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Diss Factsheets
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EC number: 446-990-1 | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 29 Feb - 28 Mar 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Comparable to guideline study with acceptable restrictions. The test substance was only administered during organogenesis and not through the entire period of gestation to the day before caesarean section. Body weights were not determined in 3-day intervals during treatment period.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- test substance was only administered during organogenesis and not through the entire period of gestation to the day before caesarean section; body weights were not determined in 3-day intervals during treatment period
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- D-Glucopyranose, oligomeric, C10-16-alkyl glycosides
- EC Number:
- 600-975-8
- Cas Number:
- 110615-47-9
- Molecular formula:
- not applicable (UVCB)
- IUPAC Name:
- D-Glucopyranose, oligomeric, C10-16-alkyl glycosides
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague Dawley, CD
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 8 weeks
- Weight at study initiation: 203 g
- Housing: individually in Makrolon Type M3 cages (EBECO, Castrop-Rauxel, Germany) with standard softwood bedding (ARWI-Center, Düsseldorf, Germany)
- Diet: pelleted Atromin Maintenance Diet 1324 (ALTROMIN GmbH, Lage, Germany), ad libitum
- Water: community tap water (Düsseldorf, Germany), ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 40-66
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: the test substance was prepared daily before administration by dissolving appropriate amounts in water.
VEHICLE
- Concentration in vehicle: 1, 3 and 10% (v/v)
- Amount of vehicle (if gavage): 10 mL/kg bw - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The formulations of test substance were analysed once in a previous study by High Performance liquid chromatography (HPLC). In this study, the determined analytical concentrations of 0.94, 2.88 and 9.23% verified the nominal concentrations of 1, 3 and 10% of the test substance in solution.
- Details on mating procedure:
- - Impregnation procedure: purchased timed pregnant
- Duration of treatment / exposure:
- (P) Females: Day 6-15 of gestation (organogenesis period)
- Frequency of treatment:
- once daily in the morning
- Duration of test:
- 20 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 24 P females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on the results of previous toxicological examinations
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: animals were checked at least twice daily (working days) for clinical signs and mortality.
BODY WEIGHT: Yes
- Time schedule for examinations: body weights were determined on Day 0, 6, 16 and 20
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: all maternal organs with emphasis on uterus - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- 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
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: No - Statistics:
- Mean values and standard deviations were calculated. Statistical analyses at significance levels of 5% and 1% were performed on the following parameters and using the following statistical tests:
- Steel test: implantation sites, embryonic and foetal resorptions, live and dead foetuses
- Fishers exact test (Bonferroni-Holm-corrected): pre- and post-implantation loss, total embryonic deaths, total and malformed foetuses, skeletal parameters
- Dunnett-test based on pooled variance: weights of live foetuses, placenta and uteri - Indices:
- Percentage of implantation sites: (no. of implantations / no. of corpora lutea) * 100
Percentage of pre-implantation loss: [(no. of corpora lutea - no. of implantations) / no. of corpora lutea] * 100
Percentage of post-implantation loss: [(no. of implantations - no. of live foetuses) / no. of implantations] * 100
Percentage of embryonic resorptions: (no. of embryonic resorptions / no. of implantations) * 100
Percentage of foetal resorptions: (no. of foetal resorptions / no. of implantations) * 100
Percentage of total foetuses: (no. of total foetuses / no. of implantations) * 100
Percentage of malformed foetuses: (no. of malformed foetuses / no. of total foetuses) * 100
Percentage of male foetuses: (no. of male foetuses / total no. of live foetuses) * 100
Percentage of female foetuses: (no. of female foetuses / total no. of live foetuses) * 100
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
MORTALITY:
No deaths occurred in dams receiving the vehicle or the test substance at doses of 300 mg/kg bw/d. Due to an application error, test substance-unrelated mortalities were found on Day 11 and 13 each in one animal of the 100 and 1000 mg/kg bw/d test group.
CLINICAL SIGNS:
No substance-related symptoms were observed at any dose level during the study. The animal of the 100 mg/kg bw/d test group found dead on Day 11 showed impeded respiration, lethargy, and a decrease in body weight on Day 10. One animals of the high dose group (1000 mg/kg bw/d) showed impeded respiration on Day 15 and 16 and lethargy on Day 16. However, these findings were not related to treatment.
BODY WEIGHTS:
Maternal body weights were not affected by treatment.
REPRODUCTION DATA:
No substance-related effects on reproduction data were noted compared to controls.
NECROPSY:
At scheduled necropsy, no macroscopic changes were observed between treated and control animals. Incidental findings in two animals either comprised white nodules in the left inguinal region or haematoma in the region of larynx.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
EMBRYOTOXICITY/FETOTOXICITY:
No substance-related differences in pre-and post-implantation loss, mean figures of resorptions, embryonic deaths and total foetuses were observed in treated animals compared to controls.
BODY WEIGHTS:
The weight of live foetuses exhibited not significant differences on a litter or individual basis.
PLACENTA AND UTERUS WEIGHT:
The weight of placenta and uteri including content showed no significant differences between treated and control animals.
SEX RATIOS:
The foetal sex ratio was comparable in all test groups.
EXTERNAL OBSERVATIONS:
No abnormal findings were observed that were considered to be related to treatment. Incidental findings comprised the occurrence of only one placenta for two foetuses in the control group and one foetus with hydrops in the high dose group (1000 mg/kg bw/d).
VISCERAL OBSERVATIONS:
The main figures of visceral variations (hydronephrosis, dilated and waved ureters) were similar compared to controls and not considered to be related to treatment. All other findings except for situs inversus total in the high dose group and enlarged parenchymous organs in the controls were considered to be incidental.
SKELETAL EXAMINATION:
The figures of skeletal variations (absent or malformed cervical vertebrae arches, luxation and malposition of the mandible) in all test groups were within the range of normal spontaneous findings. Retarded ossification was found in all treatment groups and was similar to the level of skeletal ossification in the control group. The isolated statistically significant difference in the figure “14 ribs short/rudimentary bilateral” in the high dose group (100 mg/kg bw/d) was considered to be incidental and not related to treatment, since no dose-response relationship was apparent.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no treatment related
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- According to the study described, the test substance does not reveal any embryotoxic or teratogenic potential.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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