GHS Classification Result （Revision of the past classification result）

Chemical Name：Zinc oxide
CAS：1314-13-2

Result：
ID: 21B3033
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government （March, 2009）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
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 solids 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 - - - - Insoluble in water (Merck (14th, 2006))
13 Oxidizing liquids Not applicable - - - - Solid (GHS definition)
14 Oxidizing solids Classification not possible - - - - No data by the test method designated by UNRTDG are available. Divalent zinc oxide is the most stable and it is considered that contained oxygen does not enhance combustion of cellulose.
15 Organic peroxides Not applicable - - - - Inorganic compound
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Not classified - - - - Based on LD50 values of >5000 mg/kg bw and >15000 mg/kg bw for rats (EU-RAR (2004)), the substance was classified into "Not classified".
1 Acute toxicity （Dermal） Classification not possible - - - - No data available.
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Solid (GHS definition)
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - No data available.
1 Acute toxicity （Inhalation: Dusts and mists） Not classified - - - - Based on a LC50 value of >5.7 mg/L (4h) for rats (EU-RAR (2004)), the substance was classified as "Not classified" in JIS Classification (correspond to Category 5 or "Not classified" in GHS classification).
2 Skin corrosion/irritation Not classified - - - - In a test using rabbits, no dermal reactions were noted after the application (ear) of 500 mg during 24-hour under occlusion (EU RAR (2004)). No signs of skin irritation were noted after open or occlusive application of 0.5 mL on the dorsal skin of rabbits for 5 consecutive days (EU-RAR (2004)). Based on these data, the substance was classified as "Not classified". No signs of skin irritation were noted after open application on the skin of mice and guinea pigs for 5 consecutive days (ACGIH (2003)). Additionally, In humans, a rash and follicular pustules developed in one of 6 volunteers who received treatment with a 40% ointment under occlusive dressings. However, it could not be derived whether the dermal effects 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 TG405) where 3 rabbits were treated by instillation into the conjunctival sac, no corneal opacity was observed, iridial irritation (grade 1) was observed in 1 animal at 1-hour only, conjunctivae redness (grade 1 - 2) was seen in all animals and completely resolved at 72-hour, chemosis (grade 2) and discharge (grade 1) were observed in all animals at 1-hour only (EU-RAR (2004)). Based on the data, the substance was classified as "Not classified". In other rabbit tests, slight erythema and edema were observed up to 2 days after treatment, therefore the substance was considered to be "not irritating" or "borderline positive for irritation" (EU-RAR (2004).
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Not classified - - - - Three well-performed skin sensitizing tests in guinea pigs (Maximization test: Directive 96/54/EC B.6, OECD TG406) were reported (EU-RAR (2004)). The positive rates were 1) 40% (4/10) in experimental group, 0% (0/5) in control group, 2) 0% (0/10) in experimental group, 20% (1/5) in control group, and 3) 0% (0/10) in experimental group, 0% (0/5) in control group. While the first test produced conflicting results (positive rate of 40%), the weight of evidence does not indicate that zinc oxide is a very potent sensitizing agent (EU-RAR (2004)). In a patch test for contact allergy, no positive responses were observed in the 14 patients when only zinc oxide was used (EU-RAR (2004)). It was concluded in EU-RAR (2004) that Zinc oxide does not have to be classified/labelled for skin sensitization, therefore, the substance was classified as "Not classified".
5 Germ cell mutagenicity Classification not possible - - - - There is a report of positive results from a rat bone marrow chromosomal aberration test following exposure by inhalation for 5 months (in vivo somatic cell mutagenicity test) (EU RAR (2004)). The results are hard to interpret since only a slight increase was seen, the experimental procedures employed are not commonly used, and the observed aberration was aneuploidy such as hyperdiploid cells. Classification was not possible due to lack of sufficient data from in vivo mutagenicity tests. As relevant information, from in vitro mutagenicity tests, there are reports of a negative Ames test (EU RAR (2004)), a positive mouse lymphoma gene mutation test (EU RAR (2004)) and a positive hamster embryo cell transformation assay (EU RAR (2004).
6 Carcinogenicity Not classified - - - - Based on the classification of "D" in EPA (PATTY (5th, 2001)), the substance was classified as "Not classified".
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ... 		In a rat test, the administration of 0.4% in diet for 21 days prior to mating until day 15 of gestation resulted in resorptions of all fetuses (EU-RAR (2004)). In rats administered in diet from day 0 of gestation to day 14 of lactation, stillborn pups were observed at 2000 ppm and higher concentrations (EU-RAR (2004)). Since the manifestation of maternal general toxicity was not denied at the above toxic levels, the substance was classified into Category 2.
8 Specific target organ toxicity - Single exposure Category 1 (lung, systemic toxicity) Danger H370: Causes damage to organs (lung, systemic toxicity) P307+P311: IF exposed: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment （see ... on this label）.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Numerous cases of metal fume fever caused by inhalation exposure of zinc oxide micro dusts are reported and symptoms such as cough, chest pain, chill, fever, dyspnea, muscular pain and nausea may occur (ACGIH (2003), IRIS (2005), ATSDR (2005)). Since metal fume fever presents mainly symptoms in the respiratory system, the substance was classified into Category 1 (lung, systemic toxicity). In a rat test by gavage at doses of 5,000 mg/kg and 15,000 mg/kg, no mortality occurred. Additionally, no signs of toxicity were observed except for ruffled fur, decreased body weights and diarrhea at a dose level of 15,000 mg/kg (EU-RAR (2004)). Based on the rat data, the substance corresponds to "Not classified" with oral exposure.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - Classification not possible due to lack of data. Although there are reports of oral and inhalation tests in rats (EHC 221 (2001), EU-RAR (2004), IUCLID (2000)) (1953), these tests was conducted in an earlier time (in 1953), during which only one dose level was tested or only female rats were used. It is questionable that these data can be used as the basis of classification.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Category 1 Warning H400: Very toxic to aquatic life P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Classified into Category 1 since its 48h-LC50 = 0.098 mg Zn/L (0.122 mg/L as Zinc oxide) for Crustacea (Daphnia magna) (Initial Risk Assessment Report (NITE, CERI, NEDO), 2008).
11 Hazardous to the aquatic environment （Long-term） Category 1 Warning H410: Very toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Classified into Category 1 since its acute toxicity is Category 1 and the behavior in water is unknown from which it is a metal compound.
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.

Reference：
Reference Manual
Definitions / Abbreviations
Model Label by MHLW

 MHLW Website （in Japanese Only）
Model SDS by MHLW

 MHLW Website （in Japanese Only）

To GHS Information