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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
adverse effect observed
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Toxicity to reproduction: other studies

Description of key information

Administration of Candesartan in pregnant: case reports of oliguria, perinatal renal failure, neonatal kidney dysfunction, developmental delay, and death associated with use of candesartan during the 2nd and 3rd trimester. A series of 20 pregnancies with oligohydramnios.

Mode of Action Analysis / Human Relevance Framework

The adverse fetal effects appear to reflect a pharmacologic response of the fetus to Candesartan during the second half of gestation rather than abnormal embryogenesis.

Justification for classification or non-classification
No data are available for CAN 5 (target substance). Read-across with Candesartan is performed for this hazard. There is a substantial risk of oligohydramnios and fetal distress or death in hypertensive women treated with Candesartan in the latter part of the pregnancy; therefore, the use of the drug during these trimesters is contraindicated. Rats are not a good model for this human teratogen although fetal death and decreased weight occur after treatment on days 15-20. Candesartan did not impair fertility in male or female rats. Overall, considering all these data, CAN 5 should be classified for this hazard class as Repr 2; H361d.

Additional information