Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
18 000 mg/kg bw/day
Additional information

Metabolic data demonstrate that the notifiable substance, as well as the read-across substances (maltose, maltitol, sorbitol, wheat glucose syrup (WGS), and dextrin) share a common metabolic pathway as they are converted to D-glucose and/or sorbitol via hydrolysis of their glycosidic linkages by the intestinal brush border carbohydrases. On the basis of their common mono- and disaccharide metabolites, the properties of the notifiable substance, is expected to be similar to the read-across substances maltose, sorbitol, maltitol, WGS and dextrin. Considering this, it is anticipated that exposure to any of the aforementioned saccharides would ultimately result in the formation of D-glucose and/or sorbitol. As such, maltose, sorbitol, maltitol, WGS, and dextrin may be used as appropriate surrogates for the notifiable substance, considering their common metabolic products.

 

In a 3-generation non-GLP reproductive toxicity study, male and female Sprague-Dawley rats were orally administered Lycasin 80/55 via the drinking water at concentrations of 0 (control) or 18% , corresponding to approximately 0 or 18 g/kg body weight/day (equivalent to OECD test guideline 416) (Modderman, 1993). Treatment of F1 animals began 12 weeks prior to mating and from birth for subsequent generations until Day 21 of lactation or until week 11 for the F3 generation (further mating details were not reported). No significant changes were noted in either the parental or subsequent generations in any parameter examined (e.g., body weight, food consumption, reproductive performance, pup viability, etc.) and, therefore, the reproductive no-observed-effect level was 18% in the drinking water.


Short description of key information:
A 3-generation, non-GLP, weight of evidence study in Sprague-Dawley rats with Lycasin 80/55 demonstrated no toxic or reproductive effects when administered in the drinking water at 18%, the only dose level tested.

Effects on developmental toxicity

Description of key information
A developmental toxicity/teratogenicity study conducted with Lycasin in rats did not demonstrate any toxicity either in the parents or in the offspring.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
7 000 mg/kg bw/day
Additional information

A key, non-GLP, developmental toxicity/teratogenicity study (equivalent to OECD test guideline 414) was conducted in male and female Sprague-Dawley rats (Modderman, 1993). The animals received Lycasin via oral (gavage) at doses of (control), 3,000, 5,000, or 7,000 mg/kg body weight/day from Days 6 to 15 of gestation. Maternal and offspring evaluations were unremarkable in all species; no significant changes were noted in any of the following parameters: daily observations, body weights, food and water consumption, ovary and uterine content, external offspring examinations, soft tissue examinations, skeletal examinations, and head examinations. The NOEL was 7,000 mg/kg body weight/day, the highest dose examined.

Justification for classification or non-classification

 The reproductive and developmental studies available indicate that the notifiable substance does not adversely affect sexual function and fertility in adult males and females, as well as not affecting development in the offspring. As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.7.