Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 481-170-7 | CAS number: 502453-61-4
Skin irritation / corrosion
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:
- 2 002
- 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
- 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
- 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
Constituent 1
Constituent 2
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
