NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	7733-02-0
Chemical Name	Zinc sulfate
Substance ID	25B0002
Classification year (FY)	FY2013
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 by the Japanese Government (July, 2013)
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 applicable	- -	-	-	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 solid	Not classified	- -	-	-	Not combustible (HSDB (Access on June 2013)).
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9	Pyrophoric liquids	Not applicable	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Not classified	- -	-	-	Not combustible (HSDB (Access on June 2013)).
11	Self-heating substances and mixtures	Not classified	- -	-	-	Not combustible (HSDB (Access on June 2013)).
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	From information on water solubility: 22 g/100 mL (20 deg C) (good) (ICSC (2007)), it is recognized that it does not react vigorously with water.
13	Oxidizing liquids	Not applicable	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Classification not possible	- -	-	-	No data available.
15	Organic peroxides	Not applicable	- -	-	-	It is an inorganic substance.
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	It is reported that LD50 = 1,000-2,000 mg/kg bw (EU-RAR (2004)), 1,757.17 mg/kg (males), 1,229.27 mg/kg (females) (Japan Crop Protection Association (1994)) for rats for zinc sulfate heptahydrate (CAS: 7446-20-0). After converting these values to zinc sulfate anhydrate, LD50 = 561.5-1,123 mg/kg, 986.6 mg/kg (males), 690.2 mg/kg (females), therefore it was classified in Category 4. [Note] Please also refer to the classification results of zinc sulfate monohydrate (CAS RN 7446-19-7) and zinc sulfate heptahydrate (CAS RN 7446-20-0), both of which are the hydrates of this substance.
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, there is a report on LD50 for rats of > 2,000 mg/kg bw for zinc sulfate heptahydrate (CAS: 7446-20-0) (EU-RAR (2004)). LD50 will be > 1,123 mg/kg bw after converting the value to zinc sulfate anhydrate. [Note] Please also refer to the classification results of zinc sulfate monohydrate (CAS RN 7446-19-7) and zinc sulfate heptahydrate (CAS RN 7446-20-0), both of which are the hydrates of this substance. The classification was conducted by molecular weight conversion of LD50 for the heptahydrate in this hazard class.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	There is a description of practically 0 mmHg for the vapor pressure of zinc sulfate heptahydrate (CAS: 7446-20-0) in NITE CHRIP (2012), therefore there seems to be no possibility of vapour exposure. It was classified as "Not applicable" because it is similar also for zinc sulfate anhydrate. [Note] Please also refer to the classification results of zinc sulfate monohydrate (CAS RN 7446-19-7) and zinc sulfate heptahydrate (CAS RN 7446-20-0), both of which are the hydrates of this substance.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data. [Note] Please also refer to the classification results of zinc sulfate monohydrate (CAS RN 7446-19-7) and zinc sulfate heptahydrate (CAS RN 7446-20-0), both of which are the hydrates of this substance.
2	Skin corrosion/irritation	Not classified	- -	-	-	Regarding zinc sulfate heptahydrate (CAS: 7446-20-0), in a primary skin irritation test with rabbits (according to Directive 92/69/EEC B.4 and OECD guideline 404), no irritation was observed after a 4-hour semi-occlusive application of 0.5 g of the substance to the auricle (EU-RAR (2004)). And in another primary skin irritation test with rabbits on zinc sulfate heptahydrate, after 0.5 g of the substance was applied to two sites (normal and abraded skin) of the dorsal skin for 4 hours, no skin reactions were observed in either normal or abraded skin (Japan Crop Protection Association (1994)). Furthermore, it is described in EU-RAR (2004) that "this substance is not corrosive to the skin" for zinc sulfate heptahydrate, and it is concluded that zinc sulfate is considered not irritating/corrosive to the skin based on the test according to EU and OECD guidelines. This substance was classified as "Not classified" based on the above information.
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	Regarding zinc sulfate heptahydrate (CAS: 7446-20-0), in an eye irritation/corrosion test with rabbits (according to Directive 92/69/EEC B.5 and OECD guideline 405), corneal injury, conjunctival redness, chemosis, and discharge were observed. Yellow/white spots were found in the tissue of the lower eyelid, nictitating membrane, and/or sclera from seven days after application, and they did not disappear during the test period (EU-RAR (2004)). It is described in EU-RAR (2004) that these yellow/white spots are signs of necrosis, this substance is considered to induce severe ocular irritation, and it should be labelled as R41 according to EC criteria. Furthermore, zinc sulfate is classified in "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.
