Registration Dossier
Registration Dossier
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EC number: 210-498-3 | CAS number: 616-91-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Toxicity to reproduction: other studies
Additional information
In a fertility study in rat and rabbit, no effects or slight, non dose related, reduction of fertility were observesd after test item administration of 1000 - 2000 mg/kg bw [1]. After daily administration of the test item to pregnant mice for 17 or 18 days, a TDLo of 8500 mg/kg bw/d (Effect Code T39) or 9000 mg/kg bw/d (Effect Code T83), respectively, was determined [2].
In contrast, infertility was observed in female rats treated with 1000 mg/kg bw/d test item for longer than one week. Infertility was based on the altered structure (thinning of zona pellucida) of the ovarian follicles. Fertility recovered after the end of test item administration [3]. However, the administration route was i.v., thereby bypassing the hepatic clearance. Metabolic studies have shown a strong first pass effect for the test item, limiting the bioavailability after oral administration. Furthermore, these studies were not conducted according to existing guidelines for reprotox-screening. Therefore, the results of these studies were disregarded for classification.
[1] Eur J Respir Dis, 61, Suppl. 111, 1980
[2] Carcinogenesis, 27, 240, 2006
[3] Congenital anomalies, Vol. 43, No. 3, pp. 168-76, 2003
Justification for classification or non-classification
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.
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