GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 1318-02-1
Chemical Name Zeolites
Substance ID H28-A-005, C-016A
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 (GL Science SDS (Access on May 2016)).
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 (GL Science SDS (Access on May 2016)).
11 Self-heating substances and mixtures Not classified
-
-
- -  It is not combustible (GL Science SDS (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 (GL Science SDS (Access on May 2016)).
13 Oxidizing liquids Not applicable
-
-
- -  Solid (GHS definition).
14 Oxidizing solids Classification not possible
-
-
- -  It 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) 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."
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."
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) 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.
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).
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.
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.
 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.
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.
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."
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.
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- -  Classification not possible due to lack of data.
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).
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) Not classified
-
-
- -  From 96-hour EC50 = 377.17 mg/L for crustacea (Daphnia magna) (AQUIRE, 2016; Maki, 1979), it was classified as "Not classified."
11 Hazardous to the aquatic environment (Long-term) 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."
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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