Registration Dossier

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: OECD 406 / EG B.6 (Maximierungstest)
GLP compliance:
yes

In vivo test system

Test animals

Species:
other: gpg, Pirbright White

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) intradermal: 1,25 % in flüssigem Paraffin

b) epidermal: 25 % in flüssigem Paraffin


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a) intradermal: 1.25 % in liquid paraffine

b) epidermal: 25 % in liquid paraffine

Concentration of test material and vehicle used for each challenge:
a) 25 % in flüssigem Paraffin


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a) 25 % in liquid paraffine
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) intradermal: 1,25 % in flüssigem Paraffin

b) epidermal: 25 % in flüssigem Paraffin


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a) intradermal: 1.25 % in liquid paraffine

b) epidermal: 25 % in liquid paraffine

Concentration of test material and vehicle used for each challenge:
a) 25 % in flüssigem Paraffin


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a) 25 % in liquid paraffine
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
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: 25 %. No with. + reactions: 4.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
4
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 4.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 25 %

Signs of irritation during induction:
Keine Im Vorversuch hatten Konzentrationen von 2,5 % bzw. 5
% Nekrosen ausgelöst.


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Kein; in the pre-test concentrations of 2.5 % and 5 % caused
necrosis.

Evidence of sensitisation of each challenge concentration:
4 Tiere


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4 animals

Applicant's summary and conclusion

Interpretation of results:
other: irritant