Item | Information |
---|---|
CAS RN | 54-64-8 |
Chemical Name | Ethyl(2-mercaptobenzoato) mercurate sodium salt; Thiomersal |
Substance ID | R02-B-063-MHLW, MOE |
Classification year (FY) | FY2020 |
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 (FY2019 revised edition (Ver. 2.0)) |
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 classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified." |
2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. It was classified as "Not classified." |
4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
6 | Flammable liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
7 | Flammable solids | Classification not possible |
- |
- | - | No data available. Besides, there is information that it is combustible (GESTIS (Access on May 2020)). |
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." |
9 | Pyrophoric liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
10 | Pyrophoric solids | Classification not possible |
- |
- | - | No data 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 classified |
- |
- | - | It contains a metal (Hg), but it was classified as "Not classified" because it is estimated that it does not react vigorously with water from water solubility data of 1,000 g/L (GESTIS (Access on May 2020)). |
13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
14 | Oxidizing solids | Classification not possible |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine), which is chemically bonded to the element other than carbon or hydrogen (Na). However, the classification is not possible due to no data. |
15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified." |
16 | Corrosive to metals | Classification not possible |
- |
- | - | Classification is not possible because test methods applicable to solid substances are not available. |
17 | Desensitized explosives | Not classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified." |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Category 3 |
Danger |
H301 | P301+P310 P264 P270 P321 P330 P405 P501 |
[Rationale for the Classification] It was classified in Category 3 from (1), (2). [Evidence Data] (1) LD50 for rats: 75 mg/kg (AICIS (formerly, NICNAS) IMAP (2017), GESTIS (Access on May 2020), HSDB (Access on May 2020)) (2) LD50 for rats: 98 mg/kg (NTP (2001)) |
1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
1 | Acute toxicity (Inhalation: Gases) | Not classified |
- |
- | - | [Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified." |
1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | [Rationale for the Classification] It was classified as "Classification not possible" due to lack of data. |
3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | [Rationale for the Classification] Rationale data for the previous classification could not be confirmed, and it was classified as "Classification not possible" due to lack of data. |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
4 | Skin sensitization | Category 1A |
Warning |
H317 | P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501 |
[Rationale for the Classification] It was classified in Category 1A from (1) - (3). [Evidence Data] (1) Multiple skin sensitization tests with guinea pigs were conducted, and it was reported to be positive (positive rate 70%) in an optimization test, positive (positive rate 70%) in a modified maximization test (intradermal administration 0.1%), and also positive in sensitization tests by subcutaneous administration or occlusive application (MAK (DFG) vol.15 (2001)). (2) The Japan Society for Occupational Health (JSOH) classified this substance in occupational skin sensitizers Group 1 (OEL Documentations Vol. 55 (Japan Society For Occupational Health (JSOH), 2013)). (3) There were case reports in which this substance was a cause of occupational contact dermatitis, a person who was engaged in vaccination without wearing gloves developed eczema and had a positive patch test, and the symptom disappeared after wearing gloves. And in another report, a person who was suspected to be sensitized in a job of hepatitis vaccination 8 years ago developed eczema in his/her hands in another vaccination and had a positive patch test (OEL Documentations (Occupational Sensitizer classification) (Japan Society For Occupational Health (JSOH), 2013)). |
5 | Germ cell mutagenicity | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) As for in vivo, in validation tests by the European Community, it was classified as negative in a micronucleus test and a chromosomal aberration test in bone marrow cells and negative in a chromosomal aberration test in spermatocytes after intraperitoneal administration to mice (AICIS (formerly, NICNAS) IMAP (2017), NTP (2001), HSDB (Access on May 2020)). (2) As for in vitro, it was reported to be negative in a bacterial reverse mutation test (AICIS (formerly, NICNAS) IMAP (2017), NTP (2001), CEBS (Access on May 2020)). There were equivocal results in a chromosomal aberration test and a gene mutation test in cultured human lymphocytes (HSDB (Access on May 2020)). |
