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

Japanese



GENERAL INFORMATION
 
Item Information
CAS RN 78-10-4
Chemical Name Tetraethoxysilane
Substance ID m-nite-78-10-4_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) To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link) To Workplace Safety Site (MHLW)
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. FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2 Flammable gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products. FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
5 Gases under pressure Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6 Flammable liquids Category 3


Warning
H226 P303+P361+P353
P370+P378
P403+P235
P210
P233
P240
P241
P242
P243
P280
P501
It was classified in Category 3 based on a flash point of 37 deg C (Closed cup) (ICSC (1998)).
Besides, it is classified in Class 3, PG III (UN1292) in UNRTDG.
FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7 Flammable solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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. FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9 Pyrophoric liquids Not classified
-
-
- - It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 230 deg C (GESTIS (Access on August 2014)). FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10 Pyrophoric solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11 Self-heating substances and mixtures Classification not possible
-
-
- - Test methods applicable to liquid substances are not available. FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
12 Substances and mixtures which, in contact with water, emit flammable gases Classification not possible
-
-
- - No data available. FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
13 Oxidizing liquids Classification not possible
-
-
- - It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is chemically bonded to the element other than carbon or hydrogen (Si). However, the classification is not possible due to no data. FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
14 Oxidizing solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
15 Organic peroxides Not classified (Not applicable)
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
16 Corrosive to metals Classification not possible
-
-
- - No data available. FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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 reports of LD50 values of >2,000 mg/kg (OECD TG 401) (SIDS (2010)) and 6,270 mg/kg (PATTY (6th, 2012)) for rats, it was classified as "Not classified." FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1 Acute toxicity (Dermal) Not classified
-
-
- - Based on a report of an LD50 value of 6,300 microL/kg (=5,859 mg/kg) for rabbits (PATTY (6th, 2012)), it was classified as "Not classified." FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1 Acute toxicity (Inhalation: Gases) Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - Classification not possible due to lack of data. FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1 Acute toxicity (Inhalation: Dusts and mists) Not classified
-
-
- - Based on reports of LC50 values (4 hours) (OECD TG 403) (aerosol) of 10.0 mg/L (male), 16.8 mg/L (female) and >5.03 mg/L (SIDS (2010)) for rats, it was classified as "Not classified." Besides, since the application of an aerosol was clearly described in the test, the reference value as a mist was applied although the LC50 values were lower than the saturated vapor concentration (16.8 mg/L). A new information source (SIDS (2010)) was added, and the category was revised. FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2 Skin corrosion/irritation Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
In a skin irritation test (OECD TG 404) with rats, average scores of erythema and eschar 24, 48 and 72 hours after application were 3.00, 1.67, 2.22, respectively, and average scores of edema were 3.00, 2.00, 2.33, respectively, therefore, it was judged to be moderately irritating (SIDS (2010)). From the above result. it was classified in Category 2. FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3 Serious eye damage/eye irritation Category 2


Warning
H319 P305+P351+P338
P337+P313
P264
P280
There is a description that no irritation was observed in an eye irritation test with rabbits (OECD TG 405) (SIDS (2010)). In addition, there are multiple reports that it was severely irritating to the eyes in humans (PATTY (6th, 2012), HSDB (Access on July 2014)). Other than these, there is a description that it caused slight irritation to the eyes in humans (ACGIH (7th, 2001)). From the above results, although there is a result that there was no irritation in animals, there are multiple descriptions of "severe irritation'' in humans, therefore, it was classified in Category 2. Besides, this substance was classified as "Xi; R36" in the EU DSD classification, and as "Eye Irrit. 2 H319" in the CLP classification. FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data. FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4 Skin sensitization Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, there is a report that in a sensitization test (OECD TG 406) with guinea pigs, very slight erythema was observed in 2/10 and 3/10 animals during induction Phase I and II, respectively, whereas no irritation was observed during induction phase III and challenge phase (SIDS (2010)). However, since the number of animals did not meet the criteria of the GHS classification guidance for the Japanese government for judging "Not classified," the data was judged to be insufficient to be used in the classification. FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
5 Germ cell mutagenicity Classification not possible
-
-
- - Classification not possible due to lack of data. There is no in vivo data. As for in vitro, it was all negative in bacterial reverse mutation tests, a chromosomal aberration test and a sister chromatid exchange test with cultured mammalian cells (SIDS (2010), DFGOT vol. 3 (1992)). FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6 Carcinogenicity Classification not possible
-
-
- - Classification not possible due to lack of data. FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7 Reproductive toxicity Classification not possible
-
-
- - Classification not possible due to lack of data. FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
8 Specific target organ toxicity - Single exposure Category 1 (blood system), Category 3 (respiratory tract irritation, narcotic effects)



