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Toxicological information

Skin sensitisation

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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:
1992
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Vanillin
EC Number:
204-465-2
EC Name:
Vanillin
Cas Number:
121-33-5
Molecular formula:
C8H8O3
IUPAC Name:
4-hydroxy-3-methoxybenzaldehyde

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

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:
not sensitising
Remarks:
Migrated information
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.