GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 618-85-9
Chemical Name 3,5-Dinitrotoluene
Substance ID R02-B-016-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   FY2013  
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
-
-
- - There is a chemical group associated with explosive properties, a nitro group, present in the molecule, but because it is classified in Division 6.1 in UNRTDG (UN3454), and it does not correspond to explosives, hazards of the highest precedence, 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 Classification not possible
-
-
- - No data available.
8 Self-reactive substances and mixtures Type G
-
-
- - There is a chemical group associated with explosive properties, a nitro group, present in the molecule, but because it is classified in Division 6.1 in UNRTDG (UN3454), 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" because it is classified in Division 6.1 in UNRTDG (UN3454), and it does not correspond to pyrophoric substances, hazards of the highest precedence.
11 Self-heating substances and mixtures Classification not possible
-
-
- - Classification is not possible because test methods applicable to solid (melting point <= 140 deg C) substances are not 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
-
-
- - There is a chemical group associated with explosive properties, a nitro group, present in the molecule, but this substance was classified as "Not classified" for desensitized explosives because a pure substance does not correspond to any hazard class in explosives.

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
[Please also refer to dinitrotoluene (isomer mixture) (CAS RN 25321-14-6) when the classification result for this substance is "Classification not possible" for health hazards. Information on dinitrotoluene is considered to be useful, although effects of each isomer on health hazards could not be identified in dinitrotoluene (isomer mixture).]

[Rationale for the Classification]
It was classified in Category 3 from (1), (2).

[Evidence Data]
(1) LD50 for rats: 216 mg/kg (ACGIH (7th, 2001), Environmental Risk Assessment for Chemical Substances vol. 5 (Ministry of the Environment, 2006), GESTIS (Access on April 2020), HSDB (Access on April 2020))
(2) LD50 for rats: males: 309 mg/kg, females: 216 mg/kg (MAK (DFG) vol.6 (1994))
1 Acute toxicity (Dermal) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
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" from (1), (2). The classification result was changed due to new data obtained.

[Evidence Data]
(1) This substance was not irritating in a skin irritation test with rabbits (Draize test) (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2009), MAK (DFG) vol.6 (1994), ACGIH (7th, 2001)).
(2) This substance was not irritating in a skin irritation test with rabbits by a modified Draize test (GESTIS (Access on April 2020)).
3 Serious eye damage/eye irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2). The classification result was changed due to new data obtained.

[Evidence Data]
(1) Any of six isomers of dinitrotoluene, including this substance, was not irritating to the rabbit eye in an eye irritation test with rabbits (Draize test) (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2009), MAK (DFG) vol.6 (1994), ACGIH (7th, 2001)).
(2) This substance did not irritate the rabbit eye (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 Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1). The classification result was changed due to new data obtained.

[Evidence Data]
(1) This substance was reported to be negative in a skin sensitization test with guinea pigs (10 animals, sex: unknown) (maximization test) (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2009), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), ATSDR (2016), MAK (DFG) vol.6 (1994), GESTIS (Access on April 2020)).
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2).

[Evidence Data]
(1) As for in vivo, it was reported to be negative in a dominant lethal test in mice, a chromosomal aberration test in rat peripheral blood, and a DNA damage test in rat hepatocytes (ATSDR (2016), IARC 65 (1996), MAK (DFG) vol.6 (1994), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)).
(2) As for in vitro, it was reported to be positive and negative in bacterial reverse mutation tests. And there is a negative result in a gene mutation test in cultured mammalian cells (IARC (1996), MAK (DFG) vol.6 (1994), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)).

[Reference Data, etc.]
(3) It was classified in Muta. 2 in EU CLP classification.
6 Carcinogenicity Classification not possible
-
-
- - [Rationale for the Classification]
It was classified in 1B in EU CLP in (1), but its rationale is unknown. It was classified as "Classification not possible" based on the classification by IARC.

[Evidence Data]
(1) As for classification results by domestic and international organizations, it was classified in Group 3 by IARC (IARC 65 (1996)) and Carc. 1B in EU CLP (EU CLP classification (Access on April 2020)).
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
There was no data on reproductive and developmental toxicity studies. However, based on (1), a decrease in testicular weight, degeneration of the seminiferous tubules, etc. were observed in male rats, and similar changes were observed in rats dosed with 2,4-DNT (CAS RN 121-14-2) and 2,6-DNT (CAS RN 606-20-2), which were isomers. Based on (2), 2,4-DNT, which was an isomer of this substance, had effects on fertility which were considered to be related to toxicity on the male reproductive organs, and it was classified in Category 2. Therefore, this substance was also classified in Category 2. The data was reviewed and the classification result was changed from the previous classification.

