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:
other: 92/69/EWG, B.6 (Meerschweinchen-Maximierungstest (GPMT)); OECD 406 (1992)
GLP compliance:
yes

In vivo test system

Test animals

Species:
other: gpg, Hsd Win: DH

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) intradermal: 0.3 % in 0.9 %iger physiolog.

Kochsalzlösung ohne bzw. mit FCA (1:1)

b) epidermal: 50 % in 0.9 %iger physiolog.

Kochsalzlösung

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a) intradermal: 0.3% in 0.9% physiological NaCl-solution
without resp. with FCA (1:1)

b) epidermal 50 5 in 0.9 % physiological NaCl-solution

Concentration of test material and vehicle used for each challenge:
a) epidermal: 50 % in 0.9 %iger physiolog. Kochsalzlösung



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a) epidermal 50 % in 0.9 % physiological NaCl-solution
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) intradermal: 0.3 % in 0.9 %iger physiolog.

Kochsalzlösung ohne bzw. mit FCA (1:1)

b) epidermal: 50 % in 0.9 %iger physiolog.

Kochsalzlösung

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a) intradermal: 0.3% in 0.9% physiological NaCl-solution
without resp. with FCA (1:1)

b) epidermal 50 5 in 0.9 % physiological NaCl-solution

Concentration of test material and vehicle used for each challenge:
a) epidermal: 50 % in 0.9 %iger physiolog. Kochsalzlösung



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a) epidermal 50 % in 0.9 % physiological NaCl-solution
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 6

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50 %
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: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50 %
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: 50 %. No with. + reactions: 0.0. 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:
6
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: 6.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
6
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: 6.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 50 %

Signs of irritation during induction:
Keine



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none

Evidence of sensitisation of each challenge concentration:
Keine

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none

Other observations:
Systemische Effekte wurden nicht festgestellt.

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no systemic effects were detected.

Applicant's summary and conclusion

Interpretation of results:
other: not classified