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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	7705-08-0
Chemical Name	Iron (III) chloride
Substance ID	H26-B-127, R-069
Classification year (FY)	FY2014
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	FY2009 FY2006
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)
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	- -	-	-	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	- -	-	-	It is not combustible (ICSC (2004)).
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	- -	-	-	It is not combustible (ICSC (2004)).
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is not combustible (ICSC (2004)).
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	Because the observation result that it decomposes in contact with water and produces hydrogen chloride (ICSC (2004)) was obtained, it is estimated that it does not emit flammable gases when it reacts with water.
13	Oxidizing liquids	Not applicable	- -	-	-	Solid (GHS definition).
14	Oxidizing solids	Classification not possible	- -	-	-	The substance is an inorganic compound containing halogen (but not oxygen), 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	- -	-	-	Test methods applicable to solid substances are not available. Besides, there is information that it attacks most metals (Hommel (1991)).

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P362+P364 P264 P270 P330 P501	There are 5 reports of LD50 values of 500-5,000 mg/kg, 900 mg/kg, 1,872 mg/kg, about 2,900 mg/kg and about 2,900 mg/kg for rats (SIDS (2008)). Since 2 cases each corresponded to Category 4 and "Not classified," it was classified in Category 4 to which smaller LD50 values corresponded.
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Category 1	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	There is a description that this substance is a strong acid, and the pH of a 0.1M solution is 2.0 (HSDB (Access on September 2014)), and therefore, it was classified in Category 1. Besides, there are 3 reports of tests with rabbits, with 2 reports on it being irritating and 1 report of iｔ being not irritating (SIDS (2008), IUCLID (2000)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	There is a description that this substance is a strong acid, and the pH of a 0.1M aqueous solution is 2.0 (HSDB (Access on September 2014)). In addition, after application of a 40% aqueous solution of this substance to rabbits, it was severely irritating (SIDS (2008), IUCLID (2000)). From the above results, it was classified in Category 1.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data. There is a description that in a test with guinea pigs, a positive reaction was observed in 1 out of 2 animals. However, no conclusions could be drawn because of a small number of animals and insufficient details of the test method (SIDS (2008), IUCLID (2000)). In addition, there is a report of contact sensitization to iron and positive reactions in a patch test to a 2% solution of this substance in a 66-year-old white man (SIDS (2008), IUCLID (2000)), but it is only limited to this 1 case.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	It was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, it was negative in a mouse bone marrow micronucleus test (SIDS (2008)), As for in vitro, it was positive in 1 mouse lymphoma test with cultured mammalian cells but was negative in multiple bacterial reverse mutation tests and mouse lymphoma tests with cultured mammalian cells (SIDS (2008), NTP DB (Access on October 2014)). Besides, there is a negative report in an in vivo chromosomal aberration test with the testis of mice, but the details were unknown (SIDS (2008)). "A positive result in a chromosomal aberration test with bone marrow cells by the oral administration to mice (IUCLID (2000))" in the previous classification was incorrect and deleted because it was a negative result from iron sulfate (II). In addition, "a positive result in a bone marrow cell micronucleus test by the oral administration to mice (IUCLID (2000))" in the previous classification was deleted because it was described in SIDS (2008) that this test was evaluated as invalid due to multiple problems such as no control group.
6	Carcinogenicity	Classification not possible	- -	-	-	There are no carcinogenic classifications by international organizations. No carcinogenicity was observed in a carcinogenicity study with male and female F344 rats dosed by drinking water for 2 years (SIDS (2008)). However, since it was a test result with only 1 species, classification was not possible due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, there was no information on reproductive toxicity study. However, there are reports that spermatogenesis in the testis and epididymis was an effect in a test by administration to the testis of rats, and that preimplantation mortality was seen in a test by administration to the vagina of rats 1 day before mating (SIDS (2008)). These tests were not adopted as evidence of classification because the administration routes were different from the usual reproductive developmental toxicity test. In addition, there is a report that no effects on dams and fetuses were seen in a teratogenicity study with rats by the oral route (drinking water) (SIDS (2008)). However, it was the study with only one-dose and was not adopted for classification.
8	Specific target organ toxicity - Single exposure	Category 1 (systemic toxicity), Category 3 (respiratory tract irritation)	Danger Warning	H370 H335	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	Although not this substance, inhalation of ferric compounds such as dusts and mists is irritating to the respiratory tract (ACGIH (7th, 2001), SIDS (2008), HSDB (Access on September 2014)). As for this substance, there is a case report of one person who accidentally ingested 200 mL of a ferric chloride solution (pH 1) and developed hypoxemia, severe metabolic acidosis with respiratory alkalosis initially and vomiting, drowsy consciousness, tachycardia, tachypnea 3 hours after ingestion and died of severe vomiting and cardiopulmonary arrest 4 hours after ingestion (HSDB (Access on September 2014)). Besides, there is a report of vomiting, diarrhea, mild lethargy, upper abdominal pain and pallor by the oral ingestion of ferric compounds in humans, and hyperglycemia, cyanosis, stupor, acidosis, hematemesis and coma in severe cases. There is a description of effects on the stomach mucosa and the cardiovascular/peripheral circulation, metabolic acidosis, and effects on the central nervous system by the oral ingestion of iron sulfate (II) (SIDS (2008), ACGIH (7th, 2001)). From the above, this substance was considered to be irritating to the respiratory tract, therefore, it was classified in Category 3 (respiratory tract irritation). In addition, although it was considered to cause systemic effects, the target organ could not be identified, therefore, it was also classified in Category 1 (systemic toxicity). In the previous classification, systemic toxicity was classified in Category 2, however, it was revised to Category 1 because some effects on humans were severe as described above.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a 13-week study in which ferric chloride hexahydrate (III) was administered by drinking water to rats, the No Observable Adverse Effect Level (NOAEL) was reported to be 5,000 ppm (equivalent to 277 mg/kg/day for males, and 344 mg/kg/day for females) (SIDS (2008)). However, it was not the result of a study conducted with sufficient evaluation items including histopathological examination. There is a description that the divalent ferrous ion is oxidized to the trivalent ferric ion in the stomach despite the low pH, and this then chelates with proteins which retain the iron in soluble form available for absorption into the small intestinal mucosa (SIDS (2008)). Although repeated dose toxicity studies were extensively investigated including those on divalent iron compounds, in combined repeated dose toxicity studies with the reproduction/developmental toxicity screening test (OECD TG 422) in which ferrous sulfate heptahydrate (II) for up to 49 days or ferrous chloride (II) for up to 54 days was administered by gavage to rats, respectively, there was no toxicity within or lower than the dose range for Category 2, and even in the high dose group (converted guidance value: higher than 233 mg/kg/day), only pigmentation (hemosiderin) in the spleen and liver, and hemal effects, etc. were seen but no serious target organ toxicity was observed (SIDS (2008)). From the above, although it was considered corresponding to "Not classified" by the oral route, there was no toxicity information by the other routes. Therefore, it was classified as "Classification not possible" due to lack of data.
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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)	Category 3	- -	H402	P273 P501	It was classified in Category 3 from 48-hour LC50 = 37.5 mg/L (12.9 mgFe/L) for crustacea (Daphnia pulex) (SIDS, 2008).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	Although environmental dynamics of the inorganic compound are unknown, it was classified as "Not classified" from 21-day NOEC = 2.0 mg/L for crustacea (Daphnia magna) (0.70 mgFe/L) (SIDS, 2008).
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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