Syrups, corn, hydrogenated

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

A multigeneration reproduction study in Sprague-Dawley rats was conducted, in which males received 5.4 - 8.5 g HGS per day and females received 5.3 - 13.5 g of the same compound per day in drinking water as an 18% (dry weight/volume) aqueous solution for 3 successive generations, each comprising 2 consecutive litters. Concurrent controls were given water only. The initial number of animals in each
generation was 10 males and 10 females.

Fertility, length of gestation, litter size, number of live and stillborn pups, post-natal survival, and the lactation index were not affected by treatment. Sex ratios of treated litters exhibited an approximate 10% decrease in the number of female pups (Leroy & Dupas, 1983 - Lycasin(R) 80/55 Three generation reproduction toxicity studies. Volume I - Study of reproductive functions. Volume II - Study of reproductive periods. Unpublished report from Roquette Freres, Lestrem, France. Submitted to WHO).

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

18 000 mg/kg bw/day

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

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

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

7 000 mg/kg bw/day

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Species:

other: rat and rabbit

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.

Furthermore, Bussi et al. reported at the European Teratology Society, 13th conference in September 1985 in Rostock-Warnemünde (GDR) having investigated female New Zealand White rabbits for developmental toxicity by exposing three dose groups of 1.25, 2.5 and 5 g/kg bw/day during gestation days 6 to 18 by gavage (test substance hydrogenated glucose syrup, tradename Malbit®). Only at 5 g/kg bw/day there were some abortions, an increase in the number of early
resorptions and of post-implantation losses. No effects were observed in any treated group on maternal body weight increase, on number of viable and dead fetuses or on fetal body weights. No malformed fetuses were found at any of the dosages administered.

Thus, in two different species no developmental toxicity was observed for hydrogenated glucose syrups.

 

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.