Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

The suggested source chemicals, i.e. Lovastatin, Simvastatin, Simvastatin ammonium and Pravastatin sodium, were considered sufficient similar in relation to reproductive toxicity and aquatic toxicity to the target chemical Compactin, to apply the read-across approach. Their similarity was evaluated in terms of structural, mechanistic, physicochemical and reactivity similarity. The analysis performed showed that the structural similarity of the source chemicals Lovastatin and Simvastatin with respect to the target Compactin is also supported by a high mechanistic similarity (same profiler results) and high physicochemical and reactivity similarity. On the other hand, Simvastatin ammonium and Pravastatin sodium showed a slightly lower similarity with respect to the target Compactin due to their lower mechanistic (profiler results) similarity and physicochemical and reactivity similarity. These results were therefore taken into account, weighting the experimental test data of Simvastatin ammonium and Pravastatin less than the ones of the other source chemicals in the read-across prediction.

In the current read-across analysis, the target chemical Compactin has been predicted as DANGEROUS for reproductive toxicity, category 1A,hazard H360 which means that it may damage fertility or the unborn child and hazard H362, which means that it may cause harm to breast-fed children.

Short description of key information:
Statin chemicals as potential source chemicals, were evaluated according to their structural similarity with the target chemical Compactin to support the read-across analysis.

Justification for classification or non-classification

Additional information