Registration Dossier
Registration Dossier
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EC number: 248-299-9 | CAS number: 27178-16-1
Endpoint summary
Administrative data
Description of key information
Read-across substance, bis(2-ethylhexyl) adipate, was determined to be not a skin sensitiser based on the results of a QSAR assessment (OASIS Times Mix 2.26.3).
Read-across substance, diisononyl adipate, was determined to be not a skin sensitiser based on the results of a QSAR assessment (OASIS Times Mix 2.26.3).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation, other
- Remarks:
- QSAR
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- Please see Section 13 below.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Run / experiment:
- other:
- Parameter:
- other: QSAR
- Remarks on result:
- other: he QSAR program calculated a negative sensitization potential of the test substance.
- Interpretation of results:
- GHS criteria not met
- Endpoint:
- skin sensitisation, other
- Remarks:
- QSAR
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- Please see Section 13 below.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Run / experiment:
- other:
- Parameter:
- other: QSAR
- Remarks on result:
- other: The QSAR program calculated a negative sensitization potential of the test substance.
- Interpretation of results:
- GHS criteria not met
- Endpoint:
- skin sensitisation, other
- Remarks:
- QSAR
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Validated QSAR System-Substance is in domain of the system.
- Justification for type of information:
- QSAR prediction
Validated QSAR System-Substance is in domain of the system. - Principles of method if other than guideline:
- A quantitive structure-activity relationship (QSAR) system for the estimation of the skin sensitization potency that incorporates skin metabolism and consideres the potential of parent chemicals and/or their activated metabolites to react with skin proteins. A chemically divers training set was used and their skin sensitization potency assigned to one of three classes.
- GLP compliance:
- no
- Key result
- Run / experiment:
- other:
- Parameter:
- other: QSAR
- Remarks on result:
- other: The QSAR program calculated a negative sensitization potential of the test substance.
- Interpretation of results:
- GHS criteria not met
- Endpoint:
- skin sensitisation, other
- Remarks:
- other: Calculated
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Validated QSAR System-Substance is in domain of the system.
- Justification for type of information:
- QSAR prediction
Validated QSAR System-Substance is in domain of the system. - Qualifier:
- no guideline available
- Principles of method if other than guideline:
- A quantitive structure-activity relationship (QSAR) system for the estimation of the skin sensitization potency that incorporates skin metabolism and consideres the potential of parent chemicals and/or their activated metabolites to react with skin proteins. A chemically divers training set was used and their skin sensitization potency assigned to one of three classes.
- GLP compliance:
- no
- Key result
- Run / experiment:
- other:
- Parameter:
- other: QSAR
- Remarks on result:
- other: The QSAR program calculated a negative sensitization potential of the test substance.
- Interpretation of results:
- GHS criteria not met
Referenceopen allclose all
A stimulation index neither animals no. with + reactions could not be derived, as a QSAR was used that predicted the test substance as not sensitizing.
The QSAR program calculated a negative sensitization potential of the test substance.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the above mentioned results, classification according to the CLP Regulation (EC) 1272/2008 is not necessary.
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