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EC number: 201-788-0 | CAS number: 87-99-0
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Food and Drug Administration (1966). Guidelines for Reproductive Studies for Safety Evaluations of Drugs for Human Use.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Committee on Safety of Medicines. Guidelines on Reproduction Studies for the Guidance of Applicants for Product Licences and Clinical Trial Certificates, June 1974.
- Deviations:
- no
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Xylitol
- EC Number:
- 201-788-0
- EC Name:
- Xylitol
- Cas Number:
- 87-99-0
- Molecular formula:
- C5H12O5
- IUPAC Name:
- (2R,3r,4S)-pentane-1,2,3,4,5-pentol
- Details on test material:
- - Purity: not reported
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Yellow-Silver
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal Farm Füllinsdorf (BL), Switzerland
- Age at study initiation: 3-4 months
- Weight at study initiation: 2.7-3.0 kg
- Housing: housed in individual stainless steel cages
- Diet (e.g. ad libitum): For all dose levels portions of 150 g food per day were given from 1st to 30th day of gestation.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: acclimatized for a period of at least four weeks prior to the experiment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): fully air-conditioned rooms at a temperature of 18 ± 1ºC
- Humidity (%): 50-60 %
- Photoperiod (hrs dark / hrs light): 12 h/day light
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- DIET PREPARATION: The test substance, sorbitol, or sucrose was baked into Nafag 814 food. Control were fed Nafag 814 without addition.
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused: 10-15 healthy untreated Yellow Silver bucks of proven fertility were employed. Each doe was caged with a buck for one to three hours and copulation observed. Ideally following two copulations with the same male, the fertilized females were distributed to the experimental groups according to a table of random numbers. - Duration of treatment / exposure:
- Gestation Days 7 to 19
- Frequency of treatment:
- Daily
- Duration of test:
- Surviving does were sacrificed on the 30th day of gestation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2 other: %
- Remarks:
- nominal in diet
- Dose / conc.:
- 5 other: %
- Remarks:
- nominal in diet
- Dose / conc.:
- 10 other: %
- Remarks:
- nominal in diet
- Dose / conc.:
- 20 other: %
- Remarks:
- nominal in diet
- No. of animals per sex per dose:
- 20 females
- Control animals:
- yes, plain diet
- other: Further groups received diet containing 20% of either sorbitol or sucrose.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations checked: changes in appearance, behaviour and pharmacological effects
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: daily
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 30
- Organs examined: Mothers were examined for possible malformations.
- Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter, including crown-rump length
- Soft tissue examinations: Yes: all per litter
- Skeletal examinations: Yes: all per litter
- Head examinations: Yes: all per litter - Statistics:
- Statistical analyses were performed using Student's "t" test for independent samples and the chi-square test (Fisher's exact probability test).
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Body weight was reduced during the treatment period at 20% xylitol and 20% sucrose.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- The average daily feed intake in the control, 2, 5, and 10% xylitol groups varied between 100 and 144 g per doe from days 2 to 28 of pregnancy. In the 20% xylitol, 20% sorbitol, and 20% sucrose groups the feed intake decreased to less than 100 g/day/doe during parts of the period of treatment but returned to normal when the diet was no longer supplemented with xylitol or other sugars. The average daily uptake of sugars (g/kg) in these groups with 10% admix to the feed showed a tendency to decrease during the treatment period. The daily uptake I the various dose groups was on average (g/kg): 0.94 (2% xylitol), 2.33 (5% xylitol), 4.17 (10% xylitol), 6.77 (20% xylitol), 7.74 (20% sorbitol), and 7.37 (20% sucrose).
- Behaviour (functional findings):
- no effects observed
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Changes in number of pregnant:
- no effects observed
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 4 170 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- Remarks on result:
- other: 10% in diet
- Dose descriptor:
- LOAEL
- Effect level:
- 6 770 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- Remarks on result:
- other: 20% in diet
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- no effects observed
- Description (incidence and severity):
- no effects observed in crown rump length
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 6 770 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: no effects at 20% (6770 mg/kg), the highest dose tested
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Maternal NOAEL: 4170 mg/kg (10% in diet) based on reduced body weights at 20%
Foetal NOAEL: 6770 mg/kg (20% in diet), highest dose tested - Executive summary:
Xylitol was investigated for embryotoxic and teratogenic action on the rabbit according to the guidelines of the American FDA and of the British CSM. The substance was administered orally to rabbits from the 7thto the 19thday of gestation (day 1 = the first 24 hours after copulation) by incorporation into the diet. Dietary concentrations of 2, 5,10, and 20% xylitol were employed, and further groups of rabbits received diets containing 20% of either sorbitol or sucrose, for comparative purposes. 20% feed admix corresponds to an average daily intake of 6.8-7.8 g/kg bw.
All doses of xylitol as well as sorbitol and sucrose were well tolerated by the pregnant does. The reproductive process was not impaired in any of the experimental groups. The measured parameters (litter size, foetal weight, resorption rate, etc.) were within the normal range and showed no difference between he treated groups and controls which could be attributed to the treatment of xylitol or the other sugars. Detailed examination for skeletal and other abnormalities showed no indications of any embryotoxic or teratogenic effect of xylitol in the rabbit at concentrations up to 20% in the diet. This corresponds to an average daily intake of 6770 mg/kg bodyweight, approximately, during the period of treatment. Weight development during the treatment period was retarded in the does at 6770 mg/kg. The maternal NOAEL is 4170 mg/kg and the developmental NOAEL is 6770 mg/kg, the highest dose tested.
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