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Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information
Short description of key 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.