Registration Dossier

Administrative data

Description of key information

GSK2609973A is not considered to be acutely toxic based upon results obtained with similar materials.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
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

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. 

GSK2609973A is not considered to be acutely toxic based upon results obtained with similar materials, as follows:

Not expected to be toxic if ingested.

Based upon data for a wide spectrum of substances with steroidal structures and read across from CCI12778, significant acute toxicity potential is not expected with GSK2609973A.

Not expected to be toxic if inhaled.

Not expected to be toxic following contact with skin.

• Low toxicity expected based upon lack of steroidal activity and comparison with similar substances.

• CCI12778 (9,11-Epoxide) produced no evidence of irritation in an acute dermal irritation study in a single rabbit.