GHS Classification Result

Chemical Name：Cerium(IV) oxide
CAS：1306-38-3

Result：
ID: 22A4064
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government （July, 2010）

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 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 solids Not classified - - - - Non-combustible solid (GESTIS (Access on July 2010))
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 - - - - Non-combustible solid (GESTIS (Access on July 2010))
11 Self-heating substances and mixtures Not classified - - - - Non-combustible solid (GESTIS (Access on July 2010))
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified - - - - Although it contains a metal (Ce), the substance is insoluble (Merck (14th, 2006), (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) Vol. 8 (2010))), and it is considered that the substance doesn't react strongly with water.
13 Oxidizing liquids Not applicable - - - - Solid (GHS definition)
14 Oxidizing solids Classification not possible - - - - Although the substance is inorganic compound containing oxygen (but not halogen), classification is not possible due to lack of data.
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 the rat LD50 value of > 5000 mg/kg bw (IUCLID (2000)), the substance was classified as "Not classified".
1 Acute toxicity （Dermal） Not classified - - - - Based on the result that administration of 2000 mg/kg bw to rats caused no mortality, and LD50 value was > 2000 mg/kg bw (IUCLID (2000)), the substance was classified as "Not classified".
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 the rat LC50 value of 5.05 mg/L (OECD TG 403) (IUCLID (2000)), the substance was classified as "Not classified" in the JIS classification (corresponding to Category 5 in the UN-GHS classification). According to the description that the test particles which was less than 3 micrometer in particle diameter were account for 85.4% (IUCLID (2000)), the criterion values for dust/mist were adopted.
2 Skin corrosion/irritation Not classified - - - - In the rabbit test (OECD TG404), application of 0.5 g of test substance caused no irritation (IUCLID (2000)). In another rabbit test, the primary skin irritation index value was 0.0 and it was concluded that the substance was not irritating (IUCLID (2000)). Based on the information, the substance was classified as "Not classified".
3 Serious eye damage/eye irritation Not classified - - - - In the rabbit test (OECD TG405), instillation of 0.1 g of test substance to eye resulted in non-irritating (IUCLID (2000)). In another rabbit test, slightly irritating was reported (IUCLID (2000)). Based on the information, the substance was classified as "Not classified".
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - In the maximization test using guinea pigs (OECD TG406), no reaction of sensitization was observed after elicitation, and concluded as a non-sensitizer (IUCLID (2000)). However, since it was the "List 2" information source designated in the GHS classification guidance for the Japanese government, the substance was classified as "Classification not possible".
5 Germ cell mutagenicity Not classified - - - - The substance was classified as "Classification not possible" due to the negative results in the micronucleus test (OECD TG474) using bone marrow cells of mice orally administered (in vivo mutagenicity test in somatic cells) (IUCLID (2000)). As relevant information, as for in vitro study, negative results in the Ames test were reported (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment), vol. 8 (2010)).
6 Carcinogenicity Classification not possible - - - - No data were available. As relevant information, the US EPA reports that the data of this substance are insufficient to evaluate the possibility of carcinogenicity in humans under the carcinogenicity risk assessment guidelines (IRIS (2009) Tox Review).
7 Reproductive toxicity Classification not possible - - - - No data available.
8 Specific target organ toxicity - Single exposure Category 2 (lung) Warning H371: May cause damage to organs (lung) P309+P311: IF exposed or if you feel unwell: 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.
P405: Store locked up.
P501: Dispose of contents/container to ... 		In the acute inhalation study in rats exposed to dust for 4 hours at the range of concentrations from 4.12 to 5.98 mg/L (OECD TG 433, GLP-compliant), labored respiration and ruffled fur were noted in two of ten animals, and the lungs of all animals were incompletely collapsed with diffuse whitish foci (IUCLID (2000)). Based on these findings observed in the concentration corresponding nearly to the upper limit within Category 2 of the guidance values, the substance was classified as Category 2 (lung). In addition, in the acute oral toxicity study in rats administered up to 5000 mg/kg bw, no mortality was recorded, body weight gain was normal, and no abnormalities were observed at necropsy (IUCLID (2000)).
9 Specific target organ toxicity - Repeated exposure Category 1 (lung) Danger H372: Cause damage to organs through prolonged or repeated exposure (lung) 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.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ... 		In the lungs of the workers exposed for many years to the fumes of rare-earth elements such as cerium, accumulation of rare-earth elements was observed, and lung lesions such as granuloma, emphysema, or interstitial fibrosis and decrease of pulmonary breathing capacity were reported (Initial Environment Risk Assessment of Chemicals (Ministry of Environment), vol. 8 (2010)). Many reports were published describing long-term residue of rare earth elements in lung and numerous cases of workers who developed adverse lung effects associated with cerium oxide as follows. In the case of the 58-year-old worker who came to hospital complaining of dyspnea at least 15 years after exposures to cerium oxide polishing agents, slight pleural thickening, and pulmonary obstruction were noted. He was diagnosed by histopathological examination as chronic pachypleuritis (Initial Environment Risk Assessment of Chemicals (Ministry of Environment), vol. 8 (2010)). In the case of 68-year-old man who was engaged in the abrasive operation of the optical lens for 35 years, rare earth pneumoconiosis associated with cerium oxide exposure was identified after 13 years of separation of work (PATTY, 5th (2001)). On the other hand, in the 13-week repeated inhalation study in rats exposed to dust, enlargement and discoloration of diaphragm in approximately half of the animals, changes of bronchial lymph nodes in all animals were found at 5 mg/m3 or higher, and discoloration of the lungs in all animals at 51 mg/m3 or higher at necropsy. Histopathologically, lymphoid hyperplasia and pigmentation in the bronchial lymph nodes, and pigmentation in the lung were noted at 5 mg/m3 or higher in both sexes, and alveolar epithelial hyperplasia in the lungs and metaplasia and pigmentation in the larynx were noted at 51 mg/m3 or higher in both sexes (Initial Environment Risk Assessment of Chemicals (Ministry of Environment), vol. 8 (2010)). These effects were observed at doses within Category 1 of the guidance values. Based on the findings for both humans and experimental animals, the substance was classified as Category 1 (lung).
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） Classification not possible - - - - No data available.
11 Hazardous to the aquatic environment （Long-term） Classification not possible - - - - No data available.
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）

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