Registration Dossier
Registration Dossier
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EC number: 696-003-5 | CAS number: 924726-92-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
A package of occupational toxicology tests and pharmacological screening assays have been completed for GSK2609973A. Functional receptor screening tests have also been conducting with this compound in order to understand its potential for interaction with the human glucocorticoid receptor.
The conclusion of the assessment relies primarily upon read across from structurally-related substances with the package of occupational toxicology tests providing data to support this approach. This is consistent with international guidelines for read across of toxicological data (1, 2).
1. European Chemicals Agency, Guidance on information requirements and chemical safety assessment 1. Chapter R.6: QSARs and grouping of chemicals, Guidance for the Implementation of REACH.May 2008
2. OECD, Series on Testing and Assessment, Number 80, Guidance on Grouping of Chemicals, September 2007
Short description of key information:
Given the lack of activity as a corticosteroid, the developmental and reproductive effects typically associated with this pharmacological activity would not be expected to occur with GSK2609973A.
Effects on developmental toxicity
Description of key information
Given the lack of activity as a corticosteroid, the developmental and reproductive effects typically associated with this pharmacological activity would not be expected to occur with GSK2609973A.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
A package of occupational toxicology tests and pharmacological screening assays have been completed for GSK2609973A. Functional receptor screening tests have also been conducting with this compound in order to understand its potential for interaction with the human glucocorticoid receptor.
The conclusion of the assessment relies primarily upon read across from structurally-related substances with the package of occupational toxicology tests providing data to support this approach. This is consistent with international guidelines for read across of toxicological data (1, 2).
1. European Chemicals Agency, Guidance on information requirements and chemical safety assessment 1. Chapter R.6: QSARs and grouping of chemicals, Guidance for the Implementation of REACH.May 2008
2. OECD, Series on Testing and Assessment, Number 80, Guidance on Grouping of Chemicals, September 2007
Justification for classification or non-classification
Developmental toxicity and fertility effects have been reported from studies with glucocorticoids. However, the information on potency with GSK2609973A and read across from a repeat dose study with CCI12778 would not suggest that this substance possesses significant steroid-type activity (devoid of significant glucocorticoid, androgenic, or oestrogenic activity. Therefore, it is not anticipated that typical glucocorticoid-mediated developmental or reproductive toxicity would occur with this substance, at least within the dose range usually used within these studies.
Taking account of the small package of studies with GSK2609973A and close structural similarity to substances for which a more complete dataset exists, it is considered justified to use a read-across approach to address any outstanding data-gaps for this material. Based upon the outcome of this read across approach it is considered that there are no major toxicological issues that have been identified for GSK2609973A. Furthermore, given the lack of activity as a corticosteroid, the developmental and reproductive effects typically associated with this pharmacological activity would not be expected to occur with GSK2609973A.
Additional information
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.
