Item | Information |
---|---|
CAS RN | 50-78-2 |
Chemical Name | Acetylsalicyclic acid |
Substance ID | H26-B-005, - |
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 |
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 |
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 500 deg C (GESTIS (Access on June 2014)). |
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. |
Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Category 4 |
Warning |
H302 |
P301+P312
P362+P364 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)). |
1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
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) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
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. |
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)). |
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. |
4 | Skin sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
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)). |
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. |
7 | Reproductive toxicity | Category 1B, Additional category: Effects on or via lactation |
Danger |
H360 |
P308+P313
P201 P202 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." |
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)). |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (haemal 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). |
10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
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 | - |
- |
- | - | - |
|