Registration Dossier
Registration Dossier
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EC number: 202-589-1 | CAS number: 97-53-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
Oral, LD50 > 2,000 mg/kg bw, rat (NTP, 1983)
Oral, LD50 > 1,500 - <3,000 mg/kg bw, mouse (NTP, 1983)
Inhalation, LC50 > 2.6 mg/L, rat (Clark, 1988)
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 2 600 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In one oral (gavage) study, eugenol was administered at dose levels of 180, 375, 750, 1,500, or 3,000 mg/kg/body weight to groups of 5 male and 5 female B6C3F1 mice and in the other study at 150, 250, 500, 1,000, or 2,000 mg/kg body weight to groups of 5 male and 5 female F344/N rats. Animals were observed over a 15-day period (NTP, 1983). In mice, mortality was seen in 1 male in the 750 mg/kg body weight dose group and in 2 males and 5 females in the 3,000 mg/kg body weight dose group. In rats, mortality was seen in 1 female in the 2,000 mg/kg body weight dose group. No other toxicological effects were reported by the authors for either study. The oral median LD50 was reported to be >1,500 mg/kg body weight for male and female mice and >2,000 mg/kg body weight for male and female rats.
The acute toxicity of inhaled eugenol was assessed in groups of 5 male and 5 female Sprague-Dawley rats; the animals were exposed to eugenol in a submicron aerosol formulation at concentrations of 0.77, 1.37, or 2.58 mg/L for 4 hours and were observed over a 14-day period (Clark, 1988). Immediately following exposure, all high-dose rats were lethargic and many mid- and high-dose rats had wet snouts and red-brown staining of their fur (actual numbers of animals with these findings were not reported). Low dose rats and control animals were normal in appearance and behaviour. Macroscopic pathological changes included dark red, slightly raised areas in the lungs of 2 animals each in the low- and high-dose groups. The 4-hour inhalation LD50 was reported to be >2.6 mg/L in both male and female rats.
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self classification:
Acute toxicity via Oral route:
Based on the available data, the substance is not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 2000 mg/kg bw.
Acute toxicity via Dermal route:
No data was available. However, the substance is not classified as skin irritating and acuted oral toxicity is greater than 2000 mg/kg bw. Moreover, considering that the skin is a physical barrier for the substance, acute toxicity by dermal is not expected.
Based on the available data, the substance is not classified according to the Regulation (EC) No. 1272/2008.
Acute toxicity (Inhalation):
Based on the available data, the substance is not classified according to the Regulation (EC) No. 1272/2008.
Specific target organ toxicity: single exposure (Oral):
The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw≥C > 300 mg/kg bw). No classification is required.
The criteria for Transient Organ effects (STOT-SE Category 3) according to Annex VI of the Regulation (EC) No. 1272/2008 are not met since narcotic effects were not observed in the acute oral toxicity study.
Specific target organ toxicity: single exposure (Dermal):
No data was available. However, the registered substance is not a skin irritant that could facilitate the penetration of the substance across the skin. Moreover, no narcotic effects were observed in the acute oral toxicity study and the skin is a physical barrier for the substance. Therefore the criteria for Transient Organ effects (STOT-SE Category 3) according to Annex VI of the Regulation (EC) No. 1272/2008 are not met since narcotic effects were not expected.
Specific target organ toxicity: single exposure (Inhalation):
A rat acute inhalative 4-hour(mist) is available. No respiratory tract irritation or narcotic effect was observed.
No Aspiration hazard symptoms were observed from available studies by oral route. However, as the substance may contain an impurity self-classified with H304, and considering the viscosity of the substance is expected to lie below the threshold of 20.5 mm2/s (measured dynamic viscosity of 8.39 mPa.s at 25°C, corresponding to kinematic viscosity of 7.9 mm2/s for a density of 1.065, and anticipated to be lower at 40°C) the classification is proposed to apply to the quality grade with high impurity content (>10%).
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