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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:
weight of evidence
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:
The Freund's Complete Adjuvant Test and the Open Epicutaneous Test
Author:
G. Klecak
Year:
1985
Bibliographic source:
Curr. Probl. Derm., vol.14, pp.152-171 (Karger, Basel 1985)

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
An Open Epicutaneous Test (OET) was performed on guinea pigs to assess the skin sensitization potential of test chemical p-Anisaldehyde (CAS No: 123-11-5).
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Anisic aldehyde/ p-Anisaldehyde
- Molecular formula: C8H8O2
- Molecular weight: 136.1492 g/mol
- Substance type: organic
- Physical state: liquid
-Smiles: COc1ccc(C=O)cc1
-InChI: 1S/C8H8O2/c1-10-8-4-2-7(6-9)3-5-8/h2-6H,1H3
Specific details on test material used for the study:
- Name of test material (as cited in study report): Anisic aldehyde/ p-Anisaldehyde
- Molecular formula: C8H8O2
- Molecular weight: 136.1492 g/mol
- Substance type: organic
- Physical state: liquid
-Smiles: COc1ccc(C=O)cc1
-InChI: 1S/C8H8O2/c1-10-8-4-2-7(6-9)3-5-8/h2-6H,1H3

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
- Weight at study initiation: 300-450g

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
other: ethanol, acetone, H20, petroleum, PEG and/or other suitable vehicles
Concentration / amount:
Concentration:100%, 30%, 10%, 3%, 1%, or 0.3%
Amount: 0.1ml
Day(s)/duration:
3 weeks (0-21 days)
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, open
Vehicle:
other: ethanol, acetone, H20, petroleum, PEG and/or other suitable vehicles
Concentration / amount:
Concentration:10%
Amount: 0.025ml
Day(s)/duration:
on days 21 and 35
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
6-8 guinea pigs
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 21
- Exposure period:24 hours
- Test groups:6-8 guinea pigs
- Control group:3 guinea pigs
- Site: an area measuring 8 cm2 on the clipped flank skin of the guinea pigs
- Frequency of applications: The applications are repeated daily for 3 weeks or done 5 times weekly during 4 weeks
- Duration: 21 days (3 weeks)
- Concentrations: 100%, 30%, 10%, 3%, 1%, or 0.3% in vehicle.
Amount: 0.1ml

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: on days 21 and 35
- Exposure period:24 hours
- Test groups: 6-8 guinea pigs
- Control group: 3 guinea pigs
- Site: contralateral flank measuring 2 cm2
- Concentrations: Concentration:10%
Amount: 0.025ml
- Evaluation (hr after challenge): 24,48 and/or 72h.
Challenge controls:
Yes concurrent vehicle.
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
72
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
8
Clinical observations:
No known signs of skin sensitization were observed.
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
No known signs of skin sensitization were observed at 24 , 48 and 72 hours.

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
The test material p-Anisaldehyde (CAS No: 123-11-5) was considered to be not sensitizing on skin of guinea pigs at concentration of 10% in an Open Epicutaneous Test (OET).

Executive summary:

An Open Epicutaneous Test (OET) was performed on guinea pigs to assess the skin sensitization potential of test chemical p-Anisaldehyde (CAS No: 123-11-5).

 

On day 1 during induction, 0.1 ml of the p-Anisaldehyde was applied at concentrations of 100%, 30%, 10%, 3%, 1%, or 0.3% in vehicle to an area measuring 8 cm2 on the clipped flank skin of the guinea pigs. The applications are repeated daily for 3 weeks or done 5 times weekly during 4 weeks, usually on the same skin sites. The application sites were left uncovered and the reactions, if continuous daily applications were performed, can be read 24 h after each application, or at the end of each week.

 

To determine whether or not contact sensitization was induced, all groups of guinea pigs previously treated for 21 days, as well as 10 untreated, or only pretreated with the vehicle, controls are tested on days 21 and 35 on the contralateral flank with the test material. This test was performed by applying with a pipette 0.025 ml of each concentration to skin areas measuring 2 cm2. The reactions were read after 24,48 and/or 72h.

 

It was observed that none of the guinea pigs induced contact sensitization at challenge concentration of 10%.Thus the chemicalp-Anisaldehyde (CAS No: 123-11-5)was considered to be not sensitizing on skin of guinea pigs at concentration of 10 % in an Open Epicutaneous Test (OET).