Item | Information |
---|---|
CAS RN | 1314-13-2 |
Chemical Name | Zinc oxide |
Substance ID | m-nite-1314-13-2_v1 |
Download of Excel format | Excel file |
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) |
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 (ICSC (2004)). | 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 (ICSC (2004)). | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
11 | Self-heating substances and mixtures | Not classified |
- |
- | - | Not combustible (ICSC (2004)). | 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 the information of being insoluble in water (Merck (2006)), 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 | Classification not possible |
- |
- | - | The classification was not possible due to no data from the prescribed test. | 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 | - |
- |
- | - | - | - | - |
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) | 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)). | 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" 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. | 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) | 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)). | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
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)). | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
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)). | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
4 | Respiratory sensitization | 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)) |
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. | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
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. | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
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. | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
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. | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
8 | Specific target organ toxicity - Single exposure | Category 1 (respiratory organs, systemic) |
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). | 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, 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. | 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)) |
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 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. | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
11 | Hazardous to the aquatic environment Long term (Chronic) | 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. |
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)) |
|