Registration Dossier

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: read-across with statins
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no OECD method used

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
no guideline followed
Guideline:
other: READ across with statins
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

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.

Applicant's summary and conclusion

Conclusions:
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.
Executive summary:

Conclusions:

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.