GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTES:
Updated date:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS number | 97-54-1 |
| Chemical name | Isoeugenol |
| Substance ID | 23A5075 |
| Fiscal year of classification conducted | FY2011 |
|
Classifier(s) (Ministries) |
Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE） |
| New/Revised | New |
| Download in Excel format | Excel file |
| Item | Information |
|---|---|
|
Guidance used for classification (External link) |
Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document （4th revised edition） |
|
Definitions / Abbreviations (Excel file) |
Definitions / Abbreviations |
|
Model Label by MHLW (External link) |
MHLW Website （in Japanese Only） |
|
Model SDS by MHLW (External link) |
MHLW Website （in Japanese Only） |
|
OECD/eChemPortal (External link) |
eChemPortal |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (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 | - | - | - |
"Liquids" according to GHS definition. |
| 3 | Aerosols | Not applicable | - | - | - |
Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable | - | - | - |
"Liquids" according to GHS definition. |
| 5 | Gases under pressure | Not applicable | - | - | - |
"Liquids" according to GHS definition. |
| 6 | Flammable liquids | Not classified | - | - | - |
From a flash point of > 93 degrees C judged from a flash point of > 100 degrees C [closed cup] (NFPA (13th, 2006)), it was classified as "Not classified." |
| 7 | Flammable solids | Not applicable | - | - | - |
"Liquids" according to GHS definition. |
| 8 | Self-reactive substances and mixtures | Classification not possible | - | - | - |
There is a chemical group present in the molecule associated with a self-reactive property (unsaturated bond), but the classification is not possible due to no data. |
| 9 | Pyrophoric liquids | Classification not possible | - | - | - |
No data. |
| 10 | Pyrophoric solids | Not applicable | - | - | - |
"Liquids" according to GHS definition. |
| 11 | Self-heating substances and mixtures | Classification not possible | - | - | - |
No established test method suitable for liquid substances. |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable | - | - | - |
Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). |
| 13 | Oxidizing liquids | Not applicable | - | - | - |
An organic compound that contains oxygen which is not chemically bonded to elements other than carbon or hydrogen. |
| 14 | Oxidizing solids | Not applicable | - | - | - |
"Liquids" according to GHS definition. |
| 15 | Organic peroxides | Not applicable | - | - | - |
An organic compound that does not contain -O-O- structure. |
| 16 | Corrosive to metals | Classification not possible | - | - | - |
No data. |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity （Oral） | Category 4 |
 |
H302 |
P301+P312 P264 P270 P330 P501 |
From LD50 values of 1560 mg/kg (PATTY (5th, 2001)) and 1290 to 1880 mg/kg (NTP TR 551 (2010)) for rats, it was classified in Category 4. |
| 1 | Acute toxicity （Dermal） | Category 4 |
|
H312 |
P302+P352 P280 P312 P322 P363 P501 |
From an LD50 value of 1912 mg/kg bw for rabbits (HERA (2005), corresponding to List 2), it was classified in Category 4. |
| 1 | Acute toxicity （Inhalation: Gases） | Not applicable | - | - | - |
"Liquids" according to GHS definition. |
| 1 | Acute toxicity （Inhalation: Vapours） | Classification not possible | - | - | - |
No data. |
| 1 | Acute toxicity （Inhalation: Dusts and mists） | Classification not possible | - | - | - |
No data. |
| 2 | Skin corrosion/irritation | Category 2 |
|
H315 |
P302+P352 P332+P313 P264 P280 P321 P362 |
From "severely irritating" concluded by 24-hour occlusive application with undiluted this substance to rabbit or guinea pig skin (HERA (2005)), it was classified in Category 2. Besides, in human, a 48-hour occlusive application test with 32% solution of this compound in acetone in adult males reported that 1 out of 50 men showed moderately irritating. (HERA (2005)) |
| 3 | Serious eye damage/eye irritation | Category 2A |
|
H319 |
P305+P351+P338 P337+P313 P264 P280 |
After application of 1% or 1.25% solution of this substance in alcohol into rabbit eyes, mild conjunctival irritation in 1% and intense conjunctival irritation accompanied by chemosis and discharge in 1.25% were observed, and eyes became normal after four and seven days respectively. (HERA (2005)) It was classified in Category 2A because severe irritation is expected if undiluted this substance is used (HERA (2005)). |
| 4 | Respiratory sensitization | Classification not possible | - | - | - |
No data. |
| 4 | Skin sensitization | Category 1 |
|
H317 |
P302+P352 P333+P313 P261 P272 P280 P321 P363 P501 |
Positive results were obtained in both a maximization test in guinea pigs and a local lymph node test in mice. (ECETOC TR 77 (1999), NTP TR 551 (2010)) In human, incidences in allergic contact dermatitis are increasing by use of cosmetics and detergents including this substance (NTP TR 551 (2010)), and many cases of a positive response in a patch test in patients who have sensitization or dermatitis to cosmetics and so on were published. Therefore, it was concluded that this substance is a skin sensitizer both in human and animal. (ECETOC TR 77 (1999)) Furthermore, this substance is included in a list of sensitizing substances recognized by the Japanese Society for Dematoallergology and Contact Dermatitis (Japanese standard allergens 2008, corresponding to List 1) and is also listed as a contact allergy substance in Contact Dermatitis (Frosch) (Contact Dermatitis (Frosch) (4th, 2006), corresponding to List 1). From the above knowledge, it was classified in Category 1. |
