NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	14807-96-6
Chemical Name	Talc (containing no asbestos or quartz)
Substance ID	m-nite-14807-96-6_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 present in the molecule associated with explosive properties.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified	- -	-	-	It is not combustible (ICSC (2006)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	It is not combustible (ICSC (2006)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is not combustible (ICSC (2006)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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))).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	It is an inorganic compound.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No established test method suitable for solid substances.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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 an LD50 value of > 5,000 mg/kg for rats (DFGOT vol. 22 (2006)), it was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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))	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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