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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	15663-27-1
Chemical Name	(SP-4-2)-Diamminedichloroplatinum (Cisplatin)
Substance ID	H30-C-023-MHLW
Classification year (FY)	FY2018
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)
New/Revised	Revised
Classification result in other fiscal year	FY2009
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	-	- -	-	-	-
2	Flammable gases (including chemically unstable gases)	-	- -	-	-	-
3	Aerosols	-	- -	-	-	-
4	Oxidizing gases	-	- -	-	-	-
5	Gases under pressure	-	- -	-	-	-
6	Flammable liquids	-	- -	-	-	-
7	Flammable solids	-	- -	-	-	-
8	Self-reactive substances and mixtures	-	- -	-	-	-
9	Pyrophoric liquids	-	- -	-	-	-
10	Pyrophoric solids	-	- -	-	-	-
11	Self-heating substances and mixtures	-	- -	-	-	-
12	Substances and mixtures which, in contact with water, emit flammable gases	-	- -	-	-	-
13	Oxidizing liquids	-	- -	-	-	-
14	Oxidizing solids	-	- -	-	-	-
15	Organic peroxides	-	- -	-	-	-
16	Corrosive to metals	-	- -	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	-	- -	-	-	-
1	Acute toxicity (Dermal)	-	- -	-	-	-
1	Acute toxicity (Inhalation: Gases)	-	- -	-	-	-
1	Acute toxicity (Inhalation: Vapours)	-	- -	-	-	-
1	Acute toxicity (Inhalation: Dusts and mists)	-	- -	-	-	-
2	Skin corrosion/irritation	-	- -	-	-	-
3	Serious eye damage/eye irritation	-	- -	-	-	-
4	Respiratory sensitization	-	- -	-	-	-
4	Skin sensitization	-	- -	-	-	-
5	Germ cell mutagenicity	-	- -	-	-	-
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on the IARC's classification result (1)-(3) and test results of (4)-(6), it was classified in Category 1B. After reviewing the previous classification due to the revision of the classification by IARC, the category remained to be 1B for this substance because the IARC's revised classification is for the combined use with other substances. Combination therapy of etoposide, this substance, and bleomycin is carcinogenic to humans as shown in (7), (8). [Evidence Data] (1) As for the carcinogenicity of this substance alone, it was classified in Group 2A by IARC (IARC Suppl. 7 (1987)) and in R by NTP (NTP RoC (14th, 2016)). (2) IARC classified combination of etoposide, this substance, and bleomycin in Group 1 based on increased acute myeloid leukemia, that was the result of reevaluation of cohort studies in the 1990s (IARC 100A (2012)). (3) Induced acute myeloid leukemia exhibits distinctive characteristics of that caused by topoisomerase II inhibitors such as etoposide, but this substance is not involved in topoisomerase II inhibition. Etoposide alone was also classified in Group 1 (IARC 100A (2012)). (4) In a test in which mice were given multiple intraperitoneal doses, an increased incidence of lung adenoma was observed (IARC Suppl. No.7 (1987)). (5) In a test in which mice were given an application of croton oil on the skin as a promoter and intraperitoneal doses, an increased incidence of skin papilloma was observed (IARC Suppl. No.7 (1987)). (6) In two tests in which rats were given multiple intraperitoneal doses, leukemia was induced (IARC Suppl. No.7 (1987)). [Reference Data, etc.] (7) As the result of reevaluation of many cohort studies on combination therapy of etoposide, this substance, and bleomycin in the 1990s, increases in acute myeloid leukemia were observed (IARC 100A (2012)). (8) This substance is used in the treatment of tumors of the testis, usually as a major component of combination chemotherapy regimens, and particularly with bleomycin and etoposide (IARC 100A (2012)).
7	Reproductive toxicity	-	- -	-	-	-
8	Specific target organ toxicity - Single exposure	-	- -	-	-	-
9	Specific target organ toxicity - Repeated exposure	-	- -	-	-	-
10	Aspiration hazard	-	- -	-	-	-

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)	-	- -	-	-	-
11	Hazardous to the aquatic environment (Long-term)	-	- -	-	-	-
12	Hazardous to the ozone layer	-	- -	-	-	-

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.

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