GHS Classification Result

Chemical Name：(R)-p-mentha-1,8-diene; d-limonene;
CAS：5989-27-5

Result：
ID: 20A2233
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government （Sep, 2008）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
2 Flammable gases （including chemically unstable gases） Not applicable - - - - Liquid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Liquid (GHS definition)
5 Gases under pressure Not applicable - - - - Liquid (GHS definition)
6 Flammable liquids Category 3 Warning H226: Flammable liquid and vapour P303+P361+P353: IF ON SKIN （or hair）: Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P370+P378: In case of fire: Use ... for extinction.
P403+P235: Store in a well-ventilated place. Keep cool.
P210: Keep away from heat/sparks/open flames/hot surfaces. ? No smoking.
P233: Keep container tightly closed.
P240: Ground/bond container and receiving equipment.
P241: Use explosion-proof electrical/ventilating/lighting/.../equipment.
P242: Use only non-sparking tools.
P243: Take precautionary measures against static discharge.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P501: Dispose of contents/container to ... 		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)
7 Flammable solid Not applicable - - - - Liquid (GHS definition)
8 Self-reactive substances and mixtures Not applicable - - - - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
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".
10 Pyrophoric solids 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 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 applicable - - - - Organic compounds containing no oxygen, fluorine or chlorine
14 Oxidizing solids Not applicable - - - - Liquid (GHS definition)
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure in the molecule
16 Corrosive to metals Classification not possible - - - - No data available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
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).
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".
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Liquid (GHS definition)
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - No data available.
1 Acute toxicity （Inhalation: Dusts and mists） Classification not possible - - - - No data available.
2 Skin corrosion/irritation Category 2 Warning H315: Causes skin irritation P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P332+P313: If skin irritation occurs: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment （see ... on this label）.
P362: Take off contaminated clothing and wash before reuse. 		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.
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.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Category 1 Warning H317: May cause an allergic skin reaction P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P272: Contaminated work clothing should not be allowed out of the workplace.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment （see ... on this label）.
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ... 		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.
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)).
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".
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.
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.
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.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Category 1 Warning H400: Very toxic to aquatic life P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Since its 48-hour EC = 0.421 mg/L for crustaceans (Daphnia magna) (NICNAS, 2002), the substance was classified into Category 1.
11 Hazardous to the aquatic environment （Long-term） Category 1 Warning H410: Very toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Since its classification for acute toxicity is Category 1, and it is not rapidly degradable (BIOWIN), the substance was classified into Category 1.


NOTE:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.

Reference：
Reference Manual
Definitions / Abbreviations
Model Label by MHLW

 MHLW Website （in Japanese Only）
Model SDS by MHLW

 MHLW Website （in Japanese Only）

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