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 (Meerschweinchen-Maximierungstest (GPMT))
GLP compliance:
yes

In vivo test system

Test animals

Species:
other: gpg, Hsd Poc:DH

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermale Induktion: 0,1 % S,S-Pyrrolopiperidin

in physiolog. NaCl-Lösung

b) Dermale Induktion: 10 % S,S-Pyrrolopiperidin

in physiolog. NaCl-Lösung

"ENGLISH"

a) Intradermal induction: 0.1 % S,S-pyrrolopiperidine

in physiolog. NaCl solution

b) Dermal induction: 10 % S,S-Pyrrolopiperidine

in physiolog. NaCl solution

Concentration of test material and vehicle used for each challenge:
Auslösephase: 1 % S,S-Pyrrolopiperidin

in physiolog. NaCl-Lösung

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Challenge phase: 1 % S,S-pyrrolopiperidine

in physiolog. NaCl solution
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermale Induktion: 0,1 % S,S-Pyrrolopiperidin

in physiolog. NaCl-Lösung

b) Dermale Induktion: 10 % S,S-Pyrrolopiperidin

in physiolog. NaCl-Lösung

"ENGLISH"

a) Intradermal induction: 0.1 % S,S-pyrrolopiperidine

in physiolog. NaCl solution

b) Dermal induction: 10 % S,S-Pyrrolopiperidine

in physiolog. NaCl solution

Concentration of test material and vehicle used for each challenge:
Auslösephase: 1 % S,S-Pyrrolopiperidin

in physiolog. NaCl-Lösung

"ENGLISH"

Challenge phase: 1 % S,S-pyrrolopiperidine

in physiolog. NaCl solution
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:
1 %
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1 %
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1 %
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: 1 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1 %
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: 1 %. 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: 6 %

Signs of irritation during induction:
Es wurden keine auf die Behandlung mit der Testsubstanz
zurückzuführende Hautreaktionen beobachtet.

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No skin reactions attributable to treatment with the test
substance were observed.

Evidence of sensitisation of each challenge concentration:
Bei einem Tier der Testgruppe wurde eine Sensibilisierung
beobachtet (1/10).

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Sensitization was observed in one animal from the test group
(1/10).

Other observations:
Es traten während des Studienverlaufs keine Todesfälle auf.
Es wurden auch keine Anzeichen von systemischer Toxizität
beobachtet.

Die Körpergewichtsentwicklung während des Studienverlaufs
war der der Kontrolltiere vergleichbar.

"ENGLISH"

No mortalities occurred in the course of the study.

No signs of systemic toxicity were observed either.

The body-weight gain in the course of the study was
comparable with that of the control animals.

Applicant's summary and conclusion

Interpretation of results:
other: not classified

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