GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 153197-14-9
Chemical Name 3-[1-(3,5-Dichlorophenyl)-1-methylethyl]-3,4-dihydro-6-methyl-5-phenyl-2H-1,3-oxazin-4-one [oxaziclomefone]
Substance ID H27-A-06-METI/M-006A_P
Classification year (FY) FY2015
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 (FY2013 revised edition (Ver. 1.1))
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 applicable
-
-
- - There are no chemical groups present in the molecule associated with explosive properties.
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- - "Solids" according to GHS definition.
3 Aerosols Not applicable
-
-
- - Not an aerosol product.
4 Oxidizing gases Not applicable
-
-
- - "Solids" according to GHS definition.
5 Gases under pressure Not applicable
-
-
- - "Solids" according to GHS definition.
6 Flammable liquids Not applicable
-
-
- - "Solids" according to GHS definition.
7 Flammable solids Classification not possible
-
-
- - Due to no data, the classification is not possible.
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 applicable
-
-
- - "Solids" according to GHS definition.
10 Pyrophoric solids Classification not possible
-
-
- - Due to no data, the classification is not possible.
11 Self-heating substances and mixtures Classification not possible
-
-
- - Due to no data, the classification is not possible.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable
-
-
- - Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable
-
-
- - "Solids" according to GHS definition.
14 Oxidizing solids Not applicable
-
-
- - It is an organic compound which does not contain fluorine but contains oxygen and chlorine, and the oxygen and the chlorine are not chemically bonded to the elements other than carbon or hydrogen.
15 Organic peroxides Not applicable
-
-
- - It is an organic compound that does not contain bivalent -O-O- structure in the molecule.
16 Corrosive to metals Classification not possible
-
-
- - No established test method suitable for solid substances.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- - From a reported LD50 value of > 5,000 mg/kg for rats (Japan Crop Protection Association: Pesticide safety information (Access on November 2015); Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)), it was classified as "Not classified."
1 Acute toxicity (Dermal) Not classified
-
-
- - From a reported LD50 value of > 2,000 mg/kg for rats (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)), it was classified as "Not classified."
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - "Solids" according to GHS definition.
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- - "Solids" according to GHS definition.
1 Acute toxicity (Inhalation: Dusts and mists) Not classified
-
-
- - From a reported LC50 value (4 hours) of > 5.54 mg/L for rats (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)), it was classified as "Not classified." Besides, because a test substance is a solid, a reference value of dust was applied.
2 Skin corrosion/irritation Not classified
-
-
- - It is reported that in a skin irritation test using rabbits, after 4-hour application of 500 mg this substance, extremely slight erythema was observed in 1 animal after 1 hour but resolved after one day (Pesticide abstract (2008)). From the above, the substance was classified as "Not classified."
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
It is reported that in an eye irritation test using rabbits, after an application of 0.1 mL this substance, an irritating change was observed in conjunctiva 1 hour after application but resolved after one day (Pesticide abstract (2008)). From reversible situations, the substance was classified in Category 2B.
4 Respiratory sensitization Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
4 Skin sensitization Not classified
-
-
- - There are reports from a maximization test and a Buehler test using guinea pigs, and it is reported that in the maximization test, this substance was slightly sensitizing (a positive rate 25%), not meeting positive in 30%, the GHS criteria. Moreover, it is reported that in the Buehler test, the substance was negative due to no skin reaction observed in a test group (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)). Because the above two tests are GLP compliance tests corresponding to OECD TG406, the substance was judged as "Not classified."
5 Germ cell mutagenicity Classification not possible
-
-
- - As for in vivo, a micronucleus test using mouse bone marrow cells after gavage administration was negative. As for in vitro, a bacterial reverse mutation test and a chromosomal aberration test in cultured mammalian cells were negative (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)). Therefore, the substance was classified as "Classification not possible" in accordance with Guidance.
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
In a carcinogenicity test in diet administration of this substance for 2 years in rats, or 1.5 years in mice, an increased incidence of hepatocellular adenoma/cancer (rats), increased incidences of hepatocellular adenoma and hepatocellular adenoma/cancer (mice) were observed in high-dose group males of 2,500 ppm for rats and 800 ppm for mice (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)). Namely, although induction of liver tumors was found only in males of both species after administration of this substance, but taking into account no classification result conducted by the international organization, the substance was classified in Category 2 in this hazard class.
7 Reproductive toxicity Classification not possible
-
-
- - In a two-generation breeding toxicity test using rats in an oral route (in the diet), parent animals showed effects on the liver (weight increase, centrilobular hypertrophy of hepatocytes) in groups of F0 males at 500 ppm or higher, F0 females at 2,500 ppm, and F1 males and females at 500 ppm or above, but toxic effects on fertility were not observed. Moreover, effects were not found in F1, F2 offspring except that males and females at 500 ppm or higher showed increased liver weight in necropsy at weaning (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)). On the other hand, in a teratogenicity test using pregnant rats, or rabbits, in gavage administration on day 6 to 15 of gestation for rats, and day 6 to 19 of gestation for rabbits up to maximum 1,000 mg/kg/day, maternal animals showed weight gain reduction at 1,000 mg/kg/day in both animal species, but toxic effects by administration of test substance were not observed in fetuses (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)).
From the above test results, findings of toxicological concern could not be found at least in sexual function and fertility in parents, fetal toxicity, teratogenicity, and growth/development after birth. The fact that increased liver weight was observed in newborns over two generations at the doses where effects on the liver occurred in maternal animals in the two-generation breeding toxicity test in rats do not correspond to findings suggesting serious reproductive/developmental toxicity, but it could be considered to be findings suggesting the possibility that general toxicity effects occurred in newborns via maternal animals. Namely, it was judged that data are not sufficient to classify as "Not classified," and the substance was classified as "Classification not possible" in this hazard class.
8 Specific target organ toxicity - Single exposure Not classified
-
-
- - There are no human data on this substance. As for experimental animals, there are test data in oral administration in rats and mice, dermal administration in rats, and inhalation exposure in rats (Pesticide abstract (2008), Pesticide evaluation report, Food Safety Commission of Japan (2008)). However, because an abnormality in signs and necropsy findings was not observed in any test even after administration up to the limit doses (or maximum possible concentration), the substance was classified as "Not classified."
9 Specific target organ toxicity - Repeated exposure Category 2 (liver, kidney)


