daphnia magna) for 4,6-dinitro-o-cresol (Environmental Risk Assessment for Chemical Substances Vol. 10 (Ministry of the Environment, 2012)). The classification result was revised from the previous classification by changing the view on which substance was targeted.
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	Because this substance is a sodium salt, it rapidly generates 4,6-dinitro-o-cresol (CAS RN 534-52-1) in water. This substance was classified in Category 2 because 4,6-dinitro-o-cresol was not rapidly degradable (a degradation rate by BOD: 4% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 2004)) and due to 31-34-day NOEC = 0.203 mg/L (a converted value equivalent to this substance) for fish (Pimephales promelas) for 4,6-dinitro-o-cresol (Environmental Risk Assessment for Chemical Substances Vol. 10 (Ministry of the Environment, 2012)). The classification result was revised from the previous classification by changing the view on which substance was targeted.
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.

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