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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:
Feb - April 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Open Epicutaneous Test (OET)
GLP compliance:
no
Type of study:
open epicutaneous test
Justification for non-LLNA method:
Sufficient information is available from the OET study, therefore it is not necessary to conduct an LLNA.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
UVCB
Specific details on test material used for the study:
Cedrene Washed: Batch 9000368155

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: GOHI (SPF)
Sex:
female

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
other: Ethanol
Concentration / amount:
100ul
Day(s)/duration:
5 days a week (Monday to Friday) for 4 consecutive weeks.
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, open
Vehicle:
other: Ethanol
Concentration / amount:
25ul
Day(s)/duration:
2 weeks
Adequacy of challenge:
other: 3%, 1%, 0.3% and 0.1%
No. of animals per dose:
6 animals per treatment group (including 6 animals in the control group).
Challenge controls:
Challenge reactions were assessed at 24hr and 48hr after application.
Positive control substance(s):
not required

Results and discussion

Positive control results:
NA

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
840
Group:
test group
Dose level:
0.1, 0.3, 1 and 3 %
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
840
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
840
Group:
positive control
Dose level:
0
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
not determinable

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

Cedrene washed when applied at the concentrations of 30% and 10% in ethanol, induced slight to severe cutaneous responses accompanied by dry scaling during the induction phase of the study. The test article, however, did not induce any skin reactions as such in the test or contorl animals during the challenge phase of the experiment when applied at the concentrations 3% or lower.

Based on the above experimental data, it is concluded that the topically applied Cedrene washed when used under the conditions of this study (<3%) did not induce skin sensitization in the guinea pig. Considering the predictive value of the guinea pig skin sensitization test it can be assumed that cutaneous exposure to Cedrene washed at the concentrations of equal to or lower than 3% in ethanol is unlikely to give rise to skin sensitization in man.