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Diss Factsheets
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EC number: 203-943-8 | CAS number: 112-18-5
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- chronic toxicity: dermal
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to guidelines/standards. Justification for read-across see chemical safety report chapter 1.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Toxicological Evaluation of Commercial Alkyldimethylamine oxides: Two-Year Chronic Feeding and Dermal Studies
- Author:
- Cardin, C.W.; Domeyer, B.E. and Bjorkquist, L.
- Year:
- 1 985
- Bibliographic source:
- Fundamental and Applied Toxicology 5, 869-878
- Reference Type:
- secondary source
- 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
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- GLP compliance:
- no
- Remarks:
- original study performed in 1979, prior to the adoption of GLP compliance standards. However, it was reviewed and found acceptable by the laboratory´s Quality Assurance Department in accordance with US FDA´s GLP Regulation of June 20, 1979
- Limit test:
- no
Test material
- Reference substance name:
- Amines, C10-16-alkyldimethyl, N-oxides
- EC Number:
- 274-687-2
- EC Name:
- Amines, C10-16-alkyldimethyl, N-oxides
- Cas Number:
- 70592-80-2
- IUPAC Name:
- dimethyl(tridecyl)amine oxide
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding laboratories Inc., Portage, Michigan, USA
- Age at study initiation: weanling animals
- Weight at study initiation: 16-20 g
- Housing: individually
- Diet: Zeigler NIH-07 diet, ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-26
- Humidity (%): 40-65
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- water
- Details on exposure:
- TEST SITE
- Area of exposure: 2 x 3 cm, applied to clipped skin
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Constant volume used: yes - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- not indicated
- Duration of treatment / exposure:
- 104 weeks
- Frequency of treatment:
- once daily, three times per week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.05, 0.13, 0.26 corresponds to average daily doses of 0, 1.1, 2.8 or 5.6 mg/kg bw/day
Basis:
other: %
- No. of animals per sex per dose:
- 75
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Doses were selected based on a 13 week study in which the high dose caused epidermal proliferative changes.
- Dose calculation according to SIDS. - Positive control:
- none
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: each treatment period
DERMAL IRRITATION (if dermal study): Yes
- Time schedule: no data
BODY WEIGHT: Yes
- Time schedule for examinations: weekly during the first 13 weeks of the study and monthly thereafter.
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: No data
CLINICAL CHEMISTRY: No data
URINALYSIS: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Statistical evaluations were performed by one-way analysis of variance. Treated groups were compared against the control by least significant difference test, provided there was homogeneity of variances by the Bartlett´s test. In the case of heterogeneity of variances, group comparisons were performed ba Cochan´s modified t-test and Wilcoxon´s nonparametric two sample sum test. Whenever permitted, the non-parametric test was performed for group comparisons in the event of heterogeneity of variances. A linear regression on doses was performed which included F-tests for regression and lack of fit. Group comparisons were performed at a 5 % two- sided risk level.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- details see below
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Males in the high dose group had decreased overall survival. In contrast, females at the mid-dose group had increased survival rates compared to controls. These random values were within historical variability of controls and were not considered treatment related.
There were no statistical differences in group average body weights, organ weights, and organ to body weight ratios among treated animals compared to controls.
Compound related skin irritation (diffuse acanthosis and hyperkeratosis) was observed microscopically in the high dose group of mice. No skin tumors were observed in any group. There were no compound-related skin or systemic neoplasms in the study. There was no evidence of a carcinogenic response after chronic percutaneous administration.
HISTOPATHOLOGY:
Tissues examined microscopically included skin, mandibular lymph nodes, mammary gland, salivary gland, thigh muscle, sciatic nerve, bone marrow, costochondral junction, thymus, larynx, trachea, lungs and bronchi, heart, thyroid, parathyroid, esophagus, stomach, duodenum, jejunum, ileum, colon, mesenteric lymph nodes, liver, gallbladder, pancreas, spleen, kidneys, adrenals, bladder, seminal vesicles, prostate, testes or ovaries and uterus, eyes, brain, pituitary, and spinal cord.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 0.26 other: %
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: There were no statistical differences in group average body weights, organ weights, and organ to body weight ratios among treated animals compared to controls.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the test, the test substance does not show any effects on male and female CD-1 mice after dermal exposure for 104 weeks. An exeption is the compound related skin irritation (diffuse acanthosis and hyperkeratosis observed microscopically in the high dose group of mice. The NOAEL for chronic repeated dose toxicity after dermal application in mice is >= 0.26 % (5.6 mg/kg bw/day).
- Executive summary:
Male and female CD-1 mice were exposed dermal against 0, 0.05, 0.13 or 0.26 % test substance for 104 wk. This corresponds to an average daily doses of 0, 1.1, 2.8 or 5.6 mg/kg bw/day. There were no statistical differences in group average body weights, organ weights, and organ to body weight ratios among treated animals compared to controls. Compound related No skin tumors were observed in any group. There were no compound-related skin or systemic neoplasms in the study. The NOAEL for chronic repeated dose toxicity after dermal application in mice is >= 0.26 % (5.6 mg/kg bw/day).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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