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Diss Factsheets

Administrative data

Description of key information

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:
weight of evidence
Justification for type of information:
See read-across justification report, attached to "Toxicological information" section.
Reason / purpose for cross-reference:
read-across source
Parameter:
SI
Value:
1.63
Test group / Remarks:
1% MEK
Parameter:
SI
Value:
2.51
Test group / Remarks:
5% MEK
Parameter:
SI
Value:
5.31
Test group / Remarks:
10% MEK
Parameter:
EC3
Value:
5.88
Test group / Remarks:
10% MEK
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
Dibenzetano is estimated to have a moderate sensitizer potential from the result of the source study. Based on this one, Dibenzetano is classified as Skin Sens.1B according to CLP Regulation.
Executive summary:

Dibenzetano is estimated to have a moderate sensitizer potential from the result of the source study (see read-across justification report).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The SI obtained for DPX-C (source substance) at 10% concentration showed a greater than three fold increase over the control value with an EC3 value found to be 5.88%. Therefore, according to a read-across approach, Dibenzetano (target substance) demonstrates moderate sensitiser potential in the local lymph node assay.

Justification for classification or non-classification

The SI obtained for DPX-C (source substance) at 10% concentration showed a greater than three fold increase over the control value with an EC3 value found to be 5.88%. Therefore, according to a read-across approach, Dibenzetano (target substance) demonstrates moderate sensitiser potential in the local lymph node assay.

Therefore according to Regulaion (EC) n. 1272/2008, Dibenzetano is classified as Skin Sens. 1B, H317.