Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 947-726-2 | CAS number: -
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study predated GLP but followed accepted scientific standards at the time of performance.
Data source
Reference
- Reference Type:
- publication
- Title:
- Metabolism of cutaneously applied surfactants
- Author:
- Drotman RB
- Year:
- 1 977
- Bibliographic source:
- Cutan. toxic., 3, 95-109
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The labeled material was applied to the skin of experimental animals. Urine, feces and carbon dioxide were collected at intervals for a predetermined period of time and finally the excess of substance was washed from the application site and the experimental animals were sacrificed. The excreta, skin washings, various organs and especially the skin at the application site were then assayed for radioactivity. When it was appropriate, biotransformation products were isolated and identified.
- GLP compliance:
- no
Test material
- Reference substance name:
- Dimethyldioctadecylammonium chloride
- EC Number:
- 203-508-2
- EC Name:
- Dimethyldioctadecylammonium chloride
- Cas Number:
- 107-64-2
- Molecular formula:
- C38H80N.Cl
- IUPAC Name:
- N,N-dimethyl-N-octadecyloctadecan-1-aminium chloride
- Reference substance name:
- 1-Octadecanaminium,N,N-dimethyl-N-octadecyl chloride
- IUPAC Name:
- 1-Octadecanaminium,N,N-dimethyl-N-octadecyl chloride
- Reference substance name:
- Dioctadecyldimethylammonium chloride
- IUPAC Name:
- Dioctadecyldimethylammonium chloride
- Details on test material:
- - Name of test material (as cited in study report):Dioctadecyl dimethyl[1- 14C] ammonium chloride
- Specific activity (if radiolabelling): 30 µCi
- Locations of the label (if radiolabelling): First carbon of one alkyl group
No other data available
Constituent 1
Constituent 2
Constituent 3
- Radiolabelling:
- yes
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data available
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 72 h (collection period)
- Doses:
- - Nominal doses: 10 mg (corresponding to 30 µCi) over a 5 - 8 cm area on the back of the rabbits
- No. of animals per group:
- one group of 4 rabbits
- Control animals:
- no
- Details on study design:
- TEST SITE
- Area of exposure: back of the animal
- % coverage: 5- 8 cm2
- The rabbits were restrained for 72 hours so they could not lick the material from thair backs or rub against their cages.
Results and discussion
- Signs and symptoms of toxicity:
- not specified
- Dermal irritation:
- not specified
- Absorption in different matrices:
- Administered radioactivity detected over a 72 hour-period expressed as mean +/- SEM (n=4)
- Skin test site: 88 ± 2.3%
- Skin, untreated site: 0.2% ± 0.1
- Urine: 0.15% ± 0.0
- Faeces: 0.16% ± 0.0
- Expired air: 0.27% ± 0.0
- Cage wash + cage wipe: 0.29% ± 0.0 - Total recovery:
- - Total recovery: 89 ± 2.4 expressed as mean +/- SEM (n=4)
Percutaneous absorption
- Dose:
- 10 mg
- Parameter:
- percentage
- Absorption:
- < 1 %
- Remarks on result:
- other: 72 hours
- Remarks:
- Only traces of administered radioactivity detected over a 72 h period. Dermal absorption of DODMAC considered to be very low.
Applicant's summary and conclusion
- Conclusions:
- The dermal absorption of the Dioctadecyldimethylammonium chloride was very low.
- Executive summary:
After dermal administration of 10 mg (≈ 30μCi) 14C-labelled test substance to the back of each of four rabbits over a 5 x 8 cm area most of the radioactivity remained at the site of application (88 ± 2.3%). Only traces of administered radioactivity were detected over a 72 h-period in urine (0.15 %), faeces (0.16 %), exhaled carbon dioxide (0.27 %), other skin (0.2%) and cage wash (0.3%).
Based hereupon, the dermal absorption and the concentration of Dioctadecyldimethylammonium chloride in the skin can be assumed to be very low.
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.
