NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	2530-83-8
Chemical Name	2-{[3-(Trimethoxysilyl)propoxy]methyl}oxirane
Substance ID	R02-A-001-METI, MOE
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)/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 (FY2019 revised edition (Ver. 2.0))
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)
Model SDS by MHLW (External link)
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 classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Not classified	- -	-	-	A flash point was 122 deg C (closed-cup) (GESTIS (Accessed June 2020)).
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with self-reactive properties (epoxides) present in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 400 deg C (GESTIS (Accessed June 2020)).
10	Pyrophoric solids	Not classified (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	- -	-	-	It contains a metalloid (Si) and decomposes in water (GESTIS (Accessed June 2020)), but the classification is not possible due to no data.
13	Oxidizing liquids	Classification not possible	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine), which 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 classified (Not applicable)	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (6). [Evidence Data] (1) LD50 for rats: 8,018 mg/kg (7.5 mL/kg) (SIDS (2004), REACH registration dossier (Accessed May 2020)) (2) LD50 for rats: > 5,345 mg/kg (5 mL/kg) (SIDS (2004)) (3) LD50 for rats: 7,010 mg/kg (SIDS (2004)) (4) LD50 for rats: 8,400 mg/kg (SIDS (2004)) (5) LD50 for rats (males): 24,159 mg/kg (22.6 mL/kg) (SIDS (2004)) (6) LD50 for rats: 16,900 mg/kg (SIDS (2004))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) LD50 for rabbits: 6,800 mg/kg (SIDS (2004)) (2) LD50 for rabbits (males): 4,244 mg/kg (3.97 mL/kg) (SIDS (2004), REACH registration dossier (Accessed May 2020))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	[Rationale for the Classification] From the saturated vapor concentration of 0.02 mg/L (vapor pressure 0.003 hPa) (SIDS (2004)), a reference for mist was applied for (1), (2). Because dead animals were not found at any exposure in (1), (2), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats (4 hours): > 5.3 mg/L (SIDS (2004), REACH registration dossier (Accessed May 2020)) (2) LD50 for rats (4 hours): > 2.7 mg/L (SIDS (2004))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (3). [Evidence Data] (1) It is reported that in a skin irritation test with rabbits (n = 6) (OECD TG 404, GLP, semi-occlusive, 4-hour application, 14-day observation), slight irritation was observed in all the animals, which resolved completely after 14 days (erythema/eschar score: 1.7/1.7/1.7/1/1/1.3, edema score: 1.3/0.3/0.3/0/0/0.3) (REACH registration dossier (Accessed May 2020)). (2) It is reported that in a skin irritation test with rabbits (n = 6) (semi-occlusive, 24-hour application, 96-hour observation), erythema was found in all the animals 24 and 48 hours after removal of patches and persisted for 96 hours, but no edema was seen (erythema/eschar score: 1.7/2/1.7/2/2/2, edema score: 0.7/0/0/0/0/0) (SIDS (2004), REACH registration dossier (Accessed May 2020)). (3) It is reported that in a skin irritation test with rabbits (n = 4) (semi-occlusive, 24-hour application, 72-hour observation), skin primary irritation index (PII) = 0.06 (Non-irritant) (SIDS (2004), REACH registration dossier (Accessed May 2020)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] It was classified in Category 1 from (1), (2). [Evidence Data] (1) It is reported that in an eye irritation test with rabbits (n = 18) (OECD TG 405, 21-day observation), pannus of the cornea was seen in two animals, corneal opacities, covering a minimal area of the cornea, persisted for 21 days (SIDS (2004), REACH registration dossier (Accessed May 2020)). (2) It is reported that in an eye irritation test with rabbits (n = 6) (OECD TG 405, GLP, 21-day observation), irritation was observed in all the animals, and there was severe irritation/corrosion to the eyes in four of them (corneal opacity score: 2.5/4/2.5/2.7/2.5/2.5, iritis score: 1/1/1/1/1/1, conjunctival redness score: 1.7/1.8/2.6/2/1.5/1.5, chemosis score: 2.7/3.3/3.7/3/3.3/3.7) (REACH registration dossier (Accessed May 2020)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (3). [Evidence Data] (1) It is reported that in a patch test in 100 persons, after induction by a 1% solution of this substance (infrascapular part of the back, semi-occlusive, 24-hour application, 9 applications in 30 days) and challenge after 10-15 days (1% solution, semi-occlusive, 24-hour application), no sensitization reactions were seen 24, 48 hours after the removal of patches (SIDS (2004), REACH registration dossier (Accessed May 2020)). (2) It is reported that in a Buehler test with guinea pigs (n = 20) (OECD TG 406, GLP, topical application: undiluted), no sensitization reactions were observed in all the animals (SIDS (2004), REACH registration dossier (Accessed May 2020)). (3) It is reported that in a maximization test with guinea pigs (n = 20) (OECD TG 406, GLP, intradermal application: 10% solution), no sensitization reactions were found in all the animals (SIDS (2004), REACH registration dossier (Accessed May 2020)).
