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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Remarks:
testing lab.
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Trilon A 92, purity 92.4%

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
Age of the animals: Young adult animals
Body weight range at the beginning of the study: 347 - 399 g
Acclimatization period: 8 days before the beginning of the study in the laboratory for dermal toxicity.
The animals were housed in fully air-conditioned rooms in which a central air-conditioning system ensured a temperature in the range of 20 - 24°C and a relative humidity in the range of 30 - 70 %.
Illumination period: 12 h light and 12 h darkness
Stainless steel wire mesh cages with plastic-coated grating, floor area 40 cm x 51 cm, were used.
No . of animals per cage: 5
Identification of the animals: Ear tattoo
Type of diet : Kliba Labordiaet 341 (Kaninchen-Meerschweinchen-Haltungsdiaet) ad libitum
Water ad libitum (tap water; about 2 g of ascorbic acid per 10 1 water was added to the drinking water twice a week)

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: percutaneous occlusive
Vehicle:
water
Concentration / amount:
The following concentrations for induction and the challenge were selected on the basis of the pretests:
1st, 2nd and 3rd induction: 50% in aqua bidest.
Challenge: test substance 50% in aqua bidest.
Challengeopen allclose all
Route:
other: percutaneous occlusive
Vehicle:
water
Concentration / amount:
The following concentrations for induction and the challenge were selected on the basis of the pretests:
1st, 2nd and 3rd induction: 50% in aqua bidest.
Challenge: test substance 50% in aqua bidest.
No. of animals per dose:
Number of animals per control group : 10
Number of animals of the test group : 20
Details on study design:
Form of application: percutaneous occlusive
Percutaneous application is simulating dermal contact with the compound also possible to occur under practical use conditions. Occlusive dressing has been recommended by the original publication / guideline to avoid evaporation and to guarantee maximum skin contact.
The study was performed on 20 guinea pigs in the test group and 10 animals in each of control groups 1 and 2.
The animals of the control groups were used to rule out a substance induced primary skin irritation.
A second control group (control group 2) has been intended for a potential rechallenge in case of borderline results at the challenge. Control group 1
cannot be used in this case due to a possible sensitization by the single application of the test substance at the challenge.
Positive control substance(s):
yes

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: challenge
Hours after challenge:
48
Group:
test group
Dose level:
test substance 50% in water
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: challenge. . Hours after challenge: 48.0. Group: test group. Dose level: test substance 50% in water. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: challenge
Hours after challenge:
48
Group:
other: control group 1
Dose level:
50% in water
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge. . Hours after challenge: 48.0. Group: other: control group 1. Dose level: 50% in water. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

The 1st, 2nd and 3rd induction with 50% test substance preparations did not cause any signs of skin irritation in all test group animals. A challenge was performed 14 days after the last induction. The number of animals with skin findings after the challenge was as followed: control group 1 - 0/10, test group - 0/20.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Based on the results of this study it was concluded that Trilon A 92 does not have a sensitizing effect on the skin of the guinea pig in the BUEHLER Test under the test conditions chosen.