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EC number: 226-901-0 | CAS number: 5538-94-3
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not specified.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Dimethyldioctylammonium chloride
- EC Number:
- 226-901-0
- EC Name:
- Dimethyldioctylammonium chloride
- Cas Number:
- 5538-94-3
- Molecular formula:
- C18H40NCl
- IUPAC Name:
- dimethyldioctylazanium chloride
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Lot numbers:
Bardac-20: B35307 (25%)
Bardac-LF: B3414 (50%)
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Adult female rats were mated with young adult males and detection of the vaginal sperm plug was considered to occur on day 0 of gestation.
- Duration of treatment / exposure:
- GD 6 to 15
- Frequency of treatment:
- Once daily.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 10 mg/kg bw/day (nominal)
- Dose / conc.:
- 25 mg/kg bw/day (nominal)
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Bardac-20:
10 mg/kg bw/day - 25 females
25 and 50 mg/kg bw/day - 24 females
Bardac-LF:
10 mg/kg bw/day - 26 females
25 mg/kg bw/day - 23 females
50 mg/kg bw/day - 26 females - Control animals:
- yes, concurrent vehicle
- other: Aspirin (250 mg/kg bw/day)
Examinations
- Maternal examinations:
- Body weights were recorded on days 0, 6, 11, 15 and 20 of gestation. All animals were observed daily for appearance and behaviour with particular attention to food consumption and weight, in order to rule out any abnormalities which may have occurred as a result of anorexic effects.
- Ovaries and uterine content:
- Uterine contentts were examined and the number of implantation sites for each uterine horn were recorded. Number of live pups, dead pups and resorption sies were also recorded. The weight of each pup and number of corpora lutea was recorded.
- Fetal examinations:
- The urogenital tract was examined for signs of gross abnormality. One third of the pups in each litter were randomly chosen and fixed in Bouin's solution and these animals were examined for soft tissue abnormalities. All pups showing any gross abnormality were included in this preparation.
- Statistics:
- Incidence of occurrence ratios of treated groups were compared with the ratio for the control group using confidence Belts for Proportions (confidence coefficient of 0.95). Fetus weights were evaluated by analyses of variance and compared to the control value sing Scheffe's test.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- not specified
- Total litter losses by resorption:
- effects observed, non-treatment-related
- Early or late resorptions:
- not specified
- Changes in pregnancy duration:
- not specified
- 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 - Changes in number of pregnant:
- not specified
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- number of abortions
- total litter losses by resorption
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not specified - Reduction in number of live offspring:
- not specified
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The most common abnormalities were hemorrhagic thorax and abdomen and gastroschisis. The incidence of accurrence was no greater in substance ttreated groups than in the controls.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- external malformations
- skeletal malformations
- visceral malformations
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
- Lowest effective dose / conc.:
- 50 mg/kg bw/day
Applicant's summary and conclusion
- Conclusions:
- No teratological findings could be ascribed to the substances employed at doses up to 50 mg/kg bw/day in rats when dosed during GD 6 to 15.
- Executive summary:
The substance was administered to pregnant rats for 10 days at doses of 10, 25 and 50 mg/kg bw/day. There were no deleterious effects on gestation, but the substances did cause more dams to resorb one or more fetuses at the 50 mg/kg bw/day dose level. No teratological findings could be ascribed to the substances employed at doses up to 50 mg/kg bw/day in rats when dosed during GD 6 to 15.
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