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Diss Factsheets

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:
1997
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The first Test Guideline (TG) for the determination of skin sensitization in the mouse, Local Lymph Node Assay (LLNA; TG 429) was adopted in 2002,

Test material

Constituent 1
Reference substance name:
Zanthoxylum, ext.
EC Number:
310-094-8
EC Name:
Zanthoxylum, ext.
Cas Number:
102242-62-6
Molecular formula:
NA
IUPAC Name:
Zanthoxylum, ext.
Test material form:
liquid: viscous

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
water
Concentration / amount:
1:100
Day(s)/duration:
24
Adequacy of induction:
highest technically applicable concentration used
No. of animals per dose:
5
Challenge controls:
5
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1:100
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1:100
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1:100
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1:100
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

 Animal  Erythema 24h  Edema 24h  Erythema 48h  Edema 48h  Erythema 72h  Edema 72h
 1  0  0  0  0  0 0 
 2  0  0  0  0  0 0
 3  0  0  0  0  0 0 
 4  0  0  0  0  0 0 
 5  0  0  0  0  0 0 
 6  0  0  0  0  0  0
 7  0  0  0  0  0  0
 8  0  0  0  0  0  0
 9  0  0  0  0  0  0
 10  0  0  0  0  0  0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
On the basis of results, interpreted according to EEC Directive 92/69, the test item (Zanthoxylum extract), can be NON sensitizing