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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	64-18-6
Chemical Name	Formic acid
Substance ID	H26-B-029, R-065
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 associated with explosive properties present in the molecule.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Category 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	It was classified in Category 3 based on a flash point of 50 deg C (closed cup) (HSDB (Access on July 2014)).
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
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 classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 520 deg C (ICSC (1997)).
10	Pyrophoric solids	Not applicable	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not 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	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.

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	Based on reports of LD50 values of 700 mg/kg (PATTY (6th, 2012), SIDS (2011)), 1,100 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008)), 1,830 mg/kg (PATTY (6th, 2012)), 730-1,830 mg/kg (DFGOT vol. 19 (2003)) and 1,100-1,850 mg/kg (NTP TR19 (1992)) for rats, it was classified in Category 4.
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Category 4	Warning	H332	P304+P340 P261 P271 P312	Based on a report of an LC50 value (4 hours) of 7.4 mg/L (=3,929 ppm) for rats (PATTY (6th, 2012), SIDS (2011), DFGOT vol. 19 (2003)), it was classified in Category 4. Besides, the LC50 value was lower than 90% of the saturated vapor concentration (42,162 ppm), the reference value in units of ppm was applied as a vapour without a mist.
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 report that corrosivity and strong irritation were observed in a skin irritation test with rabbits (DFGOT vol. 19 (2003), IUCLID (2000)), and there are many descriptions that it was corrosive to human skin (SIDS (2011), NTP TR19 (1992), OEL Documentations (Japan Society For Occupational Health (JSOH), 1978), Environmental Risk Assessment for Chemical Substances Vol.6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008)), therefore, it was classified in Category 1. Besides, this substance has pH=2.2 (at 10 g/L, 20 deg C) (IUCLID (2000)), and it was classified in "C: R35" in the EU DSD classification, and in "H314 Skin Corr. 1A" in the EU CLP classification.
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	In eye irritation tests with rabbits, there are reports that irritation or corrosivity was observed (SIDS (2011), DFGOT vol. 19 (2003)), and that burns occurred in the cornea (PATTY (6th, 2012)). In addition, there are many descriptions that it showed strong corrosivity to human eyes (SIDS (2011), NTP TR19 (1992)), and there is a description that conjunctivitis and keratitis occurred, leaving irreversible damages (PATTY (6th, 2012)). From the above results, it was classified in Category 1. Besides, the pH of this substance is 2.2 (at 10 g/L, 20 deg C) (IUCLID (2000)).
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	Based on the result that in a Buehler test (OECD TG406, GLP-compliant) with guinea pigs, after the challenge, no skin reaction was observed in all 20 treated animals and it was negative (SIDS (2011)), it was classified as "Not classified." Information in SIDS (2011) was added, and the category was changed.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. There were no in vivo data. As for in vitro, it was concluded that it was negative in all of bacterial reverse mutation tests, a gene mutation test and a chromosomal aberration test with cultured mammalian cells and sister chromatid exchange tests with human lymphocytes and cultured mammalian cells (SIDS (2011), PATTY (6th, 2012), IUCLID (2000), NTP DB (Access on July 2014), DFGOT vol. 19 (2003)).
6	Carcinogenicity	Not classified	- -	-	-	There was no classification by international organizations. As for individual information, the results were negative in carcinogenicity tests (equivalent to OECD TG 453) with rats and mice (both males and females) administered by feeding at doses of potassium formate up to 2,000 mg/kg/day for 2 years (rats: 104 weeks, mice: 80 weeks) (SIDS (2011)). In addition, it was negative in a test in which calcium formate was administered by drinking water to male and female rats at 150-200 mg/kg/day for 1.5 years (there is a description that test conditions were inadequate) (BUA 81 (1995)). From the above, it was classified as "Not classified" since both carcinogenicity tests with rats and mice were negative.
7	Reproductive toxicity	Classification not possible	- -	-	-	Although there is a report that there were no effects on the body weight and body length of the offspring in a multi-generation reproductive toxicity test with rats through the oral route (drinking water) (Environmental Risk Assessment for Chemical Substances Vol.6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008), DFGOT vol. 19 (2003)), it was a single dose test and there was inadequate information to evaluate. In addition, although there is a report that when rats were administered by drinking water at 1.0% for up to 7 months, the survival rate of offspring was reduced by 50-67% (NTP TR19 (1992)), and there was no further detailed description of the test method and results. In a teratogenicity test with mice through the oral route (gavage), no effects on the neural tube were observed in fetuses examined on days 10 and 18 of gestation (PATTY (6th, 2012), Environmental Risk Assessment for Chemical Substances Vol.6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008), DFGOT vol. 19 (2003)). Since the purpose of this test was to investigate the mechanism of methanol-induced exencephaly with sodium formate, and this is a test in which the treatment period was limited to Day 8 of gestation which is the sensitive phase of methanol-induced exencephaly, it is considered insufficient information on teratogenicity other than exencephaly. As above, it was classified as "Classification not possible" since there was inadequate information on reproductive toxicity (fertility, teratogenicity).
