GHS Classification Result
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
Reference：
Chemical Name：Isosorbide mononitrate
CAS：16051-77-7
Result：
| ID: | 07-D38 |
| Classifier: | Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE） |
| Year Classified: | FY2007 |
| Reference Manual: |
GHS Classification Manual （10 Feb, 2006） Technical Guidance Document on the GHS Classification （6 Dec, 2005） |
PHYSICAL HAZARDS
| Hazard class | Classification | Symbol | Signal word | Hazard statement | Precautionary statement | Rationale for the classification | |
|---|---|---|---|---|---|---|---|
| 1 | Explosives | Not classified | - | - | - | - | It contains chemical groups (nitrates) associated with explosive properties. However, since it is defined as UN3251, Division 4.1, packing group III, and not Class 1 or Division 4.1, packing group I, the substance was classified into the "Not classified" category. |
| 2 | Flammable gases （including chemically unstable gases） | Not applicable | - | - | - | - | Solid |
| 3 | Aerosols | Not applicable | - | - | - | - | Not aerosol products. |
| 4 | Oxidizing gases | Not applicable | - | - | - | - | Solid |
| 5 | Gases under pressure | Not applicable | - | - | - | - | Solid |
| 6 | Flammable liquids | Not applicable | - | - | - | - | Solid |
| 7 | Flammable solids | Category 2 |
|
Warning | H228: Flammable solids |
P370+P378: In case of fire: Use ... for extinction. P210: Keep away from heat/sparks/open flames/hot surfaces. ? No smoking. P240: Ground/bond container and receiving equipment. P241: Use explosion-proof electrical/ventilating/lighting/.../equipment. P280: Wear protective gloves/protective clothing/eye protection/face protection. |
Since it is defined as Division 4.1, packing group III (UN 3251) by the UNRTDG, the substance was classified into Category 2 for flammable solids. |
| 8 | Self-reactive substances and mixtures | Type G | - | - | - | - | It contains chemical groups (nitrates) associated with explosive properties. However, since it is defined as UN3251, Division 4.1, packing group III, and not Division 4.1, packing group I, the substance was rated as Type G. |
| 9 | Pyrophoric liquids | Not applicable | - | - | - | - | Solid |
| 10 | Pyrophoric solids | Not classified | - | - | - | - | No data available. |
| 11 | Self-heating substances and mixtures | Not classified | - | - | - | - | 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 |
| 14 | Oxidizing solids | Not classified | - | - | - | - | No data available. |
| 15 | Organic peroxides | Not applicable | - | - | - | - | Containing no bivalent -O-O- structure in the molecule |
| 16 | Corrosive to metals | Classification not possible | - | - | - | - | No data available. |
| Hazard class | Classification | Symbol | Signal word | Hazard statement | Precautionary statement | Rationale for the classification | |
|---|---|---|---|---|---|---|---|
| 1 | Acute toxicity （Oral） | Category 5 | - | Warning | H303: May be harmful if swallowed | P312: Call a POISON CENTER or doctor/physician if you feel unwell. | Based on its rat LD50 of 2010 mg/kg (RTECS (accessed in August 2007)), the substance was classified into Category 5. |
| 1 | Acute toxicity （Dermal） | Classification not possible | - | - | - | - | No data available. |
| 1 | Acute toxicity （Inhalation: Gases） | Not applicable | - | - | - | - | Solid |
| 1 | Acute toxicity （Inhalation: Vapours） | Classification not possible | - | - | - | - | No data available. |
| 1 | Acute toxicity （Inhalation: Dusts and mists） | Classification not possible | - | - | - | - | No data available. |
| 2 | Skin corrosion/irritation | Classification not possible | - | - | - | - | No data available. |
| 3 | Serious eye damage/eye irritation | Classification not possible | - | - | - | - | No data available. |
| 4 | Respiratory sensitization | Classification not possible | - | - | - | - | No data available. |
| 4 | Skin sensitization | Classification not possible | - | - | - | - | No data available. |
| 5 | Germ cell mutagenicity | Not classified | - | - | - | - | Negative results were obtained in an Ames test, mutation test using cultured mouse lymphoma cells, chromosomal aberration test using human lymphocytes, and in vivo mouse micronucleus test (HSDB (2005)). Based on these negative results, the substance was classified into the "Not classified" category. |
