NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	50-78-2
Chemical Name	Acetylsalicyclic acid
Substance ID	m-nite-50-78-2_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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

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 associated with explosive properties present in the molecule.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 500 deg C (GESTIS (Access on June 2014)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

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	Based on an LD50 value of 1,500 mg/kg for rats (ACGIH (7th, 2001)), it was classified in Category 4. Besides, there is a report of potentially lethal doses in humans of >500 mg/kg (adults) and 480 mg/kg (children) (IPCS, PIM 006 (1991)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2	Skin corrosion/irritation	Not classified	- -	-	-	Since there are 2 reports in which slight irritation was observed in skin irritation tests with rabbits (IUCLID (2000)), it was classified as "Not classified" (Category 3 in UN GHS classification). Besides, although the details are unknown, there are reports that it is irritating to the skin of humans (ACGIH (7th, 2001), IUCLID (2000)). The category was changed according to the revision of the GHS classification guidance for the Japanese Government.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	There are reports that moderate irritation and slight irritation were observed in eye irritation tests with rabbits (IUCLID (2000)). From the above results, it was classified in Category 2A. Besides, although the details are unknown, there are reports that it is irritating to the eyes of humans (ACGIH (7th, 2001), IUCLID (2000)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Respiratory sensitization	Category 1	Danger	H334	P304+P340 P342+P311 P261 P284 P501	Since there is a report that it was sensitizing to the respiratory organs in humans (ACGIH (2001), IUCLID (2001)) and there are cases of aspirin-induced asthma (HSDB (Access on June 2014)), it was classified in Category 1.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. There is no in vivo data. As for in vitro, it was negative in bacterial reverse mutation tests (HSDB (Access on June 2014), IUCLID (2000), NTP DB (Access on June 2014)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6	Carcinogenicity	Classification not possible	- -	-	-	There are no carcinogenicity classifications by international organizations. From the above, it was classified as "Classification not possible" due to lack of data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7	Reproductive toxicity	Category 1B,	Danger	H360 H362	P308+P313 P201 P202 P260 P263 P264 P270 P280 P405 P501	It is described in IPCS, PIM006 (1991) that in an embryo culture system, malformations were observed at around the plasma concentration of salicylic acid after a single administration, and that rats are sensitive to the teratogenicity effects of salicylic acid, whereas humans and non-human primates are regarded as being resistant. In addition, it is described that salicylate intoxication may occur through placental transfer and breast milk. In HSDB (Access on June 2014), in experimental animals, administration in early pregnancy caused various malformations (facial clefts, central nervous system and eye defects, visceral and skeletal malformations), but no malformation was observed in a control study in humans. During the last weeks of gestation, long-term high-dose salicylate therapy may cause prolonged gestation and increased risk of fetal and neonatal hemorrhage. And, theoretically, regular use in late pregnancy could cause premature closure or constriction of the fetal ductus arteriosus. Decreased birth weight and increased risk of stillbirth are not reported at therapeutic doses. Salicylic acid was classified as FDA pregnancy Category C (Animal reproduction studies have proven fetal teratogenicity, embryotoxicity, and other adverse effects, and no controlled studies were conducted in humans, or studies were not conducted in either humans or animals. Caution is required, but the benefit of medication may outweigh its risk). As in the above, although it shows teratogenicity in experimental animals, there are no reports of developmental toxicity at therapeutic doses in humans, therefore, it was classified in Category 1B. In addition, since the possibility of transfer to milk was reported, it was classified as "Additional category: Effects on or via lactation."	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system, stomach, liver, lung, )	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	As main effects by the oral route in humans, central nervous system toxicity such as tinnitus, hearing-loss, convulsions, coma, confusion, delirium, stupor, tremor, and cerebral edema, and liver toxicity and pulmonary edema are reported, other than these, vomiting, epigastric discomfort, gastrointestinal bleeding, tachypnea or hyperpnea, sweating, vasodilatation, etc. are reported (HSDB (Access on June 2014), IPCS, PIM 006 (1991)). From clinical findings on aspirin, it is known to be irritating to the gastric mucosa, and there is a report of vomiting, epigastric discomfort, ulceration, hematemesis, melaena, and occult blood loss (ACGIH (7th, 2001), HSDB (Access on June 2014), IPCS, PIM 006 (1991)). From the above, the main target organs are considered to be the central nervous system, stomach, liver, lung, sensory organ (auditory organ), and it was classified in Category 1 (central nervous system, stomach, liver, lung, sensory organ (auditory organ)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9	Specific target organ toxicity - Repeated exposure	Category 1 (blood system, central nervous system, stomach, liver, kidney, lung, )	Danger	H372	P260 P264 P270 P314 P501	Since there are descriptions that oral administration of this substance (aspirin) causes a bleeding tendency (prolongation of coagulation time) due to a mechanism of inhibition of platelet aggregation, and that blood coagulation abnormalities occur if the usual dose for treatment (600 mg) is taken for 5 days or longer (ACGIH (7th, 2001)), it was classified in Category 1 (hemal system). In addition, in IPCS, PIM 006 (1991) which was judged to be equivalent to List 1 as reliability ranks of information sources, as chronic salicylate poisoning, there are descriptions that neurological symptoms, nausea, vomiting, and gastric bleeding (it is rare as acute intoxication, and it is typical chronic toxic symptoms) in adults, and respiratory insufficiency and pulmonary edema in the elderly were frequently observed, other than these, and that hyperventilation, dehydration and severe central nervous system symptoms were also frequently observed. Moreover, there is a description that the target organs are all tissues whose cellular metabolism is affected, especially liver (liver dysfunction), kidneys (acute renal failure), lungs, and vestibulocochlear nerve. Therefore, Category 1 (central nervous system, stomach, liver, kidney, lung, sensory organ (auditory organ)) was added. Besides, The classification result was changed since the information sources are different from the previous classification (classification by the information source not listed in the information source lists of the GHS classification guidance for the Japanese government).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

ENVIRONMENTAL HAZARDS

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)	Not classified	- -	-	-	It carried out the outside of Category from 48-hour EC50>100mg/L of Crustacea (Daphnia magna) (IUCLID, 2000).	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Since not water-insoluble (aqueous solubility =4600 mg/L (PHYSPROP Database, 2005)) and acute toxicity is low.	FY2006	GHS Classification Manual （10 Feb, 2006）
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.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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