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EC number: 269-915-2 | CAS number: 68390-97-6 This substance is identified by SDA Substance Name: C16-C18 alkyl dimethyl amine and SDA Reporting Number: 19-040-00.
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From NOV 1979 to NOV 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- SIDS Initial Assessment Report for SIAM 22
- Author:
- OECD
- Year:
- 2 006
- Bibliographic source:
- OECD Existing Chemicals Database
- Report date:
- 2006
Materials and methods
- Principles of method if other than guideline:
- Two-generation study in rats
- GLP compliance:
- no
- Remarks:
- This study was conducted prior to the 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:
- rat
- Strain:
- other: Charles River CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on mating procedure:
- no data
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- approximately 4 months
- Frequency of treatment:
- daily
- Details on study schedule:
- no data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 750, 1500, 3000 ppm for 6.5 weeks, doses were reduced to 0, 188, 375 and 750 ppm. 750 ppm corresponds to 40 mg /kg / day, 375 ppm corresponds to 20 mg/ kg / day, 188 ppm corresponds to 11 mg/ kg / day
Basis:
nominal in diet
- No. of animals per sex per dose:
- 15 males, 30 females
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose calculation according to SIDS.
- Positive control:
- no data
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: no data
BODY WEIGHT: Yes
- Time schedule for examinations:
F0:males: weekly, females: weekly until mating, then weighed an days 1, 3, 7, 14, 21 post coitum and on days 1, 4, 11, 18 and 25 post partum
F1: days 1, 4, 11, 18, 25 post partum
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: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day: no
- Organs examined: adrenals, all tumors, brain, bone marrow, cecum, duodenum, epididymides, eye and optic nerve, heart, ileum, kidneys, liver, lungs, lymph nodes, mammary glands, esophagus, ovaries, pancreas, pituitary, prostate, seminal vesicles, spleen, stomach, testes, thymus, thyroid, urinary bladder and uterus - Oestrous cyclicity (parental animals):
- no data
- Sperm parameters (parental animals):
- no data
- Statistics:
- Multiple t-test; Mann-Whitney U-test; x2-test; or Fisher´s Exact Probability test.
- Reproductive indices:
- no data
- Offspring viability indices:
- Details for first generation (F1) and second generation (F2)given.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- slight reductions in weight gain of both parents and offspring, but was without adverse effect on their mating performance and fertility
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- slight reductions in weight gain of both parents and offspring, but was without adverse effect on their mating performance and fertility
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- > 40 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: slight reduction in weight gain of both parents. Reductions in weight gain did not exceed 10%. The general condition of the animals throughout the study was unaffected by treatment.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- mortality observed, treatment-related
- Description (incidence and severity):
- There was a slight reduction in the number of F2 offspring born at the 750 ppm level.
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- > 40 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Mating performance, fertility, and conception rate were not affected by treatment in either generation. Gestation and parturition proceeded normally.
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- > 40 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the test the NOAEL for the parent generation was established as >40 mg/kg bw/day. NOAEL values for F1 and F2 offsprings were >40 mg/kg bw/day as well. Slight reduction in weight gain of both parents was observed. Reductions in weight gain did not exceed 10%. The general condition of the animals throughout the study was unaffected by the treatment. Mating performance, fertility, and conception rate were not affected by treatment in either generation. Gestation and parturition proceeded normally. There was a slight reduction in the number of F2 offsprings born at the 750 ppm level, however there were no adverse effects of treatment on litter size at birth, live birth index and birth weight in either generation. Therefore, this was not considered an adverse effect.
- Executive summary:
15 Male and 30 female Charles River CD rats per dose group were exposed to feed containing 0, 750, 1500, 3000 ppm test substance for 6.5 weeks, doses then were reduced to 0, 188, 375 and 750 ppm. This corresonds to: 0, 11, 20 and 40 mg/kg / day ad libitum for 101 days before mating, throughout mating, gestation and lactation.
Slight reduction in weight gain of both parents was observed. Reductions in weight gain did not exceed 10%. The general condition of the animals throughout the study was unaffected by the treatment. Mating performance, fertility, and conception rate were not affected by treatment in either generation. Gestation and parturition proceeded normally. There was a slight reduction in the number of F2 offsprings born at the 750 ppm level, however there were no adverse effects of treatment on litter size at birth, live birth index and birth weight in either generation. Therefore, this was not considered an adverse effect.
Under the conditions of the test the NOAEL for the parent generation was established as >40 mg/kg bw/day. NOAEL values for F1 and F2 offsprings were >40 mg/kg bw/day as well.
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