Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
other: Data from the Safety Data Sheet
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: 4b: secondary literature

Data source

Reference
Reference Type:
secondary source
Title:
DELTANDROSTENEDIONE (with more than 0,3% d'Androstenedione)
Author:
Sanofi Aventis
Year:
2011
Bibliographic source:
Material Safety Data Sheet
Report Date:
2011

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Details on maternal toxic effects:
see conclusion

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Details on embryotoxic / teratogenic effects:
see conclusion

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Possible reprotoxic effects due to the androgenic activity.
The substance has been classified "H360FD: May damage fertility. May damage the unborn child", according to the 1272/2008 CLP regulation, due to the impurity Androstenedione present at a concentration > 0.3%.