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Diss Factsheets
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EC number: 214-302-7 | CAS number: 1120-24-7
- 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:
- From MAY 1980 to OCT 1980
- 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:
- review article or handbook
- Title:
- SIDS Initial Assessment Report
- Author:
- OECD
- Year:
- 2 006
- Bibliographic source:
- OECD Existing Chemicals Database
Materials and methods
- Principles of method if other than guideline:
- Test for developmental toxicity.
- GLP compliance:
- no
- Remarks:
- This study was conducted prior to adoption of GLP compliance standards. However, it was conducted in accordance with the Japanese Ministry of Health and Welfare Guidelines, and was found to be acceptable by the laboratory´s Quality Assurance Unit
- Limit test:
- no
Test material
- Reference substance name:
- Dodecyldimethylamine oxide
- EC Number:
- 216-700-6
- EC Name:
- Dodecyldimethylamine oxide
- Cas Number:
- 1643-20-5
- Molecular formula:
- C14H31NO
- IUPAC Name:
- dodecyl(dimethyl)amine oxide
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- no data
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Animals were artificially inseminated using pooled semen from New Zealand White bucks.
- Duration of treatment / exposure:
- days 6-18 (inclusive) of gestation
- Frequency of treatment:
- daily
- Duration of test:
- approximately 5 months
- No. of animals per sex per dose:
- 14 female animals per dose group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- no data
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: daily, reported on days 0, 6, 8, 10, 12, 14, 16, 18, 23, 28.
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: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 29
- Organs examined: no data - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: - Fetal examinations:
- - External examinations: Yes
- Soft tissue examinations: No
- Skeletal examinations: Yes: (all)
- Head examinations: No - Statistics:
- Multiple ´t´-test, ´t´-test, Mann-Whitney U-test, Chi-squared test and Fisher´s Exact Probability test (Armitage modification).
- Indices:
- no data
- Historical control data:
- no data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes. Remark: details see below
Details on maternal toxic effects:
Maternal condition was generally unaffected by treatment with the test material; however, maternal bodyweight gain was depressed in all treated groups, although at 40 mg/kg/day terminal bodyweights similar to those of controls were achieved. Three females receiving 80 mg/kg/day and three females receiving 160 mg/kg/day died or were killed in extremis, but no direct involvement of the test substance was apparent. Food intake, when compared with pre-treatment values, was reduced during the second half of the treatment period in groups receiving 40 and 80 mg/kg/day, and from the commencement of treatment in animals receiving 160 mg/kg/day. Water intake was also decreased in all treated groups. Reductions in body weight gain, food intake and water intake did not exceed 10%.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- > 160 mg/kg bw/day (actual dose received)
- 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:
Litter response was unaffected by any treatment with the test material. No adverse effects upon litter responses and development were recorded. No teratogenic responses were observed.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 160 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the test, the maternal animals were generally unaffected by treatment with the test material; however, maternal bodyweight gain was depressed in all treated groups, although at 40 mg/kg/day terminal bodyweights similar to those of controls were achieved. Food intake, when compared with pre-treatment values, was reduced during the second half of the treatment period in groups receiving 40 and 80 mg/kg/day, and from the commencement of treatment in animals receiving 160 mg/kg/day. Water intake was also decreased in all treated groups. Reductions in body weight gain, food intake and water intake did not exceed 10%. The NOAEL for maternal toxicity was established as > 160 mg/kg bw/day
Litter response was unaffected by any treatment with the test material. No adverse effects upon litter responses and development were recorded. No teratogenic responses were observed. The NOAEL for teratogenicity was established as > 160 mg/kg bw/day - Executive summary:
14 New Zealand white rabbits per dose group were exposed to 0, 40, 80 or 160 mg test substance/kg bw/day during days 6 -18 og gestation.
Under the conditions of the test, the maternal animals were generally unaffected by treatment with the test material; however, maternal bodyweight gain was depressed in all treated groups, although at 40 mg/kg/day terminal bodyweights similar to those of controls were achieved. Food intake, when compared with pre-treatment values, was reduced during the second half of the treatment period in groups receiving 40 and 80 mg/kg/day, and from the commencement of treatment in animals receiving 160 mg/kg/day. Water intake was also decreased in all treated groups. Reductions in body weight gain, food intake and water intake did not exceed 10%.
Litter response was unaffected by any treatment with the test material. No adverse effects upon litter responses and development were recorded. No teratogenic responses were observed.
The NOAEL for maternal toxicity was established to be > 160 mg/kg bw/day.
The NOAEL for teratogenicity is > 160 mg/kg bw/day.
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