GHS Classification Result (Revision of the past classification result)

Chemical Name:Acetaldehyde
CAS:75-07-0

Result:
ID: 21B3073
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government (March, 2009)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
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 1 Danger H224: Extremely flammable liquid and vapour P303+P361+P353: IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P370+P378: In case of fire: Use ... for extinction.
P403+P235: Store in a well-ventilated place. Keep cool.
P210: Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
P233: Keep container tightly closed.
P240: Ground/bond container and receiving equipment.
P241: Use explosion-proof electrical/ventilating/lighting/.../equipment.
P242: Use only non-sparking tools.
P243: Take precautionary measures against static discharge.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P501: Dispose of contents/container to ...
Classified into Category 1 since flash point -38 degC (closed-cup) (ICSC (2003)) is <23 degC and boiling point 20.2 degC (ICSC (2003)) is <=35 degC. The substance is classified into Class 3, PG I in UNRTDG (UN1089).
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 self-reactive properties.
9 Pyrophoric liquids Not classified - - - - Auto-ignition point is 175 degC (NFPA (13th, 2001)) exceeding 70 degC.
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 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 - - - - Test methods applicable to liquid (low boiling point) substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ...
Based on LD50 values of 1930 mg/kg and 660 mg/kg for rats (EHC 167 (1995)), the substance was classified into Category 4.
1 Acute toxicity (Dermal) Not classified - - - - Based on a LD50 value of 3540 mg/kg for rabbits (HSDB (2005)), the substance was classified as "Not classified" in JIS Classification (correspond to Category 5 in GHS classification).
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Category 4 Warning H332: Harmful if inhaled P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
Based on a LC50 value of 13300 ppm/4h for rats (EHC 167 (1995)), the substance was classified into Category 4. Since saturated vapour concentration is 990,000 ppm and the LC50 value is lower than 90% of saturated vapour concentration for the substance, the test was considered to be conducted for vapour with almost no included mists and classification criteria for gas were adopted.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - No data available.
2 Skin corrosion/irritation Not classified - - - - Based on results of "mild irritation" following application to rabbit skin (ACGIH (7th, 2001)) and "not irritating" in another rabbit test (OECD TG404 (GLP)) (IUCLID (2000)), the substance was classified as "Not classified" in JIS Classification (correspond to Category 3 or "Not classified" in GHS classification).
3 Serious eye damage/eye irritation Category 2A Warning H319: Causes serious eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
Based on a result of severe irritation following application to rabbit eyes (ACGIH (7th, 2001)) and classification of R36/37 in EU classification (EU-Annex I (access on May 2009)), the substance was classified into Category 2A.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Category 1 Warning H317: May cause an allergic skin reaction P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P272: Contaminated work clothing should not be allowed out of the workplace.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment (see ... on this label).
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ...
Although the substance was determined to be a contact allergen in a modified cumulative contact enhancement test (CCET) in guinea pigs (PATTY (5th, 2001)), the test method employed was not in accordance with international test guidelines. In humans, sensitizing results are reported in two patch tests, where positive reaction was observed in 2 and 3 subjects, respectively (IUCLID (2000)). In addition, this substance is on the Frosch contact allergen list (FROSCH, TEXTBOOK OF CONTACT DERMATITIS). The substance was classified into Category 1.
5 Germ cell mutagenicity Category 2 Warning H341: Suspected of causing genetic defects P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
Based on positive results in bone marrow micronucleus tests by intraperitoneal administration to mice and rats (in vivo somatic cell mutagenicity test) (Hazard Assessment Report (CERI, NITE) No. 61 (2004)), the substance was classified into Category 2. As relevant information, there is a negative result in a spermatid micronucleus test by intraperitoneal administration to mice (in vivo germ cell mutagenicity test) and a positive result in an embryo cell chromosomal aberration test by transamniotic administration of extremely high dose to rats (Hazard Assessment Report (CERI, NITE) No. 61 (2004)). In addition, there are positive bone marrow sister chromatid exchange tests by intraperitoneal administration to rats and Chinese hamster (in vivo somatic cell genotoxicity test), and from in vitro mutagenicity tests. There are reports of positive results in a mammalian cell chromosomal aberration test and a micronucleus test (Hazard Assessment Report (CERI, NITE) No. 61 (2004)).
