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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Glucocorticoids prescribed for clinical use have been extensively studied in non-clinical studies for reproductive and developmental effects and a considerable amount of information is available from epidemiological studies with this class of agents.

Available data suggest that glucocorticoids (if systemic exposure is sufficient) can inhibit both male and female fertility in animal studies. This is likely to occur towards the higher end of the dose range and at exposures likely to produce immune and adrenal suppression.

Short description of key information:
Possible risk of adverse effects on human fertility (males and females).

Effects on developmental toxicity

Description of key information
Presumed to produce adverse effects in developing human offspring.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

·     Glucocorticoids prescribed for clinical use have been extensively studied in non-clinical studies for reproductive and developmental effects and a considerable amount of information is available from epidemiological studies with this class of agents.

·     Glucocorticoids consistently produce developmental abnormalities including cleft palate in multiple species. However, no clear association with foetal abnormalities has been seen in epidemiological studies in humans.

Justification for classification or non-classification

As the test material has demonstrated activity equivalent to known potent glucocorticoids and based on these known effects (as discussed above), the material has been assigned the classification of Specific Target Organ Toxicity - Repeated Exposure; Category 2.

Additional information