Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Vanillin is not irritating to the skin, and irritating to the eyes, with reversibility within 8 days.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14-JUN-1991 to 13-NOV-1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was GLP
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.3 (Acute toxicity (dermal))
- Deviations:
- yes
- Remarks:
- variation of humidity beyond the norms
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: male/female
- Source: Iffa-Crédo (L'Arbresle, France)
- Age at study initiation: 5 - 8 weeks old
- Weight at study initiation: 204 - 271 g
- Fasting period before study:
- Housing: housed individually in polycarbonate cages (305 x 180 x 184 mm)
- Diet: complete pelleted rat-mouse maintenance diet, ad libitum
- Water: softened and filered mains drinking water, ad libitum
- Acclimation period: 7 days before the start of treatment
ENVIRONMENTAL CONDITIONS:
- Temperature: 20 - 24 °C
- Humidity: 43 - 85 %
- Air changes: at least 8 per hr
- Photoperiod: 12 hrs dark / 12 hrs light (artificial)
In-life dates: from 26-AUG-1991 to 09-SEP-1991 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- - Test material:
* Amount applied: 2000 mg/kg
* Concentration: 69.56 % (w/v)
* pH: 4.7
- Vehicle:
* Amount applied: data not available
* Purity: purified water - Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 14 days
- Number of animals:
- 10
- Details on study design:
- - Test site:
* Area of exposure: data not available
* % coverage: approximately 10 %
* Type of wrap if used: perforrated adhesive band 10 cm wide, applied onto an elastic crepe bandage covering the entire shaved area
- Removal of test substance:
* Washing: yes, with lukewarm water
* Time after start of exposure: 24 hours
- Scoring system: according to EU guideline - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- other: yellowish coloration
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: yellowish coloration
- Irritant / corrosive response data:
- The only effect noted was a yellowish colouration of the skin of all rats on days 2 to 15 of the study. No erythema or edema were noted during the observation period.
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- GHS EU classification: not classified.
- Executive summary:
In an acute dermal toxicity study (Lheritier, 1991), young adult Sprague-Dawley rats (5/sex) were dermally exposed to 2000 mg/kg bw of Cristallised Vanilline (purity unknown) in water for 24 hours to 10% body surface area. Test sites were covered with a semi-occlusive dressing for 24 hours. Animals then were observed for 14 days. Irritation was scored by the method of EU guideline.
In this study, Cristallised Vanilline is not a dermal irritant based on the absence of skin reaction. Only a yellowish colour was observed from days 2 to 14.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 11-DEC-2006 to 04-jul-2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Grimaud frères selection SAS, La Corbière, Roussay, France
- Age at study initiation: 3 to 4 months old
- Weight at study initiation: 3 +/- 0.15 kg
- Housing : individually in Pajon cages (50*57*75 cm)
- Diet : free access to 110C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France
- Water : ad libidum (drinking water filtered by a FG Millipore membrane (0.22 micron))
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12 cycles per hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12h/12h
IN-LIFE DATES : from 09 jan 2007 to 19 jan 2007 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the other eye served as control
- Amount / concentration applied:
- 100 mg
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- - Washing: not rinsed
- Scoring system: OECD and EU guidelines
- Tool used to assess score: fluorescein - Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritant / corrosive response data:
- A slight or moderate chemosis and a slight to severe redness of the conjunctiva were observed in all animals from day 1 until day 7.
A clear to whitish purulent discharge were noted in all animals from day 1 until day 3 (2 animals) or 4 (1 animal).
An iritis was noted in all animals between day 1 and day 3.
A slight or moderate corneal opacity, which covered the whole area of the cornea of 2/3 animals on day 2, was recorded in all animals from day 2
until day 4, 5 or 6. - Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- - Interpretation of results: Category 2A (irritating to eyes)
- Criteria used for interpretation of results: EU GHS
SUMMARY:
In a primary eye irritation study (CIT, 2007) 100 mg of Vanilline (pure product) was instilled into the conjunctival sac of right eye of a young adult New Zealand White rabbit (3 males) Animals then were observed for 8 days (period of reversibility). Irritation was scored according to the OECD and EU guidelines.
Mean scores calculated for each animal over 24, 48 and 72 hours were 1.0, 1.7 and 2.0 for chemosis, 2.0, 2.0 and 2.0 for redness of the conjunctiva, 0.7, 0.7 and 0.3 for iris lesions and 2.0, 2.0 and 2.0 for corneal opacity.
