Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

In a GLP conform study according to GLP requirements, the test item Golpanol ALS wasserfrei dissolved in ethanol:sterile water (3+7) was assessed for its skin sensitizing potential using the Local Lymph Node Assay (LLNA) in mice (Harlan CCR 2010).

Three groups each of four female mice were treated with 5, 10, and 25% (w/v) test item concentration by topical application at the dorsum of each ear once daily on three consecutive days. The appropriateness of these concentrations was previously confirmed in a pre-experiment. At concentrations higher than 25%, an applicable formulation of the test item was not achieved. A control group of four mice was treated with the vehicle only. Five days after the first topical application, the mice were intravenously injected into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised, pooled per animal and immediately weighed. Furthermore,the ears were punched after sacrifice at the apical area using a biopsy punch and were immediately pooled per animal and weighed using an analytical balance. Single cell suspensions of lymph node cells (pooled per group) were prepared and lymphocyte proliferation was quantified by measuring the incorporation of radiolabelled thymidine into the lymph node cells byb-Scintillation Counting.

The animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed. Signs of local irritation (e.g. reddening of the ear skin, ear swelling) were also not observed during the study period. A statistically significant increase in ear weights was not observed in the test item treated groups in comparison to the vehicle control group.

Stimulation Indices (S.I.) of 0.76, 0.70, and 0.45 were determined with the test item at concentrations of 5, 10, and 25% in ethanol:sterile water (3+7), respectively. A statistically significant increase in lymph node weights was not observed in the test item treated groups in comparison to the vehicle control group.

The test item Golpanol ALS wasserfrei did not show skin sensitizing potential in this assay under the conditions of this study.


Migrated from Short description of key information:
Mouse, LLNA: negative (GLP, OECD 429, Harlan CCR 2010)

Respiratory sensitisation

Endpoint conclusion
Additional information:

no data


Migrated from Short description of key information:
no data

Justification for classification or non-classification

The test substance was negative in a reliable LLNA. Therefore, no indication is given for classification according to the criteria of DSD (67/548/EEC) and CLP (1272/2008/EC), respectively.