Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January/ February 1995
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Magnusson and Kligman
Deviations:
not specified
Principles of method if other than guideline:
Study according to Magnusson and Kligman´s "Guinea Pig Maxiximization Test"
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
Strain:
Dunkin-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: different vehicles used
Concentration / amount:
1.0 % up to 25 % depending on application
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: different vehicles used
Concentration / amount:
1.0 % up to 25 % depending on application
No. of animals per dose:
20 f , 10 f als control grpup
Challenge controls:
on 22nd day after dermal application, 25 % in ethnol
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.3 ml 25 % suspension for challenge
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.3 ml 25 % suspension for challenge. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.3 ml 25 % suspension for challenge
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.3 ml 25 % suspension for challenge. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.3 ml 25 % suspension for challenge
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.3 ml 25 % suspension for challenge. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.3 ml 25 % suspension for challenge
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.3 ml 25 % suspension for challenge. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: no LLNA was performed, so not applicable.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
In the sensitization test based on Magnusson and Kligman´s "Guinea Pig Maximization Test", the substance SND 919 Propionylthiazol did not induce aany allergic reaction by skin contact in any of the 20 guinea pigs treated.
Thus the substnace SND 919 Propionylthiazol revealed no sensitizing potential under the stated study conditions.
Executive summary:

A skin sensitozation study with the substance SND 919 Propionylthiazol was carried out in guinea pigs.

The test animals were sensitized in two stages. On day 22 of the study an attempt was made to challenge an allergic contact dermatitis.

After the challenge exposure no allergic contact dermatitis was registered in the guinea pigs treated with SND 929 Propionylthiazol.

So under the stated study conditions the substance SND 919 Propionylthiazol revealed no sensitizing potential.