GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 142844-00-6
Chemical Name Refractory ceramic fibers
Substance ID H28-A-066, C-125A
Classification year (FY) FY2016
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

PHYSICAL HAZARDS
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 associated with explosive properties present in the molecule.
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
-
-
- -  It is not combustible (ICSC(J) (2012)).
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
-
-
- -  It is not combustible (ICSC(J) (2012)).
11 Self-heating substances and mixtures Not classified
-
-
- -  It is not combustible (HSDB (Access on May 2016)).
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)).
13 Oxidizing liquids Not applicable
-
-
- -  Solid (GHS definition).
14 Oxidizing solids Classification not possible
-
-
- -  The substance is an inorganic compound containing oxygen, but 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
-
-
- -  Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Classification not possible
-
-
- -  Classification not possible due to lack of data.
1 Acute toxicity (Dermal) Classification not possible
-
-
- -  Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- -  Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- -  Solid (GHS definition)
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- -  Classification not possible due to lack of data.
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.
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.
4 Respiratory sensitization Classification not possible
-
-
- -  Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- -  Classification not possible due to lack of data.
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.
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.
7 Reproductive toxicity Classification not possible
-
-
- -  Classification not possible due to lack of data.
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).
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).
10 Aspiration hazard Classification not possible
-
-
- -  Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS
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 available.
11 Hazardous to the aquatic environment (Long-term) Classification not possible
-
-
- -  No data available.
12 Hazardous to the ozone layer Classification not possible
-
-
- -  No data available.


NOTE:
* 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 (GHS) in United Nations.

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