Registration Dossier
Registration Dossier
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EC number: 223-339-8 | CAS number: 3844-45-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- no data on postive controls, report does not contain all details normally required.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- Information on postive control treatments not included.
- GLP compliance:
- no
- Type of study:
- mouse local lymph node assay (LLNA)
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
- Test material form:
- solid: particulate/powder
- Details on test material:
- - appearance: blue powder
- storage conditios: at room temperature
Constituent 1
- Specific details on test material used for the study:
- -Name in report: PURICOLOR BLEU ABL9
- Other name: VIBRACOLOR Blue ABL9
-Batch no: 001641D0A
-appearance: blue powder
-date of receipt: 15 May 2003
-storage conditios: at room temperature
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Details in Study plan No. 25910 TSS, not available in report
IN-LIFE DATES: From: 2003-05-21 To:2003-05-26
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol/water (1:1)
- Concentration:
- 5, 10 and 25%
- No. of animals per dose:
- 4
- Details on study design:
- Results of a range-finding test were not reported.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Control: 1 5% : 1.69 10%: 1.18 25%: 1.08
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see figure
Any other information on results incl. tables
No clinical signs, no mortality and no noteworthy increase in ear thickness were observed during the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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.
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