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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
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
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
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%
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
Positive control results:
- The postive controls showed sensitizing effects.
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.

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.

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In a GLP compliant sensitivity study using the Maximization-Test, performed according to OECD guideline 406, guinea pigs were treated with the test substance (Ciba-Geigy 1994). 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.


Migrated from Short description of key information:
The test substance shows a moderate to extreme grade of skin sensitising potential in guinea pigs.

Justification for selection of skin sensitisation endpoint:
Only study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the findings in the skin sensitisation study the test substance needs to be classified Xi; R43 according to the Directive 67/548/EEC and Sub category 1B:H317 according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.