NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	1314-13-2
Chemical Name	Zinc oxide
Substance ID	25B0001
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	FY2009 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 (ICSC (2004)).
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 (ICSC (2004)).
11	Self-heating substances and mixtures	Not classified	- -	-	-	Not combustible (ICSC (2004)).
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	From the information of being insoluble in water (Merck (2006)), 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	- -	-	-	The classification was not possible due to no data from the prescribed test.
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)	Not classified	- -	-	-	It was classified as "Not classified" based on LD50 for rats of > 5,000 mg/kg bw and > 15,000 mg/kg bw (EU-RAR (2004)).
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" from data of dermal LD50 > 5,000 mg/kg for rabbits (EPA Pesticide (1992)). The classification was conducted based on data in EPA Pesticide (1992) obtained in this investigation.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	It was classified as "Not classified" in the Classification JIS based on LC50 of > 5.7 mg/L (4 hours) for rats (EU-RAR (2004)).
2	Skin corrosion/irritation	Not classified	- -	-	-	It was classified as "Not classified" because the 24-hour occlusive application of 500 mg to the skin (ear) of rabbits resulted in no irritation (EU-RAR (2004)), and the open or occlusive application of 0.5 mL to the dorsal skin of rabbits for five consecutive days resulted in no irritation (EU-RAR (2004)). Besides, there was no irritation after open application to guinea pigs and mice for five consecutive days (ACGIH (2003)). And it is described that six human volunteers were given occlusive application of 40% ointment, and only one of them developed a rash and follicular pustules, but it could not be derived whether they were a result of zinc oxide or from other treatment-related stimuli (EU-RAR (2004)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	In a test (OECD TG 405) by application to the conjunctival sac of three rabbits, no corneal opacity was seen, only one animal had an iritis score of 1 one hour after application, all animals showed scores for conjunctival redness of 1-2, and this disappeared completely after 72 hours. And all animals gave chemosis scores of 2 only one hour after application (all animals had discharge scores of 1 only one hour after application) (EU-RAR (2004)). Therefore, it was classified as "Not classified." Besides, also in other tests with rabbits, only conjunctival redness and edema were observed by two days after application, and it was assessed to be not irritating or slightly irritating (EU-RAR (2004)).
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	Results of three skin sensitization tests with guinea pigs (maximization tests: Directive 96/54/EC B.6 & OECD TG 406) are reported (EU-RAR (2004)), and positive rates were (1) test group: 40% (4/10), control group: 0% (0/5), (2) test group: 0% (0/10), control group: 20% (1/5), (3) test group: 0% (0/10), control group: 0% (0/5). The first test resulted in a positive rate of 40% conflicting with others, but it is described that there is no evidence that zinc oxide is a potent sensitizer (EU-RAR (2004)). Furthermore, in a human patch test to study contact allergy, no positive response was observed in all 14 subjects when zink oxide alone was used (EU-RAR (2004)). It is concluded in EU-RAR (2004) that the substance does not have to be classified/labelled for skin sensitization. It was classified as "Not classified" based on the above information.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. In an in vivo chromosomal aberration test with bone marrow cells of rats by inhalation exposure, extremely slight aberrations were observed, but this knowledge was not regarded as clear in vivo evidence (SIDS (2006), EU-RAR (2004)). Besides, as for in vitro mutagenicity tests, it was reported to be negative in a reverse mutation test and positive in a mouse lymphoma test (NITE (2008), SIDS (2006), EU-RAR (2004), EPA IRIS (2005)). Besides, it is described in the previous classification that it was positive in a cell transformation test with hamster embryo cells (EU-RAR (2004)), but it was removed from data for investigation according to the GHS classification guidance for the Japanese government.
6	Carcinogenicity	Classification not possible	- -	-	-	It was classified as "Classification not possible" because the U.S. EPA classified it as Group I (IRIS (2005)). The category was updated according to the revised GHS classification guidance for the Japanese government.
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	It is reported that diet administration to rats 21 days before mating until day 15 of gestation caused resorption of all fetuses at a 4% concentration (NITE (2008), EU-RAR (2004)), and after diet administration to rats from day 0 to day 14 of gestation, stillborn occurred at or above 2000 ppm (NITE (2008), EU-RAR (2004)). It was classified in Category 2 because general toxicity in maternal animals was not denied at the toxicity doses mentioned above.
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs, systemic toxicity)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	In humans, there are reports on many cases developing metal fume fever by inhalation of zinc oxide dust, and observed symptoms included not only respiratory but systemic ones like cough, chest pain, chills, fever, dyspnea, muscle pain, and nausea (NITE (2008), ACGIH (2003)). Because respiratory symptoms mainly occur in cases of metal fume fever, it was classified in Category 1 (respiratory organs, systemic toxicity).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, there are reports on oral administration test with rats and ferrets (EHC (2001), NITE (2008)), but it is questionable to use either of them as repeated dose exposure tests for classification for the reasons such as being conducted in the old year (1953), being a test with one dose only, and using animal species not recommended.
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 = 0.098 mgZn/L for crustacea (Daphnia magna) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)), 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 due to unknown behavior of this substance in water, which is an inorganic compound, then it is classified in Category 1 due to 72-hour NOEC = 24 microgZn/L (29.9 microg ZnO/L) for algae (Pseudokirchneriella subcapitata) (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 this substance in water, which is an inorganic compound, and 48-hour LC50 = 0.098 mgZn/L for crustacea (Daphnia magna) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)). 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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