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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-05-16 to 2002-11-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted in general compliance with U. S. National Institute of Health publication No. 99-4494 and with OECD guideline for testing of chemicals, no. 429 "Skin sensitization: Local lymph node assay", draft document (November 2000)
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
481-170-7
EC Name:
-
Cas Number:
502453-61-4
Molecular formula:
Hill formula: C23H30BrN3O2 CAS formula: C23H30N3O2.Br
IUPAC Name:
dimethyl(3-{[4-(methylamino)-9,10-dioxo-9,10-dihydroanthracen-1-yl]amino}propyl)propylazanium bromide
Constituent 2
Reference substance name:
Dimethyl-(3-(4-methylamino-9,10-dioxo-9,10-dihydro-anthracen -1-ylamino)propyl)propylammonium bromide
IUPAC Name:
Dimethyl-(3-(4-methylamino-9,10-dioxo-9,10-dihydro-anthracen -1-ylamino)propyl)propylammonium bromide
Details on test material:
- Name of test material (as cited in study report): 3-((9,10-Dihydro-9,10-dioxo-4-(methylamino)-1-anthracenyl)amino)-N,N-dimethyl-N-propyl-1- Propanaminium-bromid (Bluequat-bromid)
- Molecular formula (if other than submission substance): C23H30N3O2Br
- Molecular weight (if other than submission substance): 460.42
- Substance type: Pure active substance
- Physical state: Solid
- Analytical purity: See below
- Impurities (identity and concentrations): None
- Composition of test material, percentage of components: See below
- Isomers composition: Not available
- Purity test date: See below
- Lot/batch No.: See below
- Expiration date of the lot/batch: See below
- Stability under test conditions: The substance on storage in dryness and darkness is considered to be stable more than 5 years
- Storage condition of test material: At room temperature, kept away from light and humidity
- Other: None

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa Credo, BP 0109, 69592'Arbresle cedex, France
- Age at study initiation: 9 weeks
- Weight at study initiation: 21 to 26 grams
- Housing: Animals were housed in groups of 5 of the same dose group in plastic cages (265 x 160 x 140 mm)
- Diet (e.g. ad libitum): Mouse pelleted complete diet , ad libitum
- Water (e.g. ad libitum): Softened and filtered (0.2µm) ad libitum
- Acclimation period: 9 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 55+/- 15%
- Air changes (per hr): Minimum 8 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light (artificial)/ 12 hours dark


IN-LIFE DATES: From: 2002-05-16 To: 2002-11-22

Study design: in vivo (LLNA)

Vehicle:
other: Acetone/water (1:1) mixed with olive oil (3 volumes of acetone/water to 1 volume of olive oil)
Concentration:
The test item was prepared as a solution in the vehicle at the following concentration: 1%, 2.5%, 5% and 10% (w/v)

No. of animals per dose:
5 females per dose

Details on study design:
RANGE FINDING TESTS: Not applicable
- Compound solubility: Not applicable
- Irritation: Not applicable
- Lymph node proliferation response: Not applicable


MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA of 3-((9,10-Dihydro-9,10-dioxo-4-(methylamino)-1-anthracenyl)amino)-N,N-dimethyl-N-propyl-1-Propanaminium-bromid (Bluequat-bromid)
- Criteria used to consider a positive response: SI = or > than 3x control


TREATMENT PREPARATION AND ADMINISTRATION: The test item was prepared as a solution in the vehicle at the following concentration: 1%, 2.5%, 5% and 10% (w/v). On day 0, 1 and 2 the animals received 25 µl of one of the test item or vehicle on the the dorsal surface of each ear.
Positive control substance(s):
other: N,N'-bis(4-Aminophenyl)-2,5-diamino-1,4-Benzochinondiimin (Bandrowski-Base)
Statistics:
Not available

Results and discussion

Positive control results:
The positive control groups were included in study 762/014 and are common to studies 762/014, 762/015 and 762/016. Positive control induced a positive response as it elicited at least a 3 fold increase in isotope incorporation relative to the vehicle, with a calculated EC3 value of 0.33%. The mean stimulation indices were 0.9, 0.7, 2.9 and 3.3 at the concentration of 0.001%, 0.01%, 0.1% and 1% respectively.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
Treatment of mice with 3-((9,10-Dihydro-9,10-dioxo-4-(methylamino)-1-anthracenyl)amino)-N,N-dimethyl-N-propyl-1-Propanaminium-bromid (Bluequat-bromid) induced a negative response, as it did not elicit at least 3 fold increase in isotope incorporation relative to the vehicle. The mean stimulation indices were 0.8, 0.6, 0.6 and 0.6 at the concentration of 1%, 2.5%, 5% and 10% respectively.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: The mean DPM values were 805, 674, 580 and 595 at the concentration of 1%, 2.5%, 5% and 10% respectively.The mean DPM value for vehicle is 1040.

Any other information on results incl. tables

Test substance  Dose  Mean DPM H3 Thymidine  Stimulation index
Acetone/water (1:1) mixed with olive oil  Vehicle control 1040   1.00
3-((9,10-Dihydro-9,10-dioxo-4-(methylamino)-1-anthracenyl)amino)-N,N-dimethyl-N-propyl-1 -Propanaminium-bromid (Bluequat-bromid)  1% in vehicle  805  0.8
   2.5%  674  0.6
   5%  580  0.6
   10%  595  0.6
 Positive control      
 Vehicle control   3381  1.00
 N,N'-bis(4-Aminophenyl)-2,5-diamino-1,4-Benzochinondiimin (Bandrowski-Base)  0.001% in DMSO  2995  0.9
   0.01% in DMSO  2363  0.7
   0.1% in DMSO  9725  2.9
   1% in DMSO  11097  3.3

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Conclusions:
3-((9,10-Dihydro-9,10-dioxo-4-(methylamino)-1-anthracenyl)amino)-N,N-dimethyl-N-propyl-1-Propanaminium-bromid (Bluequat-bromid) is not a skin sensitizer.

Executive summary:

The potential of 3-((9,10-Dihydro-9,10-dioxo-4-(methylamino)-1-anthracenyl)amino)-N,N-dimethyl-N-propyl-1-Propanaminium-bromid (Bluequat-bromid) to induce contact hypersensitivity was examined using the Murine local lymph node assay. Groups of 5 female mice in each were treated with 1%, 2.5%, 5% and 10% of test substance in vehicle (Acetone/water (1:1) mixed with olive oil) for 3 daily treatments. One group of mice was treated with vehicle (Acetone/water (1:1) mixed with olive oil). On day 5, all the animals were injected with 250 µl PBS containing 21.1 µCi of H3 methyl thymidine. Auricular lymph nodes were excised and assessed for thymidine uptake.

Treatment of mice with 3-((9,10-Dihydro-9,10-dioxo-4-(methylamino)-1-anthracenyl)amino)- N,N-dimethyl-N-propyl-1-Propanaminium-bromid (Bluequat-bromid) induced a negative response, as it did not elicit at least 3 fold increase in isotope incorporation relative to the vehicle. The mean stimulation indices were 0.8, 0.6, 0.6 and 0.6 at the concentration of 1%, 2.5%, 5% and 10% respectively.