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Diss Factsheets
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EC number: 451-900-9 | CAS number: 894406-76-9
- 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)
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- 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: see 'Remark'
- Remarks:
- - Reliability: GLP study according to EU- and/or OECD-guidelines - Read-across justification: As both source (Didecyldimethylammonium chloride, DDAC) and target chemicals (Didecyldimethylammonium carbonate, DDA carbonate) have identical organic cations with hydrophobic side chains - the only difference is the inorganic anion carbonate or chloride with negligible contribution to the hazard properties- both substances can be predicted to have similar movement and fate characteristics.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD draft. OECD guideline for the testing of chemicals. Skin absorption: in vitro method. Draft supplied to the OECD by ECPA: 17 December 1999.
- Qualifier:
- according to guideline
- Guideline:
- other: OECD draft. OECD guidance document for the conduct of skin absorption studies. Draft supplied to the OECD by ECPA: 17 December 1999.
- Qualifier:
- according to guideline
- Guideline:
- other: COLIPA. Cosmetic ingredients: guidelines for percutaneous absorption/penetration. COLIPA, Brussels, 1995.
- GLP compliance:
- yes
Test material
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material: Didecyldimethylammonium chloride (DDAC)
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14-C
Administration / exposure
- Vehicle:
- water
- Duration of exposure:
- 24 hours
- Doses:
- - Concentration: 1.85 %
- Application rate: 10 µL/cm
- Target dose level: 185 µg/cm - Details on in vitro test system (if applicable):
- - Test system: Human dermatomed skin membranes in vitro
- Method of application: Flow through diffusion cell system
- Application media: Water
- Concentration: 1.85 %
- Receptor fluid: Tissue culture medium with ca. 4 % bovine serum albumin maintained with 5 % CO2 in O2
- Remarks: 14C-DDAC was applied in aqueous solution. Receptor fluid was collected hourly from 0-6h 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
- Absorption in different matrices:
- After 24 hours less than 0.1 % of the 14C-DDAC penetrated human skin. Total absorption was 2.92 %.
- Total recovery:
- See table 1 below.
Percutaneous absorption
- Dose:
- 185 µg/cm
- Parameter:
- percentage
- Absorption:
- 2.92 %
- Remarks on result:
- other: 24
- Remarks:
- Less than 0.1 % of the applied 14C-DDAC 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./cm.
Any other information on results incl. tables
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 14C-DDAC penetrated human skin. Total absorption was 2.92 %.
- Executive summary:
A study was carried out according to OECD draft guideline for the testing of chemicals (1999), OECD draft guidance for the conduct of skin absorption studies (1999) and COLIPA cosmetic ingredients: guidelines for percutaneous absorption/penetration (1995) using the structural analog Didecyldimethylammonium chloride (DDAC). In view of the chemical and structural similarities (the relevant chemical part of both, DDAC and DDACarbonate, under the conditions of this test is the common quaternary ammonium cation Didecyldimethylammonium+), it is considered that the data are adequate for DDACarbonate. 14C-DDAC 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-DDAC 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/cm.
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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