Registration Dossier
Registration Dossier
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EC number: 204-155-7 | CAS number: 116-75-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD guideline study without GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- The study was not performed under GLP but the experiments were conducted according to GLP standards in a certified laboratory and the quality of the results is considered equivalent to the results obtained from a GLP compliant study
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1,4-bis(mesitylamino)anthraquinone
- EC Number:
- 204-155-7
- EC Name:
- 1,4-bis(mesitylamino)anthraquinone
- Cas Number:
- 116-75-6
- Molecular formula:
- C32H30N2O2
- IUPAC Name:
- 1,4-bis(mesitylamino)anthraquinone
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: 7 - 12 weeks
- Weight at study initiation: 18.1 - 19.8 grams
- Housing: Single caging. Makrolon Type I, with wire mesh top (EHRET GmbH, D-79302 Emmendingen)
- Bedding: granulated soft wood bedding (Harlan Winkelmann GmbH, D-33178 Borchen)
- Diet: pelleted standard diet, (Harlan Winkelmann GmbH, D-33178 Borchen) (ad libitum):
- Water: tap water, (Gemeindewerke, D-64380 Rossdorf) (ad libitum):
- Acclimation period: Under test conditions after health examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-3°C
- Humidity (%): 30 - 92
- Photoperiod: artificial light 6.00 a.m. - 6.00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0.0, 6.25, 12.5, 25.0 %
- No. of animals per dose:
- 4
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- EC3 = 6.7% (w/v) (in acetone:olive oil (4+1))
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: S.I. 6.25 % (w/v): 2.16 12.5 % (w/v): 1.50 25.0 % (w/v): 1.23
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: DPM per lymph node Control: 565.1 6.25 % (w/v): 1218.6 12.5 % (w/v): 847.0 25.0 % (w/v): 696.6
Any other information on results incl. tables
Test item concentration % (w/v) |
Group |
Measurement DPM |
Calculation |
Result |
||
DPM-BGa) |
number of lymph nodes |
DPM per lymph nodeb) |
S.I. |
|||
--- |
BG I |
30.89 |
--- |
--- |
--- |
--- |
--- |
BG II |
21.80 |
--- |
--- |
--- |
--- |
--- |
1 |
4547.15 |
4520.8 |
8 |
565.1 |
|
6.25 |
2 |
9775.26 |
9748.9 |
8 |
1218.6 |
2.16 |
12.5 |
3 |
6802.58 |
6776.2 |
8 |
847.0 |
1.50 |
25.0 |
4 |
5599.37 |
5573.0 |
8 |
696.6 |
1.23 |
Vehicle: acetone:olive oil (4+1)
BG = Background (1 ml 5% trichloroacetic acid) in duplicate
1 = Control Group
2-4 = 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
The EC3 Value could not be calculated, since all SI´s are below 3.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was not a skin sensitiser in this assay.
- Executive summary:
In the study the test item dissolved in acetone:olive oil (4+1) 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.
In this study Stimulation Indices (S.I.) of 2.16, 1.50, and 1.23 were determined with the test item at concentrations of 6.25, 12.5, and 25 % in acetone:olive oil (4+1), respectively.
The test item was not a skin sensitiser in this assay. The EC3 value could not be calculated, since all S.I. were below 3.
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