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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	124-04-9
Chemical Name	Adipic acid
Substance ID	H26-B-004, R-002
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	- -	-	-	Solid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not applicable	- -	-	-	Solid (GHS definition)
7	Flammable solids	Classification not possible	- -	-	-	No data available.
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9	Pyrophoric liquids	Not applicable	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 420 deg C (SIDS (2006)).
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data 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	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Not applicable	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
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 solid substances 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)	Not classified	- -	-	-	There are 5 reports of LD50 values of 940 mg/kg, 3,615 mg/kg (ACGIH (7th, 2001)), 5,050 mg/kg (HPVIS (2008)), 5,560 mg/kg (SIDS (2006)), and >11,000 mg/kg (PATTY (6th, 2012)) for rats. It was classified as "Not classified" (3 cases) to which the largest number of data corresponds based on the revision of the GHS classification guidance for the Japanese Government. Besides, one case corresponds to Category 4, and one case to "Not classified" (Category 5 in UN GHS classification).
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on a report of >7,940 mg/kg (converted value to pure substance: >3,176 mg/kg) as an LD50 value for rabbits using corn oil (40% concentration of this substance) (SIDS (2006), HPVIS (2008)), it was classified as "Not classified." New information sources (SIDS (2006), HPVIS (2008)) were added, and the classification was revised.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	Based on a report of an LC0 value (4 hours) of 7.7 mg/L (SIDS (2006), HPVIS (2008)) for rats, it was classified as "Not classified." Besides, since the LC0 value is higher than the saturated vapor concentration (0.57 mg/L), the reference value as the dust was applied.
2	Skin corrosion/irritation	Not classified	- -	-	-	In a skin irritation test with rabbits, reversible redness and edema were observed, and the irritation score was 2.21 (SIDS (2006)). Other than this, slight irritation was observed in skin irritation tests with rabbits and guinea pigs (SIDS (2006), BUA 68 (1991)). In addition, there is a report that it exerts a drying action on the skin and may cause dermatitis in humans (ACGIH (7th, 2001)). From the above results, it was classified as "Not classified" (Category 3 in UN GHS classification). The category was revised according to the revision of the GHS classification guidance for the Japanese Government.
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	Corneal opacity (score 1-3) was observed in an eye irritation test (OECD TG 405) with rabbits (SIDS (2006)). In addition, in another eye irritation test with rabbits, mean scores of cornea reaction, iritis, conjunctivitis, and conjunctival edema were reported as 1.33, 0.83, 2, 2, respectively (SIDS (2006)). From the above results, it was classified in Category 2A. Besides, this substance was classified as "Xi; R36" in the EU DSD classification, and as "Eye Irrit. 2 H319" in the EU CLP classification.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, there is a description that two workers handling adipic acid developed bronchial asthma although details are unknown (PATTY (6th, 2012), ACGIH (7th, 2001)).
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, there is a report that there was no skin sensitization in a test with guinea pigs (SIDS (2006), PATTY (6th, 2012)), but the information was judged to be inadequate for classification for the following reasons: There was no positive control group, no adjuvant was used, etc.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The substance 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, it was negative in a dominant lethal test with rats, and a negative result is reported in a chromosomal aberration test with bone marrow cells of rats (SIDS (2006), ACGIH (7th, 2001), HPVIS (2008), JECFA FAS 12 (1977), PATTY (6th, 2012)). As for in vitro, it was all negative in bacterial reverse mutation tests, and a mouse lymphoma test and a chromosomal aberration test with cultured mammalian cells (SIDS (2006), ACGIH (7th, 2001), HPVIS (2008), JECFA 12 (1977), PATTY (6th, 2012)).
6	Carcinogenicity	Classification not possible	- -	-	-	There are no carcinogenicity classifications by international organizations. There is a report in SIDS (2006) that no carcinogenicity was observed in a 2-year feeding study with rats (male: dose at or less than 5% (3,750 mg/kg bw/day), female: dose at 1% (750 mg/kg bw/day)), but it is reported that this study is information with limitation because other than being non-GLP, the number of animals and the organs examined were few, the number of animals used for histopathological examination was unknown, and so on. In addition, it is also reported in PATTY (6th, 2012) that there was no evidence of carcinogenicity in a 2-year study with rats, but there is not enough information. Moreover, also in BUA (1991), there is a description of a 2-year study with rats. From the above, it was classified as "Classification not possible" due to lack of data on this substance as a whole.
7	Reproductive toxicity	Classification not possible	- -	-	-	No teratogenicity was observed in teratogenicity tests with rats, mice, and rabbits by the oral route (SIDS (2006), JECFA FAS12 (1977), ACGIH (2001), PATTY (6th, 2012)), but since information on fertility is not obtained, it was classified as "Classification not possible."
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	In humans, there are reports of functional disorders of the autonomic nervous system, gastrointestinal tract, and upper respiratory tract mucosa, irritation of the nasal mucosa by inhalation exposure of workers to the dust of this substance and aggravation of asthmatic reactions and slight burning sensations of the respiratory organs by inhalation exposure to a solution of this substance (ACGIH (7th, 2001), SIDS (2006), PATTY (6th, 2012)). In rats, effects of irritation and bleeding due to this substance such as acute dilatation of the heart in dead animals, acute congestive hyperaemia and ulceration of the glandular stomach (corrosive gastritis) were observed at doses exceeding the guidance value in the oral route, but there were no signs of toxicity in the inhalation route and occlusive dermal application (SIDS (2006), HPVIS (2008)). From the above, it was classified in Category 3 (respiratory tract irritation).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In the oral route, no symptoms of toxicity were observed even by oral administration of 100 mg/kg/day to human volunteers for 10 days, and in a study in which this substance was administered by feeding to rats for 2 years, only decreased body weight gain was observed at higher doses (2,250 mg/kg/day (converted value described in SIDS (2006))) corresponding to "Not classified" (calculated as 2,250 mg/kg/day in SIDS (2006)) (SIDS (2006), ACGIH (1977), JECFA FAS 12 (7th, 2001), HPVIS (2008)). Therefore, it is judged as equivalent to "Not classified." As for the inhalation route, there is a description that rats were exposed to the dust of this substance at a concentration of 0.126 mg/L for 6 hours/day, 5 days/week for 3 weeks (converted guidance value: 0.021 mg/L), but no abnormality was observed (ACGIH (7th, 2001)), but including this test, no inhalation exposure test covering the range up to Category 2 was conducted, and no data are available for classification. Therefore, this substance is equivalent to "Not classified" for the oral route, but there are no data available for classification for inhalation and dermal routes. Therefore, it was classified as "Classification not possible" due to lack of data. Besides, in the previous classification, it was classified in Category 1 (autonomic nervous system) from the description that in worker who inhaled the dust of this substance, effects on the autonomic nervous system were observed, however, since it was confirmed in ACGIH (7th, 2001) and PATTY (6th, 2012) that the corresponding descriptions were effects from single exposure and effects at concentrations causing irritation to the eyes, it was excluded from this classification.
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)	Category 3	- -	H402	P273 P501	It was classified in Category 3 from 48-hour EC50 = 46 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1997)).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" due to rapid degradability (a degradation rate by BOD = 85, 68, 90% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1989)), and 21-day NOEC = 6.3 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1997)). 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 (a degradation rate by BOD = 85, 68, 90% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1989)), and a low bioaccumulation estimate (log Kow = 0.08 (PHYSPROP Database, 2009)) despite 96-hour LC50 = 97 mg/L for fish (Pimephales promelas) (SIDS, 2004). From the above results, it was classified as "Not classified."
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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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