4	Respiratory sensitization	Classification not possible	- -	-	-	Respiratory sensitization: Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	Skin sensitization: Classification not possible due to lack of data. [Note] Please also refer to the classification results of zinc sulfate monohydrate (CAS RN 7446-19-7) and zinc sulfate heptahydrate (CAS RN 7446-20-0), both of which are the hydrates of this substance.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. Most information on zinc sulfate has no description of anhydrate or hydrate. The information with a description of anhydrate is limited to a positive result in an in vivo comet assay with mice (NITE (2008)). Besides, as for in vivo information on zinc sulfate (no description of anhydrate or hydrate), there are negative results in all of the chromosomal aberration test, micronucleus test, and dominant lethal test (NITE (2008), EU-RAR (2004), ATSDR (2009), EHC (2001), IUCLID (2000), HSDB (Access on June 2013)). Furthermore, as for in vitro information on zinc sulfate (no description of anhydrate or hydrate), it was negative in a bacterial reverse mutation test (NITE (2008), EU-RAR (2004), ATSDR (2009), EHC (2001), IUCLID (2000), HSDB (Access on June 2013)) and a chromosomal aberration test with cultured mammalian cells (NITE (2008), EU-RAR (2004), IUCLID (2000), HSDB (Access on June 2013)), and positive in an HGPRT gene mutation test with cultured mammalian cells (IUCLID (2000)). Besides, it is described in the previous classification that it was positive in in-vivo somatic cell mutagenicity tests (a micronucleus test, a chromosomal aberration test). However, it was judged to be negative because it was assessed to be negative in EU-RAR (2004) and EHC (2001). [Note] Please also refer to the classification results of zinc sulfate monohydrate (CAS RN 7446-19-7) and zinc sulfate heptahydrate (CAS RN 7446-20-0), both of which are the hydrates of this substance.
6	Carcinogenicity	Classification not possible	- -	-	-	It was classified as "Classification not possible" because there are no classification results by other organizations or toxicity information.
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	Reproductive and developmental toxicity (decreased gestation rate, decreased numbers of implantations, reduced male fertility) was observed from descriptions in EHC 221 (2001), EU-RAR (2004), and ATSDR (2005), although a description of general toxicity in parent animals is unknown. It was classified in Category 2 according to the GHS classification guidance for the Japanese government.
8	Specific target organ toxicity - Single exposure	Category 2 (respiratory organs, gastrointestinal tract)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	The drug poisoning case of a girl is described in EU-RAR (2004) and NITE (2008), and epigastric discomfort and anemia from gastrointestinal hemorrhage are reported. However, because these are findings in only one case, they cannot be judged to be target organ toxicity by the administration of this substance in humans. On the other hand, as for experimental animals, in oral administration tests with mice and rats, findings such as dyspnea, hemorrhagic lung, diarrhea, thickened gastric mucosa, and hemorrhagic small intestine were observed at the doses within the guidance value range for Category 2 (NITE (2008), EU-RAR (2004)). Therefore, it was classified in Category 2 (respiratory organs, gastrointestinal tract). The previous classification was conducted based on data from the information source not in List 1, but data in NITE (2008) and EU-RAR (2004), which are information sources in List 1, were available this time and were used for classification. Besides, the liver and kidney were adopted as the target organs in the previous classification, but data on the liver and kidney did not exist in the information sources used this time, therefore the liver and kidney were removed.
9	Specific target organ toxicity - Repeated exposure	Category 1 (gastrointestinal tract)	Danger	H372	P260 P264 P270 P314 P501	It was classified in Category 1 (gastrointestinal tract) because there are reports on many cases of humans who developed gastrointestinal symptoms (nausea, vomiting, loss of appetite, gastrointestinal bleeding) by ingestion (EU-RAR (2004), ATSDR (2005), NITE (2008)). The knowledge on the pancreas, adrenal gland, and vascular system (ATSDR (1980)) adopted in the previous classification is not included in the current version of ATSDR (ATSDR (2005)), therefore these were removed from the target organs.
10	Aspiration hazard	Classification not possible	- -	-	-	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 (Acute)	Category 1	Warning	H400	P273 P391 P501	From 48-hour LC50 = 0.04 mgZn/L (equivalent to 0.099 mg ZnSO4/L) for crustacea (Daphnia hyalina) (EHC 221, 2001), it was classified in Category 1.
11	Hazardous to the aquatic environment (Long-term)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 1 due to unknown behavior of the metal compound in water, and 72-hour NOEC = 10 microg Zn/L (equivalent to 24.6 microg ZnSO4/L) for algae (schroederella schroederi) (EU-RAR, 2010). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 due to unknown behavior of the metal compound in water, and 48-hour LC50 = 0.04 mgZn/L (equivalent to 0.099 mg ZnSO4/L) for crustacea (Daphnia hyalina) (EHC 221, 2001). From the above results, it was classified in Category 1.
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.

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