Registration Dossier
Registration Dossier
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EC number: 304-661-9 | CAS number: 94277-77-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and OECD guideline compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Hydrogen [tris[[[3-[(2-ethylhexyl)oxy]propyl]amino]sulphonyl]-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
- EC Number:
- 304-661-9
- EC Name:
- Hydrogen [tris[[[3-[(2-ethylhexyl)oxy]propyl]amino]sulphonyl]-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
- Cas Number:
- 94277-77-7
- Molecular formula:
- C65 H84 Cu N11 O12 S4 .C11 H25 N O .H
- IUPAC Name:
- copper(2+) hydrogen 3-[(2-ethylhexyl)oxy]propan-1-amine 14,24,32-tris({[({3-[(2-ethylhexyl)oxy]propyl}amino)oxy]sulfonyl})-2,11,20,29,37,38,39,40-octaazanonacyclo[28.6.1.1³,¹⁰.1¹²,¹⁹.1²¹,²⁸.0⁴,⁹.0¹³,¹⁸.0²²,²⁷.0³¹,³⁶]tetraconta-1,3(40),4,6,8,10,12,14,16,18,20,22,24,26,28(38),29,31,33,35-nonadecaene-37,39-diide-5-sulfonate
- Details on test material:
- - Substance type: blue solid
- Physical state: solid
- Purity: UBCB substance (100%)
- Purity test date: 2014
- Lot/batch No.: 070037P040
- Expiration date of the lot/batch: 01 January 2018
- Stability under test conditions: stable
- Storage condition of test material: at room temperature
- Other: The test substance appeared to be homogeneous.
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 15.9 - 19.3 g
- Housing: all animals in one group were housed in a cage together as a group
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 45 – 65%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2014-06-24 to 2014-07-29
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 5, 10, 25 % (w/w).
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: max 25% in DMF (suspension)
- Irritation: none (blue staining)
- Lymph node proliferation response:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: standard H-Methylthymidine incorporation
- Criteria used to consider a positive response: SI > 3
TREATMENT PREPARATION AND ADMINISTRATION: Each test group of mice was treated by topical (epidermal) application to the dorsal surface
of each ear with test item in dimethylformamide. The application volume, 25 μL/ear/day, was spread over the entire dorsal surface (diameter 8 mm) of each ear once daily for three consecutive days. A further group of mice (control animals) was treated with an equivalent volume of the relevant vehicle alone. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: 1.95 (25%) - 1.74 (10%) - 1.8 (5%)
Any other information on results incl. tables
| Lymph Node Cell Counts after Sacrifice | |||||
| Test item concentration % (w/w) |
Animal No. |
Lymph Node Cell Count x10E06 per animal |
Mean Lymph Node Cell Count x10E06 per animal |
SD | Index (Value Test Group versus Value Control |
| Vehicle Control (DMF) | 1 | 6.21 | 9.7 | 2.3 | 1.00 |
| 2 | 10.16 | ||||
| 3 | 11.23 | ||||
| 4 | 12.12 | ||||
| 5 | 8.70 | ||||
| 5 | 6 | 9.45 | 13.1 | 7.7 | 1.35 |
| 7 | 9.61 | ||||
| 8 | 26.84 | ||||
| 9 | 9.58 | ||||
| 10 | 9.92 | ||||
| 10 | 11 | 10.44 | 11.9 | 2.2 | 1.23 |
| 12 | 9.71 | ||||
| 13 | 15.17 | ||||
| 14 | 13.26 | ||||
| 15 | 11.02 | ||||
| 25 | 16 | 10.99 | 13.9 | 2.7 | 1.43 |
| 17 | 13.37 | ||||
| 18 | 17.81 | ||||
| 19 | 15.12 | ||||
| 20 | 12.14 | ||||
| Ear Weights after Sacrifice | |||||
| Test item concentration % (w/w) |
Animal No. |
Ear weight mg per animal |
Mean Ear weight (mg) | SD | Index (Value Test Group versus Value Control) |
| Vehicle Control (DMF) | 1 | 24.22 | 27.0 | 1.9 | 1.00 |
| 2 | 27.56 | ||||
| 3 | 27.88 | ||||
| 4 | 26.40 | ||||
| 5 | 29.15 | ||||
| 5.0% | 6 | 29.12 | 27.8 | 1.2 | 1.03 |
| 7 | 28.20 | ||||
| 8 | 26.06 | ||||
| 9 | 28.49 | ||||
| 10 | 27.05 | ||||
| 10% | 11 | 25.74 | 26.9 | 1.9 | 1.00 |
| 12 | 24.36 | ||||
| 13 | 29.02 | ||||
| 14 | 28.01 | ||||
| 15 | 27.41 | ||||
| 25% | 16 | 26.33 | 27.2 | 1.6 | 1.01 |
| 17 | 29.49 | ||||
| 18 | 28.08 | ||||
| 19 | 26.31 | ||||
| 20 | 25.71 | ||||
| Lymph Node Weights after Sacrifice | |||||
| Test item concentration % (w/w) |
Animal No. |
Lymph Node weight mg per animal |
Mean Lymph Node weight (mg) | SD | Index (Value Test Group versus Value Control |
| Vehicle Control (DMF) | 6 | 4.89 | 5.6 | 0.7 | 1.00 |
| 7 | 5.32 | ||||
| 8 | 6.29 | ||||
| 9 | 6.36 | ||||
| 10 | 5.14 | ||||
| 5 | 16 | 5.45 | 5.5 | 0.3 | 0.98 |
| 17 | 5.63 | ||||
| 18 | 5.03 | ||||
| 19 | 5.60 | ||||
| 20 | 5.78 | ||||
| 10 | 21 | 6.23 | 6.5 | 1.1 | 1.16 |
| 22 | 5.40 | ||||
| 23 | 8.16 | ||||
| 24 | 7.04 | ||||
| 25 | 5.58 | ||||
| 25 | 26 | 6.71 | 6.4 | 0.8 | 1.14 |
| 27 | 6.39 | ||||
| 28 | 7.27 | ||||
| 29 | 6.50 | ||||
| 30 | 5.13 | ||||
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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