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EC number: 204-464-7 | CAS number: 121-32-4
- 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
Ethylvanillin is slightly irritating to skin, and not classified according to the CLP 1272/2008/EC classification criteria.
Ethylvanillin is classified eye irritant category 2 (H319), according to the CLP 1272/2008/EC classification criteria.
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:
- From may 2003 to 28 august 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France
- Age at study initiation: 2 to 4 months old
- Weight at study initiation: 2.4 +/- 0.2 kg
- Housing: individually in polystyrene cages (48.2*58*36.5 cm)
- Diet (e.g. ad libitum): free access to 110 pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France).
- Water (e.g. ad libitum): drinking water filtered by a Millipore membrane (0.22 micron), ad libitum.
- Acclimation period: at least 5 days before the start of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 30 to 70% relative humidity
- Air changes (per hr): 12 cycles per hour of filtered, non-recycled air.
- Photoperiod (hrs dark / hrs light): 12h / 12h
IN-LIFE DATES: From: 27 may 2003 To: 30 may 2003 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: control on the other untreated flank
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: on one flank
- Type of wrap if used: the test item and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated
semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test item was miped off by means of a moistened cotton pad.
SCORING SYSTEM: according to the Commission Directive 2004/73/EC - Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Other effects:
- yellow coloration of the skin
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not irritating.
- Executive summary:
In one primary dermal irritation study of validity 1 (Klein, 2003), young adult New Zealand White rabbits (3 males) were dermally exposed to 500 mg of ethylvanillin onto one flank. Test sites were covered with semi-occlusive dressing for 4 hours. Animals then were observed for 72 hours.
Irritation was scored by the method of the Commission Directive 2004/73/EC. Mean scores over 24, 48 and 72 hours for each animal were 0.7, 0.3 and 0 for erythema and 0, 0 and 0 for edema.
In this study, ethylvanillin is very slightly irritant when applied topically to rabbits, but not classified according to the EU classification criteria (CLP 1272/2008/EC).
Reference
Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test:
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 2 |
|
60 min |
1/1/0 |
0/0/0 |
24 h |
1/1/0 |
0/0/0 |
48 h |
1/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0.7/0.3/0 |
0/0/0 |
Reversibility |
Yes at 72 hours |
/ |
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 may 2003 to 05 sept 2003
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France
- Age at study initiation: 2 to 4 months old
- Weight at study initiation: 3 +/- 0.4 kg
- Housing: individually in polystyrene cages (48.2*58*36.5 cm)
- Diet (e.g. ad libitum): free access to 110 pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France).
- Water (e.g. ad libitum): drinking water filtered by a Millipore membrane (0.22 micron), ad libitum.
- Acclimation period: at least 5 days before the start of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 30 to 70% relative humidity
- Air changes (per hr): 12 cycles per hour of filtered, non-recycled air.
- Photoperiod (hrs dark / hrs light): 12h / 12h
IN-LIFE DATES: From: 03 jun 2003 To: 17 jun 2003 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: not rinsed
SCORING SYSTEM: according to the Commission Directive 2004/73/EC
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Classified irritating according to CLP regulation.
- Executive summary:
In one primary eye irritation study of validity 1 (Klein, 2003), 100 mg of ethylvanillin was instilled into the conjunctival sac of left eye of young adult New Zealand White rabbits (3 animals). Eyes were not rinsed and the right eye served as control. Animals then were observed for 7 days.
Irritation was scored by the method according to the Commission Directive 2004/73/EC. Mean scores calculated for each animal over 24, 48 and 72 hours were 2.3, 1.3 and 1.3 for chemosis, 2.7, 1 and 1.3 for redness of the conjunctivae, 1, 0 and 0 for iris lesions and 1.3, 1 and 0.7 for corneal opacity.
In this study, ethylvanillin was slightly eye irritant and based on the EU classification criteria (1272/2008) it should be classified as Eye irrit category 2 (H319).
Reference
Eye 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 |
0/0/0 |
2/3/3 |
3/3/3 |
24 h |
2/1/1 |
1/0/0 |
3/2/2 |
3/2/3 |
48 h |
2/1/1 |
1/0/0 |
3/1/1 |
2/1/1 |
72 h |
0/1/0 |
1/0/0 |
2/0/1 |
2/1/0 |
Average 24h, 48h, 72h |
1.3/1/0.7 |
1/0/0 |
2.7/1/1.3 |
2.3/1.3/1.3 |
Reversibility*) |
c |
c |
c |
c |
Average time (unit) for reversion |
5 days |
5 days |
7 days |
6 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:
Only one study was available with the reliability 1 according to Klimish, and was selected as key study.
In this primary dermal irritation study (CIT, 2003), young adult New Zealand White rabbits (3 males) were dermally exposed to 500 mg of ethylvanillin onto one flank.
Test sites were covered with semi-occlusive dressing for 4 hours. Animals then were observed for 72 hours. Irritation was scored by the method of the Commission Directive 2004/73/EC.
Mean scores over 24, 48 and 72 hours for each animal were 0.7, 0.3 and 0 for erythema and 0, 0 and 0 for edema.
In this study, ethylvanillin is very slightly irritant when applied topically to rabbits, but not classified according to the EU classification criteria.
Eye irritation:
Two studies were available with reliability 1 according to Klimish. One in vitro study and one in vivo study. The in vivo study was selected as key study.
In this key study, a primary eye irritation study (CIT, 2003), 100 mg of ethylvanillin was instilled into the conjunctival sac of left eye of young adult New Zealand White rabbits (3 animals). Eyes were not rinsed and the right eye served as control. Animals then were observed for 7 days. Irritation was scored by the method according to the Commission Directive 2004/73/EC.
Mean scores calculated for each animal over 24, 48 and 72 hours were 2.3, 1.3 and 1.3 for chemosis, 2.7, 1 and 1.3 for redness of the conjunctivae, 1, 0 and 0 for iris lesions ans 1.3, 1 and 0.7 for corneal opacity.
In this study, Ethylvanillin is classified eye irritant category 2 (H319), according to the CLP 1272/2008/EC classification criteria.
Effects on skin irritation/corrosion: slightly irritating, but not classified according to the EU classification criteria.
Effects on eye irritation: irritating
Justification for classification or non-classification
Based on the results obtained in the studies, Ethylvanillin is:
- Not clasified for skin irritation according to CLP 1272/2008/EC criteria.
- Classified Eye irritation Cat. 2 (H319) according to CLP 1272/2008/EC criteria.
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