NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	107-02-8
Chemical Name	Acrolein
Substance ID	H26-B-003, -
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	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 2	Danger	H225	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	It was classified in Category 2 based on a flash point of -26 deg C (closed cup) and a boiling point of 52.6 deg C (HSDB (Access on June 2014)). Besides, it is classified in Division 6.1, Subsidiary Risk 3, PG I (stabilized, UN1092) in UNRTDG.
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Type G	- -	-	-	There is a chemical group (unsaturated bond) associated with self-reactive properties present in the molecule. A stabilized one is classified in Type G. As for a pure substance and the mixture with less amount of a stabilizer, classification is not possible due to no information. As a stabilizer, 0.1-0.25% hydroquinone is used (EU-RAR (2001)).
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 220 deg C (HSDB (Access on June 2014)).
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	- -	-	-	Test methods applicable to low-temperature-boiling liquids are not available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 2	Danger	H300	P301+P310 P361+P364 P264 P270 P321 P330 P405 P501	Based on reports of LD50 values of 11 mg/kg (EPA RED (2008), EPA RED Amendment (2009), IRIS Tox. Review (2003)), 26 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004)), 29 mg/kg (IRIS Tox. Review (2003)), 42 mg/kg (DFGOT vol.16 (2001)), 46 mg/kg (ACGIH (7th, 2001), ATSDR (2007), DFGOT vol. 16 (2001), EHC 127 (1992), EU-RAR (2001), IARC 36 (1985)), 7-46 mg/kg (CEPA (2000), CICAD 43 (2002)) and 42-46 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)) for rats, it was classified in Category 2.
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P280 P312 P321 P361 P364 P405 P501	There are 11 reports of LD50 values for rabbits within the range of 164-1,022 mg/kg. It was classified in Category 3 to which the largest number of data (6 reports) corresponds (231 mg/kg (EPA RED (2008), EPA RED Amendment (2009), IRIS Tox. Review (2003)), 238 mg/kg (EU-RAR (2001), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)), 335 mg/kg (EU-RAR (2001), DFGOT vol. 16 (2001), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)), 560 mg/kg (ACGIH (7th, 2001)), 562 mg/kg (EU-RAR (2001), DFGOT vol. 16 (2001), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)), 562 mg/kg (IARC 36 (1985))) according to the revised GHS classification guidance for the Japanese government. Besides, 2 cases correspond to Category 2, 1 case to Category 4, and 1 case between Category 2 and Category 4. In addition, since one case is an aggregation of multiple data, it was not included in the number.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Category 1	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	Based on reports of LC50 values (4 hours) of 7.4 ppm (EPA RED (2008)), 7.8 ppm (EHC 127 (1991), PATTY (6th, 2012), Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004)), 8.2 ppm (EPA RED (2008), EPA RED Amendment (2009)), 9.1 ppm (EHC 127 (1992)), 9.2 ppm (DFGOT vol. 16 (2001)), and 7.8-65.4 ppm (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)) for rats, it was classified in Category 1. Besides, since the LC50 values were lower than 90% of the saturated vapor concentration (360,526 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	In a patch test with volunteers using 10% of the test substance, edema, necrosis, inflammatory cell infiltrate and papillary oedema were observed in all subjects (20 cases) 48 hours after application (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), EU-RAR (2001), ATDSR (2007)). In addition, in skin irritation tests with rabbits, severe irritation (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), EU-RAR (2001)) and edema and erythema (IRIS Tox. Review (2003)) are reported. Based on the above results, this substance was classified in Category 1. Besides, this substance was classified as "C; R34" in the EU DSD classification and "Skin. Corr. 1B H314" in the EU CLP classifications.
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	In an eye irritation test with rabbits, it is reported that it caused severe irritation as a result of application of 1% of the test substance (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), EU-RAR (2001)), and that it showed conjunctival edema (EHC 127 (1992)) and eye lesions (IRIS Tox. Review (2003)). Irritation to the eyes is reported in a test with human volunteers (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), EU-RAR (2001), ATSDR (2007)). In addition, this substance was classified in Category 1 for skin corrosion/irritation and considered to have irreversible effects on the eyes. Based on the above results, it was classified in Category 1.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data. In a maximization test with guinea pigs, it is reported to be negative (EU-RAR (2001), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), CEPA (2000)), however, the details of this test are unknown, therefore, it is considered in EU-RAR (2001) that a clear judgment on sensitization cannot be made from this test. Therefore, the data was judged to be insufficient for use for classification.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	It was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, negative results were reported in a mouse dominant lethal test and chromosomal aberration tests with bone marrow cells and peripheral blood lymphocytes of rats (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004), SIAP (2000), EU-RAR (2003)). As for in vitro, negative and positive results were mixed in bacterial reverse mutation tests, and gene mutation tests, chromosomal aberration tests and sister chromatid exchange tests with cultured mammalian cells (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004), SIAP (2000), EU-RAR (2003), ACGIH (7th, 2001), ATSDR (2007)). However, it is evaluated in SIAP (2000) and EU-RAR (2003) that these positive results are generally induced at or near cytotoxic doses and are effects due to cytotoxicity. Besides, it was positive in a DNA single strand break test and a DNA-protein cross-linking test with cultured human cells (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). Based on the above results, it is considered that this substance causes DNA damage but it is not genotoxic in vivo.
