Registration Dossier
Registration Dossier
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EC number: 216-644-2 | CAS number: 1633-22-3
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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).
Reference
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.
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