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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
GPMT was already available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Korantin MAT
- Physical state: liquid
- Analytical purity: ca. 100 % (UVCB)

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann GmbH, Borchen
- Age at study initiation: About 8 weeks
- Weight at study initiation: 363 - 462 g
- Housing: 5 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 18 days before the beginning of the study in the laboratory for dermal toxicity

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-25 °C
- Humidity (%): 30-70 %
- Air changes (per hr): fully air-conditioned rooms with a central air-conditioning system
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Intradermal induction: test substance 5% in 0.9% aqueous NaCl-solution or in Freund's adjuvant / 0.9% aqueous NaCI-solution (1:1)
Epicutaneous induction: test substance undiluted
Challenge: test substance 75% in doubly distilled water
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Intradermal induction: test substance 5% in 0.9% aqueous NaCl-solution or in Freund's adjuvant / 0.9% aqueous NaCI-solution (1:1)
Epicutaneous induction: test substance undiluted
Challenge: test substance 75% in doubly distilled water
No. of animals per dose:
10 females in test group, 5 females in control group
Details on study design:
The test substance concentrations for the main test were selected based on the results of the pretests. The intradermal induction was performed with 5% test substance preparations, the epicutaneous induction with the undiluted test substance. For the challenge a 75% test substance preparation in doubly distilled water was chosen. The study was initiated with 2 control groups and 1 test group. The intradermal induction was performed on day 0, the epicutaneous induction on day 7. The challenge was carried out 14 days after the epicutaneous induction.
The intradermal induction caused moderate and confluent erythema and swelling, or in almost all injection sites necrotic skin changes and swelling in the test group animals.
After the epicutaneous induction, necrotic skin changes, partially open (caused by the intradermal induction) could be observed in addition to swelling in all test group animals.

Study design: in vivo (LLNA)

Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
not applicable

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no visible change in all animals of the control group
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no visible change in all animals of the control group.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no visible change in all animals of the control group
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no visible change in all animals of the control group.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
75 %
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
moderate and confluent erythema to intense erythema, swelling, scaling or severe scaling, eczematoid skin change and incrustation could be observed in the test group animals
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 %. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: moderate and confluent erythema to intense erythema, swelling, scaling or severe scaling, eczematoid skin change and incrustation could be observed in the test group animals.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
75 %
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
moderate and confluent erythema to intense erythema, swelling, scaling or severe scaling, eczematoid skin change and incrustation could be observed in the test group animals
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75 %. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: moderate and confluent erythema to intense erythema, swelling, scaling or severe scaling, eczematoid skin change and incrustation could be observed in the test group animals.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information