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:

A modified LLNA (IMDS; OECD TG 429) was performed on 6 female NMRI mice per dose group using the substance formulated in acetone/olive oil at 0 % (vehicle control), 2 %, 10 % and 50 %. Compared to controls the mice showed a significant increase in the weights and in the cell counts of the draining lymph nodes. For the cell counts the “positive level” of 1.4 has just been exceeded in the high (50 %) dose group.

Statistically significant increases of ear swelling and ear weights were also determined for high dose animals. An increase in these parameters does point to an acute irritant (inflammatory) response, which may partly be due to left-overs of the test item, which became a very viscous formulation at the high dose concentration (50 %). A thin layer, unremovable from animal hair and wood shavings had been recognized on the ears before sacrificing the animals. In addition, a hairless area around the base of the ears was observed.

Due to the irritant property of the test item at the highest concentration it is not quite clear whether the cell proliferation is induced by a non-specific (inflammatory) reaction or a specific (sensitizing) reaction.

Summarizing, a sensitizing potential cannot be excluded by the data presented here. The concentration of 10 % turned out to be the NOEL for the parameters investigated in this study with respect to skin sensitization. The EC 1.4 value calculated was 47.42 %

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to Regulation (EC) No 1272/2008, Annex I, the substance has to be classified as Skin Sens. 1 (H317: May cause an allergic skin reaction).

Regulation (EU) No 286/2011, amending Regulation (EC) No 1272/2008, states that, where data are sufficient, a refined evaluation allows the allocation of skin sensitizers into sub-categories (1A: strong sensitizers; 1B: other skin sensitizer). In this case the available LLNA justifies an allocation to skin sensitisation sub-category 1B, as the EC value calculated is clearly above 2 % (EC1.4 = 47.4 %) and the NOEL with respect to skin sensitization is 10 %.