NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	1318-02-1
Chemical Name	Zeolites
Substance ID	m-nite-1318-02-1_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 (GL Science SDS (Access on May 2016)).	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 (GL Science SDS (Access on May 2016)).	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 (GL Science SDS (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 (GL Science SDS (Access on May 2016)).	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	- -	-	-	It 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)	Not classified	- -	-	-	This substance is crystalline, non-fibrous synthetic zeolite, to which zeolite A (Na12[(AlO2)12(SiO2)12]27H2O, CAS RN 1344-00-9), zeolite P (Na6[(AlO2) 6(SiO2)6]15H2O), zeolite X (Na86[(AlO2)86(SiO2)106]264H2O), and zeolite Y (Na56[(AlO2)56(SiO2)136]250H2O) correspond. For the information in which a type of zeolite was specified, it was mentioned in rationale for the classification (SIDS (2006)). 　　It is reported that LD50 values in rats were > 2,000 mg/kg, > 5,000 mg/kg, > 5,110 mg/kg, > 16,520 mg/kg, > 27,400 mg/kg, > 31,600 mg/kg for zeolite A, > 2,000 mg/kg for zeolite X and 31,600 mg/kg for zeolite Y (SIDS (2006)). Based on the above, it was classified as "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the LD50 value of > 2,000 mg/kg (SIDS (2006), DFGOT Vol.56 (2014)) (in German)) for rabbits, this substance was classified as "Not classified."	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)	Not classified	- -	-	-	Based on the 4-hour LC50 value of > 14 mg/L (as zeolite A) (SIDS (2006)) for rats, this substance was classified as "Not classified." 　Although LC50 values of rats were reported as >18.3 mg/L (one hour) (converted 4-hour equivalent value: > 4.5 mg/L) and > 2.8 mg/L (one hour) (converted 4-hour equivalent value: > 0.7 mg/L) for zeolite A, > 2.3 mg/L (one hour) (converted 4-hour equivalent value: > 0.6 mg/L) for zeolite Y (SIDS (2006)), they were not adopted as the evidence for classification since category could not be specified.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	Based on a report that in a test using rabbits (OECD TG 404), there was no irritation (SIDS (2006)), it was classified as "Not classified" (Category 3 in UN GHS classification).	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	In eye irritation tests using rabbits, moderate eye irritation was observed, but all irritation reactions recovered within 7 days (SIDS (2006), DFGOT Vol.56 (2014)). 　Therefore, it 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. 　Besides, there is a report that in skin sensitization tests using guinea pigs, no sensitization was observed (SIDS (2006)). However, since test conditions or details of the results etc. were unknown, the data was judged to be inadequate for classification.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	As for in vivo, both a dominant lethal test and a chromosomal aberration test using rats for synthetic zeolite A, and a micronucleus test using mice for synthetic zeolite X were negative (SIDS (2006)). 　As for in vitro, bacterial reverse mutation tests using synthetic zeolite A and X, and a mouse lymphoma test using mammalian cultured cells with synthetic zeolite X, were negative, and a mammalian cell chromosomal aberration test using synthetic zeolite X, was positive (SIDS (2006)). It is concluded that there is no inducibility of chromosomal aberrations from this substance because two of the in vivo tests (chromosomal aberration and micronucleus) were negative (SIDS (2006)). 　Besides, as for natural zeolite, it is reported that an in vivo chromosomal aberration test using mouse bone marrow cells was weak positive, and that an in vivo chromosomal aberration test on mouse peritoneal lavage samples (polymorphonuclear leukocytes, macrophages, lymphocytes) was positive (IARC 68 (1997)). However, the IARC working group described that the test method used in this finding was not normally used, so it was not adopted as the evidence for classification. From the above, it was classified as "Classification not possible" according to the GHS classification guidance for the Japanese Government.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	There is no available data on human carcinogenicity. 　As for experimental animals, as a result of a 2-year administration by oral (in the diet) or inhalation using rats with synthetic zeolite A, no increase in the incidences of tumors was observed (IARC 68 (1997)). 　Moreover, as a result of inhalation of synthetic zeolite A in cynomolgus monkeys for up to 2 years, inflammatory changes and macrophage accumulation in the lungs only were observed, while neoplastic change was not observed (SIDS (2006)). 　In addition, in any of the tests in which a non-fibrous zeolite was injected intrapleurally in rats, tests in which synthetic zeolite was intraperitoneally injected into mice, or intraperitoneally, intrapleurally, or subcutaneously injected into rats (single dose in every tests), no increase in the incidences of tumors was indicated (IARC 68 (1997)). 　Based on the above results, IARC classified zeolite as Group 3 (IARC 68 (1997)). 　Therefore, this substance was classified as "Classification not possible."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	In developmental toxicity tests, in which synthetic zeolite A was administered by gavage to pregnant rats or rabbits during their organogenesis period (rats: 6 to 15 days of gestation, rabbits: 6 to 18 days of gestation) at doses of up to 1,600 mg/kg/day in both species, no adverse effects were observed (IARC 68 (1997), SIDS (2006)). 　Therefore, zeolite did not induce either maternal toxicity or developmental toxicity. However, there were no test results investigating the effect on fertility and sexual function, so it was classified as "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	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))
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	No data were available on humans. 　As for experimental animals, in the inhalation route, in a 6-month repeated inhalation toxicity study of synthetic zeolite A using monkeys, macrophage accumulation in the lungs, bronchiolitis and alveolitis were observed at 1 mg/m3, which is within the range of Category 1 (SIDS (2006)). 　In the oral route, repeated dose toxicity tests using rats administered by feed with zeolite A for 90 days, 200 days, or 104 weeks were conducted, and no effect was observed in the range up to Category 2 (SIDS (2006)). 　Therefore, it 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)	Not classified	- -	-	-	From 96-hour EC50 = 377.17 mg/L for crustacea (Daphnia magna) (AQUIRE, 2016; Maki, 1979), it was classified as "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Although environmental dynamics of the inorganic compound is unknown, due to 21-day NOEC = 200 mg/L for crustacea (Daphnia magna), and 21-day NOEC (lethal, growth, hatch) = 175 mg/L for fish (Pimephales promelas) (AQUIRE, 2016; Maki, 1979), it was classified as "Not classified."	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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