GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 125-12-2
Chemical Name rel-(1R,2R,4R)-Bornan-2-yl acetate
Substance ID R02-A-064-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 Category 4
-
Warning
H227 P370+P378
P210
P280
P403
P501
It was classified in Category 4 based on a flash point of 88 deg C (Closed cup) (GESTIS (Accessed Sep. 2020)).
7 Flammable solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
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.
9 Pyrophoric liquids Not classified
-
-
- - It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 430 deg C (GESTIS (Accessed Sep. 2020)).
10 Pyrophoric solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible
-
-
- - Classification is not possible because 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" from (1), (2).

[Evidence Data]
(1) LD50 for rats: > 10,000 mg/kg (REACH registration dossier (Accessed Sep. 2020), HSDB (Accessed Oct. 2020))
(2) LD50 for rats: about 9,050 mg/kg (GESTIS (Accessed Oct. 2020), HSDB (Accessed Oct. 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: about 20,000 mg/kg (REACH registration dossier (Accessed Oct. 2020), HSDB (Accessed Oct. 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" (Category 3 in UN GHS classification) from (1).

[Evidence Data]
(1) It is reported that in a skin irritation test with rabbits (n = 3) (OECD TG 404, GLP, semi-occlusive, 4-hour application, 7-day observation), erythema was seen in 2 animals but completely disappeared within 7 days (erythema/eschar score: 0/2/2, edema score: 0/0/0) (REACH registration dossier (Accessed Sep. 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 = 3) (OECD TG 405, GLP, 72-hour observation), eye irritation effects seen were fully reversible within 72 hours (corneal opacity score: 0/0/0, iritis score: 0/0/0, conjunctival redness score: 0.3/0/0, chemosis score: 0/0.3/0.3) (REACH registration dossier (Accessed Oct. 2020)).
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) It is reported that in a maximization test in 25 persons, no sensitization reactions were observed after applying 10% of this substance in petrolatum (REACH registration dossier (Accessed Oct. 2020), HSDB (Accessed Oct. 2020), GESTIS (Accessed Oct. 2020)).
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (3), it was classified as "Not classified."

[Evidence Data]
(1) In a micronucleus test using the bone marrow from mice (OECD TG 474, GLP, single dose by oral gavage, 2,000 mg/kg), negative results were reported (REACH registration dossier (Accessed Oct. 2020)).
(2) In a bacterial reverse mutation test (OECD TG 471, GLP), negative results were reported (REACH registration dossier (Accessed Oct. 2020)).
(3) In a gene mutation test using the Chinese hamster lung fibroblasts (V79) (OECD TG 476, GLP), negative results were reported (REACH registration dossier (Accessed Oct. 2020)).
6 Carcinogenicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification was not possible due to lack of data.
7 Reproductive toxicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) It was reported that in a one-generation reproduction toxicity study with rats dosed by gavage, no reproductive toxicity was observed (HSDB (Accessed Sep. 2020).
(2) It was reported that in a developmental toxicity study with rats dosed by gavage (OECD TG 414, GLP, days 7 to 16 of gestation), no developmental toxicity was observed (REACH registration dossier (Accessed Sep. 2020)).
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - [Rationale for the Classification]
Classification was not possible due to lack of data.

[Reference Data, etc.]
(1) It was reported the possibility could not be ruled out that gastrointestinal disorders, central nervous system disorders (agitation/narcotic effects), and renal disorders might occur after oral intake of high doses of this substance (GESTIS (Accessed Oct. 2020)).
9 Specific target organ toxicity - Repeated exposure Category 2 (kidney)


Warning
H373 P260
P314
P501
[Rationale for the Classification]
Based on (1), it was classified in Category 2 (kidney).

[Evidence Data]
(1) It was reported that in a 13-week oral toxicity study with rats dosed by gavage (OECD TG408), an increase in water intake and kidney effects (an increase in weight, a decrease in renal concentrating ability, exfoliation or vacuolation of renal tubular epithelial cells) were observed at 90 mg/kg/day (within the range for Category 2); and liver effects (vacuolation of the epithelium of the intrahepatic bile duct, an increase in liver weight) and an enlargement of the ceca were observed at 270 mg/kg/day (in the range corresponding to "Not classified") (EFSA (2016), REACH registration dossier (Accessed Sep. 2020)).

[Reference Data, etc.]
(2) It was reported that in a 4-week or 8-week inhalation exposure test with rats, degeneration of mitral cells of the olfactory bulb and degeneration of the olfactory epithelium were observed at 1.5 mg/L (converted guidance value: 0.467 mg/L or 0.933 mg/L, in the range corresponding to "Not classified") (GESTIS (Accessed Sep. 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 3
-
-
H402 P273
P501
It was classified in Category 3 from 96-hour LC50 > 10 mg/L and < 18 mg/L for fish (Danio rerio) (REACH registration dossier, 2021).
11 Hazardous to the aquatic environment Long term (Chronic) Category 3
-
-
H412 P273
P501
If chronic toxicity data are used, then it is classified as "Not classified" because it is not rapidly degradable (BIOWIN) and due to 72-hour NOErC = 8.54 mg/L for algae (Desmodesmus subspicatus) (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 3 because it is not rapidly degradable (BIOWIN) and due to 96-hour LC50 > 10 mg/L and < 18 mg/L for fish (Danio rerio) (REACH registration dossier, 2021).
By drawing a comparison between the above results, it was classified in Category 3.
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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