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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:
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
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
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
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
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
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.

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.

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

For androstadiendion (CAS No. 897-06-3) no skin sensitisation data are available. Therefore, skin sensitisation data of androstendion (CAS No.

63-05 -8) were used. A search for structure-analogue substances using the QSAR Toolbox 3.3.5 recommended androstendion as one out of 11 category substances for a read-across approach (for details see QSAR OECD Toolbox Report on Androstadiendion attached in chapter 7, Endpoint Summary: Toxicological information).

The test substance androstendion 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 % (paste) for epicutaneous induction and challenge. Sodium lauryl sulphate treatment (10 %) was accomplished the day before epicutaneous induction with the 25 % substance (Weijman and Schoebel, 1987).


Migrated from Short description of key information:
Androstadiendion has no skin sensitising potential based on a guinea pig maximization test with the read-across substance androstendion (Weijman and Schoebel, 1987).

Justification for selection of skin sensitisation endpoint:
Only one study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No classification required for skin sensitisation according to Regulation (EC) No. 1272/2008 (CLP).