Registration Dossier
Registration Dossier
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EC number: 909-092-5 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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)
- Remarks:
- BASF SE Experimental Toxicology and Ecology 67056 Ludwigshafen, Germany
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Reaction mass of 5,12-dihydroquino[2,3-b]acridine-7,14-dione and aluminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2-sulphonate) and dialuminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2,9-disulphonate)
- EC Number:
- 909-092-5
- Molecular formula:
- Unspecified
- IUPAC Name:
- Reaction mass of 5,12-dihydroquino[2,3-b]acridine-7,14-dione and aluminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2-sulphonate) and dialuminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2,9-disulphonate)
- Test material form:
- solid: particulate/powder
- Details on test material:
- Batch 22426
100% UVCB
storage at room temperature
storage stability until 10 Dec 2025
Constituent 1
- Specific details on test material used for the study:
- physical appearance: solid, violet to brown
purity: 100% UVCB
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: xxx
- Age at study initiation: xxweeks
- Weight at study initiation: 19 - 23.5 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:
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 5%, 10% und 30 % (w/w)
- No. of animals per dose:
- 5
- Details on study design:
- 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. 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)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.13
- Test group / Remarks:
- 30%
- Parameter:
- SI
- Value:
- 1.15
- Test group / Remarks:
- 10%
- Parameter:
- SI
- Value:
- 0.73
- Test group / Remarks:
- 5%
- Cellular proliferation data / Observations:
- Body weight development was normal during the treatment and observation phase.
Cell counts are provided in the table below.
Any other information on results incl. tables
Table: Results for 3H-Thymidine incorporation
| DPM / lymph node pair |
S.D. | Stimulation index | |
| vehicle propylene glycol | 324.5 | 122.7 | 1.00 |
| 5% in propylene glycol | 235.6 | 100.8 | 0.73 |
| 10% in propylene glycol | 373.0 | 110.0 | 1.15 |
| 30% in propylene glycol | 367.8 | 207.9 | 1.13 |
Table: Results for Cell counts
| Mean Cell [Counts / lymph node pair] |
S.D. | Stimulation Index |
|
| vehicle propylene glycol | 11'102'400 | 1'680'464 | 1.00 |
| 5% in propylene glycol | 12'016'800 | 2'167'464 | 1.08 |
| 10% in propylene glycol | 12'091'200 | 2'472'639 | 1.09 |
| 30% in propylene glycol | 11'395'200 | 3'676'285 | 1.03 |
Table: Lymph node weight results
| Lymph node weight, Mean [mg] | S.D. | Stimulation index | |
| vehicle propylene glycol | 4.5 | 0.6 | 1.00 |
| 5% in propylene glycol | 5.1 | 0.6 | 1.13 |
| 10% in propylene glycol | 5.5 | 0.7 | 1.21 # |
| 30% in propylene glycol | 5.4 | 0.7 | 1.2# |
# = Statistically significant from control
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- .
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