NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	91-53-2
Chemical Name	6-Ethoxy-1,2-dihydro-2,2,4-trimethylquinoline; Ethoxyquin
Substance ID	m-nite-91-53-2_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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	Based on the rat LD50 value of 1700 mg/kg bw (JMPR (1998)), the substance was classified into Category 4.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the rat LD50 value of > 2000 mg/kg bw (JMPR (1998)), the substance was classified as "Not classified" in the JIS classification (corresponding to Category 5 or "Not classified" in the UN-GHS classification).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	The classification was not possible due to lack of sufficient data. Although the rat LC50 value of > 2.0 mg/L was reported (JMPR (1998)), exposure time was not described. The saturated vapor pressure concentration at room temperature was 0.0015 mg/L, the criterion values for mist were adopted.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Not classified	- -	-	-	The substance was classified as "Not classified" based on the documented case that slight erythema without edema was observed and desquamation were noted at 7 days after application in the rabbit test (JMPR (1998)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	The substance was classified as Category 2B based on the documented case that the transient conjunctival redness and chemosis was noted, but symptoms were all reversible within 4 days (JMPR (1998)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	The substance which was used in animal feed as an antioxidant caused contact dermatitis to feed flour milling worker, and reported as a sensitizer (Contact Dermatitis, Frosch, 4th (2006)). Based on this information, the substance was classified as Category 1. As relevant notes, a number of reports indicated that the substance has been the probable cause of severe dermatitis often seen in workers who handle animal feed containing the substance. Positive results in patch tests were recorded in workers (JMPR (1998)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	The classification was concluded as "Not classified" based on the negative results in the micronucleus test using bone marrow obtained from mice orally administered (JMPR (1998)) as well as intraperitoneally administered (NTP DB (Access on Oct. 2010)) (in vivo mutagenicity test in somatic cells). As relevant information, as for in vitro studies, negative results in the Ames test and chromosome aberration test using CHO cells (NTP DB (Access on Oct. 2010)), and positive results in the chromosome aberration test using CHO cells (JMPR (1998)) were reported.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	The classification was not possible due to lack of sufficient test data. As relevant information, in the 2-year dietary administration test in rats, pathological changes were observed in the renal cortex of males 200 days after administration, and carcinogenicity was found in some organs without dose response 700 days after administration and these were observed also in the control group at that time. In addition, there were some data of 30-week or 1-year dietary administration test in rats (JMPR (1998)), however, no clear evidence for carcinogenicity was noted.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Not classified	- -	-	-	In the multigeneration reproductive toxicity study in rats by feeding, no effects on reproduction, as reflected in fertility, litter size, or survival of offspring, was observed. In the two-generation reproductive toxicity study in dogs by feeding, decrease in body weight due to administration was observed, but, there were no effects on copulation performance, delivery, weaning indices, semen parameters, clinical signs, number of live pups, litter size, pup weight and growth. In addition, in the study using pregnant rats orally administered on days 6 - 19 of gestation, decrease in maternal body weight were observed, however, there were no effects on uterine weights, litter size, resorption, pre- and post-implantation losses, sex ratios, and fetal weights. The findings of malformations and anomalies were within the range of historical controls (JMPR (1998)). Thus, the substance was classified as "Not classified".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 1 (liver)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	In the single dose oral study in dogs (dose levels: 50, 100 and 200 mg/kg), no treatment-related effects on hematology and necropsy were observed, but higher serum bilirubin concentrations, lower urea nitrogen concentrations and mild cholestasis in the microscopic examination were observed in both sexes of all treatment groups. In addition to cholestasis, deposits of hepatocellular glycogen were depleted in the dogs at 200 mg/kg/day. At the end of the observation period, minimal cholestasis was also observed in all treatment groups (JMPR (2005)). As stated above, since the effective doses were confirmed within Category 1 of the guidance value, the substance was classified as Category 1 (liver).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver)	Danger	H372	P260 P264 P270 P314 P501	In the 90-day oral toxicity study in dogs, total bilirubin concentration and activity of ALP, GPT, GOT and gamma-GT was increased, and hepatic changes containing increased pigment deposition, hepatocellular necrosis, cytoplasmic vacuolation and bile-duct hyperplasia were microscopically observed at 20 mg/kg/day or more. Increase of ALP, and mild pigment deposition and hepatocellular necrosis were also observed even at 4 mg/kg/day (JMPR (1998)). In another 28-day oral toxicity study in dogs, increase of activity of the serum enzymes indicating liver damage and pigment deposition of the liver was observed at 25 mg/kg/day (converted dose level as that of 90-day study: 8.3 mg/kg/day) or more (JMPR (1998)). Further, in the 28-day oral dose study in rats, increases of total bilirubin concentration and elevation of activity of gamma-GT were also reported at 250 mg/kg/day (converted dose level as that of 90-day study: 77.7 mg/kg/day) or more (JMPR (1998)). As described above, since the lowest effective doses belonged to Category 1 in the dog studies, the substance was classified as Category 1 (liver). As relevant information, the effects on the kidneys were observed in both 28-day and 13-week studies in rats, however, both of the effective doses were over the range of the guidance values. Therefore, the information was not adopted as the basis of classification.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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)	Category 1	Warning	H400	P273 P391 P501	Classified into Category 1 from its 72h-ErC50 = 0.70 mg/L for algae (Pseudokirchneriella subcapitata) (Test for the Ecological Effect of Chemical Substances (Ministry of the Environment), 1998).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Classified into Category 1 since its acute toxicity is Category 1 and it is not rapidly degradable (Non-biodegradable, BOD degradation rate: 3% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1982)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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