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EC number: 700-515-7 | CAS number: 1236007-63-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented journal publication of a GLP study conducted at a respected contract laboratory
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- An embryotoxicity/teratogenicity study was conducted in which the substance was administered orally in the diet from day 0 to day 21 of pregnancy.
- GLP compliance:
- yes
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Isomaltulose (6-O-(alpha-D-glucopyranosyl)-D-fructofuranose), CAS No. 13718-94-0, is a reducing disaccharide that occurs natually in honey and sugar cane juice. Purity of the tested substance, a white crystalline powder, was 98.5% TS.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- Twelve-week old, specific-pathogen-free-bred Wistar rats (Hsd/Cpb:WU) were obtained from Harlan-CPB, Zeist, The Netherlands, and acclimated to the animal facilities for 5 days before mating. The rats were housed in suspended stainless-steel wire-screen cages. Mated females were housed individually. The room was ventilated with 10 air changes/hour and maintained at 22-24 degrees C, a relative humidity of 50-60%, and a 12-hour light/dark cycle.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- The rats were fed the Institute's cereal-based powdered stock diet, the composition of which was 11% soybean oil meal, 7% fish meal, 4% meat and bone scraps, 36% whole ground wheat, 29.7% whole ground maize, 3% grass meal, 2% whey powder, 0.4% defatted bone meal, 3% soybean oil, 0.5% trace elements and salt, 3% brewers yeast, 0.1% vitamin B preparation, and 0.3% vitamin ADEK mixture. During the treatment period the stock diet was supplemented with 2.5% casein, 0.1% DL-methionine and 0-10% isomaltulose at the expense of the maize starch. Fresh portions were fed to the rats every 4-6 days. Feed and water were provided ad libitum.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- All diets were analyzed for isomaltulose content (after extraction in water and protein precipitation) by HPLC using a Nucleosil NH2 column. Five batches were analyzed to evaluate the mixing procedure. The stability of isomaltulose was examined after storage for 7 days at room temperature.
- Details on mating procedure:
- Young adult female rats were mated with males (male/female ratio 1:2). The day of detection of sperm cells in the vaginal smear was considered day 0 of pregnancy. Mated females were then assigned randomly to four groups of 24 animals each, which were then fed diets containing 0, 2.5, 5 or 10% isomaltulose from day 0 to day 21 of pregnancy.
- Duration of treatment / exposure:
- Mated females were exposed to isomaltulose in the diet from day 0 to day 21 of pregnancy.
- Frequency of treatment:
- Daily in the feed.
- Duration of test:
- 21 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
o, 2.5%, 5%, 10%
Basis:
nominal in diet
- No. of animals per sex per dose:
- 24 female animals per dose
- Control animals:
- yes, plain diet
Examinations
- Maternal examinations:
- The general condition and behavior of all animals were checked daily. During gestation, body weight gain and food and water consumption were measured. At autopsy, the pregnant rats were evaluated by macroscopy of major abdominal and thoracic maternal organs,and weights of the ovaries taken.
- Ovaries and uterine content:
- The number and weights of gravid and empty uterus, the number of corpora lutea, implantation sites, live and dead fetuses and early or late resorptions, the sex of the live fetuses, fetal and placental weights, fetal length and the presence of external malformations were measured.
- Fetal examinations:
- Besides that already noted, half of the fetuses of each litter were fixed in 70% ethanol, eviscerated, partly skinned, cleared and stained with Alizarin Red S for examination of the skeleton. The remaining fetuses were fixed in Bouin's fluid for visceral examination. Both skeletal and visceral screening were performed blindly in all groups.
- Statistics:
- Data on maternal body weights, food and water intake, organ weights, fetal weights and lengths, and placental weights were subjected to one-way analysis of variance (ANOVA) followed by Dunnett's multiple comparison test. Maternal survival and pregnancy status, maternal and fetal external macroscopic observations, and skeletal and visceral examinations were evaluated by Fisher's exact probability test. The percentages of pre- and post-implantation loss were subjected to Kruskal-Wallis one-way ANOVA followed by the Mann-Whitney U test.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No clinical signs attributable to the treatment were observed. None of the dams died and no gross abnormalities of the tissues or organs were observed. Body weight gain and food and water intake showed no treatment-related differences during pregnancy.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 7 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- > 7 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
There were no signfiicant differences in fertility and gestation indices, the numbers of corpora lutea and implantations, live and dead fetuses, fetal sex ratio and early and late resorptions. Weights of ovaries and gravid and empty uterus were comparable between treatment and control groups, as was placental weight, fetal weight, and fetal length in both sexes. The few fetal external findings observed were randomly distributed among all groups. No treatment-related changes in fetal soft tissues of visceral malformations were observed. No fetal skeletal malformations occurred and there were no changes of toxicological significance in fetal skeletal anomalies or fetal skeletal variations.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
A summary of the reproductive performance of rats is shown in the table below.