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) to (5), it was classified in Category 2. [Evidence Data] (1) In micronucleus tests with bone marrow cells of mice, negative results (oral administration in undiluted form and intraperitoneal administration as a suspension in corn oil) and positive results (intraperitoneal administration in distilled water) were reported. This substance is subject to rapid hydrolysis (SIDS (2004)). (2) In a rat comet assay (OECD TG489, GLP; oral administration as a suspension in corn oil), positive results (liver, duodenum and glandular stomach) were reported (REACH registration dossier (Accessed May 2020)). (3) In bacterial reverse mutation tests, positive results were reported (SIDS (2004)). (4) In mammalian cell gene mutation tests, positive results (mouse lymphoma cells) and negative results (CHO cells) were reported (SIDS(2004)). (5) In in vitro sister chromatid exchange tests, positive results were reported (SIDS (2004)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Because there was no finding on rats, and there was no sufficient finding on mice, it was classified as "Classification not possible" due to lack of data. [Reference Data, etc.] (1) In a lifetime dermal administration test using C3H mice, male mice were dermally exposed for life to 0.2 mL of an acetone solution containing 25% of this substance (3 times/week). As a result, there was no increase in tumor incidence related to the exposure to this substance. However, it should be noted that in this test, there was only one dose level and this dose was relatively low (SIDS (2004)).
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified". [Evidence Data] (1) In a one-generation reproduction toxicity study with rats dosed by gavage (OECD TG415, GLP, (males) for a 70-day pre-pairing period, during the pairing period and until the last litter had reached day 7 post partum, (females) during a 14-day pre-pairing period, and also during the pairing, gestation and lactation periods), it was reported that no reproduction toxicity was observed at 1,000 mg/kg/day (SIDS (2004), REACH registration dossier (Accessed May 2020)). (2) In a developmental toxicity study with rats dosed by gavage (OECD TG414, GLP, 6 to 15 gestation days), it was reported that no developmental toxicity was observed at 1,000 mg/kg/day (SIDS (2004)). (3) In a developmental toxicity study with rats dosed by gavage (OECD TG414, GLP, 6 to 15 gestation days), it was reported that at 3,000 mg/kg/day, the parent animals exhibited retardation of body weight gain, a decrease in food consumption, and clinical signs (hypoactivity, audible respiration, unkempt appearance), while the fetuses exhibited only slight effects (increased incidence of unossified anterior arch of the atlas) (SIDS (2004)). (4) In a developmental toxicity study with rabbits dosed by gavage, (OECD TG414, GLP, 6 to 18 gestation days), it was reported that no developmental toxicity was observed at 400 mg/kg/day (SIDS (2004)).
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 3 (respiratory tract irritation). [Evidence Data] (1) It was reported that in a single inhalation (mist) exposure test using rats, the rats exposed to the concentration of 0.8 to 5.3 mg/L exhibited dose-related signs such as lacrimation, dry/moist rales, the nasal discharge and yellow staining in the anal-genital area (SIDS (2004), REACH registration dossier (Accessed May 2020)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified" in the oral route. Based on (2), in the range as Category 1 in the inhalation route, respiratory signs occurred, but microscopic examination revealed no histopathological effects or respiratory tract effects. Therefore, it was classified as "Not classified" in the oral route, but since there was no sufficient information available for classification in the other route, it was classified as "Classification not possible" due to lack of data. [Evidence Data] (1) It was reported that in a 4-week oral administration test with rats dosed by gavage (5 days/week), no effects were observed at 1000 mg/kg/day (converted value：225 mg/kg/day, in the range corresponding to "Not classified"), (SIDS (2004), REACH registration dossier (Accessed July 2020)) [Reference Data, etc.] (2) It was reported that in a 2-week inhalation exposure test using rats (6 hours/day, 9 times in total), the rats exhibited respiratory signs (nasal discharge, dry/moist rales) at 0.225 mg/L (converted guidance value：0.0225 mg/L, within the guidance value range for Category 2), and some rats exhibited body weight reduction, died or were sacrificed in a moribund state at 0.075 mg/L (converted guidance value：0.0075 mg/L, within the guidance value range for Category 1). (SIDS (2004), REACH registration dossier (Accessed July 2020))
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] 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 Short term (Acute)	Category 3	- -	H402	P273 P501	It was classified in Category 3 from 96-hour LC50 = 55 mg/L for fish (Cyprinus carpio) (SIAR, 2004).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	If chronic toxicity data are used, then it is classified as "Not classified" because it is not rapidly degradable (BIOWIN) and due to 21-day NOEC >= 100 mg/L for crustacea (Daphnia magna) (SIAR, 2004). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 3 because it is not rapidly degradable (BIOWIN) and due to 96-hour LC50 = 55 mg/L for fish (Cyprinus carpio) (SIAR, 2004). By drawing a comparison between the above results, it was classified in Category 3.
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.
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.

To GHS Information