GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 50-00-0 |
| Chemical Name | Formaldehyde |
| Substance ID | H29-B-039 |
| Classification year (FY) | FY2017 |
| 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 | 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 (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 |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Explosives | Not applicable |
- |
- | - | Gas (GHS definition) |
| 2 | Flammable gases (including chemically unstable 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. |
| 3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
| 4 | Oxidizing gases | Classification not possible |
- |
- | - | No data available. |
| 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))). |
| 6 | Flammable liquids | Not applicable |
- |
- | - | Gas (GHS definition) |
| 7 | Flammable solids | Not applicable |
- |
- | - | Gas (GHS definition) |
| 8 | Self-reactive substances and mixtures | Not applicable |
- |
- | - | Gas (GHS definition) |
| 9 | Pyrophoric liquids | Not applicable |
- |
- | - | Gas (GHS definition) |
| 10 | Pyrophoric solids | Not applicable |
- |
- | - | Gas (GHS definition) |
| 11 | Self-heating substances and mixtures | Not applicable |
- |
- | - | Gas (GHS definition) |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable |
- |
- | - | Gas (GHS definition) |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | Gas (GHS definition) |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | Gas (GHS definition) |
| 15 | Organic peroxides | Not applicable |
- |
- | - | Gas (GHS definition) |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to gas substances are not available. |
| 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
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. |
| 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. |
| 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. |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | Gas (GHS definition) |
| 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." |
| 2 | Skin corrosion/irritation | Category 2 |
Warning |
H315 |
P302+P352
P332+P313 P362+P364 P264 P280 P321 |
There are no findings on short-term exposure to this substance (gas) in humans. However, there is a report that skin irritation was observed in 27% of volunteers in an exposure test in which they were exposed at a concentration of 2.4 plus or minus 0.49 ppm for 15 hours per day for 2 months (ATSDR Addendum (2010)). In addition, installation of ventilation fans to an anatomy laboratory reduced the concentration of this substance from 2.70 ppm to 0.715 ppm and in consequence, the intensity of dermatitis (ATSDR Addendum (2010)). From these results, it was classified in Category 2. Besides, regarding aqueous solutions of this substance, there are descriptions that an occlusive application of a 1% solution to human skin caused skin irritation in approximately 5% of the subjects involved in the test, and that 0.1-20% solutions caused mild to moderate skin irritation in rabbit skin (both reported in EHC 89 (1989)). This substance is classified in Skin Corr. 1B in the EU CLP classification (ECHA CL Inventory (Access on June 2017)). |
| 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)). |
| 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)). |
| 4 | Skin sensitization | Category 1 |
Warning |
H317 |
P302+P352
P333+P313 P362+P364 P261 P272 P280 P321 P501 |
Since this substance is classified as occupational skin sensitizers Group 1 by Japan Society For Occupational Health (JSOH) (OEL Documentations, 2007), it was classified in Category 1. Besides, this substance is classified in Skin Sens. 1 in EU CLP classification (ECHA CL Inventory (Access on June 2017)) |
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
| 10 | Aspiration hazard | Not applicable |
- |
- | - | Gas (GHS definition) |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Category 2 |
- |
H401 |
P273
P501 |
From 24-hour LC50 = 2 mg/L for crustacea (Daphnia magna) (WHO EHC: 1989), it was classified in Category 2. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 3 |
- |
H412 |
P273
P501 |
Due to being rapidly degradable (readily biodegradable, a degradation rate by BOD: 91% (J-CHECK, 1989)), no bioaccumulation (LogKow: 0.35 (PHYSPROP Database: 2017)), and 7-day NOEC (survival rate) = 1.0 mg/L for crustacea (Ceriodaphnia dubia) (NICNAS PEC: 2006), it was classified in Category 3. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
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* 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. |