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EC number: 424-310-4 | CAS number: 178452-66-9 BLUE PE 3811
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From April 22nd to May 23rd, 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.6 (Skin Sensitisation)
- Version / remarks:
- July 31st, 1992
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- July 17th, 1992
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A Guinea Pig Maximization Test was available
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
- Specific details on test material used for the study:
- Stable in water, polyethylene glicol (PEG 400), Freund’s Complete Adjuvant and physiological saline for 48 hours.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Ibm: GOHI
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5%
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- intradermal
- Vehicle:
- other: 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline
- Concentration / amount:
- 5%
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 50%
- Day(s)/duration:
- Day 8 / 48 hours
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 50%
- Day(s)/duration:
- Day 22 / 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Number of animals in pretest: 6
Number of animals in test group of main study: 20
Number of animals in negative control group of main study: 10 - Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole
Results and discussion
- Positive control results:
- The non-irritating test article concentration used for the challenge application of the positive control was 15 % in mineral oil. 95 % of the animals were observed with positive skin reactions after treatment with a non-irritating concentration of 15% in mineral oil. No skin reaction were observed in the negative control group. According to the rating of allergenicity by Magnusson and Kligman, the positive control tested under the test conditions is considered as an extreme sensitizer.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- No skin reaction
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- No skin reaction
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin reaction
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin reaction
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 15%
- No. with + reactions:
- 18
- Total no. in group:
- 19
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 15%
- No. with + reactions:
- 18
- Total no. in group:
- 19
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified within the CLP Regulation (EC1272/2008)
- Conclusions:
- The test substance is not sensitising under the condition of the test.
- Executive summary:
In order to assess the cutaneous allergenic potential of the test substance, the Maximization-test in accordance with OECD Guideline No. 406 was carried out in 30 (20 test and 10 control) albino guinea pigs.
According to the procedures used in this experiment, no differences between the test group and the vehicle-treated controls where evident after epidermal challenge application of the test substance. The test item is considered to possess no skin sensitizing (contact allergenic) potential in albino guinea pigs.
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