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Diss Factsheets

Administrative data

Description of key information

The test substance is skin sensitising.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Method: other: nach Magnusson, B. und Kligman, A.M.: J. Invest. Dermatol. 52, 268-276
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Older study available.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht Hagemann GmbH &Co. KG, Extertal
- Weight at study initiation: 345 - 455 g
- Housing: 6 animlas per cage
- Diet (e.g. ad libitum): Ssniff GK 4 mm, Standarddiät für Kaninchen und Meerschweinchen
- Water (e.g. ad libitum): water, ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 50 - 80
- Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
10%
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
5%
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
5%
No. of animals per dose:
6
Details on study design:
Induction:
Day 0: intradermal injection (3 paris of injections)
1. 2 x 0.1 ml an aqueous mixture of Freud´s complete adjuvant (FCA)
2. 2 x 0.1 ml test substance preparation (10%)
3. 2 x 0.1 ml test substance preparation (10%) and FCA
Day 7: percutane application
with 10% test substance preparation
Day 19: 1. Challange: ca. 0.15 g of test substance preparation (5%) on filter-paper under a sealed dressing
Day 28. 2. Challange: ca. 0.15 g of test substance preparation (5%) on filter-paper under a sealed dressing


Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
The test substance is a skin sensitiser.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Skin sensitisation

The test substance was tested in an guinea pig maximization test for its skin sensitisation potential. 6 animals per test concentration were used. The 1st and 2nd challenge was carried out with 5% aqueous test substance preparation. Thereby all treated animals showed clear skin changes, which indicate an earlier skin sensitisation. However, 5 of 6 animals of the control group showed slight skin erythema, definite sign of skin irritation. The 2nd challenge confirmed the skin sensitisation potential of the test substance.

Justification for classification or non-classification

Based on the results of the skin sensitization testing, the test item is classified and labelled as skin sensitising cat. 1B (H317) according to Regulation (EC) No 1272/2008 (CLP).