NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	32388-55-9
Chemical Name	1-[(3R,3aR,7R,8aS)-3,6,8,8-Tetramethyl-2,3,4,7,8,8a-hexahydro-1H-3a,7-methanoazulen-5-yl]ethanone
Substance ID	m-nite-32388-55-9_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)
Sample SDS by MHLW (External link)
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.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
6	Flammable liquids	Not classified	- -	-	-	A flash point was > 100 deg C (closed-cup) (GESTIS (Accessed June 2020)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with self-reactive properties (ethylenes) present in the molecule, but the classification is not possible due to no data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 243 deg C (ECHA (Accessed June 2020)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

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	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" (Category 5 in UN GHS classification) from (1). [Evidence Data] (1) LD50 for rats: 4,500 mg/kg (REACH registration dossier (Accessed June 2020))	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rabbits: > 5,000 mg/kg (REACH registration dossier (Accessed June 2020))	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified."	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) It is reported that in an In-vitro skin irritation test (OECD TG 439), cell viability, R = 76.2% (REACH registration dossier (Accessed June 2020)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) It is reported that in an eye irritation test with rabbits (n = 6) (equivalent to OECD TG 405, 7-day observation), no eye irritation was seen (corneal opacity score: 0/0/0/0/0/0, iritis score: 0/0/0/0/0/0, conjunctival redness score: 0/0/0/0/0/0, chemosis score: 0/0) (REACH registration dossier (Accessed May 2020)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
4	Skin sensitization	Category 1B	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] It was classified in Category 1B from (1). [Evidence Data] (1) It is reported that in a local lymph node assay (LLNA) with mice (n = 4/group) (OECD TG 429), irritation index (SI values) was 1.67 (2.5%), 1.69 (5%), 2.39 (10%), 4.72 (25%), 25.09 (50%), the EC3 value was calculated as 13.93%, and it was a potential skin sensitizer (REACH registration dossier (Accessed June 2020)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on the data (1) to (3), it was classified as "Not classified." [Evidence Data] (1) In a bacterial reverse mutation test (OECD TG471, GLP), negative results were reported (REACH registration dossier (Accessed June 2020)). (2) In a chromosomal aberration test with cultured mammalian cells (CHO-K1 cells) (OECD TG473, GLP), negative results were reported (REACH registration dossier (Accessed June 2020)). (3) In an in vitro mammalian cell gene mutation test (MLA, OECD TG 476, GLP), negative results were reported (REACH registration dossier (Accessed June 2020)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. In (1), no developmental toxicity was observed, while there was no data on effects on fertility. [Evidence Data] (1) It was reported that in a developmental toxicity study with rats dosed by gavage (gestational days 7 to 17), no developmental toxicity was observed at 100 mg/kg/day (REACH registration dossier (Accessed June 2020)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was considered to be classified as "Not classified" in the oral and dermal routes, but there was no information on toxicity in the inhalation route. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) It was reported that in an acute oral toxicity test with rats, at 2,002 to 12,883 mg/kg (2.0 to 12.65 mL/kg), irritability and passivity were observed up to 48 hours after dosing (REACH registration dossier (Accessed June 2020)). (2) It was reported that in an acute dermal toxicity test with rabbits, transient moderate erythema and drying and scaliness were observed at 5,000 mg/kg (in the range corresponding to "Not classified") and persisted through termination of test (REACH registration dossier (Accessed June 2020)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was considered to be classified as "Not classified" in the oral and dermal routes, but there was no information on toxicity in the inhalation route. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) In a 90-day repeated oral dose toxicity test with rats dosed by gavage (OECD TG 408, GLP), at 80 mg/kg/day (within the range for Category 2), a subtle increase in hepatocellular fatty changes was observed in the livers of the rats, and hyaline droplets and eosinophilic bodies at the basal levels of renal epithelium in the cortex were observed in the kidneys of only the male rats. The former finding was an adaptative change to xenobiotics, and the latter findings were judged, from an immunostaining assay, as changes associated with alpha 2mu-globulin nephropathy, which were specific to male rats and could not be extrapolated to humans. It was reported that at 250 mg/kg/day (in the range corresponding to "Not classified"), clear effects in the liver (hepatocellular fatty change associated with single cell death, well-circumscribed eosinophilic foci of hepatocytes, increases in frequency and severity of bile duct hyperplasia) were observed, and alterations in tissues were also observed in the thyroid glands and kidneys (renal tubular basophilia, females) (REACH registration dossier (Accessed June 2020)). (2) It was reported that in a 90-day sub-chronic dermal toxicity study with rats (OECD TG411, GLP) (6 to 7 hours/day), only local effects (dermal irritation effects) were observed at 50 mg/kg/day and 150 mg/kg/day (within the range for Category 2) and no systemic effects were observed (REACH registration dossier (Accessed July 2020)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

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 48-hour EC50 = 0.86 mg/L for crustacea (Daphnia magna) (REACH registration dossier, 2021).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 1 because it was not rapidly degradable (a 28-day degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 2009)) and due to 21-day NOEC = 0.087 mg/L for crustacea (Daphnia magna) (REACH registration dossier, 2021). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 because it was not rapidly degradable (not readily degradable, a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 2009)) and due to 96-hour LC50 = 2.3 mg/L for fish (Pimephales promelas) (REACH registration dossier, 2021). By drawing a comparison between the above results, it was classified in Category 1.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

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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