Registration Dossier
Registration Dossier
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EC number: 453-060-9 | CAS number: -
Skin sensitisation
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
"ENGLISH"
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.
"ENGLISH"
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).
"ENGLISH"
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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