GHS Classification Result

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GENERAL INFORMATION

Item Information
CAS number 133220-30-1
Chemical name (RS)-2-[2-(3-Chlorophenyl)-2,3-epoxypropyl]-2-ethylindane-1,3-dione [indanofan]
Substance ID H27-A-02-METI/M-002A_P
Fiscal year of classification conducted FY2015
Classifier(s) (Ministries)
Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE)
New/Revised New
Download in Excel format Excel file

REFERENCE INFORMATION

Item Information
Guidance used for classification (External link)
GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
GHS document (External link) Globally Harmonized System of Classification and Labelling of Chemicals (GHS)
Definitions / Abbreviations (Excel file)
Definitions / Abbreviations

PHYSICAL HAZARDS

Hazard class Classification Pictogram
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
Rationale for the classification
1 Explosives Not applicable - - - There are no chemical groups associated with explosive properties present in the molecule.
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 Classification not possible - - - There is a chemical group present in the molecule associated with self-reactive properties (epoxides), but the classification is not possible due to no data.
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 - - - No established test method suitable for solid substances with a melting point of 140 degrees C or lower.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - Not containing metals or semimetals (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 - - - An organic compound that does not contain fluorine but contains oxygen and chlorine which are not chemically bonded to elements other than carbon or hydrogen.
15 Organic peroxides Not applicable - - - An organic compound that does not contain -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
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
Rationale for the classification
1 Acute toxicity (Oral) Category 4

Warning
H302
P301+P312
P362+P364
P264
P270
P330
P501
From reported LD50 values of 460 mg/kg (females) and 631 mg/kg (males) for rats (Pesticide abstract (2010); Pesticide evaluation report, Food Safety Commission of Japan (2010)), it was classified in Category 4.
1 Acute toxicity (Dermal) Not classified - - - From a reported LD50 value of > 2,000 mg/kg for rats (Pesticide abstract (2010); Pesticide evaluation report, Food Safety Commission of Japan (2010)), 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) Classification not possible - - - The classification is not possible due to lack of data.
Besides, the category cannot be determined only from a reported LC50 value (4 hours) of > 1.57 mg/L for rats (Pesticide abstract (2010); Pesticide evaluation report, Food Safety Commission of Japan (2010)).
A reference value of dust was applied because a test substance is a solid.
2 Skin corrosion/irritation Not classified - - - As a result of the application of 500 mg of this substance in an irritation test using rabbits, no skin irritation change at any observation point was reported. (Pesticide abstract (2010); Pesticide evaluation report, Food Safety Commission of Japan (2010))
From the above, it was classified as "Not classified."
3 Serious eye damage/eye irritation Category 2B
No pictogram

Warning
H320
P305+P351+P338
P337+P313
P264
As a result of the application of 40 mg of this substance in an eye irritation test using rabbits, slight eye irritation was reported based on observed corneal opacity, conjunctival redness, edema, and discharges which reversed after 72 hours. (Pesticide abstract (2010); Pesticide evaluation report, Food Safety Commission of Japan (2010))
From the above, it was classified in Category 2B.
4 Respiratory sensitization Classification not possible - - - Due to lack of data, the classification is not possible.
4 Skin sensitization Category 1

Warning
H317
P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501
In a maximization test using guinea pigs, sensitization by this substance (a maximum positive rate 75%) was reported (Pesticide abstract (2010); Pesticide evaluation report, Food Safety Commission of Japan (2010)).
On the other hand, a negative in a Buehler test was reported (Pesticide abstract (2010); Pesticide evaluation report, Food Safety Commission of Japan (2010)).
Because the maximization test above is compliance with GLP corresponding to OECD TG406, and a high positive rate was reported, it was classified in Category 1.
5 Germ cell mutagenicity Classification not possible - - - From a negative in a micronucleus test by oral administration in mice (Pesticide abstract (2010)) in in vivo, and negatives in a bacterial reverse mutation test and a chromosomal aberration test in cultured mammalian cells (Japanese Journal of Pesticide Science Vol. 26 No. 3 (2001); Pesticide abstract (2010)) in in vitro, it was classified as "Classification not possible" in accordance with Guidance.
6 Carcinogenicity Classification not possible - - - In a carcinogenicity test by diet administration of this substance for 2 years in rats or 1.5 years in mice, in which rats were dosed up to 200 ppm where females showed reduced weight gain and low food consumption, and males and females showed non-neoplastic lesions, and mice were dosed up to 200 ppm for male and to 600 ppm for female where increases in in-between deaths occurred, but increased incidences of tumors related to administration of test substance were not observed. (Pesticide abstract (2010); Pesticide evaluation report, Food Safety Commission of Japan (2010))
Therefore, it corresponds to "Not classified" in an oral route, but there is neither carcinogenicity information nor a carcinogenicity classification result by the international organization in other routes.
Therefore, it was classified as "Classification not possible" in this hazard class.
7 Reproductive toxicity Category 2

