NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	1306-38-3
Chemical Name	Cerium(IV) oxide
Substance ID	m-nite-1306-38-3_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Not classified	- -	-	-	Non-combustible solid (GESTIS (Access on July 2010))	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified	- -	-	-	Non-combustible solid (GESTIS (Access on July 2010))	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Not classified	- -	-	-	Non-combustible solid (GESTIS (Access on July 2010))	FY2010	GHS Classification Guidance by the Japanese Government （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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Inorganic compound	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

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	- -	-	-	Based on the rat LD50 value of > 5000 mg/kg bw (IUCLID (2000)), the substance was classified as "Not classified".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 2 (lung)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	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)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 1 (lung)	Danger	H372	P260 P264 P270 P314 P501	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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

ENVIRONMENTAL HAZARDS

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)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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