GHS Classification Result

Chemical Name:N-[3-(1-ethyl-1-methylpropyl)-1,2-oxazol-5-yl]-2,6-dimethoxybenzamide
CAS:82558-50-7

Result:
ID: 20A2303
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government (Sep, 2008)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
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)
2 Flammable gases (including chemically unstable gases) Not applicable - - - - Solid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Solid (GHS definition)
5 Gases under pressure Not applicable - - - - Solid (GHS definition)
6 Flammable liquids Not applicable - - - - Solid (GHS definition)
7 Flammable solid Classification not possible - - - - No data available.
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.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Classification not possible - - - - No data available.
11 Self-heating substances and mixtures Classification not possible - - - - No data available.
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.
13 Oxidizing liquids Not applicable - - - - Solid (GHS definition)
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.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure in the molecule
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
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".
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).
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - No data available.
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".
2 Skin corrosion/irritation Category 2 Warning H315: Causes skin irritation P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P332+P313: If skin irritation occurs: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment (see ... on this label).
P362: Take off contaminated clothing and wash before reuse.
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.
3 Serious eye damage/eye irritation Category 2B - Warning H320: Causes eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
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.
4 Respiratory sensitization Classification not possible - - - - No data available.
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".
5 Germ cell mutagenicity Category 2 Warning H341: Suspected of causing genetic defects P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
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)).
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)).
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
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)).
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".
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.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (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".
11 Hazardous to the aquatic environment (Long-term) 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.


NOTE:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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