Item | Information |
---|---|
CAS RN | 113378-31-7 |
Chemical Name | Semduramicin |
Substance ID | m-nite-113378-31-7_v1 |
Download of Excel format | Excel file |
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) | MHLW Website (in Japanese Only) |
Sample SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
OECD/eChemPortal (External link) | To OECD/eChemPortal (External link) |
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. It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
6 | Flammable liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
7 | Flammable solids | Classification not possible |
- |
- | - | No data available. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
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. It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
9 | Pyrophoric liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
10 | Pyrophoric solids | Classification not possible |
- |
- | - | No data available. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | No data available. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
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). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
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. It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
16 | Corrosive to metals | Classification not possible |
- |
- | - | Classification is not possible because test methods applicable to solid substances are not available. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
17 | Desensitized explosives | Not classified |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
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 2 |
Danger |
H300 | P301+P310 P264 P270 P321 P330 P405 P501 |
[Rationale for the Classification] Based on (1), it was classified in Category 2. Besides, the category was changed from the previous classification by using the new information source. [Evidence Data] (1) LD50 (semduramicin sodium, CAS RN 119068-77-8) for rats: male: 66 mg/kg (a converted value equivalent to this substance: 64 mg/kg), 50-100 mg/kg (a converted value equivalent to this substance: 49-98 mg/kg), female: 46 mg/kg (a converted value equivalent to this substance: 45 mg/kg), 5-20 mg/kg (a converted value equivalent to this substance: 5-20 mg/kg) (Risk Assessment Report (Veterinary Medicinal Products and Feed Additives) (Food Safety Commission of Japan, 2017)) |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 (semduramicin sodium, CAS RN 119068-77-8) for rats: >5,000 mg/kg (a converted value equivalent to this substance: 4,877 mg/kg) (Risk Assessment Report (Veterinary Medicinal Products and Feed Additives) (Food Safety Commission of Japan, 2017)). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Inhalation: Gases) | Not classified (Not applicable) |
- |
- | - | [Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)." |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Inhalation: Dusts and mists) | Category 2 |
Danger |
H330 | P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501 |
[Rationale for the Classification] Based on (1), it was classified in Category 2. Besides, exposure concentrations were higher than the saturated vapor concentration (0.00000047 mg/L), therefore, the reference value in units of mg/L was applied as a dust. The category was changed from the previous classification by using the new information source. [Evidence Data] (1) LC50 (semduramicin sodium, CAS RN 119068-77-8) for rats: male: 82 mg/m3 (a converted value equivalent to this substance: 80 mg/m3 (0.08 mg/L)), female: 53 mg/m3 (a converted value equivalent to this substance: 52 mg/m3 (0.052 mg/L)) (Risk Assessment Report (Veterinary Medicinal Products and Feed Additives) (Food Safety Commission of Japan, 2017)) |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
4 | Skin sensitization | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
5 | Germ cell mutagenicity | Not classified |
- |
- | - | [Rationale for the Classification] There are no in vivo data for this substance, however, based on in vitro data in (1), and data in (2) and (3) of semduramicin sodium (CAS RN 119068-77-8) which is a sodium salt of this substance, it was classified as "Not classified." The classification result was changed from the previous classification by using the new information source. [Evidence Data] (1) As in vitro data for this substance, there is a negative report in a bacterial reverse mutation test (Risk Assessment Report (Veterinary Medicinal Products and Feed Additives) (Food Safety Commission of Japan, 2017)). (2) There is a negative report in an in vivo chromosomal aberration test of semduramicin sodium in mouse bone marrow cells (Risk Assessment Report (Veterinary Medicinal Products and Feed Additives) (Food Safety Commission of Japan, 2017)). (3) As for in vitro tests on semduramicin sodium, there are negative reports in a bacterial reverse mutation test, and a gene mutation test and unscheduled DNA synthesis test with cultured mammalian cells, and a chromosomal aberration test using human lymphocyte (Risk Assessment Report (Veterinary Medicinal Products and Feed Additives) (Food Safety Commission of Japan, 2017)). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
6 | Carcinogenicity | Classification not possible |
- |