Warning
H373 P260
P314
P501
In a 2-year chronic toxicity/carcinogenicity combined test using rats in diet administration, effects on the liver (diffuse hypertrophy of hepatocytes and so on) in males and females in groups of 500 ppm within a range Category 2 (males: 18.34 mg/kg/day, females: 22.48 mg/kg/day) or higher, diffuse fatty degeneration of hepatocytes and so on, and effects on the kidney (chronic nephrosis and so on, males) added in a 2,500 ppm dose group (males: 94.4 mg/kg/day, females: 116.7 mg/kg/day) were observed. In an 18-month carcinogenicity test using mice in diet administration, effects on the liver (centrilobular hypertrophy of hepatocytes, brown pigmentation in star cells and so on) were found in males and females in a 800 ppm dose group within a range Category 2 (males: 86.08 mg/kg/day, females: 77.40 mg/kg/day) (Pesticide abstract (2008); Food sanitation research, Vol.53 No.12 (2003); Pesticide evaluation report, Food Safety Commission of Japan (2008)).
As above, effects on the liver and kidney were observed both within a range Category 2.
Therefore, the substance was classified in Category 2 (liver, kidney).
10 Aspiration hazard Classification not possible
-
-
- - Due to lack of data, the classification is not possible.

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) Classification not possible
-
-
- - No data.
11 Hazardous to the aquatic environment (Long-term) Classification not possible
-
-
- - No data.
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data.


NOTE:
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* 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.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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