GHS Classification Results by the Japanese Government

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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 R02-A-009-METI, MOE
Classification year (FY) FY2020
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 (FY2019 revised edition (Ver. 2.0))
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 classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products.
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
5 Gases under pressure Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
6 Flammable liquids Not classified
-
-
- - A flash point was > 100 deg C (closed-cup) (GESTIS (Accessed June 2020)).
7 Flammable solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
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.
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)).
10 Pyrophoric solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible
-
-
- - Test methods applicable to liquid substances are not available.
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).
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.
14 Oxidizing solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
15 Organic peroxides Not classified (Not applicable)
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule.
16 Corrosive to metals Classification not possible
-
-
- - No data available.
17 Desensitized explosives Not classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecule.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
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))
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))
1 Acute toxicity (Inhalation: Gases) Not classified
-
-
- - [Rationale for the Classification]
Liquid (GHS definition). It was classified as "Not classified."
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
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)).
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)).
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
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)).
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)).
6 Carcinogenicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
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)).
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)).
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)).
10 Aspiration hazard Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
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).
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.
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in the Annexes to the Montreal Protocol.


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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