GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 14807-96-6 |
| Chemical Name | Talc (containing no asbestos or quartz) |
| Substance ID | H27-A-009, C-009A_P |
| Classification year (FY) | FY2015 |
| Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
| New/Revised | New |
| Classification result in other fiscal year | |
| Download of Excel format | Excel file |
REFERENCE INFORMATION
| Item | Information |
|---|---|
| Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| UN GHS document (External link) | UN GHS document |
| Definitions/Abbreviations (Excel file) | Definitions/Abbreviations |
| Model Label by MHLW (External link) | MHLW Website (in Japanese Only) |
| Model SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
| OECD/eChemPortal (External link) | eChemPortal |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Explosives | Not applicable |
- |
- | - | There are no chemical groups present in the molecule associated with explosive properties. |
| 2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 3 | Aerosols | Not applicable |
- |
- | - | Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 5 | Gases under pressure | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 6 | Flammable liquids | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 7 | Flammable solids | Not classified |
- |
- | - | It is not combustible (ICSC (2006)). |
| 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 |
- |
- | - | "Solids" according to GHS definition. |
| 10 | Pyrophoric solids | Not classified |
- |
- | - | It is not combustible (ICSC (2006)). |
| 11 | Self-heating substances and mixtures | Not classified |
- |
- | - | It is not combustible (ICSC (2006)). |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not classified |
- |
- | - | It is estimated that it does not react vigorously with water from water solubility data measured (water solubility: not soluble (20 degrees C) (GESTIS (Access on June 2015))). |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 14 | Oxidizing solids | Classification not possible |
- |
- | - | It is an inorganic compound does not contain halogen but contains oxygen, however, the classification is not possible due to no data. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | It is an inorganic compound. |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | No established test method suitable for solid substances. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Not classified |
- |
- | - | Based on an LD50 value of > 5,000 mg/kg for rats (DFGOT vol. 22 (2006)), it was classified as "Not classified." |
| 1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 2 | Skin corrosion/irritation | Classification not possible |
- |
- | - |
The classification is not possible due to lack of data. Besides, there is the information that irritation was not observed after 3-day occlusive application of this substance in 5 volunteers (DFGOT vol. 22 (2006)), but the details are unknown without further description. |
| 3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - |
The classification is not possible due to lack of data. Besides, it is described that despite the widespread cosmetic use of this substance and experiments conducted in volunteers for this substance, it was not reported yet that this substance is allergic (DFGOT vol. 22 (2006)). It is described that latex allergy caused by rubber gloves is attributed to starch powder, not talc. (DFGOT vol. 22 (2006)) |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - |
Due to no option of "Not classified" in the revised Classification Guidance, it was classified as "Classification not possible." As for in vivo, it is reported that a chromosomal aberration test using rat bone marrow cells and a dominant lethal test were negative (IARC (1987), ACGIH (7th, 2010), DFGOT vol.22 (2006)). As for in vitro, a reverse mutation test using bacteria, a chromosomal aberration test using cultured human cells and a sister chromatid exchange test and an unscheduled DNA synthesis test using cultured rat cells were all negative (IARC (1987), ACGIH (7th, 2010), DFGOT vol.22 (2006)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - |
For the initial epidemiological surveys, in cohort studies of humans occupationally exposured to talc (containing quartz) not containing asbestos fibers, mesothelioma was not observed in 4 out of 5 studies. The lung tumor incidence in the highest exposure group in the two cohort studies of high-level cumulative exposure to talc was lower than that of integrated data from all five studies (IARC 93 (2010)). On the other hand, in one cohort study report, an increased incidence of the lung tumor was observed in a subgroup, but the group was exposed together to radon and quartz and increased incidence of the lung tumor was not found in a whole cohort (IARC 93 (2010)). Besides, also in a case-control study nested in the combined cohorts, a tendency of higher risk for lung cancer by increasing cumulative inhalation exposure to talc dust was not shown (IARC 93 (2010)). Also in experimental animals, rats or mice were exposured by inhalation (6 or 18 mg/m3) to highly pure talc (not containing fiber component and asbestiform inorganic) with smaller particle size (particle size not more than ten micro m) for not less than two years in a