Registration Dossier
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EC number: 426-110-2 | CAS number: 98377-35-6
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 (SPF)
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) intradermale Induktion: 1 % Suspension (Vehikel: 2 %
Cremophor EL.RTM. in physiologischer Kochsalzlösung),
appliziertes Volumen/Applikation: 0.1 ml
b) topische Induktion: 50 % Suspension (Vehikel: 2 %
Cremophor EL.RTM. in physiologischer Kochsalzlösung),
appliziertes Volumen/Applikation: 0.5 ml
"ENGLISH"
a) intradermal induction: 1 % suspension (vehicle: 2 %
Cremophor EL.RTM in normal saline solution), applicated
volume/application: 0.1 ml
b) topical induction: 50 % suspension (vehicle: 2 %
Cremophor EL.RTM. in normal saline solution) applicated
volume/application: 0.5 ml
Concentration of test material and vehicle used for each challenge:
Topische Provokation: 50 % Suspension (Vehikel: 2 %
Cremophor EL.RTM. in physiologischer Kochsalzlösung),
appliziertes Volumen/Applikation: 0.5 ml
"ENGLISH"
topical challenge: 50 % suspension (vehicle: 2 % Cremophor
EL.RTM. in normal saline solution), applicated
volume/application: 0.5 ml
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) intradermale Induktion: 1 % Suspension (Vehikel: 2 %
Cremophor EL.RTM. in physiologischer Kochsalzlösung),
appliziertes Volumen/Applikation: 0.1 ml
b) topische Induktion: 50 % Suspension (Vehikel: 2 %
Cremophor EL.RTM. in physiologischer Kochsalzlösung),
appliziertes Volumen/Applikation: 0.5 ml
"ENGLISH"
a) intradermal induction: 1 % suspension (vehicle: 2 %
Cremophor EL.RTM in normal saline solution), applicated
volume/application: 0.1 ml
b) topical induction: 50 % suspension (vehicle: 2 %
Cremophor EL.RTM. in normal saline solution) applicated
volume/application: 0.5 ml
Concentration of test material and vehicle used for each challenge:
Topische Provokation: 50 % Suspension (Vehikel: 2 %
Cremophor EL.RTM. in physiologischer Kochsalzlösung),
appliziertes Volumen/Applikation: 0.5 ml
"ENGLISH"
topical challenge: 50 % suspension (vehicle: 2 % Cremophor
EL.RTM. in normal saline solution), applicated
volume/application: 0.5 ml
- 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:
- 50 %
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 4.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 5.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- 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: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- 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: 50 %. 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: 50 %
Signs of irritation during induction:
Deutlich erkennbare Hautreizungen an den Injektionsstellen
nach intradermaler Induktion.
"ENGLISH"
Clearly identifiable skin irritation at the injection sites
after intradermal induction.
Evidence of sensitisation of each challenge concentration:
In der Testgruppe traten Hauteffekte bei 4/10 Tieren nach
48 h und bei 5/10 Tieren nach 72 h auf. Insgesamt reagierten
6/10 Tiere (60 %) in der Behandlungsgruppe. 3/10 Tiere in
der Testgruppe wiesen an beiden Beobachtungszeitpunkten
Hauteffekte auf.
"ENGLISH"
Skin effects occured in the test group at 4/10 animals 48 h
and at 5/10 animals after 72 h. 6/10 animals (60 %) of the
treatment group reacted all over. 3/10 animals of the
treatment group showed skin effects at both observation
times.
Other observations:
Aussehen und Verhalten der Tiere in der Testgruppe
unterschieden sich nicht von den Beobachtungen in der
Kontrollgruppe. Die Körpergewichtsentwicklung entsprach
derjenigen der Kontrollgruppe.
"ENGLISH"
Appearance and behaviour of the animals in the test group
did not differ from the animals in the control group.
The body weight development was the same as in the control
group.
Applicant's summary and conclusion
- Interpretation of results:
- other: irritant
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