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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
other: Magnusson and Kligman maximization test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
- Age/Weight at study initiation: 1-2month-old; 358 +/-17g (males) or 352 +/-19g (females)
- Housing: 1/cage;
- Diet and water: ad libitum
- Temperature: 22 ± 2°C- Humidity: 30-70 %- Light/dark cycle: 12/12 h – Ventilation: 12 cycles/h

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: intradermal and epicutenous
Vehicle:
corn oil
Concentration / amount:
Vehicle
- Intradermal route/ induction: corn oil
- Cutaneous route/induction: 80/20 mixture of ethanol/purified water
- Cutaneous route/challenge: acetone

Concentration
- Intradermal route/ induction: 1% in vehicle or vehicle + Freund ’s Complete Adjuvant (FCA)
- C route/induction: 50% in vehicle
- Cutaneous route/challenge: 50% in vehicle
Challengeopen allclose all
Route:
other: cutaneous, 24 h occlusive dressing
Vehicle:
corn oil
Concentration / amount:
Vehicle
- Intradermal route/ induction: corn oil
- Cutaneous route/induction: 80/20 mixture of ethanol/purified water
- Cutaneous route/challenge: acetone

Concentration
- Intradermal route/ induction: 1% in vehicle or vehicle + Freund ’s Complete Adjuvant (FCA)
- C route/induction: 50% in vehicle
- Cutaneous route/challenge: 50% in vehicle
No. of animals per dose:
Test groups: 5/sex as controls; 10/sex as treated
Details on study design:
- Day 1 = Intradermal route/ induction: 2x 3 injections of 0.1ml each in the scapular area, including: FCA/NACl 50/50; Thiofestermet at 1% in corn oil; Thiofestermet 1% in FCA/NACl (50/50)
- Day 7 = induction of local irritation by lauryl sulfate cutaneous application
- Day 8 = Cutaneous route/ induction: application of the test item for 48h in the same area, using adhesive occlusive dressing
- Day 22 = Cutaneous route/Challenge: on the clipped flank (distant site); application of the test item for 24h using adhesive occlusive dressing
Examinations:
-Scoring of cutaneous reaction 24h and 48h after removal of the dressing for challenge application - Body weight evolution – No histology warranted
Challenge controls:
yes.
Positive control substance(s):
no
Remarks:
FCA for induction . No challenging positive controls.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Discrete erythema (Grade 1)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Discrete erythema (Grade 1).
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Discrete erythema (Grade 1)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Discrete erythema (Grade 1).
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Discrete erythema (Grade 1) 24 and 48h after challenge for 1 animal only.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Not classified as sensitizing to the skin.

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