NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	1222-05-5
Chemical Name	4,6,6,7,8,8-Hexamethyl-1,3,4,6,7,8-hexahydrocyclopenta[g]isochromene
Substance ID	m-nite-1222-05-5_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 present in the molecule associated with explosive properties.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified	- -	-	-	Based on a flash point of > 100 degrees C (closed cup) (EU-RAR (2008)), it was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2015	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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Classification not possible	- -	-	-	Due to no data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No established test method suitable for liquid substances.	FY2015	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 (Not applicable)	- -	-	-	Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is not chemically bonded to the elements other than carbon or hydrogen.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	It is an organic compound that does not contain bivalent -O-O- structure in the molecule.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Due to no data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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	- -	-	-	From reported LD50 values of > 3,000 mg/kg and > 3,250 mg/kg for rats (EU-RAR (2008)), it was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	From a reported LD50 value of > 6,500 mg/kg for rats (EU-RAR (2008)) and a reported LD50 value of > 3,250 mg/kg for rabbits (EU-RAR (2008)), it was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	In 3 skin irritation tests with 4-hour application of a 65% solution of this substance to rabbits (Directive 79/831/EEC, GLP compliance), very slight to apparent erythema and very slight edema were observed, but there is only one animal whose average score of erythema exceeded 2. It is written that erythema and edema found in these tests did not resolve in 7 out of 15 animals even seven days after application, but the results after that were not shown (EU-RAR (2008)). Therefore, judging that a degree of irritation was slight, the substance was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Not classified	- -	-	-	It is reported that the substance is practically not irritating from a primary eye irritation index of 3.5, 1.17 and 0 (average 1.6) after 24, 48 and 72 hours based on irritation found in 2 out of 6 animals in an eye irritation test in which 0.1 mL of a 65% solution of the substance was applied to rabbits (OECD TG 405, GLP compliance) (EU-RAR (2008)). Therefore, the substance was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Not classified	- -	-	-	It is reported that in multiple skin sensitization tests in humans (an HRIPT test, a maximization test, and a patch test), sensitization was not observed (EU-RAR (2008)). Moreover, it is reported that in maximization tests using guinea pigs, the substance is unclear or not sensitizing (EU-RAR (2008)). It is concluded in EU-RAR (2008) that this substance is not a sensitizing substance because there is no clear evidence that it induces sensitization. From the above, the substance was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	As for in vivo, a micronucleus test in mouse bone marrow cells was negative, and as for in vitro, a bacterial reverse mutation test, a chromosomal aberration test in cultured mammalian cells, a micronucleus test and a sister chromatid exchange test in human lymphocytes were negative (EU-RAR (2008)). From the above, the substance was classified as "Classification not possible" in accordance with Guidance.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	There is no information on human reproductive effects. However, this substance was detected in human body milk in multiple reports. For example, it is reported that in a German study which analyzed body milk samples taken from 107 mothers who had use experiences of commodities containing this substance and were nursing babies, the substance was detected at maximum 1,316 micro g/kg fat (corresponding to 48 micro g per 1 kg of body milk assuming a milk fat content of 3.67%) (EU-RAR (2008), SIDS SIAP (2008)). As for experimental animals, in a teratogenicity test in pregnant rats in gavage administration of this substance during an organogenetic period, maternal animals showed weight gain reduction and decreased food consumption at 150 mg/kg/day or higher and clinical signs (salivation, urine-stained abdominal region and so on) added at 500 mg/kg/day. In fetuses, an increased incidence of malformations in vertebrae/ribs in addition to lower fetus weight and increased unossification/unossified sternebrae were observed at 500 mg/kg/day. It is written that an incidence of skeletal malformations significantly increased not only per fetus but per brood (EU-RAR (2008), SIDS SIAP (2008), HSDB (Access on October 2015)). On the other hand, there is no report from a multiple-generation reproductive toxicity test of this substance, and toxic effects on fertility and development/growth of next generation in the high-dose administration are unknown. Besides, in a gavage administration test in pregnant rats administered from late gestation by weaning of F1 and in F1 pregnant females obtained by mating after growth administered from perinatal period by weaning of F2 respectively at maximum 20 mg/kg/day, toxic effects were not found in fertility of F0 and F1 parent animals, and development and postnatal growth of F1 and F2 offspring. However, in a kinetics test built in this test in oral administration (of a 14C-labeled compound) at 2 and 20 mg/kg/day in F0 maternal animals, the result suggesting that this substance (including metabolites) was transferred to F1 newborns via milk (corresponding to 2.28 and 32.8 mg this substance /L milk) were obtained (EU-RAR (2008), SIDS SIAP (2008)). From the above, although only in one report because skeletal malformations were found in fetuses at a dose where maternal toxicity occurred in a teratogenicity test in rats, the substance was classified in Category 2 in this hazard class. Besides, although there are reports of milk transfer in rats and cases detecting this substance in human body milk, toxic effects on next generation via lactation were not reported so far. Therefore, it is thought that a concentration in milk did not reach the toxicity level, and the additional category for effects on or via lactation was not adopted.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	There are no human data. As for experimental animals, in a 90-day diet administration toxicity test using rats, effects were not found up to 150 mg/kg/day, the maximum dose of this test. Besides this, there are reports from toxicity tests in inhalation and dermal routes for a mixture, but the test conditions are not appropriate to specify target organs. Therefore, the substance was classified as "Classification not possible."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	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	From 48-hour LC50 = 0.47 mg/L for crustacea (Acartia tonsa) (SIAP, conclusions agreed in SIAM 28, 2009), it was classified in Category 1.	FY2015	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	Due to being not rapidly degradabile (BioWin), and 6-day NOEC (develop) = 0.038 mg/L for crustacea (Acartia tonsa) (EU-RAR, 2008), it was classified in Category 1.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data.	FY2015	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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