GHS Classification Result

Chemical Name：Potassium iodide
CAS：7681-11-0

Result：
ID: 22A4012
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government （July, 2010）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement 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 Not classified - - - - Not flammable (Weiss (2nd, 1986))
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 Not classified - - - - Not flammable (Weiss (2nd, 1986))
11 Self-heating substances and mixtures Not classified - - - - Not flammable (Weiss (2nd, 1986))
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified - - - - Although it contains a metal (K), its water solubility is 148 g /100 g (HSDB (2006)) at 25 degC and it is considered stable in contact with water. The substance was classified as "Not classified".
13 Oxidizing liquids Not applicable - - - - Solid (GHS definition)
14 Oxidizing solids Classification not possible - - - - This substance is an inorganic compound containing halogen atom (iodine), but classification is not possible because no data is available.
15 Organic peroxides Not applicable - - - - Inorganic compound
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available. In addition, it is reported that this substance is corrosive in all concentrations to most metals, except stainless steel, titanium, and tantalum (Weiss (2nd, 1986)).

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Classification not possible - - - - The mouse LDLo value of 1862 mg/kg was documented (PATTY, 5th (2001)). As the category cannot be specified from only this datum, the substance was classified as the "Classification not possible". As relevant information, the rat LD50 value of 4340 mg/kg (GESTIS (Access on May 2010)) was documented as the datum from the "List 3" information source designated in the GHS classification guidance for the Japanese government.
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 were available. As relevant information, no reaction was reported when the patients that have skin reactions to topical administration of preparation of iodine were exposed to potassium iodide (CICAD 72 (2009)).
3 Serious eye damage/eye irritation Category 2B - Warning H320: Causes eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling. 		The substance was classified as Category 2B based on the documented test result on rabbit eyes that instillation of 3% solution to cornea caused only slight reaction, and graded 17 out of the maximum scale of 100 (HSDB (2006)).
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - Insufficient data were available. As the information of the "List 3" datum of the GHS classification guidance for the Japanese government, there were several studies on the skin sensitizing potential of the substance, but positive reaction was not reported (GESTIS (Access on May 2010)). Details containing testing methods and results were not provided.
5 Germ cell mutagenicity Classification not possible - - - - Since there was no well-conducted in vivo test, the classification was not possible. As relevant information, as for in vitro tests, negative results of both gene mutation test using mouse lymphoma L5178Y cells and the cell transformation test using Balb/c3T3 cells were reported (CICAD 72 (2009)).
6 Carcinogenicity Classification not possible - - - - The substance was classified as "Classification not possible", because it was classified as "A4" as iodine and iodide in carcinogenic evaluation by the ACGIH (ACGIH (2008)). Although no increase of proliferative lesions in the thyroid and no generation of tumors of the thyroid was observed, tumors of the salivary gland were observed in the high dose group, which was not observed in the control group, in the 2-year carcinogenicity test in rats administered via drinking water (ACGIH (2008)).
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ... 		In the animal studies, in the oral administration study using pregnant rabbits and minks, decreased viability index and number of live pups were observed (CICAD 72 (2009), HSDB (2006)). As data about humans, two or more reports that the mothers who have infants having goiter took the potassium iodide for the pregnancy period (ATSDR (2004), Birth Defects, 3rd (2000)). In addition, hypothyroidism in the newborn infant was reported (ATSDR (2004)). Because it was suggested from the reports mentioned above that the exposure during pregnancy period in animals and human influences the child's generation harmfully, and the reproductive toxicity to humans was suspected, thus, the substance was classified as Category 2.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - The classification was not possible due to lack of sufficient data. As relevant information, there was one suicide attempt case report by oral ingestion (CICAD 72 (2009)), but no details of symptoms and their progress were given. Moreover, it was reported that in at least two cases ingested orally, transient dermal lesions were elicited, but was suggested to be a possible cross reaction with other chemicals (ATSDR (2004)). In either case, the effects could not be considered as those attributed to single exposure to the substance concerned due to insufficient information.
9 Specific target organ toxicity - Repeated exposure Category 1 (thyroid, skin, systemic toxicity) Danger H372: Cause damage to organs through prolonged or repeated exposure (thyroid, skin, systemic toxicity) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ... 		There were multiple cases reported in which patients who were administered with therapeutic drugs containing this substance as a part of the treatment of some pulmonary diseases, developed proliferative dermal lesions of the face, scalp, trunk and arms etc. (ATSDR (2004)). Another case was also reported that iodine eruption occurred in patients who ingested the substance (ATSDR (2004)). From these, the classification was determined as Category 1 (skin). In patients who were given the drugs containing this substance, hypertrophy of thyroid or hypothyroidism accompanied by decrease in serum T4 level and increase in TSH level were commonly seen (ATSDR (2004)). In contrast, multiple cases with hyperthyroidism were also reported (CICAD 72 (2009), JECFA (1889)). The classification was, thus, determined as Category 1 (thyroid). Furthermore, the possibility of occurrence of serious side effects or iodism by intake the substance for long time was suggested. Symptoms of iodism other than those related to skin and thyroid were described as follows: irritations in the eyes, mouth and throat, asthma, parotitis, gastritis, exhaustion, etc. (Handbook of Japanese pharmaceutical drugs (2010), HSDB (2006)). In addition, the patients who ingested the substance orally could induce fevers that were thought to have an immunological basis (CICAD 72 (2009)). As it was difficult to specify the target organ(s) judging from these symptoms, the classification was concluded as Category 1 (systemic toxicity). From overall effects mentioned above, the classification was determined in conclusion as Category 1 (thyroid, skin, systemic toxicity).
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Not classified - - - - Classified as "Not classified" from its 96h-LC50 = 896 mg/L for fish (Oncorhynchus mykiss) (AQUIRE, 2011).
11 Hazardous to the aquatic environment （Long-term） Not classified - - - - Classified as "Not classified" since it is not non-water soluble (water solubility: 148 g/100 g (HSDB, 2010)) and its acute toxicity is "Not classified".
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* 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.

Reference：
Reference Manual
Definitions / Abbreviations
Model Label by MHLW

 MHLW Website （in Japanese Only）
Model SDS by MHLW

 MHLW Website （in Japanese Only）

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