Registration Dossier

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:
1. to 26. Sep 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline GLP test
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The LLNA method was not available yet by the time the study was conducted and an appropriate guinea pig maximisation test is available which would not justify conducting an additional LLNA due to animal welfare.
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
Induction: 0.1 ml of test substance (5 w/v %)
Challenge: 0.1 ml of test substance (25 w/v %)
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
Induction: 0.1 ml of test substance (5 w/v %)
Challenge: 0.1 ml of test substance (25 w/v %)
No. of animals per dose:
5/sex/dose
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 w/v %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 w/v %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
25 w/v%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25 w/v%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Testosterone is not classified according to Directive 67/548/EEC and Regulation 1272/2008/EC (CLP) systems as read-across substance has as no skin sensitizing potential in vivo.
Executive summary:

There are no available skin sensitisation studies on testosterone. Results of a study conducted with a structurally similar compound (androstenedione, ZK5155) are reported and used for read-across.

Testing of ZK 5155 in a maximization test in guinea pigs did not reveal a skin sensitizing potential.

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

Data generated using the read across substance, androstenedione in a GPMT study did not indicate that the substance was a skin sensitiser.

Migrated from Short description of key information:

Testing of ZK 5155 (androstenedione) in a maximization test in guinea pigs did not reveal a skin sensitising potential.   Therefore, by read-across, testosterone is not a skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Additional information:

Read-across justification summary is attached to this endpoint summary.

Justification for classification or non-classification

Based on read across to androstenedione, testosterone is not classified as a skin sensitising agent according to the Directive 67/548 EEC or according to Regulation (EC) 1272/2008 (CLP).