carcinogenicity test. There was no increased incidence of the lung tumor in either species, and especially in rats, an increased incidence of lung tumor was not observed even at the dose (18 mg/m3) at which non-neoplastic lesions were found notably in the lung (IARC 93 (2010), ACGIH (7th, 2010), NTP TR421 (1993)). On the other hand, in the U.S. and Europe, talc-based body powder has been applied to the perineum and sexual organ through sanitary napkins and diaphragms. IARC reviewed one prospective cohort study and 19 case-control studies as a whole. It is considered that the increased relative risk for ovarian cancer associated with the use of cosmetic talc was shown in many of the study reports. It is considered that the evidence for retrograde transport of topically applied talc to the ovaries in healthy women is weak, however, in women with impaired clearance function by surgery and so on, some evidence for retrograde migration was found. Therefore, IARC concluded that there is limited evidence of increased risk for ovarian cancer by perineal use of talc-containing body powder (IARC 93 (2010)). From the above, IARC classified talc not containing asbestos or asbestiform fibers in Group 3 for an inhalation route and in Group 2B for perineal application of talc-based body powder (IARC 93 (2010)). ACGIH classified the substance in A4 for carcinogenicity by limiting only to occupational exposure even though they took carcinogenicity evaluation results by IARC into account (ACGIH (7th, 2010)). In this evaluation, IARC's "Group 2B in perineal use of talc-based products" was judged to be the carcinogenicity classification result for the highly limited special use and application route of this substance, therefore, that was removed from the view point of comprehensive evaluation for the classification of this hazard class. Furthermore, the IARC classification results in an inhalation route and the ACGIH classification results were judeged to be appropriate and talc not containing asbestos (or asbestiform fibers, inorganic) was classified as "Classification not possible" in this hazard. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - |
The classification is not possible due to lack of data. Besides, it is described that in studies where talc (component information not disclosed) was orally administered to rats or mice at 1,600 mg/kg/day on day 6 to 15 of gestation, or to rabbits at 900 mg/kg/day on day 6 to 18 of gestation, teratogenicity was negative (DFGOT vol. 22 (2006), ACGIH (7th, 2010)). |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (respiratory organs) |
 Danger |
H370 |
P308+P311
P260 P264 P270 P321 P405 P501 |
A little information shows acute effects of this substance. As for human, in an accident where an infant inhaled talc (detailed information such as concentration is unknown), cough, sneezing, dyspnea, shortness of breath, vomiting, foreign-body reaction (unknown details), overload of the lung, respiratory disorder, and pneumonia were reported (DFGOT vol. 22 (2006)). As for experimental animals, after intratracheal injection of this substance (using granite (12% quartz) and talc dust (quartz and asbestos-free) collected from workplaces in Vermont, where relatively highly-pure talc occurs) to hamsters at 0.15, 3.75 mg/100g body weight, the following was reported (ACGIH (7th, 2010)): Elevated enzyme levels (unknown details), pulmonary edema and inhibition of macrophage phagocytosis occurred one day after the injection. Two weeks after exposure, a granite-exposed group recovered rapidly, but a group exposed to talc dust continued to experience elevated enzyme levels (unknown details) and inhibition of macrophage phagocytosis. From the above, although data in experimental animals and humans are limited, the substance was classified in Category 1 (respiratory organs) because effects on the respiratory organs is a concern. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (respiratory organs) |
Danger |
H372 |
P260
P264 P270 P314 P501 |
For an inhalation route, it is reported that in humans, occupational exposure caused lung function disorder and an increasing prevalence rate of lung shadow in x-ray examination (ACGIH (7th, 2010)). Therefore, it was classified in Category 1 (respiratory organs). Besides, as for experimental animals, in a 113 to 122-week inhalation toxicity test using rats, lesions in the lung (granulomatous inflammation, interstitial fibrosis, hyperplasia of alveolar epithelium, cysts, and alveolar squamous metaplasia) were observed at 0.006 or 0.018 mg/L. In a 24-month inhalation toxicity test using mice, lesions in the lung (chronic inflammation, accumulation of macrophages) were found at 0.006 mg/L or higher (ACGIH (7th, 2010)). These findings were observed at the doses above the range of Category 2. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Classification not possible |
- |
- | - | No data. |
| 11 | Hazardous to the aquatic environment (Long-term) | Classification not possible |
- |
- | - | No data. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data. |
NOTE:
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* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * 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. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals iGHSj in United Nations. |