Registration Dossier
Registration Dossier
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EC number: 214-130-2 | CAS number: 1091-93-6
Endpoint summary
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
Pharmacological studies with subcutaneous application of the test substance revealed the following results:
Significant
estrogenic effect in the rat (Allen-Doisy test). Threshold dose
subcutaneous ca. 0.3 mg/animal (~300-fold less effective than estradiol).
Anti-gonadotropic effect in the rat (testis inhibition test). At 1 mg/animal/day subcutaneous (body weight = 35 g) 44% testicular inhibition. Cause: inhibition of central gonadotropin secretion, presumably via estrogenic mode of action.
100%
inhibition of implantation in the rat at 1 mg/animal/day subcutaneous.
This may be due to an estrogenic or anti-gonadotropic mode of action.
Effects on developmental toxicity
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
Justification for classification or non-classification
Based on pharmacological data (estrogenic and anti-gonadotropic effect, 100% inhibition of implantation in the rat) a self classification of the substance according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is recommended as follows:
DSD: R62, Repr. Cat. 3 (Possible risk of impaired fertility) and R63, Repr. Cat. 3 (Possible risk of harm to the unborn child)
GHS: Repr. 2 (H361fd: Suspected of damaging fertility, suspected of damaging the unborn child)
DSD: R64 (May cause harm to breast-fed babies)
GHS: Additional category for effects on or via lactation (H362: May cause harm to breast-fed children)
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
