Registration Dossier
Registration Dossier
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EC number: 453-850-3 | 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: 92/69/EWG, 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: 2,5 % Substanz formuliert in
Polyethylenglykol 400
b) Topische Induktion: 12 % Substanz formuliert in
Polyethylenglykol 400
"ENGLISH"
a) Intradermal induction: 2.5 % substance formulated in
polyethylene glycol 400
b) Topical induction: 12 % substance formulated in
polyethylene glycol 400
Concentration of test material and vehicle used for each challenge:
6 % Substanz formuliert in Polyethylenglykol 400
"ENGLISH"
6 % substance formulated in polyethylene glycol 400
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) Intradermale Induktion: 2,5 % Substanz formuliert in
Polyethylenglykol 400
b) Topische Induktion: 12 % Substanz formuliert in
Polyethylenglykol 400
"ENGLISH"
a) Intradermal induction: 2.5 % substance formulated in
polyethylene glycol 400
b) Topical induction: 12 % substance formulated in
polyethylene glycol 400
Concentration of test material and vehicle used for each challenge:
6 % Substanz formuliert in Polyethylenglykol 400
"ENGLISH"
6 % substance formulated in polyethylene glycol 400
- 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:
- 6 %
- 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: 6 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 6 %
- 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: 6 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 6 %
- 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: 6 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 6 %
- 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: 6 %. 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: 25 %
Signs of irritation during induction:
Im Injektionsbereich wurden 48 Stunden nach der
intradermalen Induktion an den Tieren der Kontrollgruppe
rote Quaddeln oder graue Quaddeln mit rotem Rand oder weiße
Quaddeln mit rotem Rand beobachtet. Die Tiere der Testgruppe
zeigten die gleichen Effekte und zusätzlich nach 48 Stunden
im Injektionsbereich verkrustete Quaddeln und Rötungen. An
beiden Gruppen wurden nach 7 Tagen Verkrustungen und
Quaddeln im Injektionsbereich der ersten Induktion
festgestellt.
"ENGLISH"
Red wheals or grey wheals with a red border or white wheals
with a red border were observed in the injection area in
the animals from the control group 48 hours after
intradermal injection. The animals from the test group
exhibited the same effects and, in addition, incrusted
wheals and rednesss in the injection area after 48 hours.
Incrustations and wheals in the injection area of the first
induction were determined in both groups after 7 days.
Evidence of sensitisation of each challenge concentration:
Kein Tier (0/10)
"ENGLISH"
No animal (0/10)
Other observations:
Das Aussehen und das Verhalten der Tiere der Testgruppe
unterschied sich nicht von denen der Kontrollgruppe.
Am Studienende lag das durchschnittliche Körpergewicht der
Tiere der Testgruppe im selben Bereich wie das der
Kontrollgruppe.
"ENGLISH"
The appearance and behaviour of the animals from the test
group did not differ from those of the control group. At the
end of the study the average body weight of the animals from
the test group was located in the same range as that of the
control group.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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