NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	50-00-0
Chemical Name	Formaldehyde
Substance ID	m-nite-50-00-0_v2
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)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Category 1	Danger	H220	P210 P377 P381 P403	From explosion limit (7-73% (GESTIS (Access on June 2017))), it was classified in Category 1.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Liquefied gas	Warning	H280	P410+P403	A boiling point is -20 deg C (ICSC (J) (2012)), and liquid phase exists partially at temperatures below that at normal pressures. Low pressure liquefied gas (a critical temperature 137.2-141.2 deg C (HSDB (Access on June 2017))).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	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 (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to gas substances are not available.	FY2017	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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	Although this substance is a gas according to the GHS definition, LD50 values of 600-700mg/kg and 800mg/kg for rats by oral administration of 2-4% aqueous solutions of this substance (both SIDS (2003)) were reported. Based on these reports, it was classified in Category 4.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	Although this substance is a gas according to the GHS definition, an LD50 value of 270 mg/kg for rabbits is reported in a dermal exposure test in formalin, which is the aqueous solution of this substance (HSDB (Access on June 2017)). Based on this report, it was classified in Category 3.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	Based on a report of an LC50 value of 480 ppm for rats in a 4-hour inhalation exposure test (SIDS 2003), it was classified in Category 2.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	This substance is gas according to the GHS definition. Since there is no information on mist originated from a solution of this substance, it was classified as "Classification not possible."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	There are multiple cases showing that this substance causes eye irritation as follows: eye irritation was observed in a person exposed to this substance (gas) at or above 0.06 mg/m3 for a short time; and 9 out of 53 medical students exposed at 0.39-0.60 mg/m3 for 8 h/week, for 8 weeks, complained of a burning sensation in their eyes (EHC 89 (1989)). Furthermore, there is a description that eye irritation was observed in an eye irritation test with mice at 0.6 mg/m3 of this substance (gas) (EHC 89 (1989)). Therefore, it was classified in Category 2. Besides, as for aqueous solutions of this substance, there is a description that in an eye irritation test with rabbits, 5% and 15% solutions showed Grade 8 (on a scale maximum of 10) eye irritation (EHC 89 (1989)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Category 1	Danger	H334	P304+P340 P342+P311 P261 P284 P501	Since this substance is classified as occupational sensitizers to the airway Group 2 by Japan Society For Occupational Health (JSOH) (OEL Documentations, 2007), it was classified in Category 1. Besides, it is described that in sensitivity tests with mice and guinea pigs, this substance enhanced their sensitization to inhaled allergens (CICAD 40 (2002)). As for humans, multiple cases are described, including those who developed respiratory dysfunction on continuous exposure to this substance (DFGOT (2014) (Access on June 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Category 1A	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	As for in vivo, dominant lethal tests with rats and mice dosed by inhalation exposure and intraperitoneal administration, respectively, gave weakly positive and negative results, but it was concluded that these weakly positive results did not constitute evidence of genotoxicity (Initial Risk Assessment Report (NITE, CERI, NEDO, 2006), ACGIH (7th, 2015), NICNAS (2006), ECETOC TR2 (1981)). Cases of occupational exposure to the vapor of this substance showed micronucleus induction in nasal mucosa cells, and in oral administration in rats, micronucleus induction was shown in gastrointestinal tract cells (ATSDR (1999), Initial Risk Assessment Report (NITE, CERI, NEDO, 2006)). However, a micronucleus test with bone marrow cells of mice intraperitoneally dosed was negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2006), NICNAS (2006)). In addition, chromosomal aberrations and sister