Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
Maurer optimisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: 10% propylene glycol + 90 % physiological saline (intradermal), vaseline (epicutaneous)
Concentration / amount:
0.1 % (w/w) (intradermal)
30 % (w/w) (epicutaneous)
Challengeopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: 10% propylene glycol + 90 % physiological saline (intradermal), vaseline (epicutaneous)
Concentration / amount:
0.1 % (w/w) (intradermal)
30 % (w/w) (epicutaneous)
No. of animals per dose:
20 (control)
20 (testgroup)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: intradermal challenge application
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1%
No. with + reactions:
3
Total no. in group:
20
Remarks on result:
other: Reading: other: intradermal challenge application. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1%. No with. + reactions: 3.0. Total no. in groups: 20.0.
Reading:
other: intradermal challenge application
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other: Reading: other: intradermal challenge application. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 2.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
30%
No. with + reactions:
14
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 30%. No with. + reactions: 14.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
skin-sensitising (contact allergenic) potency