6 Carcinogenicity Category 2 Warning H351: Suspected of causing cancer P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
Based on the classifications of "Group 2B" in IARC (IARC vol. 71 (1999)), the substance was classified into Category 2. In a carcinogenicity test in rats where groups of 105 male and 105 female rats were exposed to vapours of the substance for a maximum of 28 months, the incidence of nasal carcinomas was increased at high doses (>2700 ppm) (IARC 36 (1985)). In a 52-week inhalation test in male and female hamsters, respiratory-tract tumours (laryngeal carcinomas and nasal carcinomas) at 2500 - 1650 were produced (IARC 36 (1985)).
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
In a rat test with intraperitoneal injection on gestation day 10, 11 or 12, increased fetal resorptions and increased incidences of malformations (syndactyly, hydrocephaly, exencephaly, cataract and etc.) were observed at dose levels at which no toxicity was manifested in parental animals (Hazard Assessment Report (CERI, NITE) No. 61 (2004)). In a mouse developmental toxicity test with intraperitoneal injection, malformations such as exencephaly, polydactyly and pes valgus were observed (Hazard Assessment Report (CERI, NITE) No. 61 (2004)). Although the reproductive toxicity was observed dose-dependently, maternal toxicity was not evaluated appropriately. Intraperitoneal injection is an unconventional exposure route. Because of the inappropriate evaluation of maternal toxicity and the unconventional exposure route employed, there is no adequate report for reproductive and developmental toxicity (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 1 (2002)). The substance was classified into Category 2 since there is insufficient evidence to classify it in Category 1B.
8 Specific target organ toxicity - Single exposure Category 1 (respiratory system, central nervous system), Category 3 (narcotic effects) Danger
Warning
H370: Causes damage to organs (respiratory system, central nervous system)
H336: May cause drowsiness or dizziness (narcotic effects)
P307+P311: IF exposed: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
In humans, "headache, coma, irritation in the eyes, skin, respiratory tract and throat, bronchitis, pulmonary edema, paralysis and death following accidental exposure to acetaldehyde" (Hazard Assessment Report (CERI, NITE) No. 61 (2004)) and "systemic effects such as narcotic effects, clouding of consciousness, bronchitis and pulmonary edema" (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 1 (2002)) are reported. The clinical signs of inhalation or dermal exposure include respiratory system symptoms and CNS depression. At high concentrations, paralysis that leads to death can occur (PATTY (5th, 2001)). Based on the data, the substance was classified into Category 1 (respiratory system, central nervous system) and Category 3 (narcotic effects). The substance is classified into R37 (respiratory tract irritation) in EU classification (EU-Annex I (access on May 2009)).
9 Specific target organ toxicity - Repeated exposure Category 1 (upper respiratory tract) Danger H372: Cause damage to organs through prolonged or repeated exposure (upper respiratory tract) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
In a 4-week exposure (vapour) inhalation test in rats, there are reports of degeneration of nasal mucosa at 720 mg/m3 (90-day equivalent: 0.222 mg/L) and higher levels (Hazard Assessment Report (CERI, NITE) No. 61 (2004)). Following 5-week of inhalation exposure, hyperplasia of olfactory epithelium and inflammation of the mucous membrane of the nose was observed in rats at the 437 mg/m3 (90-day equivalent: 0.168 mg/L) treatment level (Hazard Assessment Report (CERI, NITE) No. 61 (2004)). Degeneration of the olfactory epithelium and replacement of olfactory epithelium by respiratory epithelium was observed in rats at all dose groups (1.365 - 5.460 mg/L) following 52-weeks of inhalation exposure (IRIS (1998)). Additionally, in a 90-day inhalation test with hamsters, stratified epithelium in the trachea was observed at dose levels of 0.435 mg/L and higher (IRIS (1998)). The cause of early death at the high dose level was occlusion of the nose by excessive amounts of keratin and inflammatory exudate (IRIS (1998)). Based on the data, the substance was classified into Category 1 (upper respiratory tract). In humans, pulmonary edema, bronchitis and narcotic effects are reported (ACGIH (7th, 2001), CaPSAR (2000)), however, all of the findings reported are due to single dose exposure.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Category 3 - - H402: Harmful to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
Classified into Category 3 from its 96h-LC50 = 27.4 mg/L for Crustacea (Mysid shrimp) (Initial Risk Assessment Report (NITE, CERI, NEDO), 2007).
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Classified into Not classified since it is rapidly degradable (BOD degradation rate: 80% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1980)) and low bioaccumulative potential is estimated (log Kow = -0.34 (PHYSPROP Database, 2009)).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* 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.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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