Registration Dossier
Registration Dossier
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EC number: 204-465-2 | CAS number: 121-33-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 06-JUN-1991 to 17-FEB-1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a recognised test guideline, and in compliance with GLP. The purity of the test substance in unknown.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Cited as Directive 84/449/EEC, B.6
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study performed before the adoption of the LLNA OECD guideline
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:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France
- Age at study initiation: young adult
- Weight at study initiation: 300 - 500 g
- Housing: 5 per cage (same sex), in polystryrene cages
- Diet: UAR formule 114, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C (a maximum was noted at 31°C)
- Humidity: 18 - 81 %
- Air changes: data not available
- Photoperiod: 12 hrs light, 12 hrs dark
IN-LIFE DATES: from 30-JUL-1991 to /
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: ethanol
- Concentration / amount:
- 35% (intradermal induction), 73% (epicutaneous induction and challenge)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 35% (intradermal induction), 73% (epicutaneous induction and challenge)
- No. of animals per dose:
- 10 males and 10 females
- Details on study design:
- *** RANGE FINDING TEST:
Subcutaneous injection of vanillin in a 35% solution provoked a moderate irritation with burnt aspect during the preliminary study.
The epicutaneous application of a 73% (w/w) paste in absolute ethanol provoked a weak irritation during the preliminary study.
*** MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- type of epicutaneous induction: occlusive
- SLS application: yes (at 10% in Codex paraffin)
- Exposure period: 48 hrs (epicutaneous)
- Test groups: test substance in FCA
- Control group: FCA only
- Site: back
- Frequency of applications: on days 1 and 9
- Duration: 9 days
- Concentrations: 35% (intradermal induction), 73% (epicutaneous induction)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 22
- Exposure period: 24 hrs
- Test groups: Test substance
- Control group: Test substance
- Site: back
- Concentrations: 73%
- Evaluation (hr after challenge): 48 and 72 hrs - Challenge controls:
- no data
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 73%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 73%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 73%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 73%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
RESULT OF THE TEST:
Reading |
Hours after challenge |
Group |
No. of animals with (+) reactions |
1st reading |
48 |
test group |
0/20 |
2nd reading |
72 |
test group |
0/20 |
1st reading |
48 |
control group |
0/20 |
2nd reading |
72 |
control group |
0/20 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
In a dermal sensitization study (Hazleton, 1992) with Vanilline cristallisée (purity unknown) in ethanol, young adult Dunkin-Hartley guinea pigs (10/sex) were tested using the method of Maximization.
Signs of irritation were noted during the induction.
The macroscopic examinations did not reveal any lesion of delayed hypersensitivity in the 20 treated animals. No cutaneous abnormality was noted in the 20 guinea pigs examined in the control group.
From the result obtained under the experimental conditions employed, vanillin did not provoke any reaction of cutaneous sensitization in the animals examined.
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