Warning
H361
P308+P313
P201
P202
P280
P405
P501
In a two-generation reproductive toxicity test in rats by diet administration of this substance, in parent animals, eye abnormality in one each of F1 male and female at 100 ppm which was considered to be an effect by bleeding, an increased incidence of females without corpus luteum (5/27), and a slight decrease in ovary weight were observed. But the finding in ovary was judged as an incidental change. (Pesticide abstract (2010); Pesticide evaluation report, Food Safety Commission of Japan (2010)).
In offspring, in both F1 and F2 generations, internal hemorrhage by bleeding was confirmed by signs and necropsy during an early nursing period at 100 ppm, and eye abnormality by bleeding was also found. And in the same group in the F2 generation, an increased number of mothers with all dead pups, a decreased survival, low body weight, and a delay in time to achieve a reflex response in live offspring were observed. But decreased reflex response in the F2 pups was considered to be effects of a slight developmental delay. (Pesticide abstract (2010); Pesticide evaluation report, Food Safety Commission of Japan (2010))
Besides, in an additional test with regard to bleeding signs and eye abnormality found in F1 and F2 pups in a 100 ppm group in the reproductive test, prolongation of blood coagulation time (PT/APTT) was observed in 1 and 2 weeks after birth as a result of a measurement of blood coagulation system in F1 pups after pregnant rats were administered 100 ppm in the diet through a gestation period and had a natural birth. (Pesticide abstract (2010))
On the other hand, in a teratogenicity test in which pregnant rats or pregnant rabbits were orally administered this substance by gavage during an organogenetic period (rats: day 6 to 15 of gestation, rabbits: day 7 to 19 of gestation), in fetuses, an increased number of metacarpal bones in rats and an increased incidence of lumbar ribs in rabbits were observed as a result of administration up to 20 mg/kg/day where vaginal bleeding in a part of maternal animals occurred.
But it was reported that this substance does not have teratogenicity due to no toxicological significance or no findings relevant to skeletal malformation but skeletal variation. (Pesticide abstract (2010); Pesticide evaluation report, Food Safety Commission of Japan (2010))
Because findings by bleeding during a nursing period in F1 and F2 pups and a decreased survival in F2 pups were observed at the dose where eye abnormality by bleeding was found as general toxicity effects in parent animals from the above, it was classified in Category 2 in this hazard class.
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system), Category 3 (respiratory tract irritation)


Danger
Warning
H370
H335
P308+P311
P260
P264
P270
P321
P405
P501
P304+P340
P403+P233
P261
P271
P312
There are no human data.
Irritation was reported in experimental animals, And increased spontaneous motility, decreased spontaneous motility, piloerection, salivation, hunched posture, tonic convulsion, clonic convulsion, tremor, tachypnea, bradypnea, and lethargy in oral administration in rats and mice (doses corresponding to Category 1), and lacrimation, salivation, decreased spontaneous motility, and irregular respiration in inhalation exposure to rats (a dose corresponding to Category 1) were reported. (Pesticide abstract (2010); Pesticide evaluation report, Food Safety Commission of Japan (2010)).
This substance has effects on the central nervous system besides respiratory tract irritation from the above, therefore, it was classified in Category 1 (central nervous system), Category 3 (respiratory tract irritation).
9 Specific target organ toxicity - Repeated exposure Category 1 (blood coagulation system), Category 2 (liver)

Danger
Warning
H372
H373
P260
P264
P270
P314
P501
In a 104-week diet administration toxicity test using rats, effects on blood coagulation system at 60 to 200 ppm (2.1 to 8.7 mg/kg/day) within a range of Category 1, and prolongation of PT and APTT, tar-like contents in an intestinal tract, massive bleeding as findings in a 200 ppm group were observed.
In a 13-week diet administration toxicity test using rats, effects on blood coagulation system (prolongation of PT and APTT, bleeding in the anterior chamber and so on) at 200 ppm (11.9 to 12.7 mg/kg/day) within a range of Category 2 were also observed.
In test using mice, effects on the liver (high liver weight and hepatocellular hypertrophy) besides effects on blood coagulation system (prolongation of PT and APTT) at 600 ppm (males: 68.1 mg/kg/day, females: 76.7 mg/kg/day) within a range of Category 2 in a 13-week diet administration toxicity test and effects on the liver (hepatocellular hypertrophy/necrosis) besides effects on blood coagulation system (prolongation of PT and APTT, bleeding tendency throughout the body and so on) at 100 to 600 ppm (14.4 to 58.7 mg/kg/day) within a range of Category 2 in an 18-month diet administration toxicity test were observed.
In tests using dogs, effects on the liver at 750 to1,500 ppm (22.1 to 47.1 mg/kg/day) within a range of Category 2 and high alkaline phosphatase activity, high liver weight, and hepatocellular hypertrophy as findings in a 1,500 ppm group in a 13-week diet administration toxicity test and at 500 to 1,500 ppm (12.3 to 38.7 mg/kg/day) within a range of Category 2 in a 1-year diet administration toxicity test were observed. (Pesticide abstract (2010); Pesticide evaluation report, Food Safety Commission of Japan (2010); Japanese Journal of Pesticide Science, Vol. 26 No. 3 (2001))
From the above, the effect on the blood coagulation system was mainly observed from Category 1. In addition, the effect on the liver was observed in a range of Category 2.
Therefore, it was classified in Category 1 (blood coagulation system), and Category 2 (liver).
10 Aspiration hazard Classification not possible - - - Due to lack of data, the classification is not possible.

ENVIRONMENTAL HAZARDS

Hazard class Classification Pictogram
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
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.


NOTES:
* 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.

Updated date:
  2017/3/31 Addition of Rationale for the classification
  2016/6//8 Created

List of GHS Classification Results