Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

No data available.

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

Description of key information

No data available.

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

Toxicity to reproduction: other studies

Description of key information

No data available.

Justification for classification or non-classification

There is no reproductive toxicity study with bromhydrin-valerate (CAS No. 54605-02-6) available. However, due to its chemical structure bromhydrin-valerate belongs to the group of steroids characterised by an hydroxyl group on C11 and a carboxyl ester on C21 which is typical for glucocorticoids. Therefore, it is assumed that for glucocorticoids typical toxicological properties occur.

In animal experiments glucocorticoids have embryolethal and teratogenic effects. However, since there are no clear signs of such effects following therapeutic use in humans, pregnancy is not regarded as a contraindication to the use of glucocorticoids. Higher levels during pregnancy could, however, lead to a risk of an embryotoxic effect. Following long-term systemic therapy with glucocorticoids such as prednisone and beclomethasone proprionate for asthmatic and other chronic diseases reduced birth weight and placental weight were reported, which are supposed to be an indication for a reversible fetotoxic effect. Similar effects might be expected at high levels of bromhydrin-valerate. Long-term exposure to glucocorticoids can impair fertility (due to a negative influence on the hypophyseal-gonadal axis).

Based on animal experiments and human experience with glucocorticoids the following self classification of bromhydrin-valerate is recommended according to Regulation (EC) No. 1272/2008 (CLP):

Repr. 1A (H360Df: May damage the unborn child. Suspected of damaging fertility).

The classification is in accordance with German legislation for classification of glucocorticoides. The German Committee on Hazardous Substances (AGS) recommended for glucocorticoides classification as Repr. Cat. 2 for effects on fertility and Repr. Cat. 1A for developmental toxicity each according to criteria of CLP Regulation, Annex I.

(see Technical Rule for Hazardous Substances 905; elaborated by the German Committee on Hazardous Substances (AGS) and published by the German Federal Ministry of Labour and Social Affairs, version: 19.04.2016, only available in German, URL http://www.baua.de/de/Themen-von-A-Z/Gefahrstoffe/TRGS/Begruendungen- 905-906.html).

The associated documentation and justification for grouping steroid hormones and their classification was published in Sep. 1999.