[Evidence Data]
(1) For various DNT isomers (2,3-DNT, 2,4-DNT, 2,5-DNT, 2,6-DNT, 3,4-DNT, this substance), 14-day repeated dose toxicity studies using male rats were conducted. As a result, it was found that 2,4-DNT, 2,6-DNT, and this substance had effects on the male reproductive organs. In male rats dosed with this substance at 19 mg/kg/day, small testes, a decrease in testicular weight, degeneration of the seminiferous tubules, and multinucleated giant cell formation in the testes were observed. Similar effects were observed after the administration of 2,4-DNT at 142 mg/kg/day and 2,6-DNT at 68 mg/kg/day. On the other hand, 2,3-DNT, 2,5-DNT, and 3,4-DNT had no effects on the male reproductive organs (such as testicular and epididymal weight and histopathological effects) (ATSDR (2016)).
(2) 2,4-DNT had effects on fertility which were considered to be related to toxicity on the male reproductive organs at doses at which toxicity effects were observed in parental animals. Therefore, the substance was classified in Category 2 in the classification in the current fiscal year (FY2020).

[Reference Data, etc.]
(3) In the EU CLP classification, it was classified as Repr.2 (Classification in EU CLP (Access on April 2020)).
8 Specific target organ toxicity - Single exposure Category 1 (blood system), Category 3 (narcotic effects)



Danger
Warning
H370
H336
P308+P311
P260
P264
P270
P321
P405
P501
P304+P340
P403+P233
P261
P271
P312
[Rationale for the Classification]
There was no report on effects on humans exposed to this substance. Based on (2) and (3), hematological toxicity and depression of the central nervous system were known as acute intoxication by dinitrotoluene, and the information (4) on this substance also indicated related findings. Therefore, it was classified in Category 1 (blood system) and Category 3 (narcotic effects). The information in the information sources was reviewed and the classification result was changed from the previous classification.

[Evidence Data]
(1) The general composition of dinitrotoluene is about 75% of 2,4-DNT and about 20% of 2,6-DNT (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)).
(2) There was a statement about dinitrotoluene that acute intoxication in humans was caused by formation of methemoglobin, which produced cyanosis, headache, irritability, dizziness, weakness, nausea, vomiting, dyspnea, drowsiness, unconsciousness, and possible death (ACGIH (7th, 2001)).
(3) There was a statement about dinitrotoluene that acute intoxication in experimental animals included central nervous system depression, respiratory depression, muscular incoordination, and cyanosis (ACGIH (7th, 2001)).
(4) There was information about this substance that in acute toxicity tests by oral administration to rats and mice, depression of the central nervous system including depression of the respiratory center, coordination disorders, loss of muscle coordination, and bluish discoloration of the skin were observed. Among dinitrotoluene isomers, this substance in addition to 2,6-DNT, and 2,4-DNT had the highest toxicity, and the oral LD50s were 210 to 310 mg/kg for rats and about 610 mg/kg for mice (GESTIS (Access on May 2020)).
9 Specific target organ toxicity - Repeated exposure Category 1 (blood system, nervous system, reproductive organs (male))


Danger
H372 P260
P264
P270
P314
P501
[Rationale for the Classification]
Based on (1) to (3), it was classified in Category 1 (blood system, nervous system, reproductive organs (males)).

[Evidence Data]
(1) The general composition of dinitrotoluene is about 75% of 2,4-DNT and about 20% of 2,6-DNT (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)).
(2) Results of occupational exposure studies and studies in laboratory animals identified the blood system (methemoglobinemia, anemia, and compensatory hematopoiesis) as the most sensitive target of dinitrotoluene-induced toxicity (ATSDR (2016)).
(3) It was reported that in an oral toxicity test with rats dosed with this substance for 14 days, smaller testes, a decrease in testicular weight, degeneration of the seminiferous tubules, and multinucleated giant cell formation in the testes were observed in males at 19 mg/kg/day (converted guidance value: 3 mg/kg/day, within the range for Category 1); and facial twitching and paralysis and inflammatory infiltrates of the brain were observed in males at 39 mg/kg/day (converted guidance value: 6 mg/kg/day, within the range for Category 1) (ATSDR (2016)).

[Reference Data, etc.]
(4) Available human data provided only limited evidence, as studies did not include appropriate control groups and exposure concentrations were not reported (ATSDR (2016)).
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 3
-
-
H402 P273
P501
It was classified in Category 3 from 96-hour LC50 = 22 mg/L for fish (Pimephales promelas) (Initial Risk Assessment (NITE, CERI, NEDO, 2005)).
11 Hazardous to the aquatic environment Long term (Chronic) Category 3
-
-
H412 P273
P501
Reliable chronic toxicity data were not obtained. It was classified in Category 3 because it is not rapidly degradable (BIOWIN), and it was classified in Category 3 in acute toxicity.
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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