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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
Study period:
November 2, 2004 to February 2, 2005
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
The study was conducted in accordance with the “Principles of Biological Safety Evaluation of Medical Devices (Pharmaceutical and.Food Safety Bureau, Japanese Ministry of Health, Labour and Welfare, Notification lyakushinhatsu No.0213001,Feb. 13,2003), and Memorandum Iryokiki-shinsa No. 36,March 19, 2003.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Existing study

Test material

Test material form:
liquid

In vivo test system

Test animals

Species:
other: Guinea pig: Hartley, (Std: Hartley, clean)
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Japan SLC
- Age at study initiation: 4 weeks old
- Weight at study initiation:374--435g
- Housing:The animals were housed in metal hanging cages with a metal, mesh bottom(260W× 380D× 200 H mm).Three or two animals were
housed in cach cage during the quarantine period and then individually from the day of grouping.
- Diet (e.g. ad libitum):pellet feed(RC4,Oriental Yeast)
- Water (e.g. ad libitum): drinking water(Hadano city water)ad libitum.
- Acclimation period: # days not stated

ENVIRONMENTAL CONDITIONS
- Temperature (°C):21.O to 25.O C
- Humidity (%): 45-75%
- Air changes (per hr): 15 ACH
- Photoperiod (hrs dark / hrs light):12-hour light/12-hour dark cycle



Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: acetone
Concentration / amount:
Concentration of test material and vehicle used at induction:
10% w/v FM0411M olive oil

Concentration of test material and vehicle used for each challenge:
10%, 1%, 0.1%, 0.01% and 0.l00% w/v FM0411M acetone solutio
n
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: acetone
Concentration / amount:
Concentration of test material and vehicle used at induction:
10% w/v FM0411M olive oil

Concentration of test material and vehicle used for each challenge:
10%, 1%, 0.1%, 0.01% and 0.l00% w/v FM0411M acetone solutio
n
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
maximization test- 1st induction phase (day 1) Freund complete adjuvant and 10 w/v% of test substance olive oil solution injected intradermally at the interscapular region. On day 9, 2nd induction phase, 10 w/w % sodium lauryl sulfate (SLS) was topically applied without covering in interscapular region. On day 10, 10 w/v% of test substance in polive oil was topically applied in same region for 48 hours, occlusive covering. For challenge phase, the test concentration of the test substance in acetone solution and acetone were topically applied for 24 hours with occlusive dressings ( day 22). The challenge sites were observed for 24 and 48 hours after removal of the patches an dressing and their appearence was evaluated using the classification system in Draize's method.
Positive control substance(s):
yes
Remarks:
Chloro-2,4-dinitrobenzene[DNCB]

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
.1 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: .1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
.1 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: .1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 10 %

Signs of irritation during induction:
There were no signs of irritation.

Evidence of sensitisation of each challenge concentration:
There was no evidence of any sensitisation reaction at any
of the concentrations tested. No eythema or oedema was
observed at 24 and 48 hours after removal of the dressing
and patches. In addition, the same animals did not show any

reaction to the vehicle control challenge.


All animals in the positive control showed evidence of a
sensitisation reaction to the positive control substance
when challenged at 0.1% and 0.01%.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Conclusions:
The test substance exhibited no skin senstization potency in guinea pigs under conditions of this study.