Registration Dossier
Registration Dossier
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EC number: 242-016-2 | CAS number: 18127-01-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Effects on fertility
Description of key information
In a GLP OECD 422 study, Bourgeonal was administered via oral gavage to male and female Crl:CD(SD) Sprague Dawley rats once daily beginning before cohabitation, through mating and continuing for at least 28 days (male rats) or through parturition until Day 12 of lactation (female rats) at doses of 0.5, 1, or 5 mg/kg/dose. Administration of Bourgeonal did not produce any mortality or clinical signs in the P generation males or females at any dose. There were no Bourgeonal related effects on mating and fertility in the P generation males or females or any effects on estrous cycling and natural delivery parameters in the P generation females. There were no Bourgeonal-related differences in any preweaning developmental parameter evaluated in the F1generation offspring. Furthermore, there were no Bourgeonal-related macroscopic or microscopic findings or alterations in the organ weights in the P generation adults or F1generation pups. Based on these findings, the no-observed-adverse-effect-level (NOAEL) for general toxicity, mating, and fertility for Bourgeonal in P generation males and females was 5 mg/kg/dose. The NOAEL for development of the F1 generation offspring was also 5 mg/kg/dose.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 5 mg/kg bw/day
- Study duration:
- subchronic
- Experimental exposure time per week (hours/week):
- 168
- Species:
- rat
- Quality of whole database:
- GLP and OECD guideline study.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a GLP OECD 422 study, Bourgeonal was administered via oral gavage to male and female Crl:CD(SD) Sprague Dawley rats once daily beginning before cohabitation, through mating and continuing for at least 28 days (male rats) or through parturition until Day 12 of lactation (female rats) at doses of 0.5, 1, or 5 mg/kg/dose. Administration of Bourgeonal did not produce any mortality or clinical signs in the P generation males or females at any dose. There were no Bourgeonal related effects on mating and fertility in the P generation males or females or any effects on estrous cycling and natural delivery parameters in the P generation females. There were no Bourgeonal-related differences in any preweaning developmental parameter evaluated in the F1generation offspring. Furthermore, there were no Bourgeonal-related macroscopic or microscopic findings or alterations in the organ weights in the P generation adults or F1generation pups. Based on these findings, the no-observed-adverse-effect-level (NOAEL) for general toxicity, mating, and fertility for Bourgeonal in P generation males and females was 5 mg/kg/dose. The NOAEL for development of the F1 generation offspring was also 5 mg/kg/dose.
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
Toxicity to reproduction: other studies
Description of key information
No other study available
Justification for classification or non-classification
Following an ECHA decision, a GLP OECD 422 guideline study in rats by gavage was performed on Bourgeonal itself. No reproductive or developmental effects were observed at non systemically toxic dose levels.
Based on the data available on Bourgeonal, no classification for reproductive toxicity is deemed necessary according to the (EC) No 1272/2008 Regulation (CLP).
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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