Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Scientific and detailed study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
eight concentrations: 0.25, 0.5, 2.5, 1, 10, 25, 50, 75 %
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
eight concentrations: 0.25, 0.5, 2.5, 1, 10, 25, 50, 75 %
No. of animals per dose:
3 per dose

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:
2
Total no. in group:
20
Clinical observations:
redness score of 1 on the test article site
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: redness score of 1 on the test article site.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10 %
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
redness score of 1 at the test article site
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: redness score of 1 at the test article site.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was a mild skin sensitizer under the test conditions but does not require labeling as skin sensitizer under EU criteria.
Executive summary:

The cutaneous allergenic potential of THL-PE salt was assessed using the Magnusson-Kligman method carried out on Harley Albino guinea pigs (acc. to OECD 406). Fifteen femals and fifteen males were assigned to the study. At challenge, erythma was absent to moderate on the test article site and absent on the vehicle dose site. 2 of 20 animals were observed to have a redness score of 1 at the 24 hour observation period; 3 of 20 animals had a redness score of 1 at the 48 hour observation period. The test substance was considered a mild sensitiser under the test conditions but does not require labeling as a skin sensitizer under EU criteria.