chromatid exchanges were found in peripheral blood lymphocytes in cases of occupational exposure to the vapor of this substance, furthermore, a chromosomal aberration test with peripheral blood and lung cells of rats and spleen lymphocytes of mice showed positive results (CICAD 40 (2002), Initial Risk Assessment Report (NITE, CERI, NEDO, 2006), NICNAS (2006), ATSDR (1999)), however, there are also reports of negative results of a chromosomal aberration test on bone marrow cells of rats and a sister chromatic exchange test on peripheral blood of mice, and a negative result in a chromosomal aberration test on spermatocytes of mice (Initial Risk Assessment Report (NITE, CERI, NEDO, 2006), NICNAS (2006), ATSDR (1999)). As for in vitro, a bacterial reverse mutation test, and a gene mutation test, a chromosomal aberration test, and a sister chromatid exchange test in cultured mammalian cells were positive (Initial Risk Assessment Report (NITE, CERI, NEDO, 2006), NICNAS (2006), ATSDR (1999)). From the above, it was classified in Category 2 according to the GHS classification guidance for the Japanese government.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Category 1A	Danger	H350	P308+P313 P201 P202 P280 P405 P501	From many epidemiological studies, formaldehyde is reported to cause cancer of the nasopharynx and leukemia. In addition, a positive correlation is reported between exposure to this substance and sinonasal cancer, and IARC concluded that there is sufficient evidence of carcinogenicity in humans (IARC 100F (2012)). Also as for experimental animals, it is concluded that there is sufficient evidence for carcinogenicity, based on the results of carcinogenicity tests in rats or mice exposed by inhalation including tumors of the nasal cavity (primarily squamous-cell carcinomas, but also squamous-cell papillomas, polypoid adenomas and carcinomas) in rats and squamous-cell carcinoma of the nasal cavity and lymphoma in mice (IARC 100F (2012)). From the above, IARC classified this substance in Group 1 (IARC 100F (2012)). Also, EPA classified it in B1 (IRIS (1989)), NTP in K (NTP RoC (14th, 2016)), ACGIH in A1 (ACGIH (7th, 2017)), EU in Carc. 1B (ECHA CL Inventory (Access on June 2017)), and Japan Society for Occupational Health (JSOH) in Group 2A (Recommendation of Occupational Exposure Limits (2016): Proposal in 1991). From the above, the classification results by other organizations correspond to either Group 1A or 1B, and since the classification results by IARC, ACGIH and so on were prioritized, it was classified in Category 1A.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	As to a report of increased period of pregnancy observed in women workers exposed to formaldehyde and a report that in exposed workers, no difference was found in pregnancy in women and sperm counts and sperm morphology in men from the control groups, it is described in NICNAS that any reliable conclusions can be drawn from these due to limitations of study design and so on (NICNAS (2006)). As for experimental animals, two developmental toxicity studies with pregnant rats exposed by inhalation showed only a minor effect on the fetuses (low values of fetal weight) at concentrations (10 ppm, 39 ppm) where reduced weight gain occurred in the maternal animals (CICAD 40 (2002), Initial Risk Assessment Report (NITE, CERI, NEDO, 2006)), in other instances, a test on pregnant mice dosed by drinking water showed no developmental effects even at lethal doses for the maternal animals (Initial Risk Assessment Report (NITE, CERI, NEDO, 2006)). It is concluded in NICNAS that from the data on humans and experimental animals, formaldehyde does not meet the criteria for classification as a reprotoxicant or a developmental toxicant (NICNAS (2006)). In addition, it is described in ACGIH that there is no conclusive evidence of reproductive or development adverse effects from exposure to formaldehyde in animals and humans (ACGIH (7th, 2015)). From the above, there is insufficient information on humans, and as to experimental animals, while it is considered there are no developmental effects, information on fertility and sexual function is lacking. Therefore, classification was not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system, respiratory organs)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	As for humans, it is described that acute inhalation exposure to this substance causes irritation of the nose and throat, along with concentration-dependent