Registration Dossier
Registration Dossier
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EC number: 229-633-2 | CAS number: 6635-20-7
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)
Data source
Reference
- Reference Type:
- publication
- Title:
- Occupational contact dermatitis in manufacture of Vanillin.
- Author:
- Wang, Xia-Sheng et al.
- Year:
- 1 987
- Bibliographic source:
- Chinese. Medical J. 100 (3): 250-254
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- other: Modified Buehler test and guinea pig Patch test
- 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
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: 6-8 weeks old
- Weight at study initiation: 300 to 450 g
- Housing: in separate cages
- Diet: animals were fed on a pellet diet, green vegetables
- Water: standard tap water ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS: no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- pure product (100%)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- pure product (100%)
- No. of animals per dose:
- 5 or 10
- Details on study design:
- Patch test on guinea pigs:
- 5 animals used to determined the treshold irritation concentration
- Exposure period: 48 hours
- Test group: 5% and 100%
- Control group: white petrolatum
- site: flank
- frequency: one
- Readings: 1, 24 and 48 hours after removal of the material.
- Amount applied: 0.1 g
*** Modified Buehler test.
MAIN STUDY
A. INDUCTION EXPOSURE (10 animals)
- Exposure application: 24 hours
- Test groups: 1 treated with pure product (10 animals)
- Control group: 1 treated with petrolatum (10 animals)
- Site: nape
- Frequency of applications: 3 times a weeks for 2 weeks.
- Duration: 24 hours
- Concentrations: 10% - Challenge controls:
- 10 animals treated with pure petrolatum
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: challange
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- pure product
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: other: challange. . Hours after challenge: 48.0. Group: test group. Dose level: pure product. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- other: challange
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Pure product
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: other: challange. . Hours after challenge: 48.0. Group: negative control. Dose level: Pure product. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- other: patcch test
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: other: patcch test. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Pure Vanillin was negative in a modified Buehler test, and Patch test on guinea pigs.
- Executive summary:
Pure Vanillin was negative in a modified Buehler test, and Patch test on guinea pigs.
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