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EC number: 229-291-4 | CAS number: 6470-17-3
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed journal.
Data source
Reference
- Reference Type:
- publication
- Title:
- Compilation of historical local lymph node data for evaluation of skin sensitization alternative methods.
- Author:
- Gerberick GF, Ryan CA, Kern PS, Schlatter H, Dearman RJ, Kimber I, Patlewicz GY, Basketter DA.
- Year:
- 2 005
- Bibliographic source:
- Dermatitis, 2005 Dec; 16(4):157-202
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Principles of method if other than guideline:
- The skin sensitizing potential of the test chemical Vanillin (CAS No: 121-33-5) was assessed by using the Mouse Local Lymphnode Assay.
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Vanillin
- EC Number:
- 204-465-2
- EC Name:
- Vanillin
- Cas Number:
- 121-33-5
- Molecular formula:
- C8H8O3
- IUPAC Name:
- 1-butoxypropan-2-ol
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Vanillin
- Molecular formula: C8H8O3
- Molecular weight: 152.1482 g/mol
- Substance type: organic
- Physical state: Solid
-Smiles: c1(cc(ccc1O)C=O)OC
-InChI: 1S/C8H8O3/c1-11-8-4-6(5-9)2-3-7(8)10/h2-5,10H,1H3
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Vanillin
- Molecular formula: C8H8O3
- Molecular weight: 152.1482 g/mol
- Substance type: organic
- Physical state: Solid
-Smiles: c1(cc(ccc1O)C=O)OC
-InChI: 1S/C8H8O3/c1-11-8-4-6(5-9)2-3-7(8)10/h2-5,10H,1H3
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Age at study initiation: 7-12 weeks
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25 µl
- No. of animals per dose:
- No data
- Details on study design:
- Treatment was performed daily for 3 consecutive days. Five days after initiation of exposure all mice were injected via the tail vein with 250µl of PBS containing 20µCi of tritiatied thymidine. The mice were sacrificed 5 hours later, and draining the auricular lymph nodes were excised and pooled for each experimental group or each individual animal. The incorporation of tritiated thymidine measured by β-scintillation counting and was reported in disintegrations /minute. An SI was calculated for each chemical group as the ratio of disintegrations/minute of the treated group to the disintegrations/minute of the concurrent vehicle control group. A substance was classified skin sensitizer , if at one or more than one concentrations, it induced a three-fold or greater increase in local lymph node proliferative activity when treated with the concurrent vehicle treated controls (SI ≥3)
- Positive control substance(s):
- not specified
- Statistics:
- The approach to estimation of the relative skin sensitization potential is based on the mathematical estimation of the concentration of chemical necessary to obtain a threshold positive response (SI = 3); this is termed as the EC3 value
Refer Table 1 and 2 for more information
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- EC3
- Value:
- 100
- Remarks on result:
- other: The relative potency index of Vanillin was not calculated but on the basis of classification system it was considered to be >100.
- Cellular proliferation data / Observations:
- The relative potency index of Vanillin was not calculated but on the basis of classification system it was considered to be >100.
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The relative potency index of Vanillin (CAS No: 121-33-5) was estimated to be >100. Based on the relative potency index Vanillin (CAS No: 121-33-5) was considered as non skin sensitizer
- Executive summary:
The skin sensitizing potential of the test chemical Vanillin (CAS No: 121-33-5) was assessed by using the Mouse Local Lymphnode Assay.
The LLNA was conducted on groups of CBA mice (7-12 weeks of age) by mean of topical application of chemical on the dorsum of both ears at a dose of 25µl or to an equal volume of relevant vehicle (Acetic acid in olive oil (4:1))only. Treatment was performed daily for 3 consecutive days. Five days after initiation of exposure all mice were injected via the tail vein with 250µl of PBS containing 20µCi of tritiatied thymidine. The mice were sacrificed 5 hours later, and draining the auricular lymph nodes were excised and pooled for each experimental group or each individual animal. The incorporation of tritiated thymidine measured by β-scintillation counting and was reported in disintegrations /minute.
An SI was calculated as the ratio of disintegrations/minute of the treated group to the disintegrations/minute of the concurrent vehicle control group.
A substance was classified skin sensitizer , if at one or more than one concentrations, it induced a three-fold or greater increase in local lymph node proliferative activity when treated with the concurrent vehicle treated controls (SI ≥3)
The approach to estimation of the relative skin sensitization potential is based on the mathematical estimation of the concentration of chemical necessary to obtain a threshold positive response (SI = 3); this is termed as the EC3 value.
The relative potency index of Vanillin (CAS No: 121-33-5) was not calculated but on the basis of classification system it was considered to be >100. Thus the chemical Vanillin (CAS No: 121-33-5) was considered as non skin sensitizer.
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