Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A local lymph node assay was conducted according to OECD 429 and under GLP conditions (BASF SE 2012, reliability score 1). Five female CBA mice per dose (5%, 10% or 25% of the test material in propylene glycol) were treated by daily application of 25 µL of the appropriate concentration of either the test material or with vehicle alone to the dorsal surface of each ear for 3 consecutive days. Five days following the first topical application, all mice were injected via the tail vein with 250 µL of phosphate buffered saline (PBS) containing 20 µCi 3H-thymidine to each mouse. Animals were observed post dose, any signs of toxicity were recorded. The body weight of the animals was determined prior to dosing and prior to termination. 5 hours following administration of 3HTdR all animals were killed. The draining auricular lymph nodes were excised, pooled for each animal and a single cell suspension of the cells was prepared. 3H-thymidine incorporation was measured by ß-scintillation counting. The proliferation response of the lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node pair (dpm/lymph node pair) and as the ratio of 3HTdR incorporation into the lymph node cells of test nodes relative to that recorded for the control nodes (stimulation index). A slight reduction in the mean body weight was observed in test group 3. No signs of systemic toxicity were noticed in all animals during general observation. Compound residues on the application area were noted in all animals of test groups 3 and 4 (10 and 25%, respectively). Blue stained ear skin was observed at all test substance concentrations during the whole observation period. The test substance did not induce biologically relevant increases in the 3H-thymidine incorporation (no increase above the cut off Stimulation Index of 3) into the cells from the auricular lymph nodes or in lymph node cell counts (no increase to 1.5 fold or above of control value = stimulation index (SI) ≥ 1.5). Additionally, the lymph node weights were statistically significant increased at all concentrations. All test-substance preparations caused statistically significant increases in ear weights as indication of some ear skin irritation. It is concluded that the test substance does not exhibit a skin sensitizing potential in the Murine Local Lymph Node Assay under the test conditions chosen.

A negative result was also described in a publication of Baer (1960, reliability score 4). The test was done in vivo with guinea pigs. However, relevant data were not reported (i.e. induction/ challenge routes and concentrations).


Migrated from Short description of key information:
Sensitisation:
- skin: not sensitising (mouse: BASF SE 2012; guinea pig: Baer 1960)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC):

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for sensitisation under Directive 67/548/EEC.

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008:

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for sensitization under Regulation (EC) No. 1272/2008.