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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Start: 17 February 1998 Completed: 20 March 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Study performed according OECD and or EC guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Identification: TS-2863
Description: White solid
Batch: 85-36
Purity: 99.8%
Test substance storage: at room temperature in the dark
Stability under storage conditions: stable
Expiry date: 18 December 1998

In vivo test system

Test animals

Species:
guinea pig
Strain:
Himalayan
Sex:
female
Details on test animals and environmental conditions:
young adult animals
conditions : air-conditioned room / T=21°C / relative humidity = 50%

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
induction exposure :
intradermal =5%
epicutaneous=50%
challenge exposure :
epcutaneous=20 and 0%
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
corn oil
Concentration / amount:
induction exposure :
intradermal =5%
epicutaneous=50%
challenge exposure :
epcutaneous=20 and 0%

Results and discussion

Positive control results:
Test substance concentrations selected for the Main study were based on the results of a preliminary study.
In the Main study, ten experimental animals were intradermally injected with a 5% concentration and epidermally exposed to a 50% concentration. Five control animals were similary treated, but with the vehicle (corn oil) only. Two weeks after the epidermal application all animals were challenged with a 20% test substance concentration and the vehicle.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Group:
test group
Dose level:
5%
No. with + reactions:
6
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 5%. No with. + reactions: 6.0. Total no. in groups: 10.0.
Reading:
2nd reading
Group:
test group
Dose level:
50%
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
No oedemas
Remarks on result:
other: Reading: 2nd reading. Group: test group. Dose level: 50%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: No oedemas.
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
20%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
20%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
No evidence was obtained that TS-2863 had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase.
This result indicates a sensitisation rate of 0 per cent.
Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), TS-2863 does not have to be classified and has no obligatory labelling requirements for sensitisation by skin contact.