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:

In an LLNA according to OECD 429 and GLP (BASF 2011), the test substance dissolved in acetone:olive oil (4+1 (v/v)) was assessed for its skin sensitizing in mice using concentrations of 1.19, 2.94, and 6% (w/w).The highest concentration tested was the highest concentration that could be applied whilst avoiding excessive local skin irritation (as determined by three pre-experiments).

The animals did not show any signs of systemic toxicity or local skin irritation during the course of the study and no cases of mortality were observed. A statistically significant increase in ear weights was observed in the high dose group in comparison to the vehicle control group (p >0.05). However, this was considered to be not biologically relevant, as the mean value of the group was still within the range of historical vehicle control data for the ear weight. In this study Stimulation Indices (S.I.) of 0.88, 0.87, and 1.84 were determined with the test item at concentrations of 1.19, 2.94, and 6% (w/w), respectively. A clear dose response was not observed. A statistically significant increase in DPM value and in lymph node cell count was determined in the high dose group in comparison to the vehicle control group (p > 0.05). Still, as the Stimulation Index determined for this group was well below the threshold value of 3 for a positive response, this was not biologically relevant. Also, the cutoff-value for a positive response regarding the lymph node cell count index of 1.55 reported for BALB/c mice was not exceeded in any dose group. The lymph node weights did not show a statistically significant increase in any dose group in comparison to the vehicle control group.


Migrated from Short description of key information:
LLNA: negative (BASF 2011, GLP, OECD 429)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Oxirane, methyl-, polymer with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3 -propanediol (3:1), 2 -propenoate did not cause sensitization as determined in the LLNA. Thus the test substance has not to be classified according to EU criteria and CLP/GHS-EU.

There are no data available to for classification of Oxirane, methyl-, polymer with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3 -propanediol (3:1), 2 -propenoate as a sensitizer of the respiratory tract.