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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
fertility, other
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004
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:
2004

Materials and methods

Test guideline
Qualifier:
no guideline followed
Guideline:
other: not applicable
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

Spontaneous testicular degeneration

(e.g., testicular atrophy, decreased spermatogenesis, spermatocytic degeneration

and giant cell formation) was observed in dogs treated with 20 mg/kg/day for one

year, however this effect was poorly reproducible and not dose-dependent (AHFS,

2004; PDR, 2005). It is not clear if fertility was altered in dogs. No effects on

fertility were observed in rats (details not specified).

We suggest classifying lovastatin as Reproductive toxiciy cat 2 , H361: Suspected ofdamaging fertility or the unborn child

Applicant's summary and conclusion

Conclusions:
Spontaneous testicular degeneration
(e.g., testicular atrophy, decreased spermatogenesis, spermatocytic degeneration
and giant cell formation) was observed in dogs treated with 20 mg/kg/day for one
year, however this effect was poorly reproducible and not dose-dependent (AHFS,
2004; PDR, 2005). It is not clear if fertility was altered in dogs. No effects on
fertility were observed in rats (details not specified).
Executive summary:

Spontaneous testicular degeneration

(e.g., testicular atrophy, decreased spermatogenesis, spermatocytic degeneration

and giant cell formation) was observed in dogs treated with 20 mg/kg/day for one

year, however this effect was poorly reproducible and not dose-dependent (AHFS,

2004; PDR, 2005). It is not clear if fertility was altered in dogs. No effects on

fertility were observed in rats (details not specified).

We suggest classifying lovastatin as Reproductive toxiciy cat 2 , H361: Suspected ofdamaging fertility or the unborn child