Registration Dossier
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EC number: 204-465-2 | CAS number: 121-33-5
- 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
LD50 oral (rat): 3978 mg/kg bw. Vanilline is not harmful by ingestion.
LD50 dermal (rat): > 2000 mg/kg bw (no mortality observed at this dose). Vanilline is not harmful by dermal route.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 3 978 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
Additional information
Acute oral toxicity
Seven studies were available which 3 of them were of validity 2.
All data gave LD50 results above 2000 mg/kg, except results in Jenner (1964) publication (1580 mg/kg in rat and 1400 mg/kg in guinea pig) which was not taken into consideration, because it was validity 3 according to Klimish scale.
The three studies with validity 2 (Hazleton 1992, Monsanto 1955 and 1976,) were selected as key studies. The results were similar, the study ofHazleton(1992), was the most detailed.
In this study groups of fasted, 5-7 weeks old Sprague-Dawley rats (5/sex) were given a single oral dose of crystallised Vanilline (purity unknown) in CMC at doses of 0, 2000, 2510, 3160 and 3980 mg/kg bw and observed for 15 days. Lethargy, prostration or subdued behaviour were observed in all groups, and sialorrhea was observed in some animals. Death occurred in animals tested of main experiment: for limit test 2/10 at 2000 mg/kg bw for principal study: 0/10 at 0 mg/kg bw 1/10 at 2000 mg/kg bw 2/10 at 2510 mg/kg bw 3/10 at 3160 mg/kg bw 5/10 at 3980 mg/kg bw. In the preliminary study, 3 groups of 2 males and 2 females per group were treated under the same conditions as those employed in the main study, at the dose levels of 500, 1000 and 2000 mg/kg. Animals were observed for 15 days. Neither clinical signs nor death were seen at all dose level tested.
Oral LD50 Combined Males/Females = 3978 mg/kg bw (95% C.I. 2484 - 6368 mg/kg bw) according to Bliss' method
The key studies provided a LD50 range from 3300 to 3978 mg/kg.
According to classification criteria of EC regulation 1272/2008 Vanillin should not be classified for acute oral toxicity.
Inhalation route:
Only one study on rat (Makaruk, 1980) was available. In this study, only one dose was tested which is the saturated vapour concentration. It gave a result of LC50 above 41.7 mg/m3after 4 hours exposure for rats and 2 hours for mouse with no other details. It was in validity 3 according to Klimish scale, and no purpose flag was selected.
Dermal route:
In an acute dermal toxicity study (Hazleton, 1991) of validity 2, groups of 5 -7 weeks old Sprague-Dawley rats (male / female) were dermaly exposed to Vanillin for 24 hours to approximately 10% area of the body at doses of 2000 mg/kg bw. Animals then were observed for 14 days.
In the preliminary study, 2 males and 2 females per group were treated under the same conditions as those employed in the main study, at the dose levels of 1000 and 2000 mg/kg. No deaths were seen at all dose level tested of 2000 mg/kg.
Dermal LD50 Combined>2000mg/kg bw. No clinical sign, except yellowish coloration of the skin and no mortality occurred at this dose.
According to classification criteria of EC regulation 1272/2008 Vanillin should not be classified for acute dermal toxicity based on the LD50 in male and female rats.
Justification for classification or non-classification
Regarding data available, vanilline was not classified for acute toxicity by oral and dermal routes.
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