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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
limited material and methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This study was already available.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no details provided

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
Animals were intradermally injected with a 5% concentration and epidermally exposed to a 50% concentration
Day(s)/duration:
14 days
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
All animals were challenged with a 50%, 25% and 10% test substance concentration and vehicle.
Day(s)/duration:
The challenge reactions were assessed 24 and 48 hours after application
Adequacy of challenge:
not specified
No. of animals per dose:
In total, 7 animals were exposed. Each animal was exposed to each of the challenge concentration.
Details on study design:
Test substance concentrations selected for the main study were based on the results of a preliminary study using four animals. In the main study, seven experimental animals were intradermally injected with a 5% concentration and epidermally exposed to a 50% concentration, while three control animals were similarly treated, but with vehicle only. Immediately after the epidermal exposure, the skin irritation was scored. Two weeks after the epidermal application all animals were challenged with a 50%, 25% and 10% test substance concentration and vehicle. The challenge reactions were assessed 24 and 48 hours after bandage removal.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%, 25%, 10 and 0% test substance concentration
No. with + reactions:
0
Total no. in group:
7
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%, 25%, 10 and 0% test substance concentration
No. with + reactions:
0
Total no. in group:
7
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%, 25%, 10 and 0% vehicle concentration
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%, 25%, 10 and 0% vehicle concentration
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No evidence was obtained that V184844 (CH02586) caused skin hypersensitivity with the guinea pig maximisation test. This result leads to a sensitisation rate of 0%, indicating that V184844 (CH02586) need not be regarded as a potential skin sensitiser.