Registration Dossier

Administrative data

Description of key information

The test article was not sensitizing in a murine local lymph node assay.

Key value for chemical safety assessment

Skin sensitisation

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

In an OECD 429 and GLP compliant LLNA, three groups each of four female mice were treated once daily with the test item at concentrations of 5, 10, and 25% in PG by topical application to the dorsum of each ear for three consecutive days. The highest concentration tested was the highest concentration that could technically be achieved. A control group of four mice was treated with the vehicle (PG) only. Five days after the first topical application the mice were injected intravenously 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 and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in ab-scintillation counter. All treated animals survived the scheduled study period and no signs of systemic toxicity or local skin irritation were observed. From day 1 to day 3, redness of ear skin could not be examined, due to the colour of the test item. A statistically significant or biologically relevant increase in ear weight was not observed. Stimulation Indices of 1.26, 1.39, and 1.82 were determined with the test item at concentrations of 5, 10, and 25% in PG. The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. greater than the threshold value of 3. The test article is considered to be not sensitizing.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

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

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for sensitization is not warranted under Regulation (EC) No.1272/2008.