NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	7681-11-0
Chemical Name	Potassium iodide
Substance ID	m-nite-7681-11-0_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive properties.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified	- -	-	-	It is non-flammable (GESTIS (Access on June2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	It is non-flammable (GESTIS (Access on June2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is non-flammable (GESTIS (Access on June2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	It is estimated that it does not react vigorously with water from water solubility data measured. Water solubility: 148 g/100 g (HSDB (Access on June 2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Classification not possible	- -	-	-	It is an inorganic compound that does not contain oxygen but contains halogen (I), but the classification is not possible due to no data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	It is an inorganic compound.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No established test method suitable for solid substances.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Classification not possible	- -	-	-	The classification is not possible due to lack of data. Besides, the classification is not possible only from a reported LDLo value of 1,862 mg/kg for mice (PATTY (6th, 202)). Besides, an LD50 value of 2,779 mg/kg for rats is reported as the List 3 information (GESTIS (Access on June 2015)), but it was not used for the classification because its reference source could not be confirmed.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Classification not possible	- -	-	-	The classification is not possible due to lack of data. Besides, edema of the face and neck is described as acute toxicity signs in humans (CICAD 72 (2009)), but the details are unknown.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	It is reported that in a test using rabbits, slight irritation was observed after application of this substance (3% solution) into the cornea, and the extent of irritation was 17 against the maximum of 100 (HSDB (Access on July 2015)). From the above results, it was classified in Category 2B. Besides, conjunctivitis, blepharedema and so on are listed as adverse effects in the long-term repeated use (Ethical Pharmaceuticals 2016 (2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	The classification is not possible due to lack of data. Besides, an asthmatic attack is listed as an adverse effect in the long-term repeated use of this substance (Ethical Pharmaceuticals 2016 (2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	The classification is not possible due to lack of data. Besides, it is reported that it sensitization was not observed after application of a 25% aqueous solution of this substance in humans (GESTIS (Access on July 2015)), but it was judged to be insufficient data to be used for the classification due to unknown details. Moreover, rash and urticaria are listed as adverse effects in the long-term repeated use of this substance (Ethical Pharmaceuticals 2016 (2015)). Besides, Japan Society for Occupational Health classified iodine and its compounds as a skin sensitizer Group 2, but there is a cautionary statement that not all compounds were identified (The Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (2014)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The classification is not possible due to lack of data. There are no in vivo data, and as for in vitro, a mouse lymphoma test in cultured mammalian cells was negative (ATSDR (2004), CICAD 72 (2009)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	As to a relationship between iodine ingestion and thyroid cancer, as the results of multiple large-scale epidemiological studies, it is suggested that increased iodine ingestion could be a risk factor for thyroid tumor especially in special groups such as an iodine deficit group and regions where endemic goiter often occurs. However, it is written that because an increased risk of cancer was not observed not in all of the studies, a relationship between iodine ingestion and thyroid tumor is still unknown (CICAD 72 (2009)). Moreover, it is reported that an increased incidence of thyroid cancer, especially thyroid papillary carcinoma was observed after increased iodine ingestion by a group of people who reside in the areas of iodine deficit soil (CICAD 72 (2009), ATSDR (2004)). As for experimental animals, it is reported that after lifetime oral exposure (in the diet) to this substance at the dose of about 50 mg/kg/day, only salivary gland tumor in male and female rats (a significant increase only in a statistical test of both male and female combined) was observed (CICAD 72 (2009)). Moreover, it is reported that because in a two-stage carcinogenicity test in which rats were orally administered (drinking water) this substance after initiation by nitrosamine, thyroid follicular epithelial cell carcinoma was induced, promotion action was suggested (CICAD 72 (2009)). ACGIH classified iodine and its compounds in A4 in 2008 (ACGIH (7th, 2008)). From the above, the substance was classified as "Classification not possible" in this hazard class.