Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation
Adequacy of study:
other information

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 96/54/EWG, B.6
GLP compliance:
yes

In vivo test system

Test animals

Species:
other: gpg, Hsd Poc:DH (Harlan)

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) intradermal: 5 % in Sesamöl

b) dermal: 100 %

"ENGLISH"

a) intradermally: 5 % in sesame oil

b) dermally: 100 %

Concentration of test material and vehicle used for each challenge:
100 %
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) intradermal: 5 % in Sesamöl

b) dermal: 100 %

"ENGLISH"

a) intradermally: 5 % in sesame oil

b) dermally: 100 %

Concentration of test material and vehicle used for each challenge:
100 %
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 100 %

Signs of irritation during induction:
Nach der intradermalen Injektion von Freund's Adjunvant mit
und ohne Testsubstanz zeigten sich sowohl schwere Erytheme
und Oedeme als auch Verhaertungen und Verkrustungen. Die
Behandlung mit der Loesung aus Testsubstanz und Sesamöl
verursachte leichte Erytheme und Oedeme. Die intradermale
Injektion des Vehikels allein verursachte keine Zeichen von
Reizung.


Nach dermale Applikation zeigten die Stellen, die zuvor mit
Freund's Adjuvants behandelt wurden, schwere Erytheme und
Oedeme, Verhaertugnen und Verkrustungen und Nekrosen. Die
nur mit Testsubstanz oder Vehikel behandelten Stellen
zeigten keine Anzeichen von Reizung.

"ENGLISH"

Severe erythemas and oedemas as well as indurations and
incrustations were observed after intradermal injection of
Freund's adjuvant with and without test substance. The
treatment with the solution consisting of the test substance
and sesame oil caused slight erythemas and oedemas. The
intradermal injection of the vehicle on its own did not
cause any signs of irritation.


After dermal application the areas previously treated with
Freund's adjuvant exhibited severe erythemas and oedeams,
indurations, incrustations and necroses.The areas only
treated with the test substance or the vehicle did not
exhibit any signs of irritation.

Evidence of sensitisation of each challenge concentration:
Behandlungsgruppe: 0/10

Kontrollgruppe: 0/5

"ENGLISH"

Treatment group: 0/10

Control group: 0/5

Applicant's summary and conclusion

Interpretation of results:
other: not classified

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