discomfort, lacrimation, sneezing, coughing, nausea, and dyspnea, with some cases resulting in death (Initial Risk Assessment Report (NITE, CERI, NEDO, 2006)). It is reported that irritation of the nose and throat was found at or above 0.6 mg/m3 (0.48 ppm) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2006)). As for experimental animals, it is reported that in a single inhalation exposure test in rats exposed by inhalation at 10 ppm for 4 hours, cilia lesions in mucous membranes in the nasal cavity, cellular swelling and secretion of mucus of goblet cells were found (SIDS (2003)). In addition, it is reported that another 30-minute single inhalation exposure test with rats resulted in salivation, dyspnea, vomiting, muscular spasms, convulsions and deaths at or above 120 mg/m3 (equivalent to 100 ppm, converted 4-hour equivalent value: 35.36 ppm), and in histopathology examination respiratory tract irritation, bronchoalveolar constriction and lung oedema were seen (SIDS (2003), EHC 89 (1989), Initial Risk Assessment Report (NITE, CERI, NEDO, 2006)). The doses at which effects were observed in experimental animals correspond to the range of Category 1. Therefore, it was classified in Category 1 (nervous system, respiratory organs).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (central nervous system, respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	As for humans, there are multiple reports of irritation of the nasal cavity such that deciliation and goblet cell hyperplasia (11%), squamous metaplasia (78%), and mild heteromorphy (8%) in the nasal mucosal epithelium etc. were observed in 75 wood products manufacturing workers who had been exposed to formaldehyde at 0.07-0.7 ppm for 10.5 years (OEL Documentations (Japan Society For Occupational Health (JSOH), 2010)). In addition, it is reported that lightheadedness, dizziness, disturbed equilibrium, and diminished dexterity were observed in histology laboratory technicians who had been occupationally exposed to formaldehyde (ACGIH (7th, 2015)). As for experimental animals, it is reported that in an inhalation toxicity test with rats exposed to the vapor for 13 weeks (6 hours/day, 5 days/week), at or above 3.6 mg/m3 (converted guidance value: 0.0026 mg/L) which is within the guidance value range for Category 1, squamous cell hyperplasia, metaplasia and localized disarrangements were found in the anterior portion of the nasal cavity (Initial Risk Assessment Report (NITE, CERI, NEDO, 2006), CICAD 40 (2002), CaPSAR (1999), EHC 89 (1989)). As for a 2-year inhalation toxicity study with rats and mice exposed to the vapor, in rats, epithelial dysplasia, squamous metaplasia, rhinitis, and goblet cell hyperplasia in the nasal cavity were found at or above 2 ppm (0.0025 mg/L), which is within the guidance value range for Category 1, and olfactory epithelial atrophy, hyperkeratosis, squamous epithelial atypia, respiratory epithelial hyperplasia, goblet cell metaplasia/squamous hyperplasia of the olfactory epithelium, epithelial dysplasia/squamous metaplasia of the trachea, and bone marrow hyperplasia were observed at 15 ppm (0.018 mg/L). For mice, it is reported that epithelial dysplasia and squamous metaplasia of the nasal cavity at or above 6 ppm (0.0074 mg/L) which is within the guidance value range for Category 1, and rhinitis, olfactory epithelial atrophy and epithelial hyperplasia of the nasolacrimal duct at 15 ppm (0.018 mg/L) were observed (ECETOC TR6 (1982)). In addition, as for the oral route, in a 24-month repeated oral dose toxicity test with rats dosed by drinking water, hyperplasia of the glandular stomach, localized hyperkeratosis of the forestomach and gastritis were observed at 1,900 mg/L (82 mg/kg/day) which is within the guidance value range for Category 2 (Initial Risk Assessment (NITE, CERI, NEDO, 2006), CICAD 40 (2002), CaPSAR (1999), Environmental Risk Assessment for Chemical Substances Vol. 1 (Ministry of the Environment, 2002)). From the above, it was classified in Category 1 (central nervous system, respiratory organs). The findings in the stomach by the oral route were considered to be attributable to stimuli, and therefore, were not adopted as evidence of the classification.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	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)	Category 2	- -	H401	P273 P501	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))

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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