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/EG, B.6 (Magnusson-Kligman-Test)
GLP compliance:
yes

In vivo test system

Test animals

Species:
other: gpg, Dunkin-Hartley

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) intradermal: 20 % in Sesamöl

b) dermal: 100 %

"ENGLISH"

intradermal: 20 % in sesame oil

dermal: 100 %

Concentration of test material and vehicle used for each challenge:
dermal: 50 % in Sesamöl

"ENGLISH"

dermal: 50% in sesame oil
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) intradermal: 20 % in Sesamöl

b) dermal: 100 %

"ENGLISH"

intradermal: 20 % in sesame oil

dermal: 100 %

Concentration of test material and vehicle used for each challenge:
dermal: 50 % in Sesamöl

"ENGLISH"

dermal: 50% in sesame oil
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:
50 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
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: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
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: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
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: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

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

Signs of irritation during induction:
Nach den intradermalen Injektionen mit FCA wurden klar
ausgebildete Erytheme festgestellt. Entsprechende
Injektionen mit FCA und Testsubstanz führte zu starken
Erythemen und starker Schorfbildung. Nur mit Testsubstanz
behandelte Injektionsstellen führten zu keinen Reaktionen
oder zu sehr leichten Erythemen. Die ausschließliche
Injektion des Vehikels ergab keine Reizerscheinungen.


Die dermale Applikation mit der unverdünnten Testsubstanz
führte zu mässigen bis deutlichen Erythemen und
Schwellungen. Daneben trat Abschuppung, Verhärtung und grüne
Verfärbung der Behandlungsstellen auf. Leichte Erytheme
wurden bei den mit dem Vehikel allein behandelten Tieren
festgestellt. Daneben trat bei diesen Tieren ebenfalls
Abschuppung, Verhärtung und grüne Verfärbung der
Behandlungsstellen auf.

"ENGLISH"

Clearly defined erythemas were determined after intradermal
injections with FCA. Corresponding injections with FCA and
the test substance resulted in severe erythemas and the
severe formation of eschar. Only injection sites treated
with the test substance did not result in any reactions or
only in very slight erythemas. The exclusive injection

of the vehicle did not result in any signs of irritation.


The dermal application involving the undiluted test
substance resulted in moderate to clear erythemas and
swellings. Desquamation, induration and green discoloration
of the treatment sites additionally occurred. Slight
erythemas were determined in the animals treated with the
vehicle alone. Desquamation, induration and green
discoloration of the treatment sites additionally also
occurred in these animals.

Evidence of sensitisation of each challenge concentration:
Behandlungsgruppe: 0/20

Kontrollgruppe:    0/10

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Treatment group: 0/20

Control group: 0/20

Applicant's summary and conclusion

Interpretation of results:
other: not classified