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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-08-06 To 2002-08-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: As per OECD guideline 404
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:
other: 92/69/EWG, B.4;OECD 404 (1992)
Deviations:
no
GLP compliance:
yes

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): Bluequat-Bromid (3-((9,10-dioxo-4-(methylamino)-1-anthracenyl)amino-N,Ndimethyl-N-propyl-1-propanaminium-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): See below
- Composition of test material, percentage of components: See below
- Isomers composition: See below
- Purity test date: See below
- Lot/batch No.: See below
- Expiration date of the lot/batch: See below
- Stability under test conditions: Not available
- Storage condition of test material: At room temperature in the dark
- Other: None

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan, Horst, the The Netherlands
- Age at study initiation: 6 weeks
- Weight at study initiation: 1.0 Kg
- Housing: Individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56 x 44x 37.5cm)
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (Teklad Global Rabbit diet, code 2030), approx 100 gm per day
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/-3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 artificial fluorescent light

IN-LIFE DATES: From: 2002-08-06 To: 2002-08-16

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: dorsal fur was clipped with electric clipper
Vehicle:
other: The pure substance was moistened woth 0.5ml water to ensure close skin contact
Controls:
no
Amount / concentration applied:
500mg
Duration of treatment / exposure:
4 h
Observation period:
1h, 24, 48 and 72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Dorsal fur was clipped with electric clipper , exposing an area of approximately 150 square centimeters (10 x 15 cm2)
- % coverage: Not availablw
- Type of wrap if used: 0.5 gm of test substance moistened with 0.5 ml of water was applied to the skin of one flank, using a metalline patch of 2x3 cm. The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elestic bandage.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): After removal of dressing the skin was cleaned of residual test substance using water and ethanol
- Time after start of exposure: Four hours after application


SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Max. score:
0
Remarks on result:
other: Max. duration : 0d; max. value at end of observation period : (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period : (related to all animals)
Irritant / corrosive response data:
No irritating response was noted.

Other effects:
Blue staining of the skin of the treated animals was
observed during the study but did not hamper scoring of skin
reactions.

There were no systemic toxic effects.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
The test material Bluequat-Bromid (3-((9,10-dioxo-4-(methylamino)-1-anthracenyl)amino-N,Ndimethyl-N-propyl-1-propanaminium-bromid) is not irritating to the rabbit skin.

Executive summary:

Three rabbits were taken. Dorsal fur of rabbit skin was clipped with electric clipper and was exposed to 0.5 gm of test substance moistened with 0.5 ml of water Observations were taken at 1h, 24, 48 and 72 hours. No positive response was observed. From these observations it can be concluded that the test material Bluequat-Bromid is not irritating to the rabbit skin.

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