Registration Dossier
Registration Dossier
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EC number: 951-761-9 | CAS number: 55722-64-0
Dissociation constant
Administrative data
Link to relevant study record(s)
- Endpoint:
- dissociation constant
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- the study does not need to be conducted because the substance has no ionic structure
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with REACH Regulation (EC) No. 1907/2006 Annex IX, column 2 section 7.16 the study does not need to be conducted if it is scientifically not possible to perform the test: based on structural assessment and with consideration to relevant (Q)SAR models, the substance does not possess an ionisable functional group which may dissociate in the relevant pH range: pH 4 to 9 and/or does not possess a functional group with a pKa in the 0 to 14 range, as such determination appears technically not possible. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.1.17, July 2017) the study does not need to be conducted.
References:
1. ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.1.17, July 2017)
2. ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7b: Endpoint Specific Guidance, June 2017)
3. ECHA Guidance on Application on the CLP Criteria, (v5.0, July 2017)
4. ECHA Guidance on PBT/vPvB assessment (v3.0, June 2017)
Reference
Description of key information
Dissociation Constant: no relevant ionisable functional groups, no pKa in 0 to 14 range based on structural assessment
Key value for chemical safety assessment
Additional information
In accordance with REACH Regulation (EC) No. 1907/2006 Annex IX, column 2 section 7.16 the study does not need to be conducted if it is scientifically not possible to perform the test: based on structural assessment and with consideration to relevant (Q)SAR models, the substance does not possess an ionisable functional group which may dissociate in the relevant pH range: pH 5 to 9 and/or does not possess a functional group with a pKa in the 0 to 14 range, as such determination appears technically not possible. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.1.17, July 2017) the study does not need to be conducted.
References:
1. ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.1.17, July 2017)
2. ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7b: Endpoint Specific Guidance, June 2017)
3. ECHA Guidance on Application on the CLP Criteria, (v5.0, July 2017)
4. ECHA Guidance on PBT/vPvB assessment (v3.0, June 2017)
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.