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 1B,	Danger	H360 H362	P308+P313 P201 P202 P260 P263 P264 P270 P280 P405 P501	As for humans, excretion into breast milk is one of excretion routes out of the body for iodine ingested. From the results of a study administrating radioactive iodine, an excretion rate of absorbed iodine into body milk is different depending on the function of thyroid tissues. It is reported that about 2.5% of the dosed radioactivity was excreted into body milk in 5.5 days after sodium iodide (Na123I) was orally administered to hyperthyroid patients (CICAD 72 (2009)). Similarly, it is reported that hyperthyroid patients showed about a 2.6% iodine excretion rate into body milk (CICAD 72 (2009)). However, it is reported that in hypothyroid patients, 25% of the dosed radioactivity was excreted into body milk within 41 hours after radioactive sodium iodide was orally dosed (CICAD 72 (2009), ATSDR (2004)). As health effects by excessive iodine ingestion in humans, it is written that goiter and thyroid failure occur, with which cretinism, brain dysfunction and so on are related and could occur in newborns and children, and disorder of menstrual cycle including uterus hemorrhage and anovulation could happen in adults as secondary effects on the reproductive system (ATSDR (2004)). On the other hand, as for experimental animals, it is reported that after 12-day diet administration (2,500 mg/kg/day) of iodine in pregnant rats in the latter half of gestation period, 25% of maternal animals showed delayed parturition from difficult delivery, and increased mortality was found in newborns (CICAD 72 (2009)), and that after pregnant rabbits were orally dosed of iodide (not knowing if it is this substance) (250 mg/kg/day) for two days before delivery, 2/3 of newborns died (CICAD 72 (2009)). As above, excessive iodine ingestion in humans causes thyroid failure, and effects on sexual function such as menstrual abnormality could occur as secondary effects, and there is the information that absorbed iodine is excreted into body milk, and it is possible that iodine transferred to newborns via body milk causes developmental disorder in infants. Because it is hard to say that there is sufficient evidence of reproductive toxicity caused by excessive exposure to iodide in humans, the substance was classified in Category 1B in this hazard class, and the Category of effects by lactation was added.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (thyroid)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	As human cases, it is reported in New York City Medical Examiners Office (USA) that there were 18 suicide cases by oral ingestion of iodine tincture (iodine is dissolved in ethanol, containing potassium iodide (KI) as an additive), and at iodine tincture concentrations of 1,200-9,500 mg (17-120 mg/kg body weight), deaths were observed within 48 hours after ingestion. Besides this, it is reported that suicide was attempted by a solution of this substance (15 g as iodine), but there was a recovery (CICAD 72 (2009), ATSDR (2004), PATTY (6th, 2012)). Moreover, it is written that acute excessive iodine ingestion causes a transient decrease in thyroid hormone production (ATSDR (2004)). As the signs by iodides, it is written that toxicity signs at or near-lethal doses were abdominal cramps, hemorrhagic diarrhea, ulcer of the digestive tract, edema of the face and neck, pneumonia, hemolytic anemia, metabolic acidosis, fatty degeneration of the liver, renal failure (CICAD 72 (2009)) (these were not adopted due to no detailed information mentioned.). From the above, because this substance has effects on thyroid, it was classified in Category 1 (thyroid). By adding new information, the previous classification was revised.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (skin, thyroid, systemic)	Danger	H372	P260 P264 P270 P314 P501	In the oral administration of this substance as drug therapy, iodine eruption is observed. It is characterized by acneiform pustules, and proliferating nodular lesions which coalesce with cysts were found on the face, extremities, trunk and so on in multiple cases. Moreover, cases were reported where fever was observed in using this substance as drug therapy. Furthermore, by excessive oral exposure to this substance, hypothyroidism was found, but on the other hand, cases showing hyperthyroidism were also reported (ATSDR (2004), CICAD 72 (2009)). Besides these, as serious adverse effects in long-term repeated use, other than lesions in skin and thyroid, laryngitis, bronchitis, glottal edema, asthmatic attack, salivary gland edema, parotitis, gastritis, along with iodine cachexia such as generalized weakness, palpitation, depression, sleeplessness, and nervousness are listed as iodine poisoning (Ethical Pharmaceuticals 2016 (2015)). As above, other than skin and thyroid, various systemic signs for which it is difficult to identify a target organ were observed. Therefore, the substance was classified in Category 1 (skin, thyroid, systemic toxicity).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Classification not possible	- -	-	-	The classification is not possible because appropriate data are not obtained.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	The classification is not possible because appropriate data are not obtained.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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