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EC number: 245-728-1 | CAS number: 23552-74-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: current guideline; GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
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:
- 3,3'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[N-cyclohexyl-2,4,6-trimethylbenzenesulphonamide]
- EC Number:
- 245-728-1
- EC Name:
- 3,3'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[N-cyclohexyl-2,4,6-trimethylbenzenesulphonamide]
- Cas Number:
- 23552-74-1
- Molecular formula:
- C44H52N4O6S2
- IUPAC Name:
- 3,3'-[(9,10-dioxo-9,10-dihydroanthracene-1,4-diyl)diimino]bis(N-cyclohexyl-2,4,6-trimethylbenzenesulfonamide)
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands B.V. Postbus 6174; NL - 5960 AD Horst / The Netherlands
- Age at study initiation: 8-12 weeks
- Weight at study initiation:
- Housing: single; Makrolon Type I, with wire mesh top
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 30 - 86
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- other: methyl ethyl ketone
- Concentration:
- 6,25 -12,5 -25 % (w/v)
- No. of animals per dose:
- 4
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- positive (SI = 2,29 to 8,44)
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 0,8
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: < 465 per lymph node
Any other information on results incl. tables
Vehicle: methyl-ethyl-ketone
Test item concentration % (w/v)
|
Group |
Measurement DPM |
Calculation |
Result |
||
DPM-BGa)
|
number of lymph nodes
|
DPM per lymph nodeb) |
S.I.
|
|||
--- |
BG I |
0,0 |
--- |
--- |
--- |
--- |
--- |
BG II |
9,0 |
--- |
--- |
--- |
--- |
--- |
CG 1 |
4661,5 |
4657,0 |
8 |
582,1 |
|
6,25 |
TG 2 |
3721,3 |
3716,8 |
8 |
464,6 |
0,8 |
12,5 |
TG 3 |
3290,7 |
3286,2 |
8 |
410,8 |
0,7 |
25 |
TG 4 |
3535,1 |
3530,6 |
8 |
441,3 |
0,8 |
BG = Background (1 ml 5% trichloroacetic acid) in duplicate
CG = Control Group
TG = Test Group
S.I. = Stimulation Index
a)= The mean value was taken from the figures BG I and BG II
b)= Since the lymph nodes of the animals of a dose group were pooled, DPM/node
was determined by dividing the measured value by the number of lymph nodes
pooled
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material did not induce sensitisation raction in mice in an LLNA assay.
- Executive summary:
In the study the test item dissolved in methyl ethyl ketone was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed using test item concentrations of 6.25, 12.5, and 25 %.
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. After the second application reddening of the ears could not be determined since the ear skin of the animals was dyed blue by the test item.
In this study Stimulation Indices (S.I.) of 0.8, 0.7, 0.8 were determined with the test item at concentrations of 6.25, 12.5, and 25 % (w/v) in methyl ethyl ketone, respectively.
The test item was not a skin sensitiser in this assay.
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