Reaction mass of Fatty acids, montan-wax and Fatty acids, montan-wax, ethylene esters and Fatty acids, montan wax, mixed esters with fatty acids C16-18 and ethylene glycol and Fatty acids, montan-wax, stearyl esters and Montan wax

Endpoint summary

Description of key information

A local lymph node assay (LLNA) according to guideline revealed that a member of the Montan waxes category, i.e. Montan wax, type E is not sensitising.

Although no specific studies are available, the members of the Montan waxes category are considered not to exert any sensitizing effects on the respiratory tract. Furthermore, the inhalation pathway is not considered to be relevant for this group of substances.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Justification for type of information:

For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.

Reason / purpose for cross-reference:

assessment report

Key result

Parameter:

SI

Value:

2.5

Test group / Remarks:

25%

Remarks on result:

other: Montan wax, type E

Key result

Parameter:

SI

Value:

2.3

Test group / Remarks:

50%

Remarks on result:

other: Montan wax, type E

Key result

Parameter:

SI

Value:

2.3

Test group / Remarks:

100%

Remarks on result:

other: Montan wax, type E

Parameter:

EC3

Test group / Remarks:

could not be calculated

Remarks on result:

not determinable

Interpretation of results:

GHS criteria not met

Conclusions:

In a reliable study a member of the category of Montan waxes (an extract of Montan wax, type E (25-100%)) was not sensitising in a Local Lymph Node Assay in mice under the conditions of this study (extracted in acetone:olive oil (4:1) for 72 h at 37 °C).

Executive summary:

The study used as source investigated the skin sensitising potential of a member from the category of Montan waxes.

The study results of the source compounds were considered applicable to the target compound and were used for classification and labelling acc. to REGULATION (EC) No 1272/2008. Justification and applicability of the read-across approach (category approach) is outlined in the read-across report in

section 13 or find a link in cross reference “assessment report”.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

There is one LLNA assay available to assess the sensitising properties of Montan waxes (guideline study, RL1). Montan wax, type E was extracted in acetone:olive oil (4:1) for 72 h at 37 °C, and a local lymph node assay was performed using this extract diluted and undiluted extract. After the last application of the test item extract, a slight reddening of the ears of treated animals was observed. This observation was, however, not relevant, since the reddening was not severe. In this study Stimulation Indices (SI) of 2.5, 2.3 and 2.3 were determined with the test item extract concentrations of 25, 50 and 100 %, respectively. Therefore, the extract of the test item was not considered to be a skin sensitiser in this assay.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the findings of a guideline study with Montan waxes, type E, the Montan waxes category members have not to be classified for sensitisation according to Regulation (EC) No 1272/2008.