Latest GHS Classification Results by the Japanese Government (edited by NITE)
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 75-07-0 |
| Chemical Name | Acetaldehyde |
| Substance ID | m-nite-75-07-0_v1 |
| 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) |
| 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) |
- |
- | - | There are no chemical groups present in the molecule associated with explosive properties. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | "Liquids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not an aerosol product. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | "Liquids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | "Liquids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 6 | Flammable liquids | Category 1 |
 Danger |
H224 | P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501 |
Based on a flash point of -38 degrees C (Closed cup) (ICSC (2003)), and a boiling point of 20.1 degrees C (HSDB (Access on July 2015)), it was classified in Category 1. Besides, it is classified in class 3, PGI in UNRTDG (UN1089). | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 7 | Flammable solids | Not classified (Not applicable) |
- |
- | - | "Liquids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 8 | Self-reactive substances and mixtures | Not classified (Not applicable) |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 9 | Pyrophoric liquids | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an ignition point of 175 degrees C (HSDB (Access on July 2015)). | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 10 | Pyrophoric solids | Not classified (Not applicable) |
- |
- | - | "Liquids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | No established test method suitable for liquid substances. | FY2015 | 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) |
- |
- | - | Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is not chemically bonded to the elements other than carbon or hydrogen. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 14 | Oxidizing solids | Not classified (Not applicable) |
- |
- | - | "Liquids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | It is an organic compound that does not contain bivalent -O-O- structure in the molecule. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | No established test method suitable for a liquid with a low boiling point. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 17 | Desensitized explosives | - |
- |
- | - | - | - | - |
| 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 |
From LD50 values of 660 mg/kg (Initial Risk Assessment, NITE (2007); EHC 167 (1995)) and 1,930 mg/kg (Initial Risk Assessment, NITE (2007); Result of the initial environmental risk assessment of chemicals, Vol. 1, Ministry of the Environment in Japan (2002); ACGIH (7th, 2001); EHC 167 (1995); DFGOT vol. 3 (1992); Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (1990)) for rats, it was classified in Category 4. | FY2015 | 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 |
From a reported LD50 value of 640 mg/kg (Initial Risk Assessment, NITE (2007)) for rats, it was classified in Category 3. Based on the new information source with higher precedence, a classification was revised. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 1 | Acute toxicity (Inhalation: Gases) | Not classified (Not applicable) |
- |
- | - | "Liquids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 1 | Acute toxicity (Inhalation: Vapours) | Category 4 |
Warning |
H332 | P304+P340 P261 P271 P312 |
Because an LC50 value (4 hours) of 13,300 ppm (Initial Risk Assessment, NITE (2007); ACGIH (7th, 2001); EHC 167 (1995); Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (1990); IARC 36 (1985)), and an LC50 value (0.5 hour) of 20,200 ppm (converted to a 4-hour equivalent: 7,142 ppm) (Initial Risk Assessment, NITE (2007); ACGIH (7th, 2001); EHC 167 (1995); DFGOT vol. 3 (1992)) are reported for rats, it was classified in Category 4. Besides, a reference value in the unit of ppm was applied as vapour without mist because the LC50 values are lower than the saturated vapour pressure concentration (1,000,000 ppm). | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | Because it is reported that slight irritation was observed after the application of 500 mg this substance in a skin irritation test using rabbits (ACGIH (7th, 2001)), it was classified as "Not classified" (Category 3 in UN GHS classification). Besides, the information from the informaton source on List 1 was prioritized over the information without details described in HSDB (Access on August 2015) that it is corrosive. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 3 | Serious eye damage/eye irritation | Category 2A |
Warning |
H319 | P305+P351+P338 P337+P313 P264 P280 |
Because it is reported that in an eye irritation test using rabbits, severe irritation was observed after 40 mg this substance was applied (ACGIH (7th, 2001)), it was classified in Category 2A. Besides, it is not detailed information, but it is written that the liquid or vapour of this substance is corrosive to eyes (PATTY (6th, 2012); Result of the initial environmental risk assessment of chemicals, Vol. 1, Ministry of the Environment in Japan (2002)). This substance is classified in "Eye. Irrit. 2 H319" in EU CLP classification (ECHA CL Inventory (Access on September 2015)). | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 4 | Skin sensitization | Category 1 |
Warning |
H317 | P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501 |
