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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:
supporting study
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:
Screening of fragrance materials for allergenicity in the guinea pig I. Comparison of four testing methods.
Author:
G. Klecak , H. Geleick , J. R. Frey
Year:
1977
Bibliographic source:
Journal of the Society of Cosmetic Chemists, Vol. 28, No. 2, 53-64; 1977

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mmentioned below
Principles of method if other than guideline:
Guinea pig maximisation test was conducted in Himalayan white-spotted guinea pigs (male and female) to determine the skin sensitization potential of test chemical.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Currently no LLNA study is available for assessment. The guinea pig maximisation test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Himalayan white-spotted
Sex:
male/female
Details on test animals and environmental conditions:
- Source: Institute of Biomedical Research , Fullinsdrof Switzerland

- Weight at study initiation: 400-500g

- Diet (e.g. ad libitum): pelleted feed supplemented with green: Vegetables carrots and vitamin C in the drinking water, all available ad libitum.
- Water (e.g. ad libitum): ad libitum

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: Epicutaneous : petrolatum
Concentration / amount:
Intradermal Concentration:2 X 0.1 ml of a 5% solution of the compound tested, with 0.1 ml of a 5 % emulsion of the same compound in Freund's complete adjuvant (FCA) and with 0.1 ml of FCA alone.

Epicutaneous Concentration: 25%
Amount: 250 mg in petrolatum
Day(s)/duration:
10 days
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
Concentration: at a sub-irritant Concentration in petrolatum (25%)
Day(s)/duration:
48 hours
Adequacy of challenge:
not specified
No. of animals per dose:
6-8 guinea pigs
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE: intradermal
- No. of exposures: 2
- Exposure period: 7 days
- Test groups:6-8 guinea pigs
- Control group: 6-8 guinea pigs
- Site: intradermal
- Frequency of applications: no data
- Concentrations: 5% (0.1ml)

B. INDUCTION EXPOSURE: epicutaneous
- No. of exposures: 1
- Exposure period: 24 hours
- Test groups:6-8 guinea pigs
- Control group: 6-8 guinea pigs
- Site: clipped skin area of the neck
- Frequency of applications: no data
- Concentrations: 25% (250 mg)



B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: On day 21
- Exposure period: no data
- Test groups: 6-8 guinea pigs
- Control group: 6-8 guinea pigs
- Site: flank
- Concentrations: at a sub-irritant Concentration in petrolatum
- Evaluation (hr after challenge): 24 and 48 hours
Challenge controls:
yes concurrent vehicle used.

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
At a sub-irritant Concentration in petrolatum (25%)
Total no. in group:
8
Clinical observations:
Positive results were observed in treated groups.
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Sensitizing
Conclusions:
The test material was considered to be sensitizing on Himalayan white-spotted guinea pigs in Guinea pig maximisation.
Executive summary:

Guinea pig maximisation test was conducted in Himalayan white-spotted guinea pigs (male and female) to determine the skin sensitization potential of test chemical.

 

During induction, on day 0the animals were injected intradermally with 0.1 ml of a   5% solution of the compound tested, with 0.1 ml of a 5 % emulsion of the same compound in Freund's complete adjuvant (FCA) and with 0.1 ml of FCA alone. On day 8 the animals were induced epicutaneously with 250 mf of 25% test compound in dissolved in petrolatum on clipped skin area of the neck under occlusion for 2 days.

 

On day 21, animals were challenged with the compound at a subirritant concentration in petrolatum was applied to the flank for 24 h. The reactions were read 24 and 48 h after removing the patch.

 

Since the test chemical showed positive signs of contact sensitization during the observation period, it was considered to be sensitizing to the skin of Himalayan white-spotted guinea pigs.