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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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well described.
Data source
Reference
- Reference Type:
- publication
- Title:
- Contact allergy to balsam of Peru. II. Patch test results in 102 patients with selected balsam of Peru.
- Author:
- Hausen BM
- Year:
- 2 001
- Bibliographic source:
- American Journal of Contact Dermatitis, 12(2), 93-102
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Patch test
- GLP compliance:
- no
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
- Details on test material:
- Purchased from pharmaceutical companies, no more data.
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- other: patients chose to participate to this study
- Subjects:
- - Number of subjects exposed: 102
- Sex: 32 men and 70 women
- Age: from 18 to 88 years old
- Race: European
- Demographic information:
- Other: Details were given on 25 selected patients with particular habits (patient number, sex, age, profession, site of skin lesions / symptoms, if positive reactions to Balsam of Peru (BP) or Fragance Mix (FM) or propolis (PO), if they have positive reaction with one or more contituents of BP, if positive reactions with other allergens, individual habits, possible etiologies, and then comments/remarks). - Clinical history:
- In a previous study, the main contact sensitizers in Balsam of Peru (BP) were identified and a series of 20 compounds, the BP series, was established.
From 1995 to 1998, 2273 patients with contact dermatitis were tested with the standard series, which include BP.
Out of 445 patients positive for BP, 102 individuals were agreed to participate in an additionnal test with BP series. - Controls:
- none
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: patch tests with substance to test were applied to the backs of the patients for 24 hours using Finchamber on Scanpor (Epitest, Finland) and self-adhesive tape (Mefix, Mölnlycke, Sweden).
- Vehicle / solvent: none
- Concentrations: 5%
- Volume applied: no data
- Testing/scoring schedule: application during 24hours
- Removal of test substance: none
EXAMINATIONS
- Grading/Scoring system: Readings were done 24 and 72 hours according to the rules of the International Contact Dermatitis Research Group (ICDRG).
- Statistical analysis: none
- Other: only the 72-hour readings were used for evaluation.
Results and discussion
- Results of examinations:
- Of these 102 patients, 44 were positive to BP alone and negative to fragance mix (FM) and propolis (PO). Simultaneous reactions to BP and FM occured in 49 cases. A combined response to BP, FM and PO was seen in 5 individuals, and 4 patients reacted only to BP and PO but not to FM.
Skin lesions were observed at the following sites:
- eczema of the face, neck and décolleté: 25 cases;
- hands: 25 cases;
- trunk or whole body: 10 cases;
- hands and feet: 7 cases;
- vulva and/or genitals: 7 cases;
- feet alone: 6 cases;
- shin bones: 5 cases;
- thighs: 3 cases;
- forearms/wrists: 2 cases
Ulcus cruris was seen in 10 patients, urticaria and Quincke's edema in 5, atopic eczema in 3, and psoriasis vulgaris and eczema nummulare in 1 patient.
Of the 102 patients tested with the BP series, 93 reacted to 1 or more compounds, and 9 patients with a positive reaction to BP were negative to all 20 compounds of the BP series.
There were NO positive reaction with Vanillin.
Applicant's summary and conclusion
- Conclusions:
- Vanillin was negative in Patch test on patients who have positive reactions with Balsam of Peru.
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