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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | CAS number: -
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29/03/05 - 27/04/05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Reference substance name:
- N-(3-methacrylamidopropyl)-N,N-dimethyldodecan-1-aminium bromide
- Cas Number:
- 129684-50-0
- Molecular formula:
- C21H43N2O.Br
- IUPAC Name:
- N-(3-methacrylamidopropyl)-N,N-dimethyldodecan-1-aminium bromide
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- other: Albino rat
- Strain:
- other: Crl:CD®(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Body Weight Range: Approximately 170 to 300 grams at initiation of dosing, ± 20% of the mean of previously tested animals.
Approximate Age: Eight to 12 weeks old at initiation of dosing.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test article was dosed undiluted based on its specific gravity. The dose volume was determined by dividing the dose levels of 360, 630, 1120 and 2000 mg/kg (represented as g/kg for the purpose of dose calculations) by the specific gravity (1.0463 g/mL, as determined by WIL Research Laboratories, LLC pharmacy personnel). Individual doses were calculated based on fasted body weights taken just prior to dosing and the dose volumes of 0.34, 0.60, 1.1 and 1.9 mL/kg for the 360, 630, 1120 and 2000 mg/kg groups, respectively.
- Doses:
- 360, 630, 1120 and 2000 mg/kg
- No. of animals per sex per dose:
- Group 1 consisted of two animals, Group 2 consisted of three animals and Groups 3 and 4 consisted of one animal each.
- Control animals:
- no
- Details on study design:
- The acute oral toxicity of Cationic Surfactant DP/CR 2287 was evaluated in this single-dose study in rats. The test article was administered once orally via gavage to four groups of fasted female albino rats at dose levels of 360, 630, 1120 and 2000 mg/kg. Group 1 consisted of two animals, Group 2 consisted of three animals and Groups 3 and 4 consisted of one animal each. The study was conducted using the EPA-provided software package AOT425StatPgm, Version 1.0 (Westat) (Appendix A) using a limit test level of 5.0 g/kg, assumed LD50 of 2000 mg/kg and assumed sigma of 0.25 mg/kg. Dosing was discontinued when AOT425StatPgm indicated that the stopping criteria had been met. Mortality, clinical observations and body weight changes were evaluated over a 14-day observation period. All animals were subjected to a gross necropsy.
- Statistics:
- At the termination of the project, all data will be collected and the acute oral median lethal dose (LD50) will be determined using the EPA-provided statistical program AOT425StatPGM (Westat).
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 360 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 414 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 360 - 630
- Mortality:
- Group 1 = 0
Group 2 = 3
Group 3 = 1
Group 4 = 1 - Clinical signs:
- diarrhoea
- lethargy (hypoactivity)
- other:
- Body weight:
- lower than 10% body weight loss
- Remarks:
- There were no remarkable body weight changes for surviving animals.
- Other findings:
- Macroscopic findings for animals found dead included a distended stomach and yellow matting over the entire ventral surface for one rat each in the 630 mg/kg group.
No macroscopic findings were noted at the scheduled necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD0/rat and LD50/rat was found to be 360 and 414 mg/kg bw, respectively.
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