NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	142844-00-6
Chemical Name	Refractory ceramic fibers
Substance ID	m-nite-142844-00-6_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 associated with explosive properties present in the molecule.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified	- -	-	-	It is not combustible (ICSC(J) (2012)).	FY2016	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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	It is not combustible (ICSC(J) (2012)).	FY2016	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 (HSDB (Access on May 2016)).	FY2016	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 due to the observation result of being insoluble in water (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2014)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Classification not possible	- -	-	-	The substance is an inorganic compound containing oxygen, but the classification is not possible due to no data.	FY2016	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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2016	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)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	It is reported that in epidemiologic studies of ceramic-fiber production workers, a positive association between increased concentrations of airborne fibers and the development of skin irritation was observed (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2014), NIOSH (2006)). In addition, based on the observations of skin irritation due to exposure to this substance in multiple epidemiologic studies, NIOSH recommended that protective measures be implemented (NIOSH (2006)). Therefore, this substance was classified in Category 2.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	It is reported that in epidemiologic studies of ceramic-fiber production workers, a positive association between increased concentrations of airborne fibers and the development of eye irritation was observed (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2014), NIOSH (2006)). In addition, based on the observations of eye irritation due to exposure to this substance in multiple epidemiologic studies, NIOSH recommended that protective measures be implemented (NIOSH (2006)). Therefore, this substance was classified in Category 2.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	There is no in vivo data. As for in vitro data, results were negative in a bacterial reverse mutation test and in mammalian cell gene mutation tests, positive in micronucleus tests, and positive and negative in chromosome aberration tests (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2014), IARC 81 (2002), ECHA (Access on August 2016)). In the Risk Assessment Report by the Ministry of Health, Labour and Welfare (2014), it is concluded that the genotoxicity of this substance is secondary. From the above, this substance was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	The results of a US epidemiological study of workers exposed to this substance (refractory ceramic fibers (RCFs)) were deemed to be inadequate for evaluation of the cancer risk (IARC 81 (2002)). As for experimental animals, it is reported that in a study in which rats were exposed by whole-body inhalation to RCF (95 WHO fibers/cm3: approximately 90% of the fibers were < 3 micrometers in length and < 0.3 micrometers in diameter and the ratio of particles to fibers was approximately 4:1) at 10 mg/m3 for 12 months and were observed for up to 32 months, 8/48 animals developed pulmonary neoplasms (adenoma, carcinomas, and malignant histiocytomas); there were also eight benign and eight malignant tumors including peritoneal mesothelioma. It is reported that in two studies in which hamsters were exposed by nose-only inhalation to RCF (Fiberfrax: 200 fibers/cm3; GML: 22 micrometers; GMD: 0.9 micrometers; ratio of particles to fibers: 33:1) at 10.8 mg/m3 for 24 months or RCF1 (215 WHO fibers/cm3; GMD: 0.78 micrometers; GML: 15.9 micrometers) at 30 mg/m3 for 18 months, 1/70 animals in the former and 42/102 animals in the latter developed peritoneal or pleural mesotheliomas (IARC 81 (2002)). Furthermore, it is described that tumor incidences were related to fiber lengths and doses in tests by intraperitoneal administration to rats and hamsters (IARC 81 (2002)). From the above, IARC concluded that there is inadequate evidence in humans but sufficient evidence in experimental animals for the carcinogenicity of this substance, and thereby classified this substance in Group 2B (IARC 81 (2002)). In addition, the EPA classified this substance in B2 (IRIS Summary (1992)), and the Japan Society for Occupational Health classified man-made mineral fibers (ceramic fibers and micro glass fibers) in Group 2B (Recommendation of Occupational Exposure Limits (2015)). Meanwhile, the EU classified man-made fibers with alkaline oxide and alkali earth oxide (Na2O + K2O + CaO + MgO + BaO) content less or equal to 18 % by weight in Carc. 1B. On the basis that RCF meets the above condition, the EU classified this substance in Carc. 1B (ECHA SVHC Support Document (2011)). 　From the above, this substance corresponds to Category 2 based on the classification result of IARC, etc. However, considering the sufficient evidence for carcinogenicity in two species of experimental animals and the recent classification result by the EU, this substance was classified in Category 1B for this hazard class.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	As for humans, it is described that ceramic fibers including this substance cause temporary irritation of the upper respiratory tract among workers (ACGIH (7th, 2001) "Synthetic Vitreous Fibers"). Based on this information, ceramic fibers were classified in Category 3 (respiratory tract irritation) in the GHS classification of FY 2007. Therefore, this substance was classified in Category 3 (respiratory tract irritation).	FY2016	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	As for humans, it is reported that impaired lung function occurred in cohort studies in the US and Europe. In the US cohort study, the relative risk for 736 workers manufacturing refractory ceramic fibers of respiratory symptoms was 2.9 for men and 2.4 for women. In the European cohort study, obstruction of the airways associated with cumulative exposure to refractory ceramic fibers was limited to current and ex-smokers. In the update of this cohort, a negative association was found between cumulative exposure and lung function (IARC 81 (2002)). In addition, an excess of pleural plaques (thickened plaques) was observed in the European cohort of refractory ceramic fiber production workers, but a dose–response was not shown. In the US cohort, pleural abnormalities was found to be correlated with latency period and cumulated duration of exposure. For the highest classes of exposure duration (> 20 years), latency (> 20 years) and cumulative exposure (> 135 fibers/cm3–months), the odds ratios were 3.7, 6.1, and 6.0, respectively (IARC 81 (2002)). 　As for experimental animals, in a 12-month inhalation toxicity study using rats, macrophage infiltration and microgranulomas indicating inflammation of the lung were observed at or above 0.003 mg/L, which corresponds to Category 1 (IARC 81 (2002)). Therefore, this substance was classified in Category 1 (respiratory organs).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	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 available.	FY2016	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 available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2016	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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