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EC number: 204-466-8 | CAS number: 121-34-6
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-10-03 to 2002-11-18.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No certificate of analysis; only few animals are tested: 5 instead of 10.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Comparable to OECD 406. However, only few animals are tested (Simplified study).
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study performed before the ECHA recommendations.
Test material
- Reference substance name:
- Vanillic acid
- EC Number:
- 204-466-8
- EC Name:
- Vanillic acid
- Cas Number:
- 121-34-6
- Molecular formula:
- C8H8O4
- IUPAC Name:
- 4-hydroxy-3-methoxybenzoic acid
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Vanillic acid
- Expiration date of the lot/batch: no data
- Purity test date: no data
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient temperature
- Stability under test conditions: yes
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elm Hill Breeding Labs, Chelmsford, MA.
- Age at study initiation: at least 4 weeks old
- Weight at study initiation: 377.5 to 402.6 grams.
- Housing: the animals were housed individually in group in suspended stainless steel.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Minimum 5 days under the same conditions as for the actual test.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 5 °C
- Humidity (%): 30 – 70 %
- Air changes (per hr): 10 to 15 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12hr/12hr
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- cotton seed oil
- Concentration / amount:
- 100% TS +/- FCA (treated group) or cottonseed oil +/- Freund Complete Adjuvant (control group) or FCA (both groups) in scapular region.
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- cotton seed oil
- Concentration / amount:
- treatment with 10% SLS in petrolatum
- Day(s)/duration:
- Day 7
- Route:
- epicutaneous, occlusive
- Vehicle:
- cotton seed oil
- Concentration / amount:
- 100% TS occlusive dressing for 48h (treated) or cottonseed oil (control)
- Day(s)/duration:
- Day 8
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- cotton seed oil
- Concentration / amount:
- 100% TS under occlusive dressing for 24 h (all group) on the right flank and cottonseed oil on the left flank.
- Day(s)/duration:
- Day 22
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 5 animals and a control group of 3 animals.
- Details on study design:
- RANGE FINDING TESTS:
1- Intradermal injection tolerance test:
Six concentrations of the test substance were administered in Cottonseed Oil (CSO). The hair was removed from an area overlying the scapulae of a single animal. One of 6 concentrations of the test substance was administered by intradermal injection (0.1 mL) to each of 6 test sites. A single examination was undertaken 5 to 7 days after injection for evidence of skin reaction.
2- Dermal application tolerance test:
Four concentrations of the test substance were investigated. At each site, a 0.2 mL aliquot of the substance was spread over a 20 mm square of gauze or filter paper. This was then placed onto the skin and covered by an occlusive dressing for 24 hours. The treated sites on each animal were examined 24 and 48 hours after removal of the dressings for evidence of skin reaction which was scored according to the following scheme:
Reaction to treatment:
No visible change (score: 0)
Discrete or patchy erythema (score: 1)
Moderate and confluent erythema (score: 2)
Intense erythema and swelling (score: 3)
3- Selection of dose-levels for the sensitization test:
* Induction by intradermal injection:
the test substance was used at a concentration (100%) that is systemically tolerated and is judged not to cause excessive reaction at the injection site.
* Induction by topical application:
The test substance was used at the concentration (100%) that is systemically tolerated and is judged not to cause excessive reaction at the injection site.
* Induction by topical application:
The test substance was used at the concentration 100% that is found to be systemically tolerated and provokes a weak inflammatory response.
* Challenge:
The test substance was used at the maximum non-irritant concentration.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 24 hours (Day 1: Induction by intradermal injection. Day 2: Day 2: Assessment of reaction), 48 hours (Day 8: Induction by dermal application. Day 10: removal of dressings).
- Site:
* Anterior sites: Freund's complete adjuvant (FCA) in emulsified form
* Middle sites: Test substance in selected vehicle (or selected vehicle alone)
* Posterior sites: Test substance (or selected vehicle) in FCA.
- Duration: Day 1 and Day 8
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 hours
- Test groups: yes
- Control group: yes
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 hours - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions of this study, Vanillic acid is not considered as sensitizing to skin. Therefore, no classification is required according to EU criteria.
- Executive summary:
In a dermal sensitization study using the method of Maximization test within Vanillic acid, Dunkin-Hartley guinea pigs (11 females) were tested under test conditions comparable to the guideline OECD 406 (Simplified study, Reliability 2, GLP). On day 1, three intradermal injections were performed in a row on each side of the shoulder. 24 hours before the topical sensitization (day 7), all the animals were treated on the shoulder with a preparation consisting of sodium lauryl sulphate (SLS) 10% in petrolatum. On day 8, topical sensitization on the same skin area was then performed with a solution of the test substance. The patch was covered by an occlusive dressing for 48 hours. On day 22 (= Challenge ), a 24 -hour occluded patch was performed on the right flank with 0.2 mL aliquot of the test substance. On day 24, assessment of challenge reaction was performed. On day 25, assessment of challenge reaction was again assessed. The concentration used for induction phase (intradermal and topical) and for challenge phase was 100%.
Under the test conditions of this study, 0/5 treated animals showed no indication of skin sensitization. Based on these results, no classification is required according to EU criteria.
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.
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