Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
23. Feb to 22. March 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well reported GLP study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: see principles of method
Principles of method if other than guideline:
Combined acute dermal toxicity and local irritation study; single dermal application of test substance (application volume 0.3 ml) to male and female rats; occlusive conditions; exposure for 24 hours; values for reddening, scab formation and swelling obtained immediately after removal of the bandage and the substance and 24, 48 and 72 h after the end of administration.
GLP compliance:
yes

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

Test animals

Species:
rat
Strain:
Wistar

Test system

Type of coverage:
semiocclusive
Vehicle:
physiological saline
Controls:
no
Duration of treatment / exposure:
24 h
Observation period:
14 days
Number of animals:
3/sex

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 30-60 min, 24 h, 48 h, 72 h
Score:
0
Max. score:
0
Other effects:
none

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Testosterone is not classified according to Directive 67/548/EEC and Regulation 1272/2008/EC (CLP) criteria, based on no irritating potential in vivo of the read-across substance, androstenedione
Executive summary:

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

ZK 5155 did not show a skin irritating or corrosive potential in rats when administered semi-occlusively to the back for 24 hours.