Registration Dossier

Toxicological information

Skin sensitisation

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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