Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-016-5 | CAS number: 90-80-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
In accordance with column 2 of REACH Annex VIII, the reproductive toxicity study (required in section 8.7.1) does not need to be conducted as a pre-natal developmental toxicity study is available.
Effects on developmental toxicity
Description of key information
Prenatal development toxicity studies on D-glucono-1,5-lactone in rats and mice (predating GLP) that were equivalent to OECD guideline 414 reported oral NOAELs for developmental toxicity of 594 mg/kg bw/day (rats) and 695 mg/kg bw/day (mice), which were the highest dose levels tested.
Supportive development toxicity studies, conducted in rabbits and hamsters have not reported teratogenic effects following oral administration of D-glucono-1,5-lactone.
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 594 mg/kg bw/day
Additional information
The effects of D-glucono-1,5-lactone were evaluated in a prenatal development toxicity study that was equivalent to OECD test guideline 414 (Report No. FDABF-GRAS-149). This study was conducted prior to the implementation of the GLPs. D-glucono-1,5-lactone was administered by oral gavage to timed-pregnant Wistar rats at dose levels of 0 (water vehicle), 5.94, 27.6, 128.0, or 594.0 mg/kg bw/day (n=21 to 24/group). There were no discernable effects on nidation or on maternal or fetal survival. Also, no evidence of fetotoxicity or teratogenicity were observed. The NOAEL for developmental toxicity in rats was considered to be 594 mg/kg bw/day, the highest dose level evaluated.
The effects of D-glucono-1,5-lactone also were evaluated in a prenatal development toxicity study that was equivalent to OECD test guideline 414 (Report No. FDABF-GRAS-149). This study was conducted prior to the implementation of the GLPs. D-glucono-1,5-lactone was administered by oral gavage to CD-1 mice at dose levels of 0 (water vehicle), 6.95, 32.5, 150.0, or 695.0 mg/kg bw/day (n=21 to 25/group). There were no discernable effects on nidation or on maternal or fetal survival. Also, no evidence of fetotoxicity or teratogenicity was observed. The NOAEL for developmental toxicity in mice was considered to be 695 mg/kg bw/day, the highest dose level evaluated.
Supportive evidence also was provided by prenatal development toxicity studies in hamsters and rats. These studies predated the GLPs and were equivalent to OECD test guideline 414. In these studies, orally administered D-glucono-1,5-lactone was not associated with any adverse effects on nidation or maternal or fetal survival at dose levels up to 780 mg/kg bw/day (rabbits) or 560 mg/kg bw/day (hamsters). Also, no evidence of fetotoxicity or teratogenicity was observed at any dose levels tested. These were the highest dose levels evaluated.
Justification for classification or non-classification
The substance does not meet the criteria for classification and labelling for this endpoint, as set out in Regulation (EC) NO. 1272/2008.
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.
