Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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:
1980

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

Constituent 1
Chemical structure
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

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