Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The skin sensitisation potential of SIKA Hardener LI was tested in a Local Lymph Node Assay (LLNA) according to EU method B.42 and OECD guideline 429. Vehicle compatibility was verified in a preliminary test with Acetone: Olive oil 4:1 mixture (AOO), in which the test item was completely miscible. A preliminary irritation toxicity test was performed with the test item at concentrations of 100 % (the undiluted test item) and 50 % (%w/v) in the selected vehicle. In the main assay sixteen female CBNCa Ola Hsd mice were allocated to four groups of four animals each: three groups received the appropriate formulation of SIKA Hardener LI at concentrations of 100 %, 50 % or 25 %, and the negative control group concurrently received the vehicle (AOO) only. Each concentration was applied on the external surface of ears (25 µL/ear) for three consecutive days (Day 1, 2 and 3). There was no treatment on days 4, 5 and 6. On day 6, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine. Obtained values were used to calculate stimulation indices (SI).

No mortality or systemic clinical signs were observed during the study. No treatment related effect on the body weights was observed. No signs of irritation or other cutaneous effect were observed in any of the treated groups. A significant lymphoproliferative response (SI > 3) was noted for SIKA Hardener LI at all tested concentrations. The stimulation index values (SI) were 6.2, 4.8 and 4.1 at concentrations of 100 %, 50 % and 25 %, respectively. The stimulation index values obtained were compatible with the conventional biological dose-response. An EC3 value was extrapolated from the data according to Annex IV of the Updated ICCVAM-Recommended Protocol. A value of 8.4 % was extrapolated from the raw data. The result of the latest reliability check was used to demonstrate the appropriate performance of the assay in according to test guidelines. The result with the positive control substance a-Hexylcinnamaldehyde (HCA) confirmed the validity of the LLNA. Under the conditions of the presented assay SIKA Hardener LI revealed sensitisation potential (sensitiser).


Migrated from Short description of key information:
The skin sensitisation potential of SIKA Hardener LI was tested in a Local Lymph Node Assay (LLNA) according to EU method B.42 and OECD guideline 429. Under the conditions of the presented assay SIKA Hardener LI revealed sensitisation potential (sensitiser).

Justification for selection of skin sensitisation endpoint:
only one study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results of the presented LLNA study, SIKA Hardener LI was classified and labled as R43 (may cause sensitisation by skin contact) and Skin Sensitiser cat. 1B (H317: may cause an allergic skin reaction) according to Directive 67/548/EEC (DSD) and to Regulation (EC) No 1272/2008 (CLP), respectively.