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Diss Factsheets
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EC number: 211-669-5 | CAS number: 683-10-3
- 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
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Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 days 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)
- Version / remarks:
- The actual details of the guideline followed were not included in the report. From the details given, it is concluded that the OECD method has been followed
- Principles of method if other than guideline:
- 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. 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. On gestation day 20, all surviving females were sacrificed by carbon dioxide inhalation. The uterus was exposed and the lumber 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. 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.
- GLP compliance:
- yes
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:
- (Carboxylatomethyl)hexadecyldimethylammonium
- Test material form:
- liquid
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).
The members of the alkyl betaines category are amphoteric surfactants containing a quaternary ammonium ion and a carboxylic structure. They are referred to as inner salts due to their zwitterionic character. They are all manufactured from natural materials such as vegetable oils and can vary in chain length from C8 to C18. Because of the structural and functional similarities and comparable physico-chemical properties these inner salts and sodium salts, a similar ecotoxicological and toxicological profile can be expected. This substance has been assessed as a suitable surrogate substance for lauryl betaine. The only difference in structure is in the length of the alkyl chain. Cetyl betaine (C16) and Lauryl betaine (C12).
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- ethanol
- Duration of treatment / exposure:
- The rats received the test material daily for 10 days starting on gestation day 6.
- Frequency of treatment:
- The rats received the test material daily for 10 days starting on gestation day 6.
- 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
- Remarks:
- received 50 mg/kg /day of 30.4% active cetyl betaine in 10% ethanol (correction factor of 3.2895 was utilized to achieve proper amount of active ingredient)
- Dose / conc.:
- 150 mg/kg bw/day
- Remarks:
- received 150 mg/kg /day of 30.4% active cetyl betaine in 10% ethanol (correction factor of 3.2895 was utilized to achieve proper amount of active ingredient)
- Dose / conc.:
- 250 mg/kg bw/day
- Remarks:
- received 250 mg/kg /day of 30.4% active cetyl betaine in 10% ethanol (correction factor of 3.2895 was utilized to achieve proper amount of active ingredient)
- Control animals:
- yes
- Details on study design:
- The animals were observed twice daily for signs of toxicity and body weights and feed consumption were recorded on day 0, 6, 9, 12, 16, and 20 of gestation. On gestation day 20, all surviving rats were killed and the uterus and the fetuses were examined and measured for number and location of viable and nonviable fetuses, early and late resorptions, number of total implantations and corpora lutea, fetal body weights, sex, external malformations or developmental variations, and skeletal abnormalities. Microscopic examination of the parental reproductive organs not described.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- No deaths occurred in any dams in the control or treated groups. 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. 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. 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. Necropsy revealed no treatment-related differences among the groups. - Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Inhibition of maternal body weight gain was observed as a dose-related trend during overall gestation and the treatment periods at all dose levels. Weight loss was observed during the first treatment interval in the 150 and 250 mg/kg dose groups. Decreased feed consumption was also observed in all treated groups during the treatment period in a dose-dependent manner. .
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Feed consumption was noted to be inhibited at 250 mg/kg during the overall gestation period, but the mean values for the 50 and 150 mg/kg dose groups were comparable to controls
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Dead fetuses:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed
Effect levels (maternal animals)
- Dose descriptor:
- LOAEC
- 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)
- Fetal body weight changes:
- not specified
- Description (incidence and severity):
- 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.
Effect levels (fetuses)
- Dose descriptor:
- LOAEL
- Effect level:
- 250 mg/kg bw/day
- Based on:
- act. ingr.
- Basis for effect level:
- other: developmental
Fetal abnormalities
- Abnormalities:
- no effects observed
- Description (incidence and severity):
- 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.
Overall developmental toxicity
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 250 mg/kg bw/day
- Treatment related:
- not specified
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
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.
Cetyl betaine has been assessed as a suitable surrogate substance for lauryl betaine. The only difference in structure is in the length of the alkyl chain. Cetyl betaine (C16) and Lauryl betaine (C12).
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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