Registration Dossier
Registration Dossier
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EC number: 413-810-8 | CAS number: 65181-78-4 OP-262; ST 16-1.1; ST 16-1.2; SUBSTANCE S123104
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study, well documented and scientfically acceptable
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- (Buehler-Test)
- GLP compliance:
- not specified
- Type of study:
- Buehler test
Test material
- Reference substance name:
- N,N'-diphenyl-N,N'-bis(3-methylphenyl)-(1,1'-diphenyl)-4,4'-diamine
- EC Number:
- 413-810-8
- EC Name:
- N,N'-diphenyl-N,N'-bis(3-methylphenyl)-(1,1'-diphenyl)-4,4'-diamine
- Cas Number:
- 65181-78-4
- Molecular formula:
- C38H32N2
- IUPAC Name:
- N4,N4'-bis(3-methylphenyl)-N4,N4'-diphenyl-[1,1'-biphenyl]-4,4'-diamine
- Details on test material:
- Name of test material: N4,N4'-Diphenyl-N4,N4'-di-m-tolyl-biphenyl-4,4'-diamine
Xerox chemical 17641-2-1
Physical state: white powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: saline 0,9%
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
0.4 g + 0.5 ml 0.9% - physiol. NaCl-solution
Concentration of test material and vehicle used for each challenge:
0.4 g + 0.5ml 0.9 % - physiol. NaCl-solution
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: saline 0,9%
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
0.4 g + 0.5 ml 0.9% - physiol. NaCl-solution
Concentration of test material and vehicle used for each challenge:
0.4 g + 0.5ml 0.9 % - physiol. NaCl-solution
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.4g with 0.5 ml of 0.9% saline
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.4g with 0.5 ml of 0.9% saline. No with. + reactions: 2.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.4g with 0.5 ml of 0.9% saline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.4g with 0.5 ml of 0.9% saline. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0,9% Sodium chloride
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0,9% Sodium chloride. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0,9% Sodium chloride
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0,9% Sodium chloride. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1% Chloro-2,4-Dinitrobenzene
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1% Chloro-2,4-Dinitrobenzene. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1% Chloro-2,4-Dinitrobenzene
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1% Chloro-2,4-Dinitrobenzene. No with. + reactions: 9.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Evidence of sensitisation of each challenge concentration:
none
Other observations:
In two animals of the test group slight skin irritations
were observed.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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