Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Study duration:
chronic
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

D-xylose, a pentose sugar, is not expected to cause adverse reproductive or developmental effects and additional animal testing is not scientifically justified. In a 2-year rat study, a diet of 5% D-xylose (2214 and 2513 mg/kg/day for males and females, respectively) did not result in adverse effects on reproductive organs (Kuroiwa, 2005). Further, there is a history of the safe use of D-xylose in humans. D-xylose is commonly administered to humans as a diagnostic tool to study intestinal malabsorption. This test typically involves the oral administration of a large dose (approximately 25 g, 400 mg/kg in a 60 kg human) (for example, Worvag, 1987).

In summary, there is no indication that exposure to D-xylose results in adverse effects to reproduction. This is further supported by the fact that D-xylose is administered routinely to humans, including pregnant females, without adverse effect.

Short description of key information:
No adverse effects were observed in reproductive organs at >5% (highest dose tested) in a 104-week feeding study in rats.

Effects on developmental toxicity

Description of key information
No adverse litter effects were observed in rats after administration of D-xylose to pregnant dams.  In addition, the use of D-xylose in pregnant human females has also been documented, with no adverse effects noted following administration.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Species:
other: rat and humans
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

D-xylose, a pentose sugar, is not expected to cause adverse reproductive or developmental effects and additional animal testing is not scientifically justified. In a rat study, groups of pregnant rats were fed 4 grams of test substance in their diet for 7 days (Thiersch, 1971). Following removal of the uteri, implantation sites were counted, and placentas and foetuses weighed and measured. The foetuses were examined for malformations. Several of the foetal skeletons were cleared. The treatment of groups of pregnant rats with the test substance during the gestation period had no apparent effect on the litter. Further, there is a history of the safe use of D-xylose in humans. D-xylose is commonly administered to humans as a diagnostic tool to study intestinal malabsorption. This test typically involves the oral administration of a large dose (approximately 25 g, 400 mg/kg in a 60 kg human) (for example, Worvag, 1987). The use of D-xylose in pregnant human females has also been documented (Egwuatu, 1981; Hofmann, 2001). In the first study, 16 pregnant females in the second and third trimesters of their first pregnancy and 18 non-pregnant females were given an oral bolus of 5 grams of D-xylose. In the second study, 53 pregnant women in labour were given an intravenous infusion of 5% D-xylose. Glucose, insulin, and bilirubin were measured in both maternal and foetal blood; no adverse effects were noted following xylose administration.

In summary, there is no indication that exposure to D-xylose results in adverse effects to reproduction and development. This is further supported by the fact that D-xylose is administered routinely to humans, including pregnant females, without adverse effect.

Justification for classification or non-classification

The test substance was not uniquely toxic to the developing foetus and no effects were observed in reproductive organs in a 104-week dietary study, therefore no classification is required for developmental or reproductive toxicity according to EU Directive 67/548/EEC and EU Classification and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.