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Toxicological information

Skin sensitisation

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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:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
(Buehler-Test)
GLP compliance:
not specified
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 group
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 group
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