Registration Dossier
Registration Dossier
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EC number: 241-793-5 | CAS number: 17832-28-9
Endpoint summary
Administrative data
Description of key information
Murine Local Lymph Node Assay (OECD 429; BASF, 2010): not sensitising
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitising potential of 4 -(vinyloxy)butan-1 -ol was assessed using the radioactive Murine Local Lymph Node Assay (OECD 429; BASF 2010). The study was performed as a limit test using 1 test group and 1 control group. Each test animal was applied with 25 μL per ear of the undiluted test substance to the dorsum of both ears for three consecutive days. Three days after the last application the mice were injected intravenously with 20 μCi of 3H-thymidine in 250 μL of sterile saline into a tail vein. About 5 hours after the 3H-thymidine injection, the mice were sacrificed and the auricular lymph nodes were removed. The weights of each animal’s pooled lymph nodes were determined. Thereafter lymph nodes were pooled group wise and further evaluated by measuring their cellular content and 3H-thymidine incorporation into the lymph node cells (indicators of cell proliferation). Moreover, a defined area with a diameter of 0.8 cm was punched out of the apical part of each ear and for each test group the weight of the pooled punches was determined in order to obtain an indication of possible skin irritation.
No signs of systemic toxicity were noticed. When applied undiluted, the test substance did not induce a biologically relevant response (no increase to 1.5 fold or above of control value = stimulation index (SI) ≥ 1.5) in the auricular lymph node cell counts. There was no relevant increase in lymph node weights, as well. Concomitantly, the increase of 3H-thymidine incorporation into the cells was not biologically relevant (no increase above the cut off stimulation index of 3). The test substance caused some increase in ear weights as indication of ear skin irritation.
Under the test conditions chosen, 4 -(vinyloxy)butan-1 -ol did not show a skin sensitising effect in the Murine Local Lymph Node Assay.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
No data available.
Justification for classification or non-classification
Based on the available data, classification for skin sensitisation is not warranted according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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