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Toxicological information

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Administrative data

Description of key information

Information on sensitization are derived from reliable, experimental data of a structural analogue. The skin sensitizing potential of the test item (analogue) was assessed in a murine local lymph node assay in mice (OECD 429, GLP). 0.2, 2 and 20% solution was applied onto the dorsum of both ears for three consecutive days. The test item did not cause clinical symptoms and the SI of all treatment groups was below 3. Therefore, the substance is not considered to be a skin sensitizer.

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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Further information are included as attachment in chapter 13 of the IUCLID dossier.
Reason / purpose:
read-across source
Reason / purpose:
read-across: supporting information
Parameter:
SI
Value:
1
Test group / Remarks:
negative control
Parameter:
SI
Value:
9.56
Test group / Remarks:
postive control
Parameter:
SI
Value:
1.18
Test group / Remarks:
0.2 % test group
Parameter:
SI
Value:
1.05
Test group / Remarks:
2% test group
Parameter:
SI
Value:
1.58
Test group / Remarks:
20 % test group
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

LLNA (OECD 429)

The substance was tested for the assessment of skin sensitisation potential with the murine local lymph node assay with radionuclides in mice. Five mice per group were exposed on the dorsum of both ears once a day by test substance (0.2, 2, 20%) and control substances during 3 consecutive days. Primary proliferation of lymphocytes in the lymph node was evaluated and the SI determined. The animals exposed to the test substance at all concentrations showed no pathological skin reactions and no other negative clinical symptoms of intoxication. Comparison of Stimulation Indexes (SI) between all treated groups and control vehicle group revealed that the test substance did not cause significant increase in radioisotope incorporation into the DNA of dividing lymphocytes.

 

Discussion

Thus, the test item is not considered to be a skin sensitizer.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008, as amended for the thirteenth time in Regulation (EU) No 2018/1480. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008.