In this study, Vanilline is irritating to the eye based on the EU classification criteria.
Classification: irritating - Executive summary:
In a primary eye irritation study (CIT, 2007) 100 mg of Vanilline (pure product) was instilled into the conjunctival sac of right eye of a young adult New Zealand White rabbit (3 males). Animals then were observed for 8 days (period of reversibility). Irritation was scored according to the OECD and EU guidelines.
Mean scores calculated for each animal over 24, 48 and 72 hours were 1.0, 1.7 and 2.0 for chemosis, 2.0, 2.0 and 2.0 for redness of the conjunctiva, 0.7, 0.7 and 0.3 for iris lesions and 2.0, 2.0 and 2.0 for corneal opacity.
In tis study, Vanillin is irritating to the eye based on EU classification criteria.
Reference
Irritant/corrosive response data for each animal at each observation time:
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0 |
1/0/0 |
3/2/2 |
2/2/2 |
24 h |
2/2/2 |
/1/1 |
2/2/2 |
1/2/2 |
48 h |
2/2/2 |
1/1/0 |
2/2/2 |
1/2/2 |
72 h |
2/2/2 |
0/0/0 |
2/2/2 |
1/1/2 |
Average 24h, 48h, 72h |
2/2/2 |
0.7/0.7/0.3 |
2/2/2 |
1/1.7/2 |
Reversibility*) |
c |
c |
c |
c |
Average time (unit) for reversion |
(8 days) |
(8 days) |
(8 days) |
(8 days) |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin irritation:
Concerning Vanillin which composition is described in chapter 1, three studies were available. One of them performed on rat was selected as key study (Hazleton 1991, validity 1), and another one performed on rabbit (Birck 1976, validity 2) as supporting study. The third one tested on guinea pig (Makaruk 1980, validity 3) was not taken into account for assessment because the original reference was in Russian language.
The two selected studies gave the same results:not irritating to the skin. Summaries of these studies are the following:
In an acute dermal toxicity study (Hazleton, 1991), young adult Sprague-Dawley rats (5/sex) were dermally exposed to 2000 mg/kg bw of Vanilline Cristallisée (purity unknown) in water for 24 hours to 10% body surface area. Test sites were covered with a semi-occlusive dressing for 24 hours. Animals then were observed for 14 days. Irritation was scored by the method of EU guideline. In this study, cristallised Vanillin is not a dermal irritant based on the absence of skin reaction. Only a yellowish colour was observed from day 2 to 14.
In a primary dermal irritation study (Birck, 1976),New Zealandwhite rabbits (6 animals) were dermally exposed to 0.5 g of vanillin (purity unknown) for 24 hours. In this study, vanillin was not a dermal irritant.
Eye irritation:
Three studies performed on rabbit were available on Vanillin which composition was described in chapter 1. One of them was selected as key study (CIT 2007, validity 1), and another one (Birck 1976, validity 2) as supporting study. The third one (Makaruk 1980, validity 3) was not taken into account for assessment because the original reference is in Russian language.
The two in vivo selected studies gave the same result: irritating to the eyes. Summaries of these studies are the following:
In a primary eye irritation study (CIT, 2007) 100 mg of Vanillin (pure product) was instilled into the conjunctivae sac of right eye of a young adult New Zealand White rabbit (3 males). Animals then were observed for 8 days (period of reversibility). Irritation was scored according to the OECD and EU guidelines. Mean scores calculated for each animal over 24, 48 and 72 hours were 1.0, 1.7 and 2.0 for chemosis, 2.0, 2.0 and 2.0 for redness of the conjunctiva, 0.7, 0.7 and 0.3 for iris lesions and 2.0, 2.0 and 2.0 for corneal opacity. In this study, Vanillin is irritating to the eye.
In a primary eye irritation study [Birck, 1976], 0.1 mL of vanillin (purity unknown) undiluted was instilled into the conjunctivae sac of New Zealand White rabbits (6 animals) for 24 hours. Animals then were observed for 7 days. Irritation was scored by the method of Kay and Calandra, and in this study, vanillin is an eye irritant.
According to classification criteria of EC regulation 1272/2008 Vanillin was not classified as irritant for the skin and should be classified as irritant for the eyes (Eye. Irrit. Category 2, H319).
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