It is reported that in two patch tests in humans, sensitization was observed (IUCLID (2000)). Moreover, contact allergy was reported in the textile industry (FROSCH, TEXTBOOK OF CONTACT DERMATITIS), and it is written that this substance is a contact allergen (PATTY (6th, 2012)). From the above, it was classified in Category 1. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 5 | Germ cell mutagenicity | Category 2 |
 Warning |
H341 | P308+P313 P201 P202 P280 P405 P501 |
As for in vivo, it is reported that a micronucleus test in mouse spermatids after intraperitoneal administration was negative, a micronucleus test in rat bone marrow cells, peripheral blood erythrocytes, mouse bone marrow cells after intraperitoneal administration was positive, a chromosomal aberration test in rat embryo cells after intra-amniotic administration on day 13 of gestation and a chromosomal aberration test in rats (details unknown) were positive, and a sister chromatid exchange test in mouse bone marrow cells and Chinese hamster bone marrow cells after intraperitoneal administration was positive. (Initial Risk Assessment, NITE (2007); IARC 71 (1999); CEPA (2000); ACGIH (7th, 2001)) As for in vitro, a bacterial reverse mutation test was negative, and a mouse lymphoma test, an HPRT gene mutation test, a micronucleus test, a chromosomal aberration test, and a sister chromatid exchange test in cultured mammalian cells were all positive. (Initial Risk Assessment, NITE (2007); IARC 71 (1999); CEPA (2000)) From the above, due to positive in vivo somatic cell mutagenicity test and in vivo somatic cell genotoxicity test, a negative in vivo germ cell mutagenicity test, no in vivo germ cell genotoxicity test data, and a positive in vitro mutagenicity test result, the substance was classified in Category 2. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 6 | Carcinogenicity | Category 1B |
Danger |
H350 | P308+P313 P201 P202 P280 P405 P501 |
This substance is a metabolite of ethanol, and by claiming that acetaldehyde associated with the consumption of alcoholic beverages has sufficient evidence of forming esophageal cancer and so on in humans, IARC classified it in Group 1 (IARC 100E (2012)). As for carcinogenicity classifications for this substance excluding effects of drinking alcoholic beverage, it was classified in A3 by ACGIH (ACGIH (7th, 2001)), B2 by EPA (IRIS Summary (1991)), and R by NTP (NTP RoC 6th (1991)). As for experimental animals, in a carcinogenicity test using rats in an inhalation route, tumors of the nasal mucosa (squamous cell carcinomas, adenocarcinomas) increased at doses of 1,500 ppm or higher, and in an inhalation exposure test in hamsters laryngeal carcinomas were found, therefore, IARC classified this substance in "Group 2B" in the carcinogenicity classification in 1999 because there is solid evidence of carcinogenicity in experimental animals but inadequate evidence in humans (IARC 71 (1999)). From the above, carcinogenicity is certain in experimental animals, and there is no evidence of carcinogenicity for exposure except the consumption of alcoholic beverages in humans. However, it is thought that carcinogenicity in the nasal mucosa and larynx in an inhalation route in experimental animals may also occur in humans in occupational exposure in an inhalation route. Therefore, the substance was classified in Category 1B in this hazard class. Besides, both this substance and ethanol are classified in Carc. 2 in EU CLP classification (ECHA CL Inventory (Access on August 2015)). |
FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 7 | Reproductive toxicity | Category 1B |
Danger |
H360 | P308+P313 P201 P202 P280 P405 P501 |
As reproductive toxicity effects in humans, there is no report on direct exposure to this substance. As for experimental animals, it is written that in a teratogenicity test in pregnant mice in intravenous injection of this substance (about 31, 62 mg/kg/day) on day 7 to 9 of gestation, a dose-dependent increase in resorptions, decreased fetal weight, and an increased incidence of malformations such as exencephaly and neural tube closure anomalies were observed in fetuses (Initial Risk Assessment, NITE (2007); PATTY (6th, 2012)), and that in a test in pregnant rats in intraperitoneal injection on day 10 to 12 of gestation, increased resorptions, decreased fetal weight, decreased crown-rump length and tail length, and increased malformations (digital anomalies, cranial and facial malformations) were found (ACGIH (7th, 2001)). It is written that also in a test in pregnant rats in oral administration, skeletal malformations were also found in fetuses (Initial Risk Assessment, NITE (2007)), and it is written that fetal malformations were found in rats and mice treated with this substance in vivo and in vitro (IARC 71 (1999)). From the above, it is thought that exposure to this substance in pregnant animals during an organogenetic period surely induces malformations. Besides, in a recent report, in an experiment in which ethanol and aldehyde were added in an in vitro culture test system using marketed cell line of "trophoblast" which is said to be differentiated into the placenta, cellular proliferation was depressed in all groups added, and groups with aldehyde showed apoptosis as well. The authors hypothesized that exposure to either ethanol or acetaldehyde in pregnant women could become pathogenesis of fetal alcohol spectrum disorder by reducing placental growth (Lui, S. et al., PLoS One, 2014 Feb 4;9 (2): e87328 (2014)). As above, malformation induction by this substance is apparent in experimental animals. Although teratogenicity in humans is unknown, because this substance is suspected as a causative substance of fetal alcohol spectrum disorder in humans, a research study is being conducted as above. Therefore, the substance was classified in Category 1B in this hazard class. |
FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (central nervous system, respiratory organs), Category 3 (narcotic effects) |
Danger Warning |
H370 H336 |
P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312 |
This substance is irritating to the respiratory tract (Initial Risk Assessment, NITE (2007); Result of the initial environmental risk assessment of chemicals, Vol. 1, Ministry of the Environment in Japan (2002); Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (1990); ACGIH (7th, 2001); EHC 167 (1995); IARC 36 (1985); PATTY (6th, 2012); CEPA (2000); DFGOT vol. 3 (1992)). In human poisoning cases, headache, cough, bronchitis, pulmonary edema, coma, central nervous system depression (narcotic effects), decreased heart rate and respiratory rate, motor paralysis, and death in inhalation, and cough, pulmonary edema, lung necrosis, and central nervous system depression in dermal exposure were observed, and convulsions and death were found at the high doses (Initial Risk Assessment, NITE (2007); Result of the initial environmental risk assessment of chemicals, Vol. 1, Ministry of the Environment in Japan (2002); Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (1990); ACGIH (7th, 2001); EHC 167 (1995); IARC 36 (1985); PATTY (6th, 2012); CEPA (2000); DFGOT vol. 3 (1992)). As for experimental animals, the following was reported in rats (Initial Risk Assessment, NITE (2007); Result of the initial environmental risk assessment of chemicals, Vol. 1, Ministry of the Environment in Japan (2002); Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (1990); ACGIH (7th, 2001); EHC 167 (1995); IARC 36 (1985); CEPA (2000)): central nervous system depression, decreased respiratory rate, increased heart rate, increased blood pressure, pulmonary edema, and proteinuria in oral (the dose corresponding to Category 2) and dermal (the dose corresponding to Category 1); and narcotic effects, clouding of consciousness, bronchitis, and pulmonary edema in inhalation (the dose corresponding to Category 1). From the above, because this substance has mainly respiratory tract irritation, effects on the central nervous system, narcotic effects, effects on respiratory organs, it was classified in Category 1 (central nervous system, respiratory system), Category 3 (narcotic effects). |
FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (respiratory organs) |
Danger |
H372 | P260 P264 P270 P314 P501 |
As for humans, "erythema, cough, pulmonary edema, narcotic effects" (ACGIH (7th, 2001)), "headache, narcotic effects, paralysis, decreased respiratory rate, irritation to respiratory organs, bronchitis, pulmonary edema" (CEPA (2000)) were listed, but all of these describe effects of single exposure. As for experimental animals, in a 4-week inhalation toxicity test using rats, degeneration of the nasal mucosa was observed at 400 ppm (converted to a Guidance value equivalent: 0.16 mg/L) within a range of Category 1 (Initial Risk Assessment, NITE (2007); ACGIH (7th, 2001); EHC 167 (1995)), and in a 5-week inhalation toxicity test using rats, hyperplasia of the olfactory epithelium, inflammation of the nasal mucosa, increased residual volume and functional residual capacity, damage of the distal airways in lung function tests were found at 243 ppm (converted to a Guidance value equivalent: 0.16 mg/L) within a range of Category 1 (Initial Risk Assessment, NITE (2007); EHC 167 (1995)). Besides these, in a 52-week inhalation toxicity test using rats, degeneration of the olfactory epithelium and replacement of olfactory epithelium by respiratory epithelium were observed at 750 ppm (1.37 mg/L) or higher, a range above Category 2, and in a 90-day inhalation toxicity test using hamsters, stratified respiratory epithelium was found at 1,340 ppm (0.435 mg/L) within a range of Category 2 (IRIS (1998), ACGIH (7th, 2001)). From the above, the substance was classified in Category 1 (respiratory system). |
FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | The classification is not possible due to lack of data. Besides, kinematic viscosity is calculated to be 0.314 mm2/sec (15/18 degrees C) from the numerical data (viscosity: 0.2456 mm2/sec (15 degrees C), density: 0.7834 g/cm3 (18 degrees C)) listed in HSDB (Access on August 2015). | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 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 3 |
- |
H402 | P273 P501 |
From 72-hour ErC50 = 26 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Eco-toxicity tests of chemicals conducted by Ministry of the Environment in Japan, 2008), it was classified in Category 3. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 11 | Hazardous to the aquatic environment Long term (Chronic) | Not classified |
- |
- | - | If chronic toxicity data are used, then it is classified as "Not classified," due to rapid degradability (readily degradable: a degradation rate by 28-day BOD = 80%, a degradation rate by TOC = 93%, a degradation rate by GC = 100% (Official Bulletin of Ministry of International Trade and Industry, 1980)), and 72-hour NOEC = 1.9 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Eco-toxicity tests of chemicals conducted by Ministry of the Environment in Japan, 2008). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified," due to rapid degradability, and a low bioaccumulation estimate (log Kow = -0.34 (PHYSPROP Database, 2008)) although 96-hour LC50 = 27.4 mg/L for crustacea (Mysidopsis bahia) (Initial Risk Assessment, NITE, 2007). From the above, it was classified as "Not classified." |
FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
NOTE:
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