NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	10380-28-6
Chemical Name	Bis(8-quinolinolato)copper; Oxine-copper
Substance ID	m-nite-10380-28-6_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 (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	There is information that it is combustible (ICSC (J) (2018)), but the classification is not possible due to no data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	It was classified as "Not classified" because it is estimated that it does not react vigorously with water from water solubility data of 1.04 mg/L (20 deg C, A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Classification not possible	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine), which is chemically bonded to an element (Cu) other than carbon or hydrogen. However, the classification is not possible due to no data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	Not classified	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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	[Rationale for the Classification] Based on (1), it was classified in Category 4. Besides, (1) was adopted because it was conducted as a GLP test. [Evidence Data] (1) LD50 for rats: male: 585 mg/kg, female: 500 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)) [Reference Data, etc.] (2) LD50 for rats: > 5,000 mg/kg (EPA Pesticide (2007)) (3) LD50 for rats: male: 4,700 mg/kg, female: 3,900 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013))	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified" for rats and rabbits [Evidence Data] (1) LD50 for rabbits: > 2,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)) (2) LD50 for rats: male: > 5,000 mg/kg, female: > 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)) [Reference Data, etc.] (3) LD50 for rabbits: 2,000 mg/kg (EPA Pesticide (2007))	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), the category could not be specified, therefore, it was classified as "Classification not possible." The category was changed from the previous classification by the use of new information sources. Besides, GLP test results were adopted with the weight on reliability. [Evidence Data] (1) LC50 for rats (dust, 4 hours): male: > 0.94 mg/L, female: > 0.94 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)) [Reference Data, etc.] (2) LC50 for rats (dust, 4 hours): 0.82 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)) (3) LC50 for rats (exposure time is unknown): 0.089 plus or minus 0.031 mg/L (EPA Pesticide (2007))	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) It was judged as a non-irritant in a skin irritation test according to EPA OPPTS 870.2500 (equivalent to OECD TG 404) in which this substance (99.7%) was applied to rabbits (EPA Pesticide (2007)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Based on (1), it was classified in Category 1. The category was changed because the new data was obtained. [Evidence Data] (1) It was judged as a corrosive substance in an eye irritation test according to EPA OPPTS 870.2400 (equivalent to OECD TG 405) in which this substance (98%) was applied to rabbits (EPA Pesticide (2007)). [Reference Data, etc.] (2) It has been reported to be mildly irritating in an eye irritation test with rabbits to which this substance (41 mg) was applied (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) No skin sensitization was revealed in a skin sensitization test according to EPA OPPTS 870.2600 (equivalent to OECD TG 406), in which this substance (99.7%) was administered to guinea pigs (EPA Pesticide (2007)). (2) It was negative in a skin sensitization test with guinea pigs (maximization method, GLP, intradermal induction: 0.1%, induction (topical application): 20%, challenge: 0.6%, 1.3%, 2.5%). (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), since it was negative in in vivo tests and negative or weakly positive in in vitro tests, it was classified as "Not classified." [Evidence Data] (1) As for in vivo, there are negative reports in a chromosomal aberration test in mice, micronucleus test in rats or mice (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), EPA Pesticide (2007)), and an unscheduled DNA synthesis test in rats (EPA Pesticide (2007)). (2) As for in vitro, there are negative or weakly positive reports in bacterial reverse mutation tests and chromosomal aberration tests with cultured mammalian cells (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Based on classification results by other organizations (1), it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) In classification results by domestic and international organizations, it was classified in Group 3 by IARC (IARC Suppl.7 (1987)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1)-(3), it was classified as "Not classified." [Evidence Data] (1) In two two-generation reproduction toxicity studies with rats dosed by feeding, no reproductive effects were seen (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (2) In a developmental toxicity test with female rats dosed by gavage during gestational day 6-15, no effect was observed on the fetus even at the dose at which it would be killed in extremis due to deterioration of its general condition was observed in the maternal animals (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (3) No effect was observed on the maternal animals or fetuses in either a developmental toxicity test by gavage administration to female rabbits on gestational day 7-19, or a developmental toxicity test by gavage administration to female rabbits on gestational day 6-18 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] There are no reports on a single exposure to this substance in humans. In experimental animals, as shown in (1) and (2), oral and inhalation exposure to this substance has effects on the gastrointestinal tract and respiratory organs, respectively. Since the effects on the gastrointestinal tract are considered to be associated with irritation, it was not adopted as evidence of the classification. Therefore, it was classified in Category 1 (respiratory organs). Besides, the category was changed from the previous classification by the use of new information sources. [Evidence Data] (1) In a test with a single oral dose of 347-1,037 mg/kg (equivalent to Category 2) of this substance to rats, decreased locomotor activity, lateral position, prone position, hypothermia, lacrimation, nasal discharge, ptosis, eyelid closure, piloerection, diarrhea and loose stool were noted. Deaths were seen at 500 mg/kg or more in males and 417 mg/kg or more in females, and at necropsy, focal and diffuse reddish changes in the mucous membrane of the glandular stomach were observed in the dead animals (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)). (2) In a 4-hour single inhalation test with rats exposed to the dust of this substance, gasping, rales, nasal discharge, tremors, and abnormality of the cornea were observed at 0.94 mg/L. In another 4-hour single inhalation exposure test with rats, eye stimulation, dyspnea, nasal discharge and salivation were observed. In necropsy, lung congestion was observed at 0.95 mg/L or higher, and pulmonary emphysema and pleural effusion were observed at 1.21 mg/L or higher (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)). The concentrations at which these effects were observed correspond to Category 2 or near the upper limit of Category 1. [Reference Data, etc.] (3) Regarding copper (CAS RN 1317-38-0), there are reports that digestive symptoms (nausea, vomiting, gastric pain, etc.) were observed in humans ingesting drinking water containing high copper concentrations and that inhalation exposure causes effects on the respiratory organs (respiratory tract irritation) (EHC 200 (1998), ACGIH (7th, 2001), ATSDR (2004)). Based on these pieces of information, copper was classified in Category 1 (digestive system) and Category 3 (respiratory tract irritation) in the 2013 GHS classification.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1)-(4), as a result of oral administration to experimental animals, an effect on the liver was observed within the range of Category 2, therefore it was classified in Category 2 (liver). Regarding effect on the gastrointestinal tract, it was not adopted as a target organ because this is considered to be an effect associated with the irritation of this substance. As a result of examination using a new information source, the classification result was changed from the previous classification. [Evidence Data] (1) As a result of a 90-day study by gavage administration to dogs at doses of 1-50 mg/kg/day, vomiting, loose stools, bleeding in the submucosal tissue in the stomach were observed at or above 5 mg/kg/day (within the range of Category 1), and hyperemia of the submucosal tissue in the duodenum the submucous membranes was noted at 50 mg/kg/day (within the range of Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (2) As a result of oral administration by capsules at doses of 1-25 mg/kg/day to dogs for 1 year, loose stools and vomiting were observed at or above 5 mg/kg/day or more (within the range of Category 1), while diarrhea, decreased body weight gain, an increase in bilirubin, etc. were noted at 25 mg/kg/day (within the range of Category 2). (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (3) As a result of a 2-year carcinogenicity study in rats dosed by feeding, decreased body weight gain and chronic inflammation of the liver were observed at a dose of 2,000 ppm (male/female: 96/125 mg/kg/day, male: within the range of Category 2, female: more than Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (4) As a result of a 2-year study with dogs dosed by feeding at doses of 10-3,000 ppm, there is a report that increases in alpha 1 globulin and beta globulin, etc. were observed at or above 1,000 ppm (male/female: 35/30 mg/kg/day, within the range of Category 2), and decreased body weight gain and food consumption, increased ALT and AST, lymph node edema, dilatation of medullary sinus of lymph node, submucosal edema of the stomach, small intestine and large intestine, pancreatic edema, alveolar foamy macrophage, hepatocyte necrosis, interstitial nephrosis and so on were noted at 3,000 ppm (male/female: 96/103 mg/kg/day, male: within the range of Category 2, female: more than Category 2), but in this study, in the high dose group (three each for male and female for the group necropsied at the end, one each for male and female for the interim necropsy group), in the group necropsied at the end, two males were killed in extremis, one female died, and one female was killed in extremis, and one each for male and female animals survived at the end of the treatment (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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	It was classified in Category 1 from 96-hour LC50 = 0.0089 mg/L for fish (Oncorhynchus mykiss) (U.S. EPA: RED, 2007).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 1 because it contains copper, it was judged as not readily degradable (Official Bulletin of Economy, Trade and Industry, 2002)), and it was classified in Category 1 in acute toxicity, although it is not rapidly degradable (a 28-day degradation rate by BOD = 64% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2002).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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