| 5 | Germ cell mutagenicity | Not classified | - | - | - |
A micronucleus test using peripheral blood after 90-day oral administration to mice (in vivo somatic cell mutagenicity test) showed a negative in males and a positive in females. (NTP DB (Access on June 2011)) But the positive result was judged not to have biological significance from whose significant difference, which was only found in the highest dose group, was attributed to a low incidence of micronucleus in a control group. Therefore, it was classified as "Not classified" from the negative result in males. Besides, as in vitro tests, both an Ames test and a chromosomal aberration test using CHO cells reported negatives. (NTP DB (Access on June 2011)) |
| 6 | Carcinogenicity | Classification not possible | - | - | - |
In a 2-year oral administration carcinogenicity test in rats and mice, no evidence of carcinogenicity was found in female rats, but increased incidences of rarely occurring thymoma and mammary gland carcinoma in male rats and an increased incidence of histiocytic sarcoma in female mice were considered to be equivocal evidence of carcinogenicity. On the other hand, hepatocellular adenoma and hepatocellular carcinoma were found in male mice. (NTP TR 551 (2010)) It was classified as "Classification not possible" because the liver tumors found in male mice, which were the only clear evidence of carcinogenicity, were not sufficient to prove apparent carcinogenicity of this substance from the above. |
| 7 | Reproductive toxicity | Classification not possible | - | - | - |
In a three-generation reproductive test in oral administration in rats (70 to 700 mg/kg/day), manifestations of general toxicity such as hyperkeratosis and hyperplasia in forestomach at all doses and decreased body weight at doses of 230 mg/kg/day or higher, and a decrease in male pups number per litter at 700 mg/kg/day in F0 generation were reported. (NTP RACB 97004 (2002)) But due to insufficient evidence to show apparent reproductive toxicity from limited effects to F0 generation, and description of "mild reproductive toxicity" in the main text (NTP RACB 97004 (2002)), it was classified as "Classification not possible." Besides, in a development toxicity test in oral administration on day 6 to 19 of gestation in rats (250 to 1000 mg/kg/day), decreased weight gains at all doses, and as effects on the development of the offspring, only decreased fetal body weights and delayed ossification of sternebra but no teratogenicity were observed. (NTP TER 97006 (1999)) |
| 8 | Specific target organ toxicity - Single exposure |
Category 2 (nervous system) |
 |
H371 |
P309+P311 P260 P264 P270 P405 P501 |
In oral administration to rats, an LD50 of 1560 mg/kg, comatose state and persistent weakness, and deaths within a week were observed. (PATTY (5th, 2001)) In addition, in intraperitoneal administration in rats, anesthetic and anticonvulsant effects at doses near to LD50 values (261 to 309 mg/kg) were reported. (HERA (2005)) There is information that eugenol of related substance reduces peripheral nerve activity at a low dose and causes neurotoxicity at a high dose (HSDB (2010)). Because the LD50 value in oral corresponded to Category 2 in Guidance values from the above signs after exposure, it was classified in Category 2 (nervous system). |
| 9 | Specific target organ toxicity - Repeated exposure |
Category 2 (nasal cavity) |
|
H373 |
P260 P314 P501 |
In a 2-year repeated oral administration test dosed 75, 150, or 300 mg/kg/day to mice, incidences of respiratory metaplasia, atrophy, and hyaline droplet accumulation in the olfactory epithelium of nasal cavity in all dose groups increased significantly than those in a vehicle control group, and incidences of minimal to marked hyperplasia of Bowman’s gland also increased significantly. (NTP TR 551 (2010)) In a 2-year repeated oral administration test dosed 75, 150, or 300 mg/kg/day to rats, increased incidences of respiratory metaplasia and atrophy at doses of 150 mg/kg/day or higher and olfactory epithelium degeneration at 300 mg/kg/day were also reported. (NTP TR 551 (2010)) It was classified in Category 2 (nasal cavity) because the dose of 75 mg/kg/day at which the above effects on olfactory epithelium in mice were reported corresponds to Category 2 in Guidance values. Besides, in a 14-week repeated oral administration test in rats and mice, atrophy of olfactory epithelial tissue and nerve bundles were also reported at a dose above the upper limit of a range of Guidance values. (NTP TR 551 (2010)) |
| 10 | Aspiration hazard | Classification not possible | - | - | - |
No data. |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment （Acute） | Classification not possible | - | - | - |
No data. |
| 11 | Hazardous to the aquatic environment （Long-term） | Classification not possible | - | - | - |
No data. |
| 12 | Hazardous to the ozone layer | Classification not possible | - | - | - |
This substance is not listed in Annexes to the Montreal Protocol. |
NOTES:
|
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * 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. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |
Updated date:
|
2017/3/31 Addition of Rationale for the classification |