Reproductive performance of rats fed isomaltulose from day 0 to day 21 of pregnancy
Values for rats fed isomatulose at dietary levels (%) of
Parameters |
Statistics |
0 |
2.5 |
5 |
10 |
No. of mated females |
|
24 |
24 |
24 |
24 |
No. of pregnant females |
(f) |
23 |
22 |
23 |
24 |
Fecundity index C/011 |
|
96 |
92 |
96 |
100 |
No. of females bearing live foetuses |
|
23 |
22 |
23 |
24 |
No. of corpora lutea per dam |
(k) |
13.1 ± 0.4 |
13.3 ± 0.3 |
13.3 ± 0.3 |
13.4 ± 0.4 |
No. of implantations per dam |
(k) |
11.9 ± 0.5 |
12.1 ± 0.6 |
11.7 ± 0.5 |
12.0 ± 0.3 |
Preimplantation loss (%)2 |
(k) |
8.9 ± 2.5 |
9.6 ± 4.1 |
12.0 ± 3.3 |
10.1 ± 2.1 |
No. of resorptions per litter |
(k) |
0.4 ± 0.1 |
0.5 ± 0.1 |
0.5 ± 0.2 |
0.5 ± 0.2 |
No. of dead foetuses per litter |
(k) |
0.1 ± 0.1 |
0.0 ± 0.0 |
0.0 ± 0.0 |
0.0 ± 0.0 |
Postimplantation loss (%)3 |
(k) |
4.3 ± 1.5 |
4.0 ± 1.2 |
4.5 ± 1.4 |
4.1 ± 1.6 |
No. of live foetuses per litter |
(k) |
11.4 ± 0.5 |
11.6 ± 0.6 |
11.1 ± 0.5 |
11.5 ± 0.4 |
No. of males per litter |
(k) |
5.7 ± 0.5 |
5.7 ± 0.5 |
5.0 ± 0.4 |
5.7 ± 0.4 |
No. of females per litter |
(k) |
5.7 ± 0.4 |
5.8 ± 0.4 |
6.2 ± 0.5 |
5.8 ± 0.4 |
Ovary weight (mg) |
(a) |
101.2 + 4.1 |
98.0 + 4.0 |
99.4 + 4.8 |
94.4 + 2.3 |
Gravid uterus weight (g) |
(a) |
73.4 ± 2.9 |
74.8 ± 3.6 |
73.6 ± 2.0 |
75.0 ± 2.0 |
Empty uterus weight (g) |
(a) |
5.0 ± 0.2 |
5.1 + 0.3 |
4.8 + 0.2 |
5.0 ± 0.2 |
Placental weight (g) |
(a) |
0.52 ± 0.01 |
0.54 ± 0.02 |
0.54 ± 0.02 |
0.56 ± 0.03 |
Foetal weight (g) |
(a) |
4.85 ± 0.04 |
4.87 ± 0.06 |
4.92 ± 0.05 |
4.94 ± 0.05 |
Foetal length (cm) |
(a) |
4.1 ± 0.0 |
4.1 ± 0.0 |
4.1 ± 0.0 |
4.0 ± 0.0 |
Values (other than percentages) are means ± SEM.
Statistical analyses did not reveal any significant differences between the treatment groups and the controls; a = ANOVA/Dunnett's test; f = Fisher's exact probability test; k= Kruskal-Wallis/Mann-WhitneyUtest.
'Fecundity index (%) = (no. of pregnant females/no. of mated females) x100.
2Preimplantation loss (%) = [(no. of corpora lutea-no. of implantation sites)/no. of corpora lutea] x100.
3Postimplantation loss (%) = [(no. of implantation sites-no. of live foetuses)/no. of implantation sites] x100.
Applicant's summary and conclusion
- Conclusions:
- The test substance is not toxic.
- Executive summary:
An embryotoxicity/teratogenicity study was conducted in which the substance was administered orally in the diet from day 0 to day 21 of pregnancy. Doses were control, 2.5%, 5% and 10% isomaltulose in the feed. No maternal toxicity occurred during the study, and no effects on reproductive performance, embryotoxicity, fetal development, or teratogenicity were observed. Therefore the dietary level of 10% isomaltulose, which is equivalent to approximately 7000 mg/kg bw/day, is considered a no effect level.
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