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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	51-48-9
Chemical Name	Thyroxine
Substance ID	24A6024
Classification year (FY)	FY2012
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)	Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
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 oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure.
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)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Classification not possible	- -	-	-	No data available.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	No data available.
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	It is reported that oral administration to rats on gestational days 0-20 caused cataract in 38% of the offspring (HSDB (2003), Teratogenic (12th, 2007), corresponding to List 2). And as for humans, eye defects were observed in an infant after treatment by this substance on the mother during gestation, and medication with this substance was considered to be a risk factor for limb defects among 108 cases analyzed. Furthermore, possible associations were found with cardiovascular anomalies, Down syndrome, and polydactyly, which were seen in 537 mother-child pairs exposed during the first trimester (Birth Defects (3rd, 2000), corresponding to List 2). From the above knowledge, general toxicity in maternal animals was not described in the animal test, and all the descriptions in humans were from List 2, therefore it was classified in Category 2.
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Data are lacking. Besides, it is reported that after administration of 80-grain tablets (about 5.2 g) to a dog, it showed increased pulse rate and behavior indicating loss of vision, no light reflex and dilated pupils were observed, and it died after 12 hours (HSDB (2003)), but it cannot be used for the rationale for classification because the details are unknown. And sodium L-thyroxine (CAS 55-03-8), the sodium salt of the substance, has been used as a medicine, and as adverse effects, there are descriptions of angina and hepatic function disorder as well as circulatory system symptoms such as palpitation, arrhythmia, and increased pulse rate and neurological symptoms such as dizziness, insomnia, tremor, and irritability (Ethical Pharmaceuticals (2010), corresponding to List 1).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	No data available. Besides, sodium L-thyroxine (CAS 55-03-8), the sodium salt of the substance, has been used as a medicine, and as adverse effects, there are descriptions of angina and hepatic function disorder as well as circulatory system symptoms such as palpitation, arrhythmia, and increased pulse rate and neurological symptoms such as dizziness, insomnia, tremor, and irritability (Ethical Pharmaceuticals (2010)).
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.

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	- -	-	-	The classification is not possible because appropriate data are not obtained.
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.

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