Registration Dossier
Registration Dossier
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EC number: 212-977-2 | CAS number: 897-06-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 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:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- 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
- 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
- Details on test material:
- - Name of test material (as cited in study report): 4-Androstene -3,17- dione
- Lot/batch No.: B6
- Stability under test conditions: The formulations were freshly prepared before each application.
Constituent 1
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
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
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
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Executive summary:
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.
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