GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 70476-82-3
Chemical Name Mitoxantrone dihydrochloride
Substance ID H28-A-022, C-066A
Classification year (FY) FY2016
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 associated with explosive properties present in the molecule.
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- -  Solid (GHS definition).
3 Aerosols Not applicable
-
-
- -  Not aerosol products.
4 Oxidizing gases Not applicable
-
-
- -  Solid (GHS definition).
5 Gases under pressure Not applicable
-
-
- -  Solid (GHS definition).
6 Flammable liquids Not applicable
-
-
- -  Solid (GHS definition).
7 Flammable solids Classification not possible
-
-
- -  No data available.
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 Not applicable
-
-
- -  Solid (GHS definition).
10 Pyrophoric solids Classification not possible
-
-
- -  No data available.
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 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).
13 Oxidizing liquids Not applicable
-
-
- -  Solid (GHS definition).
14 Oxidizing solids Not applicable
-
-
- -  The substance is an organic compound containing chlorine and oxygen (but not fluorine) which are chemically bonded only to carbon or hydrogen.
15 Organic peroxides Not applicable
-
-
- -   Organic compounds containing no bivalent -O-O- structure in the molecule
16 Corrosive to metals Classification not possible
-
-
- -  Test methods applicable to solid substances are not available.

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 		 Based on the LD50 value of 682 mg/kg for rats (HSDB (Access on June 2016)), the substance was classified in Category 4.
1 Acute toxicity (Dermal) Category 2


Danger
H310 P302+P352
P361+P364
P262
P264
P270
P280
P310
P321
P405
P501 		 Based on the LD50 values of 1,640 mg/kg for rats (HSDB (Access on June 2016)) and 125 mg/kg for rabbits (HSDB (Access on June 2016)), the substance was classified in Category 2 by adopting the value of 125 mg/kg as a more hazardous category.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- -  Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- -  Solid (GHS definition)
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- -  Classification not possible due to lack of data.
2 Skin corrosion/irritation Classification not possible
-
-
- -  Classification not possible due to lack of data.
3 Serious eye damage/eye irritation Classification not possible
-
-
- -  Classification not possible due to lack of data.
4 Respiratory sensitization Classification not possible
-
-
- -  Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- -  Classification not possible due to lack of data.
5 Germ cell mutagenicity Category 2


Warning
H341 P308+P313
P201
P202
P280
P405
P501 		 As for in vivo data, a dominant lethal mutation test using rats was negative (IARC 76 (2000)) and a chromosomal aberration test using bone marrow cells of rats was positive (IARC 76 (2000)). As for in vitro data, bacterial reverse mutation tests, and mouse lymphoma assay, chromosomal aberration tests and sister chromatid exchange tests using mammalian cultured cells were positive (IARC 76 (2000)).
 Therefore, the substance was classified in Category 2.
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501 		 As for humans, in a small cohort study of premenopausal women with early-stage breast cancer who had been treated with this substance (not receiving known or suspected leukaemogenic agents), an increased risk for acute myeloid leukaemia was observed (IARC 76 (2000)). Moreover, in case reports, patients treated with this substance developed acute myeloid leukaemia, which coincides with the result of the cohort study (IARC 76 (2000)). From the above, there is limited evidence in humans for the carcinogenicity although there is no evidence in experimental animals, and IARC classified the carcinogenicity classification of this substance as Group 2B (IARC 76 (2000)). Therefore, the substance was classified in Category 2.
7 Reproductive toxicity Category 1A
Additional category for effects on or via lactation


Danger
H360 P308+P313
P201
P202
P280
P405
P501 		 In humans, a woman aged 39 who was treated for 14 weeks with this substance at 20 mg intravenously every three weeks for cystic adenoma of the adenoids became amenorrhoeic and had hot flushes after a cumulative dose of 100 mg, and measurement of luteinizing hormone, follicle-stimulating hormone and oestradiol in her blood showed that their concentrations were in the menopausal range (IARC 76 (2000)).
 As for experimental animals, an increased frequency of fetal resorptions and decreased fetal body weights were observed as a result of intravenous injection to pregnant rats with 0.25 mg/kg, however, no developmental effects were observed as a result of intravenous injection to pregnant rabbits with up to 0.5 mg/kg (IARC 76 (2000)).
 From the above, the substance was classified in Category 1A, because effects by the intravenous administration of clinical route were observed in humans and experimental animals. Moreover, it is described that it is reported there was transfer into breast milk in an animal experiment (rats) (Ethical Pharmaceuticals 2017 (2016)), therefore, "additional category for effects on or via lactation" was added to the classification.
 
8 Specific target organ toxicity - Single exposure Category 1 (haemal system)


Danger
H370 P308+P311
P260
P264
P270
P321
P405
P501 		 This substance is administered by intravenous injection as an anticancer drug. It is described that a decrease in leukocyte counts was observed in a single dose in humans, and that the lowest counts were found 10 to 14 days after a dose, with recovery by day 21 (IARC 76 (2000)). Although no details on the experiment are available, it is reported that a decrease in leukocyte counts, haematocrit and haemoglobin concentration was observed in a dog study (IARC 76 (2000)). From the above, the substance was classified in Category 1 (haemal system).
9 Specific target organ toxicity - Repeated exposure Category 1 (hematopoietic system, heart, liver, gastrointestinal tract, skin, nail, hair)


Danger
H372 P260
P264
P270
P314
P501 		 This substance is administered by intravenous injection as an anticancer drug.
 As side effect information in humans, it is reported that myelosuppression (leukopenia), cardiotoxicity, nausea, vomiting, diarrhoea, stomatitis, mucositis, alopecia, discolouration of the skin, onycholysis and hepatotoxicity (an increase in bilirubin concentration and in the activity of liver enzymes) were seen (IARC 76 (2000)).
 Therefore, the substance was classified in Category 1 (hematopoietic system, heart, liver, gastrointestinal tract, skin, nail, hair).
 
10 Aspiration hazard Classification not possible
-
-
- -  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 (Acute) Classification not possible
-
-
- -  No data available.
11 Hazardous to the aquatic environment (Long-term) Classification not possible
-
-
- -  No data available.
12 Hazardous to the ozone layer Classification not possible
-
-
- -  No data available.


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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