Latest GHS Classification Results by the Japanese Government (edited by NITE)

Japanese



GENERAL INFORMATION
 
Item Information
CAS RN 7681-57-4
Chemical Name Disodium pyrosulfite
Substance ID m-nite-7681-57-4_v1
Download of Excel format Excel file

REFERENCE INFORMATION
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) To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link) To Workplace Safety Site (MHLW)
OECD/eChemPortal (External link) To OECD/eChemPortal (External link)

PHYSICAL HAZARDS
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. FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2 Flammable gases Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products. FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
5 Gases under pressure Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6 Flammable liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7 Flammable solids Not classified
-
-
- - Not combustible (HSDB (Access on September 2013)). FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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. FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9 Pyrophoric liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10 Pyrophoric solids Not classified
-
-
- - Not combustible (HSDB (Access on September 2013)). FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11 Self-heating substances and mixtures Not classified
-
-
- - Not combustible (HSDB (Access on September 2013)). FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified
-
-
- - From information on water solubility: 54 g/100 mL (ICSC (2002)), it is recognized that it does not react vigorously with water. FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
14 Oxidizing solids Not classified
-
-
- - It is a reducing agent (ICSC (2002)). FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
15 Organic peroxides Not classified (Not applicable)
-
-
- - It is an inorganic substance. FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
16 Corrosive to metals Classification not possible
-
-
- - Test methods applicable to solid substances are not available. FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
17 Desensitized explosives -
-
-
- - - - -

HEALTH HAZARDS
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 4


Warning
H302 P301+P312
P264
P270
P330
P501 		It was classified in Category 4 based on an LD50 value for rats of 1,540 mg/kg (SIDS (2001), EPA Pesticides (2007)). Besides, there are other LD50 values of 1,131 mg/kg (EPA Pesticides (2007)) and 2,480 mg/kg (SIDS (2001)). FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1 Acute toxicity (Dermal) Not classified
-
-
- - It was classified as "Not classified" based on an LD50 value of > 2,000 mg/kg for rats (EPA Pesticides (2007)). The category was revised based on data in EPA Pesticides (2007) obtained in this investigation. FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1 Acute toxicity (Inhalation: Gases) Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1 Acute toxicity (Inhalation: Vapours) Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data. FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2 Skin corrosion/irritation Classification not possible
-
-
- - Classification not possible due to lack of data. This substance was not irritating in a test with rabbits (SIDS (2001), IUCLID (2000)). On the other hand, sufficient information was not observed in humans. Furthermore, it is described in the summary of ACGIH (7th, 2001) that sufficient data were not available to recommend a Skin notation for this substance. FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3 Serious eye damage/eye irritation Category 1


Danger
H318 P305+P351+P338
P280
P310 		Because an eye irritation/corrosion test with rabbits (according to OECD TG 405) resulted in "irritating, risk of serious damage to the eye," it is concluded in SIDS (2001) that it is an eye irritant. And this substance is classified in "Xi: R41" in EU DSD classification and "Eye Dam. 1 H318" in EU CLP classification. It was classified in Category 1 based on the above information. It was impossible to track the data in ECETOC TR 66, which was used as the rationale in the previous classification. The classification was revised based on the newly obtained information. FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4 Respiratory sensitization Category 1


Danger
H334 P304+P340
P342+P311
P261
P284
P501 		[Rationale for the Classification]
Because there is knowledge that this substance is sensitizing in humans from (1)-(4), it was classified in Category 1. Besides, it is described in the minutes of the subcommittee on diseases due to chemical substances, Expert Committee of Article 35, the Ordinance for Enforcement of the Labor Standards Act (2013) that there are case reports on allergic contact dermatitis and asthma from occupational exposure to this substance, and onset of these is possible in normal workplaces. The category was revised from the previous one because new information was obtained.

[Evidence Data]
(1) It is reported: occupational asthma of a 37-year-old female radiographer who handled this substance as the fixing agent was suspected to be associated with the substance; therefore, a challenge test was conducted on the patient and nine controls, and the patient and one control showed positive response; epidemiological evidence was confirmed for the association between this substance and occupational asthma (Eur Respir J. 25 (2), 386-388 (2005)).
(2) It is reported that a laundry worker who used this substance as an additive chemical developed occupational asthma (ACGIH (7th, 2001)).
(3) It is reported that severe asthma was provoked in a 67-year-old woman who ate vinegar in which this substance was used as a preservative (ACGIH (7th, 2001)).
(4) It is described that this substance is unlikely to induce respiratory sensitization in humans but may cause symptoms of asthma in sensitive individuals (SIAR (2001), NICNAS IMAP (Accessed Dec. 2018)).