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system, respiratory organs, haemal system, kidney)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	This substance was highly corrosive and caused damage to the mouth, throat, esophagus and gastric mucosa (NTP TR19 (1992)). In humans, on oral ingestion, sore throat, burning sensation, abdominal pain, stomach cramps, vomiting, hyperemia, edema and necrosis of the nose, throat and gastrointestinal mucosa, esophageal stricture, stomach perforation, bleeding of the gastrointestinal tract, other than these, difficulty in swallowing, unconsciousness, central nervous system depression, severe acidosis, hemolysis, hematuria, blood coagulation disorders, anuria, uremia, acute kidney failure, nephropathy, liver function disorders, vascular shock, circulatory collapse, pneumonia and deaths were reported (Environmental Risk Assessment for Chemical Substances Vol.6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008), ACGIH (7th, 2001), PATTY (6th, 2012), BUA 81 (1995), DFGOT vol. 19 (2003), NTP TR19 (1992)). Sore throat, cough, burning sensation, shortness of breath, unconsciousness, rhinitis, bronchitis, dyspnea, respiratory failure, pulmonary edema, acidosis, acute renal failure and death were observed by the inhalation exposure to the vapour (NTP TR19 (1992), Environmental Risk Assessment for Chemical Substances Vol.6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008)). By dermal exposure, death after 6 hours due to significant difficulty in swallowing and dyspnea in a worker who was accidentally splashed in the face with hot formic acid (ACGIH (7th, 2001)), and burns and severe acidosis in an accident where more than 35% of the whole body skin of a 3-year-old girl was exposed, were reported (PATTY (6th, 2012)). Other than these, although the route of exposure was not described, there were reports of central nervous system depression including visual and mental disturbances due to large amounts of exposure (PATTY (6th, 2012)), and that farmers exposed to a preservative solution of this substance developed severe cardiovascular and kidney diseases (PATTY (6th, 2012)). As for experimental animals, hunched posture, dyspnea, bloody nose and blood in the urine, and hypothermia were observed by oral administration to rats, hyperemia of the stomach, liver and kidney were observed in the pathological examination, and salivation, loss of pain reflex, dyspnea, respiration sounds, flatulence, apathy, hunched posture, and unsteady gait were observed after inhalation exposure in rats (SIDS (2011)). These findings were within the guidance value range corresponding to Category 1. From the above, it was classified in Category 1 (central nervous system, respiratory organs, blood system, kidney).
9	Specific target organ toxicity - Repeated exposure	Category 2 (respiratory organs)	Warning	H373	P260 P314 P501	There was no information on the effects of repeated exposure to this substance in humans. As for experimental animals, in studies in which rats and mice were exposed to the vapor of this substance by inhalation for 13 weeks, although no systemic effects to identify the target organ were observed, as for local effects, degeneration of the olfactory epithelium (rats and mice) and squamous metaplasia of the respiratory epithelium (rats) were observed at the concentration corresponding to Category 1 (0.12 mg/L/6 hours) in mice and at that corresponding to Category 2 (0.24 mg/L/6 hours) in rats (SIDS (2011), NTP TR19 (1992), DFGOT vol. 19 (2003), PATTY (6th, 2012)). Since the effects by inhalation exposure with humans were unknown, it was classified in Category 2 (respiratory organs) based on the category corresponding to the concentrations at which the effects on the respiratory organs were commonly observed in both of rats and mice.
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 96-hour EC50 = 25 mg/L for algae (Desmodesmus subspicatus) (HSDB, 2009).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	Reliable chronic toxicity data were not obtained. For acute toxicity, classification was conducted based on the test results on the acid that is this substance, but classification is conducted using the data on the salts for chronic toxicity. It corresponds to "Not classified" in all tests on the potassium salt: an algae growth inhibition test (72-hour ErC > 1000 mg/L for Skeletonema costatum), a crustacea acute immobilization test (48-hour EC50 = 540 mg/L for Daphnia magna), and a fish acute toxicity test (96-hour LC50 = 1560 mg/L for Danio rerio) (SIDS, 2011), and both formic acid (water solubility = 1000000 mg/L, PHYSPROP Database 2009) and calcium formate (water solubility = 16 g/100 mL, ICSC, 2006) are not water-insoluble. Therefore, it was classified as "Not classified."
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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