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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
Study period:
1. to 26. Sep 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1981
Deviations:
yes
Remarks:
, no data on reliability check reported
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
the guinea pig maximisation test was an adequate in vivo skin sensitisation test at the time of performance in 1986

Test material

Constituent 1
Chemical structure
Reference substance name:
Androst-4-ene-3,17-dione
EC Number:
200-554-5
EC Name:
Androst-4-ene-3,17-dione
Cas Number:
63-05-8
Molecular formula:
C19H26O2
IUPAC Name:
androst-4-ene-3,17-dione

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Pirbright White
- Source: Hagemann
- Age at study initiation: not reported
- Weight at study initiation: males 333-425 g, females 321-404 g
- Housing: in groups of 2 in conventional housing conditions (Makrolon type III cages)
- Diet and water: ad libitum
- Acclimation period: > 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23
- Humidity (%): 54-66
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
intradermal induction: 5 % (w/v) test substance
epicutaneous induction: 25 % (w/v) test substance
challenge: 25 % (w/v) test substance
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
intradermal induction: 5 % (w/v) test substance
epicutaneous induction: 25 % (w/v) test substance
challenge: 25 % (w/v) test substance
No. of animals per dose:
10 (5/sex for test and control group)
Details on study design:
RANGE FINDING TESTS:
The 5 % (w/v) concentration of the test substance did not produce necrosis and ulcerations in the guinea pigs after intradermal application in
the same region in a previously conducted experiment. The 25 % (w/v) formulation was proved to provoke no necrosis to the skin in a previously performed local tolerance test.

MAIN STUDY
Intradermal induction:
5 male and 5 female guinea pigs (test group) received intracutaneously into the right and left dorsal neck region each 0.1 mL of diluted complete Freund's adjuvant, the test substance at a 5 % (w/v) concentration and the test substance at a 5 % (w/v) concentration mixed with complete Freund' s adjuyant. The control group (5/sex) received in the same way 0.1 mL of diluted Freund's complete adjuvant and the vehicle.

Epicutaneous induction:
On day 8 of the study, the same skin area of both groups was pretreated with sodium lauryl sulphate (10 w/v %) and thereafter on day 9 covered with a filter paper impregnated with the test substance at a 25 % (w/v) concentration in liquid paraffin for the test group, respectively impregnated with liquid paraffin only for the controls. The filter paper was kept under occlusive conditions by a bandage for 48 hours.

Challenge: On day 23, as a challenge, the same procedure was followed as on day 9 but the controls also received the filter paper impregnated with the test substance in liquid paraffin. The application was accomplished in the more sensitive flank region of the same animals. Furthermore, the occiusive bandage remained for only 24 hours. An evaluation of the reactions in the test as weIl as in the control group was carried out on day 25 and 26 of the study (48 and 72 hours after challenge).
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Group:
positive control
Remarks on result:
not measured/tested
Remarks:
no positive control group within study, however, a structural analog, 4, 15-androstadien-3,17-dion (an intermediate in the synthesis of mespirenon) proved to be highly sensitizing with this protocol in the same laboratory and might serve as historical control
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10

Any other information on results incl. tables

In none of the animals, in the maximization test as weIl as in the parallel local tolerance test, local reactions were seen on the site of application.

Applicant's summary and conclusion

Conclusions:
The test substance did not reveal a skin sensitisation potential when tested in a Guinea pig Maximization test with a concentration of 5 % for intradermal induction and 25 % for epicutaneous induction and challenge following. Sodium lauryl sulphate treatment (10 %) was accomplished the day before epicutaneus induction with the 25 % substance.
Executive summary:

To determine the skin-sensitizing properties of androstendione a guinea pig maximisation test


was performed comparable to OECD guideline 406. 5 male and 5 female Pirbright White guinea pigs (test group) received intracutaneously at the same time into the right and left dorsal neck region each 0.1 ml of diluted complete Freund’s adjuvant, test item (5 w/v %), and test item (5 w/v %) mixed with complete Freund' s adjuyant.


The control group (5M, 5F) received in the same way 0.1 ml of diluted Freund's complete adjuvant and the vehicle.


On day 8 of the study, the same skin area of both groups was pretreated with sodium lauryl sulphate (10 w/v %) and thereafter on day 9 covered with a filter paper impregnated with the test item (25 w/v %) in liquid paraffin for the test group, respectively, impregnated with liquid paraffin only for the controls. The filter paper was kept under occlusive conditions by a bandage for 48 hours. The 25 w/v% formulation was found to be tolerated locally without any symptoms in a forerunning local tolerance test. On day 23, as a challenge, the same procedure was followed as on day 9 but the controls also received the filter paper impregnated with the test item in liquid paraffin. The application was accomplished in the more sensitive flank region of the same animals.


Furthermore, the occlusive bandage remained for only 24 hours.


An evaluation of the reactions in the test as weIl as in the control group was carried out on day 25 and 26 of the study.


In none of the animals, local reactions were seen on the site of application. Thus, there is no evidence of a sensitizing potential of Androstendione using the maximization test with guinea pigs.