- | - | [Rationale for the Classification] There are no classification results by domestic and international organizations. There is no report available on humans. Based on (1) and (2), it was classified as "Classification not possible." [Evidence Data] (1) In a 2-year study with rats fed with the sodium salt of this substance (CAS RN 119068-77-8), although tumors were observed in the treated groups and the control group, no dose-dependency was observed, and it was not thought to be an effect of the administration (Risk Assessment Report (Veterinary Medicinal Products and Feed Additives) (Food Safety Commission of Japan, 2017)). (2) In a chronic toxicity/carcinogenicity test with rats orally administered this substance for 2 years, no carcinogenicity was observed (Risk Assessment Report (Veterinary Medicinal Products and Feed Additives) (Food Safety Commission of Japan, 2017)). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
7 | Reproductive toxicity | Not classified |
- |
- | - | - | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
8 | Specific target organ toxicity - Single exposure | Category 1 (nervous system) |
Danger |
H370 | P308+P311 P260 P264 P270 P321 P405 P501 |
[Rationale for the Classification] There are no data on this substance itself, however, based on data in (1) of semduramicin sodium (CAS RN 119068-77-8) which is the sodium salt of this substance, it was classified in Category 1 (nervous system). The classification result was changed from the previous classification by using the new information source. [Evidence Data] (1) In a test in which mice were given a single oral administration of semduramicin sodium, decreased locomotor activity, dyspnea, ptosis, prone position, clonic convulsion and hindlimb paralysis were observed, but these symptoms disappeared 3-4 days after the administration in the survived animals. There is no description of the lowest dose at which effects were observed, however, it was considered to be around LD50 values (122 mg/kg (male) and 140 mg/kg (female), a converted value equivalent to this substance: 119 mg/kg (male) and 136 mg/kg (female)), which correspond to the range of Category 1 (Risk Assessment Report (Veterinary Medicinal Products and Feed Additives) (Food Safety Commission of Japan, 2017)). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (nervous system, eye, muscle) |
Danger |
H372 | P260 P264 P270 P314 P501 |
[Rationale for the Classification] There are no data on this substance, however, based on data in (1)-(4) on semduramicin sodium (CAS RN 119068-77-8), it was classified in Category 1 (nervous system, eye, muscle). Besides, with regard to the effects on the eyes, since lesions were also observed in the non-tapetum region, it was judged that the eyes could be a target organ in humans who do not have tapetum. After the review using the new information source, the classification result was changed from the previous classification. [Evidence Data] (1) In a 91-day repeated oral dose toxicity test with rats dosed by feeding, reduced body weight gain, decreased food consumption, rough fur coat, emaciation, decreased intraperitoneal fat, increased total serum cholesterol, decreased blood glucose, etc. were observed at 2.25 mg/kg/day (within the range of Category 1) (Risk Assessment Report (Veterinary Medicinal Products and Feed Additives) (Food Safety Commission of Japan, 2017)). (2) In a 1-month feeding study with dogs dosed by feeding, muscle degeneration and necrosis, increases in AST and ALT in 1 out of 4 animals and an increase in CPK in all (4 animals) were found at 2 mg/kg/day (converted guidance value: 0.67 mg/kg/day, within the range of Category 1), and at 4 mg/kg/day (converted guidance value: 1.33 mg/kg/day, within the range of Category 1), progressive ataxia (temporary dysstasia and difficulty in walking in 2 animals, irreversible dysstasia in other 2 animals) and muscle degeneration/necrosis and nerve damage (all animals), and increases in CPK, AST, ALP (all animals) were observed (Risk Assessment Report (Veterinary Medicinal Products and Feed Additives) (Food Safety Commission of Japan, 2017)). (3) In a 182-day repeated dose toxicity test with dogs dosed by feeding, small circular spots were observed in the retinal tapetum at 1.0 mg/kg/day (within the range of Category 1) (Risk Assessment Report (Veterinary Medicinal Products and Feed Additives) (Food Safety Commission of Japan, 2017)). (4) In a 1-year repeated dose toxicity test with dogs dosed by feeding, circular spots in the retinal tapetum, hyaline degeneration and separation of the retinal rod cells and cone cells in the retinal tapetum and non-tapetum regions, retinal detachment, swelling or degeneration of mitochondria in the rod-shaped cells and cone-shaped cells, and decay of the outer segment disk, etc. were observed at 1.0 mg/kg/day (within the range of Category 1) (Risk Assessment Report (Veterinary Medicinal Products and Feed Additives) (Food Safety Commission of Japan, 2017)). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
10 | Aspiration hazard | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
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) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
11 | Hazardous to the aquatic environment Long term (Chronic) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | Classification not possible due to lack of data. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
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