6 | Carcinogenicity | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. By the study using a new information source, the classification result was changed. [Reference Data, etc.] (1) In a carcinogenicity test in which rats were given this substance by subcutaneous injection for one year, no increase in tumor incidence was observed (AICIS (formerly, NICNAS) IMAP (2017)). |
7 | Reproductive toxicity | Category 1B |
Danger |
H360 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] Based on (1), in animals dosed by intraperitoneal injection or instillation into the eyes, embryo and fetal lethality was observed at a dose at which no maternal toxicity was observed. Therefore, it was classified in Category 1B. [Evidence Data] (1) In a developmental toxicity study with female rats dosed by intraperitoneal injection on days 6 to 18 of gestation and a developmental toxicity study with female rabbits dosed by instillation into the eyes on days 6 to 18 of gestation, at a dose at which no maternal toxicity was observed, embryo and fetal lethality (death, miscarriage or reabsorption) was observed but no teratogenicity was observed (AICIS (previous NICNAS) IMAP (2017)). [Reference Data, etc.] (2) Based on the available data on humans, no developmental toxicity is caused in humans at concentrations used in vaccines that contain this substance (AICIS (previous NICNAS) IMAP (2017)). |
8 | Specific target organ toxicity - Single exposure | Category 1 (nervous system, blood system, kidney) |
Danger |
H370 | P308+P311 P260 P264 P270 P321 P405 P501 |
[Rationale for the Classification] Based on (1) to (3), it was classified in Category 1 (nervous system, blood system, kidney). Dermatitis in (1) was observed in only one case, and it was not adopted as rationale for the classification in accordance with the GHS Classification Guidance for the Japanese Government. A new information source was used and the classification results were changed from the previous classification. [Evidence Data] (1) In a 44-year-old male who ingested 83 mg/kg of this substance, gastritis, renal tubular failure, dermatitis, gingivitis, delirium, coma, polyneuropathy (generalized peripheral nerve degeneration), and respiratory failure were observed (AICIS (previous NICNAS) IMAP (2017), HSDB (Access on May 2020)). (2) Several cases of acute mercury poisoning from products containing this substance were reported. At doses ranging from approximately 3 mg/kg to several hundred mg/kg of this substance, local necrosis, acute hemolysis, disseminated intravascular coagulation, acute renal tubular necrosis, obtundation, coma and central nervous system injury were observed (HSDB (Access on May 2020)). (3) Sensory disturbance of the ends of the extremities or around the mouth, visual disturbance, ataxia, dysequilibrium, and dysarthria or hypacusia caused by alkyl mercury compounds are designated as occupational diseases listed in Appended Table 1-2 of the Ordinance for Enforcement of the Labor Standards Act (Ministry of Labour Notification No. 33 (1996)). |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (nervous system) |
Danger |
H372 | P260 P264 P270 P314 P501 |
[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1 (nervous system). [Evidence Data] (1) Alkyl mercury compounds pass through the blood-brain barrier and the blood-placenta barrier rapidly, in contrast to inorganic mercury compounds. Major target organs are the central and peripheral nervous systems and the kidney (ACGIH (7th, 2001)). (2) To treat an ear infection of an 18-year-old female with tympanostomy tubes, 1.2 L of ear irrigation solution containing 0.1% of this substance was administered over a six-week period. Secondary oral ingestion occurred via drainage of this solution into the nasopharynx, with a total exposure of 127 mg/kg. Ataxia, stupor, and coma occurred at six weeks, followed by death 140 days after the treatment commenced (AICIS (previous NICNAS) IMAP (2017)). (3) Sensory disturbance of the ends of the extremities or around the mouth, visual disturbance, ataxia, dysequilibrium, and dysarthria or hypacusia caused by alkyl mercury compounds are designated as diseases listed in Appended Table 1-2 of the Ordinance for Enforcement of the Labor Standards Act (Ministry of Labour Notification No. 33 (1996)). [Reference Data, etc.] (4) This substance is an organic mercurial compound widely used as a preservative in vaccines, eyedrops, contact lens cleaning, and storage solutions (HSDB (Access on May 2020)). (5) It was reported that in experimental animals (species unknown) intranasally dosed with this substance for 190 days, no histopathological changes in the brain or kidney were observed (HSDB (Access on May 2020)). |
10 | Aspiration hazard | Classification not possible |
- |
- | - | [Rationale for the Classification] 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 Short term (Acute) | Classification not possible |
- |
- | - | No data available. |
11 | Hazardous to the aquatic environment Long term (Chronic) | Classification not possible |
- |
- | - | No data available. |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in the Annexes to the Montreal Protocol. |
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