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Diss Factsheets
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EC number: 947-036-1 | 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
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:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- not specified
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- (carboxylatomethyl)hexadecyldimethylammonium
- EC Number:
- 211-748-4
- EC Name:
- (carboxylatomethyl)hexadecyldimethylammonium
- Cas Number:
- 693-33-4
- Molecular formula:
- C20H41NO2
- IUPAC Name:
- [hexadecyl(dimethyl)ammonio]acetate
Constituent 1
- Specific details on test material used for the study:
- 30.4% active cetyl betaine in 10% ethanol (correction factor of 3.2895 was utilized to achieve proper amount of active ingredient)
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- ethanol
- Details on exposure:
- Dosage calculations were based on a 100% active component. Since the test substance was received with a 30.4% active moiety in 10% ethanol, a correction factor of 3.2895 was utilized to achieve the proper amount of active ingredient. The control group received ethanol in deionized water at a volume of 5 ml/kg. The amount of ethanol the control group received was equal to the amount given to the 250 mg/kg/day group. The stock solution was prepared daily. Dose volume was 5 ml/kg body weight, adjusted for body weight on days of gestation 6, 9 and 12.
- Duration of treatment / exposure:
- The rats received the test material daily for 10 days starting on gestation day 6.
- Frequency of treatment:
- daily
- Duration of test:
- Total duration was 20 days.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 50 mg/kg bw/day
- Dose / conc.:
- 150 mg/kg bw/day
- Dose / conc.:
- 250 mg/kg bw/day
- Control animals:
- yes
Examinations
- Maternal examinations:
- Animals were observed twice daily for signs of toxicity. Body weights were recorded on day 0, 6, 9, 12, 16 and 20 of gestation. Food consumption intervals were identical to the body weight intervals.
- Ovaries and uterine content:
- On gestation day 20, all surviving females were sacrificed by carbon dioxide inhalation. The uterus was exposed and the number and location of viable and nonviable fetuses, early and late resorptions and the number of total implantations and corpora lutea were recorded. The uterus was then excised and the fetuses were removed.
- Fetal examinations:
- Live fetuses were individually weighed, sexed, tagged and examined for external malformations or developmental variations. Approximately one half of the fetuses for each litter were fixed in Bouin's solution to examine the viscera and brain by Wilson's sectioning technique. The remaining one-half of the fetuses were processed (alizarin red staining) and examined for skeletal abnormalities.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Clinical observations noted in animals dosed at 250 mg/kg/day included stained and matted fur (noted primarily on the limbs, neck, ventral thorax and facial area), excessive salivation, respiratory rales, diarrhea, decreased activity, hypothermia, lacrimation, labored breathing and wheezing. Similar observations were evident at 150 mg/kg/day group, stained and mattered fur and respiratory rales were the predominant observations
- Mortality:
- no mortality observed
- Description (incidence):
- No deaths occurred in any dams in the control or treated groups.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- A dose-related trend of maternal body weight inhibition was noted during both the overall gestation (days 0 - 20) and treatment (days 6 - 15) periods at all dose levels. Weight loss was observed during the first treatment interval (days 6 - 9) at 150 and 250 mg/kg/day.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced food intake was also noted among all treated groups during the treatment period in an apparent dose-related trend. In addition, consumption was inhibited at 250 mg/kg/day during the overall gestation interval but mean values of the 50 and 150 mg/kg/day groups were comparable to controls.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Necropsy revealed no treatment-related differences among the groups.
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
Effect levels (maternal animals)
- Dose descriptor:
- LOAEL
- Effect level:
- 50 mg/kg bw/day
- Based on:
- act. ingr.
- Basis for effect level:
- body weight and weight gain
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 250 mg/kg bw/day
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: developmental effects
- Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: developmental effects
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 250 mg/kg bw/day
- Treatment related:
- not specified
- Relation to maternal toxicity:
- developmental effects as a secondary non-specific consequence of maternal toxicity effects
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Any other information on results incl. tables
In the fetuses, no significant differences between the control and treated groups were evident with respect to number of corpora lutea, total implantations, post implantation loss, viable fetuses, and fetal body weights. Fetal malformation in the treated groups was not significantly different from that of the controls. Reduced or absent ossification of the skull, sternebrae #5 and/or #6, and other sternebrae occurred more frequently in the 250 mg/kg dose group. These effects were considered to be biologically significant as they were observed in conjunction with reduced maternal body weight gains.
No other developmental variations were noted.
Applicant's summary and conclusion
- Conclusions:
- In oral reproductive and developmental toxicity studies of cetyl betaine in rats, the LOAEL for the dams was 50 mg/kg due to decreased body weight gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg.
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