Danger
Warning
H370
H335
H336
P308+P311
P260
P264
P270
P321
P405
P501
P304+P340
P403+P233
P261
P271
P312
This substance is irritating to the respiratory tract in humans and experimental animals (ACGIH (7th, 2001), SIDS (2010), HSDB (Access on August 2014), DFGOT vol. 3 (1992), PATTY (6th, 2012)).
There are reports of severe anemia by an inhalation exposure (30 minutes) with experimental animals (guinea pigs) at 3,070 ppm (DFGOT vol. 3 (1992)), of dyspnea, tremor, central nervous system depression and delayed profound anemia by an inhalation exposure (4 hours) at 2,530 ppm (21.56 mg/L) (PATTY (6th, 2012)), and of narcotic effects at high concentrations (PATTY (6th, 2012)). In addition, although acute splenic atrophy and the renal tubulointerstitial nephritis were observed in surviving animals by an inhalation exposure to 1000 ppm (8.52 mg/L) with mice, no findings were obtained to indicate kidney disorders on blood chemical examinations (SIDS (2010)).
The findings of severe anemia in guinea pigs were observed within the guidance value range corresponding to Category 1, and central nervous system depression and the findings of the spleen and kidney were observed at concentrations exceeding Category 2.
From the above, it was classified in Category 1 (hemal system), Category 3 (respiratory tract irritation, narcotic effects).
FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9 Specific target organ toxicity - Repeated exposure Category 1 (respiratory organs), Category 2 (kidney)


Danger
Warning
H372
H373
P260
P264
P270
P314
P501
There were no adverse findings in humans. As for experimental animals, in a test in which rats were administered by gavage for at least 28 days, degenerative/necrotic nephropathy of the renal tubules were observed at or above 50 mg/kg/day (converted guidance value: 15.4 mg/kg/day (corresponding to Category 2)) (SIDS (2010)).
By the inhalation route, in a test in which mice were exposed by inhalation to this substance (estimated as a vapor) for 4 weeks, inflammation of the nasal mucosa at 50 ppm (425 mg/m3: converted guidance value: 0.13 mg/L/6 hours (corresponding to Category 1)), and tubulo-interstitial nephritis at 100 ppm (850 mg/m3: converted guidance value: 0.26 mg/L/6 hours (equivalent to Category 2)) were observed (SIDS (2010), PATTY (6th, 2012)).
Other than these, although there is a description in ACGIH, DFGOT and PATTY that in a test in which rats were exposed by inhalation at 400 ppm for 30 days, 11 out of 30 animals died, and in the surviving animals, damage in the liver, kidneys and lungs was observed with increased liver and kidney weights (ACGIH (7th, 2001), DFGOT vol. 3 (1992), PATTY (6th, 2012)), details of the results were unknown. At the same time, the authors conducted tests in which rats, guinea pigs and mice were exposed by inhalation at up to 88 ppm for 90 days, at concentrations up to 88 ppm, no effect was observed in any animal species other than a decreased kidney weight (no histological changes, with toxicological significance unknown) in mice (ACGIH (7th, 2001), DFGOT vol. 3 (1992), PATTY (6th, 2012)). Reporting year of the original source was as old as 1951, and in SIDS (2010), the report from the repeated inhalation test with rats, etc. was not used for hazard assessment because there was not a sufficient description to judge it as reliable. In other words, the results of the inhalation toxicity test with rats, which was regarded as one part of the evidence for the previous classification, were not appropriate to be used in classification, and it is considered that "liver" should be excluded from the target organ.
From the above, it was classified in Category 1 (respiratory organs), Category 2 (kidney). Besides, in this classification, based on the results of the inhalation exposure test with mice described in SIDS (2010) issued after implementation of the previous classification, the category of "respiratory organs" as the target organ was changed to "1."
FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10 Aspiration hazard Classification not possible
-
-
- - Classification not possible due to lack of data. FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

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 72-hour ErC50 > 100 mg/L for algae (Pseudokirchneriella subcapitata), 48-hour EC50 > 75 mg/L for crustacea (Daphnia magna), and 96-hour LC0 = 245 mg/L for fish (Oryzias latipes) (all SIDS, 2008), it was classified as "Not classified." FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11 Hazardous to the aquatic environment Long term (Chronic) Not classified
-
-
- - If chronic toxicity data are used, then it is classified as "Not classified" due to rapid degradability (a 28-day degradation rate by DOC = 98% (SIDS, 2008)), and 72-hour NOEC (growth rate) = 100 mg/L for algae (Pseudokirchneriella subcapitata) (SIDS, 2008).
If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" because it corresponds to "Not classified" in acute toxicity for crustacea and fish and is not water-insoluble (water solubility = 36910 mg/L, PHYSPROP Database, 2009).
From the above, it was classified as "Not classified."
FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in the Annexes to the Montreal Protocol. FY2014 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))


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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