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:

In a murine Local Lymph Node Assay (LLNA) study (CIT, 2004), the potential of the test item Guetol to induce delayed contact hypersensitivity was evaluated. Evaluation of local irritation was also carried out in parallel.

Twenty-eight female CBA/J mice were allocated to seven groups:

           • five treated groups of four animals receiving the test item Guetol at the concentration of 5, 10, 25, 50 or 100%,

           • one negative control group of four animals receiving the vehicle (mixture acetone/olive oil (4/1)),

           • one positive control group of four animals receiving the reference item,α-hexylcinnamaldehyde (HCA), a moderate sensitizer, at the concentration of 25%.

 

During the induction phase, the test item, vehicle or reference item was applied over the ears (25μL per ear) for three consecutive days (days 1, 2 and 3). After 2 days of resting, the proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of tritiated methyl thymidine (day 6). The obtained values were used to calculate stimulation indices (SI).

 

All animals of the treated group 6 (undiluted test item) were found dead either on day 3 or on day 4. Hypoactivity, piloerection and dyspnea were observed prior to death. Piloerection and dyspnea were recorded in all animals of the treated group 5 (test item at the concentration of 50%) from day 3 up to day 6. No other clinical signs were noted during the study.

Positive lymphoproliferative responses (SI > 3) were noted at all tested concentrations but without clear evidence of a dose-response relationship.

 

No cutaneous reactions and no noteworthy increase in ear thickness were observed in the animals of the treated groups.

 

In the absence of local irritation, the observed lymphoproliferative responses were attributed to delayed contact hypersensitivity.

The EC3value for the test item Guetol is lower than 5%.

 

Based on these results, the test item Guetol is sensitizing in the murine Local Lymph Node Assay, and classified as Skin sens. 1 (H317) according to the EU GHS (CLP 1272/2008).


Migrated from Short description of key information:
Guetol is sensitizing by cutaneous application

Justification for classification or non-classification

Based on positive result obtained in LLNA study (CIT, 2004), guetol should be classified as a skin sensitizer (or skin sensitization cat. 1 (H317)), based on the criteria of Annex VI Directive 67/548/EC (or UN/EU GHS, respectively).