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Skin sensitisation

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Administrative data

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”.
Cross-reference
Reason / purpose for cross-reference:
assessment report

Data source

Materials and methods

Test material

Constituent 1
Reference substance name:
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
EC Number:
911-428-0
IUPAC Name:
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
Test material form:
solid: flakes

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
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

Applicant's summary and conclusion

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”.