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Diss Factsheets

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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

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

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): FAT 40508/A
- Batch No.: Roe TV 1P
- Storage conditions: below 5°C
- Purity: ca. 60%
- Expiration date: December 1997

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White Strain (tif: DHP)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy Ltd., Animal Production, 4332 Stein / Switzerland
- Weight at study initiation: 330-403
- Housing: Individualy in macrolon cages (type 3)
- Diet (e.g. ad libitum): ad libitum guinea pig pellets NAFAG No. 845. Gossau SG
- Water (e.g. ad libitum): drinking water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
Pretest: intradermal: 5% (w/v), epidermal: 30 and 50%
Main test: intradermal: 5% (w/v), epidermal 50%
Challenge: 30%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
Pretest: intradermal: 5% (w/v), epidermal: 30 and 50%
Main test: intradermal: 5% (w/v), epidermal 50%
Challenge: 30%
No. of animals per dose:
- 5 males and 5 females for the test group.
- 5 females for the control group.
Details on study design:
- Induction, intradermal injections (Day 0): Three pairs of intradermal injections (0.1mL per injection) were made simultaneously into the left and right side of the shaved neck of the test and control group animals.
Test group: - adjuvant/saline mixture 1:1 (v/v), - 5% test substance in physiological saline (w/v), - 5% test substance in the adjuvant/saline mixture (w/v).
Control group: - adjuvant/saline mixture 1:1 (v/v), - adjuvant/saline mixture 1:1 (v/v), - physiological saline.
- Induction, epidermal application (Day 8): the application site of all animals was pretreated with 10% sodium-laurylsulfate (open application) 24 hours prior to the epidermal induction application. In the test group, 50% test substance was incorporated in physiological saline and applied on a filterpaper patch to the neck of the animals (patch 2x4 cm; approx. 0.4g per patch; occluded administration for 48 hours).
The control group was treated with the vehicle only.
- Challenge (Day 21): The test and control group animals were tested on one flank with the 30% test substance in physiological saline and on the other flank with the vehicle alone (patch 2x2 cm; approx. 0.2g per patch; occluded administration for 24 hours). 24 and 48 hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale. The sensitising potential of the test substance was classified according to the grading of Magnusson and Kligman.
Challenge controls:
See above.
Positive control substance(s):
yes
Remarks:
Checked once or twice a year with a known mild to moderate sensitiser such as mercaptobenzothiazole, hexyl cinnamic aldehyde or potassiumdichromate

Results and discussion

Positive control results:
- The postive controls showed sensitizing effects.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30%
No. with + reactions:
6
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30%. No with. + reactions: 6.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30%. No with. + reactions: 10.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Scaling was observed in two males and two females of the test group 48 hours after removing the dressings. Under the experimental conditions employed, 60% and 100% of the animals of the test group showed skin reactions 2 4 and 48 hours after removing the dressings, respectively.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance shows a moderate to extreme grade of skin sensitising potential in guinea pigs.
Executive summary:

In a GLP compliant sensitivity study using the Maximization-Test, performed according to OECD guideline 406, guinea pigs were treated with the test substance. Ten animals were treated with the test substance and five animals with only the vehicle (physiological saline). The concentrations of the test substance used in the main study were determined by the results of the preliminary study. The intradermal induction of sensitization in the test group was performed using 5% of the test substance in both the vehicle and adjuvant/vehicle mixture. One week later this was boosted by the topical application of the test substance at 50% concentration over the injection sites. Animals of the control group were treated in the same manner but the selected vehicle was used. Two weeks after the second induction all animals were challenged by topical application of the test substance at 30% concentration. The animals in the test group showed responses (60% after 24 hours and 100% after 48 hours). Therefore it can be concluded that the test substance shows a moderate to extreme grade of skin sensitising potential in guinea pigs.