[Reference Data, etc.]
(5) In the announcement No. 316 of the Ministry of Health, Labour and Welfare (2013), this substance was designated as sodium metabisulfite in Simple chemical substances or compounds (including alloys) designated by the Minister of Health, Labour and Welfare based on Appended Table 1-2, (iv) 1 of the Ordinance for Enforcement of the Labor Standards Act, and a disease principally having specific symptoms and disorders (skin disorders, respiratory tract disorders) due to work involving exposure to this substance was designated as an occupational disease by the Minister of Health, Labour and Welfare.
(6) In humans, urticaria, asthma with itching, edema, rhinitis, and nasal congestion were reported for this substance, but it is pointed out that an immunological pathogenesis of these is not clear (SIAR (2001), NICNAS IMAP (Accessed Dec. 2018)).
(7) It is reported that this substance is associated with work-related airway diseases (irritant-induced asthma, occupational asthma, vocal cord dysfunction with underlying asthma) in one trawlerman and two prawn processors, but it is suggested that it may be due to effects of sulfur dioxide, which is generated upon contact of this substance with water (Occup Med. 58 (8), 545-550 (2008)). 		FY2018 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Skin sensitization Category 1


Warning
H317 P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501 		[Rationale for the Classification]
Because there is knowledge that this substance is sensitizing in humans from (1)-(4), it was classified in Category 1. Besides, it is described in the minutes of the subcommittee on diseases due to chemical substances, Expert Committee of Article 35, the Ordinance for Enforcement of the Labor Standards Act (2013) that there are case reports on allergic contact dermatitis and asthma from occupational exposure to this substance, and onset of these is possible in normal workplaces. The category was revised from the previous one because new information was obtained.

[Evidence Data]
(1) A 50-year-old woman who sliced potato soaked in a stock solution in which this substance was used as a preservative, using unfit plastic gloves in a restaurant developed dermatitis and showed positive response in a patch test. It is reported that dermatitis gradually resolved after she was moved to another job in the same restaurant (Contact Dermatitis. 61 (4), 244-245 (2009)).
(2) It is reported that in a patch test on 1,751 patients, 71 showed positive reactions, for 33 of which the association with this substance was specified but unknown for other 38 (HSDB (2011)).
(3) It is reported that positive patch-testing and allergic contact dermatitis were observed in a few cases (SIAR (2001)).
(4) It is reported that in a patch test on 980 eczematous patients, 14 showed positive reactions. Besides, it is written that this result does not meet the criteria for classification as a hazardous substance with respect to Sensitisation by Skin Contact according to the NICNAS Approved Criteria for Classifying Hazardous Substances (2005) (NICNAS IMAP (Accessed Dec. 2018)).

[Reference Data, etc.]
(5) In the announcement No. 316 of the Ministry of Health, Labour and Welfare (2013), this substance was designated as sodium metabisulfite in Simple chemical substances or compounds (including alloys) designated by the Minister of Health, Labour and Welfare based on Appended Table 1-2, (iv) 1 of the Ordinance for Enforcement of the Labor Standards Act, and a disease principally having specific symptoms and disorders (skin disorders, respiratory tract disorders) due to work involving exposure to this substance was designated as an occupational disease by the Minister of Health, Labour and Welfare. 		FY2018 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5 Germ cell mutagenicity Classification not possible
-
-
- - Classification not possible due to lack of data. As for in vivo, it was negative in all of a dominant lethal test with rats, micronucleus tests with mice and hamsters, chromosomal aberration tests and sister chromatid exchange tests with rats, mice, and Chinese hamsters (SIDS (2001), HSDB (Access on September 2013)). As for in vitro, negative and positive results were mixed in bacterial reverse mutation tests and chromosomal aberration tests with cultured mammalian cells (SIDS (2001), HSDB (Access on September 2013)). FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6 Carcinogenicity Classification not possible
-
-
- - It was assessed as A4 in ACGIH (1995). And disulfites were assessed as Group 3 in IARC 54 (1992). The category was changed according to the GHS classification guidance for the Japanese government. FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7 Reproductive toxicity Not classified
-
-
- - It was classified as "Not classified" because no reproductive or developmental toxicity was observed in a multi-generation test with rats (ACGIH (7th, 2001), IARC 54 (1992), SIDS (2001)) and developmental toxicity tests with rats and rabbits (SIDS (2001)). FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
8 Specific target organ toxicity - Single exposure Category 3 (Respiratory tract irritation)


Warning
H335 P304+P340
P403+P233
P261
P271
P312
P405
P501 		It was classified in Category 3 (respiratory tract irritation) because it is described that it causes inflammation of the throat in humans (HSDB (Access on September 2013)), and irritation of the upper respiratory organ was observed in mice (ACGIH (7th, 2001)). FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, the classification result was changed from the previous classification because it was determined that asthma cases were described in respiratory sensitization and were not included in repeated exposure effects. FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10 Aspiration hazard Classification not possible
-
-
- - Classification not possible due to lack of data. FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

ENVIRONMENTAL HAZARDS
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) Category 3
-
-
H402 P273
P501 		It was classified in Category 3 from 72-hour EC50 = 48.1 mg/L for algae (Desmodesmus subspicatus) (SIDS, 2004). FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11 Hazardous to the aquatic environment Long term (Chronic) Category 3
-
-
H412 P273
P501 		If chronic toxicity data are used, then it is classified as "Not classified" due to unknown behavior of the inorganic compound, this substance in water, and 21-day NOEC > 10 mg/L for crustacea (Daphnia magna) (SIDS, 2004).
If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 3 due to unknown behavior of the inorganic compound, this substance in water, and 72-hour EC50 = 48.1 mg/L for algae (Desmodesmus subspicatus) (SIDS, 2004).
By drawing a comparison between the above results, it was classified in Category 3. 		FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in the Annexes to the Montreal Protocol. FY2013 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))


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.

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