NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	5989-27-5
Chemical Name	(4R)-p-Mentha-1,8-diene; d-Limonene
Substance ID	m-nite-5989-27-5_v2
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 molecules.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Category 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	Based on its flash point of 48degC (closed cup) (HSDB (2006), ICSC (2005), ICSC (J) (2005)), the substance was classified into Category 3. It is rated as 3 III by the UNRTDG (UNRTDG, Rev. 15, 2007)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Pyrophoric liquids	Not classified	- -	-	-	Its autoignition point is 237degC (HSDB (2006), ICSC (2005), ICSC (J) (2005)). According to the classification guidelines, a substance with its autoignition point >= 70degC is classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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	- -	-	-	Based on its rat LD50 values: 4.4 g/kg for males and 5.1 g/kg for females (CICADs (No. 5, 1998)), the substance was classified into "Not classified" based on the JIS classification criteria (Category 5 in the United Nations classification).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on its rabbit LD50 value of > 5 g/kg (DFGOT (vol. 1, 1991)), the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	In humans who received patch tests, irritation lasted for 72 hours, and a 2-hour dermal exposure caused a burning, itching, aching, and purpuric rash (CICADs (No. 5, 1998)). In addition, rabbit tests (OECD TG 404) indicated that the substance was ranked 3.5 out of 8 based on the Primary Dermal Irritation Index. Based on these results, as well as its R38 rating in the EU classification (which is equivalent to Category 2 or 3) (EU-Annex 1, accessed in December 2008), the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	The substance has been recognized as an irritant in rabbits (CICADs (no. 5, 1998)), but this dataset alone is not sufficient to specify a category for the substance. Thus, the substance was classified into "Classification not possible" due to lack of data.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	Humans applied with patch tests showed signs of sensitization 10 to 15 minutes after the application (CICADs (No. 5, 1998)). Signs of sensitization were also observed in maximization tests using guinea pigs (CICADs (No. 5, 1998)). Based on these results, as well as its R43 rating in the EU classification (which is equivalent to Category 1) (EU-Annex 1, accessed in December 2008) and Sh rating by the DFG (MAK/BAT (2007)), the substance was classified into Category 1.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Not classified	- -	-	-	In vivo mutagenicity tests using somatic cells (mouse spot tests) revealed that negative results were associated with the substance (IARC (vol. 73, 1999)). Therefore, the substance was classified into "Not classified". Among in vitro tests documented, mouse lymphoma assays, chromosomal aberration tests using CHO cells, and Ames tests all yielded negative results (CICADs (No. 5, 1998)), IARC (vol. 73, 1999)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Not classified	- -	-	-	The IARC has rated the substance as Group 3 (IARC vol. 73, 1999). In life-long, forced oral administration tests using rats (F344/N), adenocarcinoma in renal tubular cells was observed only in males, and no signs of carcinogenicity were observed in females (CICADs No. 5, 1998). Additionally, in life-long, forced oral administration tests using mice (B6C3F1) (IARC vol. 73, 1999), no signs of carcinogenicity were detected. There is a description that the symptom observed in male rats is species and sex-dependent (CICADs No. 5, 1998). Accordingly, there are no suspected carcinogenic effects on humans, and the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Classification not possible	- -	-	-	In teratogenicity tests using rats or mice, a decreased organ weight (the thymus, spleen and ovary), skeletal anomalies (a fusion of a lumbar rib and a rib), and delayed ossification were observed in fetuses at the doses that cause general toxicity in maternal animals (CICADs (No. 5, 1998)). However, severity of these symptoms are unknown and information on the effects on reproductive functions in parental animals are not available; thus, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	In 2-hour inhalation tests involving eight humans (10, 225, and 450 mg/m3), no abnormalities related to the central nervous system were detected other than slight decline in vital capacity in high concentration groups (CICAD (No. 5, 1998)). In oral administration tests (20 g) involving volunteers, diarrhoea, painful constriction, and proteinuria were detected, while no abnormalities related to the liver were observed (total proteins, bilirubin, cholesterol, and enzyme groups) (CICAD (No. 5, 1998)). In forced oral administration tests using rats (0-1200 mg/kg bw), no abnormalities were detected in hepatic triglyceride, microsomal proteins, hepatic cytochrome b5 or drug metabolizing enzyme group (JECFA (1993)). These results support that the substance is to be classified into the "Not classified" category for oral and inhalation routes, as no serious changes were observed in humans and animals. However, since data on dermal exposure are not available, in conclusion, the substance was classified into "Classification not possible". Also, in single administration tests using rats (Sprague-Dawley) (both sexes were treated with 0-409 mg/kg), the level of hyaline droplets became 10 in the animal groups treated with 409 mg/kg (compared with 3 in control groups). However, since the association between this substance and alpha-2u globulin has been reported, we judged that the symptoms observed are species and sex-dependent and these datasets cannot be used as grounds for classification.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In 16-day forced oral route tests using rats (0-6600 mg/kg (90-day conversion: 73-1173 mg/kg)), no toxic symptoms or histological changes caused by this substance were detected in animal groups treated at 1650 mg/kg or lower doses (JECFA (1993)). In addition, in 30-day oral administration tests using rats that were treated with 0 to 2770 mg/kg (90-day correction: 92-923 mg/kg), no changes were detected in organ weight, urine, blood and biochemical examinations, except for the detection of granular casts in the kidneys (JECFA (1993)). Although these results found that oral-route administration of the substance fits in "Not classified" category, in conclusion, the substance was classified into "Classification not possible" due to lack of dermal and inhalation exposure data. Regarding the symptoms observed in male rats, the effects of alpha-2u globulin may have been involved, so it was not taken into consideration as grounds for the classification of the substance.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Aspiration hazard	Category 1	Danger	H304	P301+P310 P331 P405 P501	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))

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	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))

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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