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.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
