GHS Classification Result （Revision of the past classification result）

Chemical Name：Titanium (IV) oxide
CAS：13463-67-7

Result：
ID: 21B3034
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 - - - - Classified into Not classified from the description of "Not combustible" (HSDB (2005), IUCLID (2000)).
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 - - - - Classified into Not classified from the description of "Not combustible" (HSDB (2005), IUCLID (2000)).
11 Self-heating substances and mixtures Not classified - - - - Classified into Not classified from the description of "Not combustible" (HSDB (2005), IUCLID (2000)).
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified - - - - Classified into Not classified from the description of "Stable in water" (IUCLID (2000)).
13 Oxidizing liquids Not applicable - - - - Solid (GHS definition)
14 Oxidizing solids Not classified - - - - Classified into Not classified since the substance does not have oxidizing properties (IUCLID (2000)).
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 - - - - A LD50 value of >20,000 mg/kg for rats (DFGOT (1991)) corresponds to "Not classified".
1 Acute toxicity （Dermal） Not classified - - - - An approximate LD50 value of >10000 mg/kg for rabbits (IUCLID (2000)) corresponds to "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 - - - - A LC value of 6.82 mg/L/4h for rats (IUCLID (2000)) corresponds to "Not classified".
2 Skin corrosion/irritation Not classified - - - - Based on results of "slightly irritating" when 0.5 g was applied to the skin of rabbits for 24-hour (IUCLID (2000)) and "not irritating" when 0.1 g was applied to the skin of rabbits for 24-hour (IUCLID (2000)), the substance was classified as "Not classified".
3 Serious eye damage/eye irritation Category 2B - Warning H320: Causes eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling. 		Based on a result of "mild irritation" in a rabbit test (IUCLID (2000)), the substance was classified into Category 2B. As relevant information, there is a result of "not irritating" in another test where the eyes were irrigated at 5 minutes after application (IUCLID (2000)).
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - There is a result of "not sensitizing" in a guinea pig maurer optimization test (IUCLID (2000)). In a 48-hour patch test with 290 dermatitis patients, no subjects reacted and no evidence of sensitization was found (IUCLID (2000)). Since the data are reported in a document in List 2 and the guinea pig test is not recommended for classification, classification was not possible due to lack of sufficient data.
5 Germ cell mutagenicity Not classified - - - - Based on negative results in a mouse bone marrow micronucleus test and a chromosomal aberration test by intraperitoneal administration (in vivo somatic cell mutagenicity tests) (NTP DB (2005)), the substance was classified as "Not classified". As relevant information, there is a report of a negative Chinese hamster SCE test (in vivo somatic cell genotoxicity test). From in vitro mutagenicity tests, there are reports of negative Ames tests and negative chromosomal aberration and mouse lymphoma tests (NTP DB (2005)).
6 Carcinogenicity Category 2 Warning H351: Suspected of causing cancer 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 ... 		Since IARC classified the substance into "Group 2" based on the data for ultrafine grades of titanium dioxide (particle size of 10 ? 50 nm) (IARC Monograph vol. 93, in preparation), the substance was classified into Category 2. In 103-week feeding tests in rats and mice, it was concluded that the substance was not carcinogenic for both species (NTP TR No. 97 (1979)). Chronic inhalation of ultrafine grades of titanium dioxide produced an increased incidence of lung tumors in rats but not in mice (PATTY (5th, 2001)). In contrast, the available case reports and epidemiological tests do not show clear evidence for this relationship with the substance (IARC 47 (1989), ACGIH (2001), HSDB (2005)).
7 Reproductive toxicity Classification not possible - - - - No data available.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - The oral lethal dose is >20,000 mg/kg (DFGOT (1991)) for rats. In humans, it is reported that ingestion of the substance is considered to be substantially non-toxic since the ingestion of 1 pound (453.6 g, 7560 mg/kg in body weight of 60 kg) did not cause any adverse effects and the substance was excreted into the feces within 24-hour (ACGIH (2001)). The substance corresponds to "Not classified" with oral exposure, however, classification was not possible due to lack of data with other exposure routes. Although there is a report that fumes irritate the respiratory tract (HDSB (2005)), the detailed data are not reported.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - In 4 oral tests in rats and mice by 13-week or 103-week feeding administration, no exposure-related effects were observed at a dose level of 25,000 ppm (1250 mg/kg/day). This dose level exceeds the upper limit of the guidance value range (NTP TR No. 97 (1979)), therefore, the substance corresponds to "Not classified" with oral exposure. X-ray examination of the lungs of workers exposed to the substance for more than 20 years, revealed very few cases with pneumonconiotic changes which were not associated with the changes in lung function (DFGOT vol. 12 (1999)). Numerous epidemiological tests have mainly been directed at the question of whether titanium dioxide has fibrogenic effects. Most of these results contradicted the causal relationship. There is insufficient evidence to show a clear association between the substance and pulmonary fibrosis (DFGOT vol. 12 (1999), ACGIH (2001), IARC vol. 47 (1989), PATTY (5th, 2001)). In a 2-year inhalation test in rats, no significant effects were observed at a dose level of 250 mg/m3 (5 days/week, 6 hour/day, dusts) which exceeds the upper limit of the guidance value range (IUCLID (2000)). The substance corresponds to "Not classified" with inhalation exposure, but classification was not possible due to lack of data with dermal exposure.
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 - - - - Classification not possible due to lack of data.
11 Hazardous to the aquatic environment （Long-term） Classification not possible - - - - Classification not possible due to lack of data.
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