NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	82558-50-7
Chemical Name	N-[3-(1-ethyl-1-methylpropyl)-1,2-oxazol-5-yl]-2,6-dimethoxybenzamide
Substance ID	m-nite-82558-50-7_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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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	- -	-	-	Since it contains chemical groups (N-O; 1, 2-oxazole group) associated with explosive properties and its calculated oxygen balance is <= 200 (-212), the substance was classified into "Not classified". (C18H24N2O4 + 22O2 -> 18CO2 + 12H2O + N2; Oxygen balance = -1600*44/332 = -212)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	It contains chemical groups (N-O; 1, 2-oxazole group) associated with explosive properties. Due to lack of further information, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	Its water solubility is 0.001-0.002 mg/ml at 25degC (Merck (14th, 2006)) and it is stable in contact with water.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
14	Oxidizing solids	Classification not possible	- -	-	-	Organic compounds containing oxygen (but not fluorine or chlorine), which is chemically bonded to nitrogen. No further information is available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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 its rat LD50 values of > 5000 mg/kg (technical product: Pesticide Safety Information (Japan Crop Protection Association) No.18 (1995) ) and > 10000 mg/kg (HSDB (2006)), the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on its rat LD50 of > 2000 mg/kg (technical product: Pesticide Safety Information (Japan Crop Protection Association) No.18 (1995)) and rabbit LD50 of > 2000 mg/kg (HSDB (2006)), the substance was classified into "Not classified" (Category 5 or "Not classified" category in the United Nations classification).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Since its rat LC50 values: > 1.99 mg/L/1 hour (4-hour conversion: > 0.5 mg/L) (HSDB (2006)) and > 2.93 mg/L (exposure duration unknown) (Pesticide Safety Information (Japan Crop Protection Association) No.18 (1995)), are equal to or greater than its saturated vapour pressure concentration (conversion value: 7.5*10^-8 mg/L: HSDB (2006)), classification was carried out using criteria for dust and mist. Using these criteria, we were not able to determine precise category for the substance among Categories 1 through 5. Thus, it was classified into "Classification not possible".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	In topical tests using rats (50%-concentration formulation, 4-hour application), the following were observed: erythema in all treated animals, encrustation in four animals, and mild edema in one animal (Pesticide Safety Information (Japan Crop Protection Association) No.18 (1995)). Based on these results, the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	In rabbit tests (using 50%-concentration formulation), irritable change in the corneas and conjunctivas was detected in all treated animals, and irritable change in irises was detected in five of the six cases; all symptoms healed within 5 days after treatment (Pesticide Safety Information (Japan Crop Protection Association) No.18 (1995)). Overall, since all irritation symptoms healed within 7 days, the substance was classified into Category 2B.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Skin sensitization	Classification not possible	- -	-	-	In the tests using guinea pigs (Buehler method; 50%-concentration formulation; 3 days per week for 2 weeks), signs of sensitization was not detected (Pesticide Safety Information (Japan Crop Protection Association) No.18 (1995)). In other tests using Buehler method also found that the substance is not sensitizing, although animal species tested are unknown (HSDB 2006). Since these results were obtained using List 2 datasets, the substance was classified into "Classification not possible".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	In micronucleus tests using male rats (dose: 0-5000 mg/kg), the score for polychromatophilic erythrocyte was 2000 in animal groups treated with 800 or 2000 mg/kg, which indicated a statistically significant increase (HSDB (2006)). In addition, micronucleus tests using male mice (dose: 0 or 5000 mg/kg) gave positive results (HSDB (2006)) while other micronucleus tests using male mice resulted in unclear outcome (IRIS (1993)). Overall, several in vivo mutagenicity tests using somatic cells gave positive results, although few tests gave negative results; so we classified the substance into Category 2. As additional information, in vivo genotoxicity tests (Ames tests and chromosomal aberration tests using CHO cells) gave negative results (IRIS (1993), HSDB (2006)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Not classified	- -	-	-	Because of the EPA's rating of the substance as C (IRIS (1993)), it was classified into "Not classified". As additional information, in 2-year exposure tests (dose: 0-12500 ppm), a statistically significant increase of hepatocellular adenoma was detected in both sexes of B6C3F1 rats in high concentration groups; and increase in benign adrenal pheochromocytomas was detected in Fischer 344 male rats in high concentration groups (IRIS (1993)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In 3-generation tests using rats (dose: 25, 125, or 625 mg/kg/day), a decreased number of corpora lutea, and microphthalmia, anophhtalmia, exencephaly or craniofacial malformations in offspring were detected at the doses that caused suppression of body weight gain in parental animals (IRIS (1993)). In different rat tests (dose: 300 and 1000 mg/kg/day), an increase in preimplantation loss and resorptions was detected at the doses that suppress doby weight gain in parental animals (IRIS (1993)). In teratogenicity tests using rabbits (dose: 0-1000 mg/kg/day), 1 case of miscarriage and 5 cases of death were detected in 1000 mg/kg groups (Pesticide Safety Information (Japan Crop Protection Association) No.18 (1995)). Similarly, in mixed diet administration tests using rats (dose: 0, 40, 200, and 1000 mg/kg/day), exencephaly and microphthalmia were identified in offspring (HSDB (2006)). From these results, the substance was classified into Category 2 for detecting reproductive toxicity at doses that cause general toxicity in parental animals. As additional information, teratogenicity tests using rats (dose: 0-1000 mg/kg/day) found neither general nor reproductive toxicity, drawing a conclusion that the substance is in "Not classified" category (Pesticide Safety Information (Japan Crop Protection Association) No.18 (1995)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	In oral administration tests using rabbits (dose: 0-5000 mg/kg), no abnormal systemic symptoms (behavior, somatic nervous system, or autonomic nervous system) were detected (Pesticide Safety Information (Japan Crop Protection Association) No.18 (1995): The Institute of Environmental Toxicology). In addition, in forced oral administration tests using rats (dose: 0 or 5000 mg/kg), no abnormalities were detected in respiration, blood pressure, or electrocardiogram (Pesticide Safety Information (Japan Crop Protection Association) No.18 (1995): The Institute of Environmental Toxicology). These results and the description from the evaluation of this substance that "its acute toxicity is weak and is equivalent to normal substances" (Pesticide Safety Information (Japan Crop Protection Association) No.18 (1995): The Institute of Environmental Toxicology) indicate that the substance is to be placed in "Not classified" category (oral route). However, due to lack of data on other administration routes, the substance was classified into "Classification not possible".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In 1-year mixed diet administration tests using rats (dose: 10-1000 mg/kg/day), the lower limit of toxic concentration (LEL value) was found to be 100 mg/kg/day (90-day correction: 400 mg/kg/day) (IRIS (1993)). In different mixed diet tests using rats, LEL value was 1250 ppm (90-day correction: 250 mg/kg/day) (IRIS (1993)). In 90-day mixed diet tests using dogs, LEL value was 500 mg/kg/day (IRIS (1993)). In 3-month mixed diet tests using dogs (dose: 0-500 mg/kg/day), no toxic symptoms caused by the substance were discovered (Pesticide Safety Information (Japan Crop Protection Association) No.18 (1995)). These results indicate the placement of the substance in the "Not classified" category (oral route). However, due to lack of information on other administration routes, the substance was classified into "Classification not possible". As additional information, in 3-month mixed diet administration tests using rats (dose: 0-12500 ppm), hepatocyte hypertrophy was detected at the dose (12500 ppm; conversion value: 625 mg/kg) which is not in the range of guidance values, and the results were not included as grounds for classification.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）

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	- -	-	-	Its acute toxicity for fish or crustaceans has not been acquired at concentrations up to its water solubility (HSDB 2006, Aquire 2009); therefore, the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	It is insoluble in water (water solubility = 1.4 mg/L (PHYSPROP Database (2008)) and its acute toxicity has not been acquired at concentrations up to its water solubility (HSDB 2006, Aquire 2009). Since its potential for bioaccumulation is presumably low (LogPow = 3.94 (PHYSPROP Database (2008)), the substance was classified into the "Not classified" category.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
12	Hazardous to the ozone layer	-	- -	-	-	-	-	-

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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