Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-09-10 to 2008-10-27
Reliability:
1 (reliable without restriction)
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
2004
Deviations:
no
Principles of method if other than guideline:
NA
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Hungarian Supplier: WOBE Kereskedelmi Kft., H-1164, Budapest, Garmada u. 10.

- Age at study initiation: Young adult, 9-10 weeks old, age-matched within one week
- Housing: Individual caging
- Diet (e.g. ad libitum): ssniff® SM R/M-Z+H , ad libitum
- Water (e.g. ad libitum): tap water from municipal supply, ad libitum
- Acclimation period: 21 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8-12 air exchange/hour by central air-condition system.
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
25;50;100 % (w/v) (25µl)
No. of animals per dose:
4
Details on study design:
In the main assay sixteen female CBA/Ca mice were allocated to four groups of four animals each:
- three groups received the appropriate formulation of Sika Hardener LG at concentrations of 100 %*, 50 % or 25 %,
- the negative control group received the vehicle (AOO).

Each substance was applied on the external surface of each ear (25 µl/ear) of the animals 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 (3HTdR) and the obtained values were used to calculate stimulation indices (SI).
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
NA
Positive control results:
The positive control substance α-Hexylcinnamaldehyde (HCA) was examined at a concentration of 25 % in the relevant vehicle. A significant lymphoproliferative response (SI ≥ 3) was noted for HCA with stimulation index value of 11.3 in accordance with our historical data, demonstrating the test reliability.
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
A significant lymphoproliferative response (SI >= 3) was noted for Sika Hardener LG at a concentration of 100 %. The stimulation index values were 5.0, 2.6 and 1.4 at concentrations of 100 % (undiluted test item), 50 % and 25 %, respectively. The stimulation index values were compatible with the conventional biological dose-response.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: NA

clinical signs and mortality:

No mortality or signs of systemic toxicity were observed during the study. No significant effects were observed on animal body weights. No irritation or other cutaneous effect was observed in any of the groups treated.

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of the present assay Sika Hardener LG, tested as supplied and in a suitable vehicle, was shown to have weak sensitisation potential (weak-sensitiser) in the Local Lymph Node Assay.
Executive summary:

A LLNA test was conducted with Sika Hardener LG. No mortality or signs of systemic toxicity were observed during the study. No significant effects were observed on animal body weights. No irritation or other cutaneous effect was observed in any of the groups treated.

The EC3 value (the theoretical concentration of the test item in the test solution, leading a three fold increase of lymph node cell proliferation over the control) was estimated by linear interpolation using the reported SI values and the corresponding concentrations immediately above and below the SI value of 3. The estimated EC3 value of Sika Hardener LG was 58.3 % in this LLNA. On the basis of published classification of contact allergens according to their potency Sika Hardener LG can be ranked among weak sensitisers (100 >= EC3 (%) >=10).

Under the conditions of the present assay Sika Hardener LG was shown to have weak sensitisation potential (weak-sensitiser) in the Local Lymph Node Assay.

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

A LLNA test was conducted with Sika Hardener LG according to EU method B.42 and OECD guideline no.429. No mortality or signs of systemic toxicity were observed during the study. No significant effects were observed in animal body weights. No irritation or other cutaneous effects were observed in any of the groups treated.

The LLNA EC3 value was 58.3 %. On the basis of published classification of contact allergens according to their potency Sika Hardener LG was ranked among weak sensitisers (100 ≥ EC3 (%) ≥10).


Migrated from Short description of key information:
Sika Hardener LG was assessed in a Mouse Local Lymphnode Assay (LLNA, EU method B.42). Based on the results obtained, Sika Hardener LG was considered to have a weak sensitisation potential (weak-sensitiser) in the LLNA.

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 LG was classified as a sensitiser 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 1272/2008/EC (CLP), respectively.