NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

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

REFERENCE INFORMATION

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

PHYSICAL HAZARDS

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."

HEALTH HAZARDS

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.

ENVIRONMENTAL HAZARDS

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.

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

To GHS Information