Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible tor the test
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 84/449/EWG, 8.6 (Meerschweinchen-Maximierungstest (GPMT))
Principles of method if other than guideline:
84/449/EWG, 8.6 (Meerschweinchen-Maximierungstest (GPMT))
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
1st stage: 0.1 ml FCNSaline (1:1) intradermally at 4 sites,
then about 0.4 g of 30% test substance in vaseline applied
topically by occlusive patch over these sites.
2nd stage: about 0.4 g of 30% test substance in vaseline
applied topically by occlusive patch over same injection
sites. .
Concentration of test material and vehicle used for each challenge:
10% in vasleine
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
1st stage: 0.1 ml FCNSaline (1:1) intradermally at 4 sites,
then about 0.4 g of 30% test substance in vaseline applied
topically by occlusive patch over these sites.
2nd stage: about 0.4 g of 30% test substance in vaseline
applied topically by occlusive patch over same injection
sites. .
Concentration of test material and vehicle used for each challenge:
10% in vasleine

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 10 %

Signs of irritation during induction:

Keine Befunde

"ENGLISH"

No findings

Evidence of sensitisation of each challenge concentration:

Keine

"ENGLISH"

None

Other observations:

Bei dem Vortest wurde bei einem der vier Tiere Erythema

beobachtet (wahrend 24 h nach der occlusiven Applikation von

30 % der Testsubstanz in Vaseline) .

"ENGLISH"

Erythema was observed in one of the four animals in the

pretest (during 24 h after the occlusive application of 30%

of the test substance in vaseline) .

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information