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EC number: 619-057-3 | CAS number: 94667-33-1
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August - September 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Proprietary GLP guideline-compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline for the testing of chemicals. Skin absorption: in vitro method. 1999. (Draft)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: COLIPA. Cosmetic ingredients: guidelines for percutaneous absorption/penetration. 1995
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N,N-Didecyl-N,N-dimethylammonium Chloride
- IUPAC Name:
- N,N-Didecyl-N,N-dimethylammonium Chloride
- Reference substance name:
- DDAC
- IUPAC Name:
- DDAC
- Reference substance name:
- 1-Decanaminium, N-decyl-N,N-dimethyl-, chloride
- IUPAC Name:
- 1-Decanaminium, N-decyl-N,N-dimethyl-, chloride
- Reference substance name:
- Didecyldimethylammonium chloride
- EC Number:
- 230-525-2
- EC Name:
- Didecyldimethylammonium chloride
- Cas Number:
- 7173-51-5
- Molecular formula:
- C22 H48 N.Cl
- IUPAC Name:
- N-decyl-N,N-dimethyldecan-1-aminium chloride
- Reference substance name:
- Bardac 2280
- IUPAC Name:
- Bardac 2280
- Details on test material:
- Bardac 2280: Didecyldimethylammonium Chloride in aqueous/alcohol solution (DDAC; CAS RN 7173-51-5), described as a clear, yellow liquid.
The non-radiolabelled substance is hydrolytically and photolytically stable under the conditions of this study and has been shown to be stable in aqueous, alcohol and alcohol/aqueous solutions for extended periods, e.g. at least seven years under standard laboratory conditions
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
- Radiolabelling:
- yes
Administration / exposure
- Details on in vitro test system (if applicable):
- Human dermatomed skin membranes were tested in vitro. Human breast and abdominal full thickness skin samples were obtained from the Plastic Surgery Unit at a UK hospital. The test substance was applied in water at a concentration of 1.85% (target dose level 185 µg/cm²). The tissue culture medium with ca 4% bovine serum albumin maintained with 5% CO2 in O2.
14C-DDAC was applied in aqueous solution at a rate of 10 µl/cm². Receptor fluid was collected hourly from 0h-6h and every other hour from 6-24 h post-dose. At 24 h post-dose, the underside of the skin sample was washed with receptor fluid. The skin surface was washed with 2% soap solution and dried with tissue swabs. The tissue swabs were analysed by combustion. The stratum corneum was removed by successive tape strips. These were extracted with methanol:chloroform (2:1 v/v). The non-dose site skin was collected to determine lateral diffusion through the stratum corneum. The dose site skin was divided into dermis and epidermis by heat separation, then solubilised in Soluene-350. Unabsorbed material was the sum of the skin wash, cell wash, tissue swabs, stratum corneum, cling film and epidermis. Penetration was the sum of receptor rinse and 0-24 h receptor fluid. Dermal delivery was the sum of the dermis and non-dose site skin. Total absorbed material was the sum of dermal delivery and penetration.
Results and discussion
- Signs and symptoms of toxicity:
- not examined
- Remarks:
- : in vitro study
- Dermal irritation:
- not examined
- Remarks:
- : in vitro study
- Absorption in different matrices:
- Not investigated
- Total recovery:
- >99%
Percutaneous absorption
- Key result
- Time point:
- 24 h
- Dose:
- 1.85%
- Parameter:
- percentage
- Absorption:
- 2.92 %
- Remarks on result:
- other: 1.85% concentration in water
- Conversion factor human vs. animal skin:
- Not applicable
Any other information on results incl. tables
Less than 0.1% of applied 14C-Didecyldimethylammonium Chloride penetrated the human skin. 2.92% 14C-Didecyldimethylammonium Chloride was absorbed into the skin over 24 hours. 96.25% was not absorbed. Cumulative flux value = 0.11 µg equiv/cm².
Table 1. Mean % recovery after 24 hours
Commodities analysed |
Mean recovery (% of applied dose) |
Skin wash |
44.45 |
Cell wash |
3.38 |
Swab |
28.14 |
Cling film |
0.05 |
Stratum corneum |
13.75 |
Epidermis (dose site) |
6.49 |
Dermis (dose site) |
2.67 |
Non-dose site skin |
0.18 |
Receptor fluid |
0.06 |
Receptor rinse |
0.00 |
Cumulative Results
|
|
Total penetrated |
0.06 |
Dermal delivery |
2.85 |
Total unabsorbed |
96.25 |
Total absorbed |
2.92 |
Total recovery |
99.16 |
Applicant's summary and conclusion
- Conclusions:
- Less than 0.1% of the applied 14C-Didecyldimethylammonium Chloride dose penetrated human skin. 2.92% of the applied dose was absorbed into the skin. 96.25% was not absorbed. The cumulative flux value was 0.11 µg equiv/cm².
- Executive summary:
14C-Didecyldimethylammonium Chloride was applied, in an aqueous formulation, to human skin samples using a flow through diffusion cell system. Receptor fluid was collected hourly from 0-6 h and every 2 h from 6-24 h post-dose. After 24 hours the underside of the sample was washed with receptor fluid. The upper side was washed with 2% soap solution and dried with tissue swabs. The stratum corneum was removed with tape strips. The dose site skin was separated into epidermis and dermis, then solubilised. The non-dose site skin was collected. The amount of radioactivity in each commodity was determined.
Less than 0.1% of the applied 14C-Didecyldimethylammonium Chloride dose penetrated human skin. 2.92% of the applied dose was absorbed into the skin. 96.25% was not absorbed. The cumulative flux value was 0.11 µg equiv/cm².
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