Registration Dossier
Registration Dossier
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EC number: 233-242-2 | CAS number: 10099-70-4
Endpoint summary
Administrative data
Description of key information
Skin sensitisation: positive
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Study period:
- July 10, 2020
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Justification for type of information:
- The model is been assessed according to the OECD principles for the validation of QSAR, to generate a transparent, understandable, reproducible and verifiable result.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other:
- Version / remarks:
- ECHA Guidance on information requirements and chemical safety assessment - Chapter R.06: QSARs and grouping of chemicals
- Principles of method if other than guideline:
- Prediction was calculated using QSAR Toolbox v.4.1
Data gap filling method: Trend analysis, executed via AW "Skin sensitization" - Justification for non-LLNA method:
- The prediction is based on Guinea Pig Maximisation Test (GPMT) experimental existing data.
- Species:
- guinea pig
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Diisopropyl maleate is predicted to exhibit skin sensitisation by QSAR Toolbox, evaluating Guinea Pig Maximisation Test (GPMT) experimental existing data on similar substances.
- Executive summary:
Diisopropyl maleate is predicted to exhibit skin sensitisation by QSAR Toolbox, evaluating Guinea Pig Maximisation Test (GPMT) experimental existing data on similar substances.
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Study period:
- July 10, 2020
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Justification for type of information:
- The model is been assessed according to the OECD principles for the validation of QSAR, to generate a transparent, understandable, reproducible and verifiable result.
- Qualifier:
- according to guideline
- Guideline:
- other: ECHA Guidance on information requirements and chemical safety assessment - Chapter R.06: QSARs and grouping of chemicals
- Principles of method if other than guideline:
- Prediction was calculated using QSAR Toolbox v.4.4.1
Data gap filling method: Trend analysis, executed via AW "Skin sensitization" - Parameter:
- EC3
- Remarks on result:
- positive indication of skin sensitisation based on QSAR/QSPR prediction
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Diisopropyl maleate is predicted to exhibit skin sensitisation by QSAR Toolbox, evaluating Local Lymph Node Assay (LLNA) experimental existing data on similar substances.
- Executive summary:
Diisopropyl maleate is predicted to exhibit skin sensitisation by QSAR Toolbox, evaluating Local Lymph Node Assay (LLNA) experimental existing data on similar substances.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Justification for classification or non-classification
Diisopropyl maleate is predicted to exhibit skin sensitisation by QSAR Toolbox, evaluating both Local Lymph Node Assay (LLNA) and Guinea Pig Maximisation Test (GPMT).
Furthermore, diethyl maleate and dibutyl maleate are predicted to exhibit skin sensitisation as result of experimental data, confirming the above (Q)SAR result.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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