GHS Classification Result

Chemical Name:Eugenol
CAS:97-53-0

Result:
ID: 22A4107
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government (July, 2010)

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 molecule.
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 Not classified - - - - Although measurement method of the flash points 104 degC (HSDB (2010)) and > 110 degC (Gangolli (2nd, 1998)) is unknown, it is estimated that the flash point measured by the closed-cup method is > 93 degC. Therefore, the substance is classified as "Not classified".
7 Flammable solids Not applicable - - - - Liquid (GHS definition)
8 Self-reactive substances and mixtures Classification not possible - - - - It contains chemical groups (unsaturated bond) associated with self-reactive properties in the molecule. Since no test results are available, classification is not possible.
9 Pyrophoric liquids Classification not possible - - - - No data available.
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 - - - - The substance is an organic compound containing oxygen which is chemically bonded only to carbon or hydrogen.
14 Oxidizing solids Not applicable - - - - Liquid (GHS definition)
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure.
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) Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ...
Two LD50 values for rats of 1930 mg/kg and 2680 mg/kg were reported (IARC 36 (1985)). Since one is equivalent to Category 4, and the other is equivalent to "Not classified" of the JIS classification criteria. Selecting the category of greater hazard, the substance was classified as Category 4.
1 Acute toxicity (Dermal) Classification not possible - - - - No data available.
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 - - - - Insufficient data were available. Although the LC50 value of > 2.58 mg/L/4hrs was reported in RTECS (2010), which was the "List 3" information source designated in the GHS classification guidance for the Japanese government, the classification was not possible from the result. Since the test concentration (2.58 mg/L) was higher than the saturated vapor pressure concentration (0.20 mg/L), the criterion values for mist were adopted.
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.
The substance was classified as Category 2 because primary skin irritation index value of rabbits was 2.92 (ECETOC TR 66 (1995)) in the test that 0.5 mL of undiluted test substance was applied for 4 hours (OECD TG 404, GLP-compliant).
3 Serious eye damage/eye irritation Classification not possible - - - - No data available.
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 ...
Positive results were reported in the guinea pig maximization test, mouse local lymph node assay (LLNA test), and guinea pig optimization tests (ECETOC TR 77 (1999)). In the clinical patch test for 155 subjects who complained dermatitis from using cosmetics, positive reaction was found in 4 subjects (ECETOC TR 77 (1999)). And in another patch test with 18 dental patients, 16 were found to be positive (ECETOC TR 77 (1999)). The substance was concluded as a skin sensitizer for humans and animals (ECETOC TR 77 (1999)). Based on these documents, the substance was classified as Category 1. As relevant notes, the substance was also listed as a sensitizer in the literature (Contact Dermatitis, Frosch, 4th (2006)).
5 Germ cell mutagenicity Not classified - - - - The classification was concluded as "Not classified" based on the negative results in the micronucleus test using bone marrow obtained from mice after intraperitoneally administered (in vivo mutagenicity test in somatic cells) (NTP DB (Access on Oct. 2010)). As relevant information, the results of the chromosome aberration test using bone marrow cells by the intraperitoneal administration in mice (in vivo mutagenicity test in somatic cells) were equivocal, and the results of sister chromatid exchange test were positive (NTP DB (Access on Oct. 2010)). As for in vitro studies, negative results in the Ames test, negative to weakly positive results in the chromosome aberration test and positive results in the mouse lymphoma assay were reported (NTP DB (Access on Oct. 2010)).
6 Carcinogenicity Classification not possible - - - - The classification was concluded as "Classification not possible" based on the criterion of "Group 3" in the carcinogenicity assessment by the IARC (IARC Supplement 7 (1987)). As relevant information, in the 2-year dietary administration test using rats and mice, no evidence of carcinogenicity in relation to the administration was found in both sexes of rats. On the other hand, in mice, the incidences of liver carcinomas and adenomas in males of the low dose group increased and the total incidences of hepatocellular carcinomas or adenomas in females significantly increased, suggesting an equivocal evidence for carcinogenicity (NTP TR 223 (1983)).
7 Reproductive toxicity Classification not possible - - - - No data available.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - No data available.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - In the 13-week feeding studies in rats and mice treated up to the highest doses of 12500 ppm (625 mg/kg/day) and 6000 ppm (900 mg/kg/day), respectively, no treatment-related toxic effects were observed in both species except for a slight reduction in the body weight in rats at 12500 ppm (NTP TR 223 (1983)). In the 28-day feeding study in rats, there were no effects at the dietary concentration of 2% (converted dose level as that of 90-day study: 622 mg/kg/day) (JECFA WHO FAS 56 (2006)). And no effects were also confirmed in another 19-week feeding study in rats at the dietary concentration of 10000 ppm (500 mg/kg/day) (JECFA WHO FAS 56 (2006)). As stated above, no effects were noted up to the doses over the range of the guidance values, and consequently classification was considered to be equivalent to "Not classified" category for oral route. However, the effects for the other routes were unknown due to no available data. Therefore, the classification for specific target organ toxicity (repeated exposure) was concluded as "Classification not possible".
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 3 - - H402: Harmful to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
Classified into Category 3 from its 96h-LC50 = 24.0 mg/L for fish (Pimephales promelas) (AQUIRE, 2011).
11 Hazardous to the aquatic environment (Long-term) Category 3 - - H412: Harmful to aquatic life with long lasting effects P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
Classified into Category 3 since its acute toxicity is Category 3 and it is not rapidly degradable (BIOWIN).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


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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