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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key 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 journals

Data source

Reference
Reference Type:
publication
Title:
Fragrance Raw Materials: test chemical
Author:
D. L.J Opdyke
Year:
1974
Bibliographic source:
Food and Cosmetics Toxicology; 1974

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To evaluate the dermal sensitization potential of the test chemical in humans
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
no data available

Test material

Constituent 1
Chemical structure
Reference substance name:
Indole
EC Number:
204-420-7
EC Name:
Indole
Cas Number:
120-72-9
Molecular formula:
C8H7N
IUPAC Name:
1H-indole
Test material form:
solid
Details on test material:
Name: Indole
IUPAC Name: 1H-Indole
Molecular Formula: C8H7N
Molecular Weight: 117.15 g/mol
SMILES: c1ccc2[nH]ccc2c1
Substance Type: Organic
Physical State: Solid

In vivo test system

Test animals

Species:
other: humans
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1% in petrolatum
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1% in petrolatum
Adequacy of challenge:
not specified
No. of animals per dose:
25 volunteers
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: single
- Exposure period:
- Test groups: 25
- Control group:
- Site:
- Frequency of applications:
- Duration:
- Concentrations: 1% in petrolatum

B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge:
- Exposure period:
- Test groups: 25
- Control group:
- Site:
- Concentrations: 1% in petrolatum
- Evaluation (hr after challenge):

OTHER:
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test chemical
Dose level:
1% in petrolatum
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
no sensitizing reactions were observed
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
Exposure to 1% test chemical in petrolatum failed to induce dermal reactions in the test sites of 25 volunteers. Hence, the test chemical can be considered to be not sensitizing to skin.
Executive summary:

A human maximization study was performed to evaluate the dermal sensitization potential of the test chemical. 1% test chemical in petrolatum was applied to the skin of 25 volunteers and observed for signs of dermal sensitization. Exposure to 1% test chemical in petrolatum failed to induce dermal reactions in the test sites of 25 volunteers. Hence, the test chemical can be considered to be not sensitizing to skin.