| 6 | Carcinogenicity | Classification not possible | - | - | - | - | No evidence of carcinogenicity was observed in rats exposed to this substance in their diets at doses of up to 900 mg/kg/day for the first 6 months and 500 mg/kg/day for the remaining duration of a study in which males were dosed for up to 121 weeks and females were dosed for up to 137 weeks (HSDB (2005)). However, due to no other test results available, the substance was classified into the "Classification not possible" category. |
| 7 | Reproductive toxicity | Classification not possible | - | - | - | - | In both a test in which rats received administration before mating, and in tests in which rats or rabbits received administration during the embryonic development, no toxic effects of the compound administered were detected (HSDB (2005)). In addition, in a test in which rats were treated during late gestation and lactation, effects on neonatal survival and development were noted only at a high dose (750 mg/kg/day) and the NOEL was found to be 300 mg/kg/day. However, since neither presence/absence of maternal toxicity nor details in reproductive toxicity are provided, the substance was classified into the "Classification not possible" category. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (circulatory system, central nervous system, gastrointestinal tract, liver, skin) |
|
Danger | H370: Causes damage to organs (circulatory system, central nervous system, gastrointestinal tract, liver, skin) |
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 ... |
This substance has vasodilation effects and it is clinically used to treat angina pectoris. Regarding this substance used as oral agents (tablets), the following side effects (shown in more than 0.1% of the subjects) are listed: cardiovascular symptoms such as dizziness/lightheadedness and palpitation, neuropsychiatric symptoms such as headache, a heavy-headed sensation, and malaise, hypersensitivity reactions such as rash and itching, digestive symptoms such as stomachache, nausea, and loss of appetite, effects to the liver such as elevated GOT/GPT/LDH levels and jaundice with increased gamma-GTP, and elevated CPK, BUN, and creatinine levels (2007 Drugs in Japan, 1083-1084; Jiho (2006); Pharmaceuticals and Medical Devices Agency/Approved products/Package inserts (2007)). Based on this information, the substance was classified into Category 1 for its toxic effects on the cardiovascular system, central nervous system, gastrointestinal tract, liver, and skin. |
| 9 | Specific target organ toxicity - Repeated exposure | Classification not possible | - | - | - | - | In a 3-month repeated oral administration test using rats, the TDLo and NOEL are reported to be 500 mg/kg/day and 125 mg/kg/day, respectively (Konishi, Koji et al. Pharmacometrics, 30, p. 1079-1111 (1985)). Because the NOEL is above the upper limit of Category 2 guidance values, the substance was classified into the "Not classified" category. No information is available on side effects of the substance in a repeated administration to humans. However, based on a report that tolerance may develop as this substance or other nitrate- or nitrite-group drugs are repeatedly administered and activities of these drugs may recede (2007 Drugs in Japan, 1083-1084, Jiho (2006); Pharmaceuticals and Medical Devices Agency/Approved products/Package inserts (2007)). These reports indicate that both repeated and single administrations presumably induce similar side effects. However, due to lack of test results, it was classified into the "Classification not possible" category. |
| 10 | Aspiration hazard | Classification not possible | - | - | - | - | No data available. |
| Hazard class | Classification | Symbol | Signal word | Hazard statement | Precautionary statement | Rationale for the classification | |
|---|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment （Acute） | Classification not possible | - | - | - | - | No data available. |
| 11 | Hazardous to the aquatic environment （Long-term） | Classification not possible | - | - | - | - | No data available. |
NOTE:
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* 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：
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Reference Manual |
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Definitions / Abbreviations |
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Model Label by MHLW |
MHLW Website （in Japanese Only） |
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Model SDS by MHLW |
MHLW Website （in Japanese Only） |