Registration Dossier
Registration Dossier
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EC number: 424-310-4 | CAS number: 178452-66-9 BLUE PE 3811
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From April 18th to 25th, 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- July 31st, 1992
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- July 17th, 1992
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-(2,4-bis(4-((5-(4,6-bis(2-aminopropylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-disulfonaphthalen-3-yl)azo)phenylamino)-1,3,5-triazin-6-ylamino)propyldiethylammonium lactate
- EC Number:
- 424-310-4
- EC Name:
- 3-(2,4-bis(4-((5-(4,6-bis(2-aminopropylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-disulfonaphthalen-3-yl)azo)phenylamino)-1,3,5-triazin-6-ylamino)propyldiethylammonium lactate
- Cas Number:
- 178452-66-9
- Molecular formula:
- Hill formula: C63 H83 N27 O17 S4 CAS formula: C60 H77 N27 O14 S4 . C3 H6 O3
- IUPAC Name:
- 2-hydroxypropanoic acid; 5-({4,6-bis[(2-aminopropyl)amino]-1,3,5-triazin-2-yl}amino)-3-{2-[4-({4-[(4-{2-[8-({4,6-bis[(2-aminopropyl)amino]-1,3,5-triazin-2-yl}amino)-1-hydroxy-3,6-disulfonaphthalen-2-yl]diazen-1-yl}phenyl)amino]-6-{[3-(diethylamino)propyl]amino}-1,3,5-triazin-2-yl}amino)phenyl]diazen-1-yl}-4-hydroxynaphthalene-2,7-disulfonic acid
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- test substance was moistened with bi-distilled water before application.
- Controls:
- no
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 hours after the removal of the dressing, guaze patch and test substance.
- Number of animals:
- 3 animals: 1 male, 2 females
- Details on study design:
- The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing by the number of figures.
To classify the irritating potential of the test article, the mean values of erythema/eschar as well as of edema formation were calculated for each individual, using the scores between 24 and 72 hours (EEC Commission Directive 93/21/EEC, April 27th, 1993).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- COLORATION: blue to light blue staining by the test substance of the treated skin was observed.
CORROSION: no irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
MORTALITY: no mortality occured.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified within the CLP Regulation (EC 1272/2008).
- Conclusions:
- Not irritant to skìn.
- Executive summary:
The study procedures described in this report are based on the OECD Guideline 404 adopted July 17th, 1992.
Under the conditions of this experiment, the test item was found to cause blue to light blue staining of the treated skin.
No corrosion was observed at each of the measuring intervals.
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