6	Carcinogenicity	Classification not possible	- -	-	-	It was classified in Group 3 by IARC (IARC 63 (1995)), A4 by ACGIH (ACGIH (7th, 2001)) and 3B by DFGOT (DFGOT vol. 16 (2001)), and it is reported that it is not possible to classify it as a human carcinogen in all organizations. In addition, it was classified as C in EPA (1998) and this corresponds to Category 2 in GHS, however, this evaluation by EPA is old, and as for the newer evaluation, it is evaluated as inadequate for carcinogenicity in IRIS Tox. Review (2003) and it is evaluated in EU-RAR (2003) and SIAP (2000) that there were insufficient data on human carcinogenicity. From the above, it was classified as "Classification not possible." The data were added and the category was changed.
7	Reproductive toxicity	Not classified	- -	-	-	In a two-generation reproductive toxicity test with rats by the oral route, reduced body weights in pups were observed at doses where parental toxicity was seen (reduced body weights, erosion in the glandular stomach mucosa, hyperplasia/hyperkeratosis in the forestomach mucosa, death) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). In a reproductive-developmental toxicity test with rats by the inhalation route, the numbers of surviving and dead fetuses, resorptions and corpora lutea were not affected (Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004)). In a teratogenicity test with rats by the oral route, skeletal abnormalities, delayed ossification, and decreases in average fetal body weight and litter weight were observed at a dose where deaths in maternal animals (14/40 animals) were seen. On the other hand, in a teratogenicity test with rabbits by the oral route, embryo toxicity, fetotoxicity and teratogenicity were not observed at doses where maternal toxicity was seen (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). As described above, this substance was classified as "Not classified" because no effects on fertility were observed, and effects on fetuses were observed only at doses where severe maternal toxicity was observed.
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs, central nervous system, liver), Category 3 (narcotic effects)	Danger Warning	H370 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	Adverse effects in humans by the oral route or inhalation route occur locally mainly in the stomach or respiratory tract, which is the site of exposure (contact). In cases of excessive intake or exposure, there are reports of weakness, nausea, vomiting, diarrhea, panting, bronchitis, pulmonary edema and loss of consciousness (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004), OEL Documentations (Japan Society For Occupational Health (JSOH, 1973))). In rats, mice, rabbits or guinea pigs, in the inhalation route, the following results are reported: it caused respiratory tract irritation and moderate narcosis which resolved in a few hours (ACGIH (7th, 2001)); in addition, exfoliation, edema, inflammation, congestion and hemorrhagic necrosis in the bronchus or trachea, in addition, central nervous system depression (CICAD 43 (2002), CEPA (2000)); irritation to the nose, decreased breathing rate, discoloration, congestion, hemorrhages and necrosis of the lungs (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), CEPA (2000), EU-RAR (2003) and IRIS Tox. Review (2003)) and so on. In the oral route, there are reports of degenerative changes of the liver (eosinophilic degeneration with micro vesicular steatosis), degenerative changes in the forestomach and in the glandular stomach (severe inflammation, hemorrhagic gastritis, multi-focal ulceration, fibrin deposition, focal hemorrhage, edema, polymorphonuclear leukocyte infiltration) (CICAD 43 (2002), CEPA (2000)), edema and hemorrhage of the gastrointestinal tract, a decrease of motor activity, coma, loss of reflexes and muscle tone, tremor and respiratory distress (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), EU-RAR (2003), IRIS Tox. Review (2003)). As described above, this substance causes irritation to the exposure (contact) spots, in addition, causes adverse effects on the respiratory organs, the central nervous system and the liver, and effects in experimental animals were observed within the guidance value corresponding to Category 1. Therefore, it was classified in Category 1 (respiratory organs, central nervous system, liver), Category 3 (narcotic effects).
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	There are no findings in repeated exposure in humans. As for experimental animals, in tests with rats and mice dosed by gavage for 90 days, hemorrhage, necrosis and inflammation in the forestomach and the glandular stomach were observed at or above 1.25 mg/kg/day (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), CICAD 43 (2002)). Also in a test with dogs dosed by gavage for 53 weeks, vomiting was observed in the administration group of 2 mg/kg/day, however, it is not adopted as the target organ because these effects on the gastrointestinal tract were considered to be due to irritation by this substance. On the other hand, in the inhalation route, in tests in which rats, hamsters, guinea pigs, rabbits and dogs were exposed by inhalation to the vapour of this substance for 90 days, inflammatory changes, squamous metaplasia and hyperplasia of the epithelium, etc. in the nasal cavity, bronchi and lungs were observed at concentrations within the range of Category 1 (0.0005-0.0032 mg/L) generally in common to all animal species. In addition, it is described in Initial Risk Assessment Report (NITE, CERI, NEDO, 2007) that necrosis of the liver was observed in rats and guinea pigs, however, it is described in EU-RAR (2003) that non-specific inflammations in the liver, kidneys, etc. were seen in all the animal species. Furthermore, it is noted in ATSDR (2007) that liver necrosis (focal necrosis) reported in rats and guinea pigs was not observed in the higher concentration groups, and also in another test with higher exposure concentrations conducted later than this, no effects on the liver were observed in rats (concentrations at which some animals die), guinea pigs, hamsters, rabbits and dogs. Besides, also in CICAD 43 (2002), the effects of repeated inhalation exposure to this substance were limited to the respiratory organs from the nasal cavity to the lungs, and there is no description of toxicity to specific internal organs. From the above, the evidence which was adopted to take the liver and kidneys as target organs in the previous classification was judged to be inadequate, and it was classified in Category 1 (respiratory organs).
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)	-	- -	-	-	-
11	Hazardous to the aquatic environment (Long-term)	-	- -	-	-	-
12	Hazardous to the ozone layer	-	- -	-	-	-

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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