Registration Dossier

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: OECD Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Basazol Gelb 8511
- Physical state: powder
- Analytical purity: 96 %
- Lot/batch No.: 6123 V. 6781

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht,Hagemann GmbH & Co. KG,D-4923 Extertal 1, FRG
- Weight at study initiation: 285 - 335 g
- Housing: The animals were housed in fully air-conditioned rooms with a central air-conditioning system
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days before the beginning of the study in the laboratory for dermal toxicity


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
olive oil
Concentration / amount:
induction intradermal: 5% in olive oil DAB 9 resp.in Freund's adjuvant/0.9% aqueous NaCl solution (1: 1)resp. olive oil DAB 9
induction epicutan: 25% in olive oil DAB 9 resp. olive oil DAB 9
1st challenge:10% in olive oil DAB9 resp. olive oil DAB 9
2nd challenge:10% in olive oil DAB9 resp. olive oil DAB 9
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
induction intradermal: 5% in olive oil DAB 9 resp.in Freund's adjuvant/0.9% aqueous NaCl solution (1: 1)resp. olive oil DAB 9
induction epicutan: 25% in olive oil DAB 9 resp. olive oil DAB 9
1st challenge:10% in olive oil DAB9 resp. olive oil DAB 9
2nd challenge:10% in olive oil DAB9 resp. olive oil DAB 9
No. of animals per dose:
Number of animals per control group: 10
Number of animals per test group: 20
Details on study design:
RANGE FINDING TESTS:
For detecting a possible influence on irritating effects of previous intradermal treatment with Freund's adjuvant,animals pretreated with Freund's adjuvant/aqua dest.(1:1) each, in the same manner as intradermal induction(cf. page 10) about 3 weeks prior to the application oft he test substance were used.In the preliminary test after two 24-hour percutaneous occlusive applications within 96 hours the minimum4 irritant concentration was found to be a 25% test substance preparation in olive oil DAB 9 and the maximumnon-irritant concentration a 10% test substance preparation in olive oil DAB 9.
Applicability: it was possible to inject a 5 % test substance preparation in olive oil DAB 9 resp. in Freund'sa djuvant/0.9% aqueous NaCl-solution (1:1)
with a syringe.


Positive control substance(s):
yes

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
72
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
72
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
Reading of one animal not possible due to colour of TS.
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 72.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: Reading of one animal not possible due to colour of TS..

Any other information on results incl. tables

The substance Basazol Gelb 8511 was tested for its sensitizing effect on the skin of the guinea pig in the maximization test based on the method of Magnusson and Kligman. After intradermal induction distinct erythema and edema were observed at the injection sites of the control and test animals, at which only Freund's adjuvant/0.9% aqueous NaCl solution (1:1) was applied. Injection of the test substance preparation in olive oil DAB 9 resp. in Freund's adjuvant/0.9% aqueous NaCl solution (1:1) caused distinct edema in the test animals. The irritation index for erythema could not be read because of staining due to the colour of the test substance. The control animals injected with olive oil DAB9 (vehicle) showed distinct erythema. After the percutaneous induction incrustation, partially open (caused by the intradermal induction) in addition to distinct edema were observed in the test animals. The irritation index for erythema could not be read because of staining due to the colour of the test substance. The animals of control group 1 and 2 which were applied with olive oil DAB9 (vehicle) exhibited incrustation, partially open (caused by the intradermal induction), in addition to distinct erythema and edema. After the 1st challenge (20 days after intradermal induction) and after the 2nd challenge (27 days after intradermal induction) the number of animals with skin findings was determined.48 hours after the beginning of application in respect to erythema were not possible in some animals due to intensive staining of the skin by the test substance (for details see below). Therefore, an overall assessment of skin reactions based on the results of edema and readable erythema at 48 and 72 hours after the beginning of application is given in the following table:

 

 

1stchallenge

2ndchallenge

 

10% in olive oil DAB 9

Olive oil

DAB 9

10% in olive oil DAB 9

Olive oil

DAB 9

Control group 1

0/10

0/10

0/10

0/10

Control group 2

No application of test substance

0/10

0/10

0/10

Test group

0/20

0/20

0/20

0/20

x/y: number of positive reactions/number of animals tested

After the first challenge with the10% test substance preparation in olive oil DAB 9 no edema could be observed in the test group and in control group 1. No signs of erythema could be observed in 14 out of 20 test animals and in 9 out of 10 animals of control group 1. Index for erythema could not be read in 6 out of 20 test animals and in 1 out of 10 animals of control group 1 because of staining due to the colour of the test substance at 48 hours after the beginning of application. 72 hours after the beginning of application readings were possible, but signs of erythema could be observed neither in the test animals nor in the animals of control group 1.

After the second challenge with the 10% test substance preparation in olive oil DAB 9 no edema could be observed in the test group and in control group 1 and 2. No signs of erythema could be observed in 12 out of 20 test animals and 8 out of 10 animals of control group 1 as well as in 8 out of 10 animals of control group 2. Index for erythema could not be read in 8 out of 20 test animals and in respectively 2 out of 10 animals of control group 1 and 2 because of staining due to the colour of the test substance at 48 hours after the beginning of application. 72 hours after the beginning of application readings in 19 out of 20 test animals, in 9 out of 10 animals of control group 1 and in 9 out of 10 animals of control group 2 were possible but none of them showed signs of erythema. Olive oil DAB 9 applied as a vehicle did not cause any skin reactions in all animals neither after the first nor after the second challenge at the 48- and 72 hour-readings.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Even though reading of erythema was prevented in some animals due to staining of skin by the dye under test, especially at 48 hours after the beginning of application, an assessment could be made. According to our experience with this test system and to International Guidelines (OECD406) readings at 72 hours post exposure are also valuable contributions for scoring because signs of erythema are still present at this time. Since neither edema was recorded nor erythema at the 72 hours reading in almost all animals at both challenges it can be stated that under the test conditions chosen and following the results described above Basazol Gelb 8511 does not have a sensitizing effect on the skin of the guinea pig.