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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:
15 January 2002- 22 February 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
other: EPA OPPTS 870.2600 "Skin Sensitisation"
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
tert-Butyl rel-(3R,5S,6E)-7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoate
EC Number:
603-330-9
Cas Number:
129332-29-2
Molecular formula:
C28H34FNO4
IUPAC Name:
tert-Butyl rel-(3R,5S,6E)-7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoate

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:
corn oil
Concentration / amount:
For the induction exposure, ten experimental animals were intradermally injected with a 1% concentration and epidermally exposed to a 50% concentration. Five control animals were similarily treated, but with vehicle alone. Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application all animals were challenged with a 50% test substance concentration and the vehicle.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
For the induction exposure, ten experimental animals were intradermally injected with a 1% concentration and epidermally exposed to a 50% concentration. Five control animals were similarily treated, but with vehicle alone. Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application all animals were challenged with a 50% test substance concentration and the vehicle.
No. of animals per dose:
Experimental group: 10 females
Control group: 5 females

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
552
Group:
negative control
Dose level:
50%test substance concentration
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 552.0. Group: negative control. Dose level: 50%test substance concentration. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
576
Group:
negative control
Dose level:
50% test substance concentration
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 576.0. Group: negative control. Dose level: 50% test substance concentration. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
552
Group:
test chemical
Dose level:
50% test substance concentration
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 552.0. Group: test group. Dose level: 50% test substance concentration. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
576
Group:
test chemical
Dose level:
50% test substance concentration
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 576.0. Group: test group. Dose level: 50% test substance concentration. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
There was no evidence that the test substance had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental anilmals 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, Diolat does not have to be classified and has no obligatory labelling requirement for sensitisation by skin contact. Non sensitising.
Executive summary:

There was no evidence that the test substance had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental anilmals 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, the test substance does not have to be classified and has no obligatory labelling requirement for sensitisation by skin contact. Non sensitising.

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