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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	78-10-4
Chemical Name	Tetraethoxysilane
Substance ID	H26-B-065, R-026
Classification year (FY)	FY2014
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2006
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)
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	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
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.
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
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 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)).
10	Pyrophoric solids	Not applicable	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.
12	Substances and mixtures which, in contact with water, emit flammable gases	Classification not possible	- -	-	-	No data available.
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.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule
16	Corrosive to metals	Classification not possible	- -	-	-	No data 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	- -	-	-	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."
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."
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
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.
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.
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.
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 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.
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)).
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
8	Specific target organ toxicity - Single exposure	Category 1 (haemal 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).
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."
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 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."
11	Hazardous to the aquatic environment (Long-term)	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."
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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.

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