GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 7681-11-0
Chemical Name Potassium iodide
Substance ID H27-B-019/C-040B_P
Classification year (FY) FY2015
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 FY2010  
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 present in the molecule associated with explosive properties.
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- - "Solids" according to GHS definition.
3 Aerosols Not applicable
-
-
- - Not an aerosol product.
4 Oxidizing gases Not applicable
-
-
- - "Solids" according to GHS definition.
5 Gases under pressure Not applicable
-
-
- - "Solids" according to GHS definition.
6 Flammable liquids Not applicable
-
-
- - "Solids" according to GHS definition.
7 Flammable solids Not classified
-
-
- - It is non-flammable (GESTIS (Access on June2015)).
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
-
-
- - "Solids" according to GHS definition.
10 Pyrophoric solids Not classified
-
-
- - It is non-flammable (GESTIS (Access on June2015)).
11 Self-heating substances and mixtures Not classified
-
-
- - It is non-flammable (GESTIS (Access on June2015)).
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)).
13 Oxidizing liquids Not applicable
-
-
- - "Solids" according to GHS definition.
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.
15 Organic peroxides Not applicable
-
-
- - It is an inorganic compound.
16 Corrosive to metals Classification not possible
-
-
- - No established test method suitable for solid substances.

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
-
-
- - 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.
1 Acute toxicity (Dermal) Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - "Solids" according to GHS definition.
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- - "Solids" according to GHS definition.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
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.
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)).
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)).
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)).
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)).
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.
7 Reproductive toxicity Category 1B, Additional category: Effects on or via lactation


Danger
H360
H362
P308+P313
P201
P202
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.
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.
9 Specific target organ toxicity - Repeated exposure Category 1 (skin, thyroid, systemic toxicity)


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).
10 Aspiration hazard Classification not possible
-
-
- - Due to lack of data, the classification is not possible.

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
-
-
- - The classification is not possible because appropriate data are not obtained.
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
-
-
- - No data.


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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