GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 5694-00-8 |
| Chemical Name | Glycidamide |
| Substance ID | H28-A-014, C-054A |
| Classification year (FY) | FY2016 |
| Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
| New/Revised | New |
| Classification result in other fiscal year | |
| 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 (Ver. 1.1)) |
| 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 | Classification not possible |
- |
- | - | 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 | Classification not possible |
- |
- | - | There is a chemical group associated with self-reactive properties (epoxides) present in the molecule, but the classification is not possible due to no data. |
| 9 | Pyrophoric liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 10 | Pyrophoric solids | Classification not possible |
- |
- | - | Test methods applicable to solid (melting point <= 140 deg C) substances are not available. |
| 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 |
- |
- | - | It is a solid substance with a melting point of 55 deg C or lower, but the classification is not possible due to no data. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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 | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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. |
| 5 | Germ cell mutagenicity | Category 1B |
 Danger |
H340 |
P308+P313
P201 P202 P280 P405 P501 |
As for in vivo, a mouse dominant-lethal test was positive, a mouse heritable translocation assay was positive, gene mutation tests using mouse spleen lymphocytes and liver were positive, a micronucleus test using mouse peripheral blood was positive, a micronucleus test using rat peripheral blood was negative, and an unscheduled DNA synthesis test using mouse spermatids was positive (NTP TR588 (2014), HSDB (Access on June 2016)). As for in vitro, bacterial reverse mutation tests were positive, an in vitro mammalian cell gene mutation test was positive, a mouse lymphoma assay was positive, a chromosomal aberration test was positive, and a sister chromatid exchange test was positive (NTP TR588 (2014), HSDB (Access on June 2016)). From the above, this substance was classified in Category 1B according to the GHS Classification Guidance for the Japanese Government. |
| 6 | Carcinogenicity | Category 1B |
Danger |
H350 |
P308+P313
P201 P202 P280 P405 P501 |
In carcinogenicity studies using rats and mice by the oral route (in drinking water), in rats, tumors of the oral mucosa or tongue, and tumors of thyroid, mononuclear cell leukemia, tumors of the testis, epididymis, mammary gland and clitoral gland were observed (NTP TR588 (2014)). In mice, tumors of the Harder's gland, lung, skin, forestomach and mammary gland were observed (NTP TR588 (2014)). Based upon the above, it was concluded that there was clear evidence of carcinogenicity in both sexes of both rats and mice (NTP TR588 (2014)). Although there are no classifications by other organizations, since carcinogenesis was observed in multiple organs in 2 species of experimental animals, this substance was classified in Category 1B. Besides, since this substance is a metabolite of acrylamide and because tumors were observed at sites similar to those for acrylamide, NTP concluded that carcinogenic activity of acrylamide is due to its metabolic conversion to this substance (NTP TR588 (2014)). |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - |
Classification not possible due to lack of data. Besides, it is described that, as the results of intraperitoneal administration of this substance to male rats for 14 days, decreases in testicular protein content, epididymal weight and seminiferous tubule sperm viability were observed (HSDB (Access on June 2016)). |
| 8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (nervous system, eye, liver, genetic organs) |
Danger |
H372 |
P260
P264 P270 P314 P501 |
As for humans, there is no relevant information. As for experimental animals, in a 2-year repeated dose toxicity study using rats administered by drinking water, effects on the nervous system (brain gliosis, axonal degeneration of the lumbar spinal cord), effects on the liver (hepatocyte degeneration, liver necrosis), effects on the uterus (uterine endometrial hyperplasia) and effects on the testis (exfoliated germ cells within the epididymis) were observed at 15.3 to 61.2 ppm (converted guidance value: 0.77 to 3.06 mg/kg/day), which is within the range of Category 1 (NTP TR588 (2014)). In a 2-year repeated dose toxicity study using mice administered by drinking water, effects on the nervous system (axonal degeneration of the cervical spinal cord), effects on the eye (cataracts, corneal inflammation), effects on the liver (hepatic angiectasis and necrosis), effects on the forestomach (squamous cell hyperplasia), effects on the spleen (hematopoietic cell proliferation of the spleen) and effects on the ovary (ovarian cysts) were observed at 15.3 to 61.2 ppm (converted guidance value: 2.3 to 9.2mg/kg/day), which is within the range of Category 1 (NTP TR588 (2014)). In a 3-month repeated dose toxicity study using mice administered by drinking water, effects on the nervous system (hind-limb paresis, peripheral neuropathy (primarily the sciatic nerve), atrophy in skeletal muscle of the hind limb, dilation of the urinary bladder) and effects on the testis (degeneration of the germ cells in the testes) were observed at 306 ppm (converted guidance value: 45.9 mg/kg/day), which is relevant to Category 2 (NTP TR588 (2014)). Regarding the effects on the forestomach, the forestomach was not considered a target organ as the forestomach does not exist in humans. In addition, the effects on the spleen were not adopted as the evidence for classification because they were a proliferation of hematopoietic cells, which were not findings of a defect. Therefore, this substance was classified in Category 1 (nervous system, eye, liver, genetic organs). |
| 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) | Classification not possible |
- |
- | - | No data available. |
| 11 | Hazardous to the aquatic environment (Long-term) | Classification not possible |
- |
- | - | No data available. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
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* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * 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. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |