Registration Dossier
Registration Dossier
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EC number: 223-339-8 | CAS number: 3844-45-9
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draft OECD Guideline (1996)
- Principles of method if other than guideline:
- Percutaneous absorption in vitro (400 – 900 μm thickness skin from porcine ears)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)]amino]-2'-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt
- EC Number:
- 223-339-8
- EC Name:
- Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)]amino]-2'-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt
- Cas Number:
- 3844-45-9
- Molecular formula:
- C37 H34 N2 Na2 O9 S3
- IUPAC Name:
- disodium 2-({4-[ethyl(3-sulfonatobenzyl)amino]phenyl}{4-[ethyl(3-sulfonatobenzyl)iminio]cyclohexa-2,5-dien-1-ylidene}methyl)benzenesulfonate
- Details on test material:
- FD&C Blue 1 (CI 42090) (experiment I) and formulation with SC Hair
Colour Gel – containing 0.5% FD&C Blue 1 (experiment II)
Batch no 0789AG (colour) and C1 L371 1 (formulation)
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 0789AG (color) and C1 L371 1 (formulation)
- Purity of color: certified color content 88%
Results and discussion
- Total recovery:
- The mean recovery was 93.3% ± 4.05% (SD) in experiment I, and 115,2% ± 6.43% (SD) in experiment II.
Percutaneous absorption
- Time point:
- 24 h
- Dose:
- 5 mg
- Remarks on result:
- other: No absorption observed
Any other information on results incl. tables
Any measurable permeation through skin was not detected (Limit of detection: 5.5 - 5.7 μg/cm2 in
the two experiments, equivalent to 0.09-0.12% of the applied total amount.)
Applicant's summary and conclusion
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.
