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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:
2002
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: preliminary study 14 days, main study 24 days
- Weight at study initiation: positive control group 228-341 g
- Housing: animals were kept in pairs/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 55% +/- 15%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 06.11.2002 To: 05.01.2003

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
First induction week (intradermal injection): 5% in vehicle
Second induction week (epidermal application): 50% in vehicle
Challenge (epidermal application): 50% in vehicle
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
First induction week (intradermal injection): 5% in vehicle
Second induction week (epidermal application): 50% in vehicle
Challenge (epidermal application): 50% in vehicle
No. of animals per dose:
15
Details on study design:
Guinea Pig Maximization test:
Possible sensitising properties of the test compound were evaluated by administration of the test substance to the shoulder region, first by
intracutaneous application (stage 1) and 7 days later by topical administration (stage 2, exposure time: 48 hours).
In a challenge test (stage 3) the test compound was again applied topically but to the flank region (exposure time: 24 hours). This area was then
examined for reactions which might indicate sensitising properties of the test compound.

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
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: test group. Dose level: 50% . No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
Under the test conditions the test substance revealed no sensitizing properties in guinea-pigs in a test model according to MAGNUSSON and KLIGMAN.