Registration Dossier

Administrative data

Description of key information

ZK 5155 (androstenedione) did not show a skin irritating or corrosive potential in rats when administered semi-occlusively to the back for 24 hours.  ZK 5155 provoked slight to moderate transient irritations (vessel injection and secreation in 2/4 animals) on the rabbit eye after single interconjunctival application on the day of administration. ZK5155 is not regarded as an eye irritant.

Based on data from the read across substance androstenedione, testosterone is not considered to be a skin or eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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
Species:
rat
Strain:
Wistar
Type of coverage:
semiocclusive
Vehicle:
physiological saline
Controls:
no
Duration of treatment / exposure:
24 h
Observation period:
14 days
Number of animals:
3/sex
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline, GLP study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
other: left eye served as control
Duration of treatment / exposure:
substance was not flushed out, application of 0.1 ml substance only into the right eye
Observation period (in vivo):
0.5, 1, 2, h after application and then every 24 h until day 4 of test
Number of animals or in vitro replicates:
4 animals
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Other effects:
ZK 5155 provoked slight to moderate transient irritations (vessel injection and secreation in 2/4 animals) on the rabbit eye after single interconjunctival application on the day of administration.
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 read-across substance androstenedione.
Executive summary:

There are no available eye 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 provoked slight to moderate transient irritations (vessel injection and secretion in 2/4 animals) on the rabbit eye after single interconjunctival application on the day of administration. ZK5155 is not regarded as an eye irritant.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

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 classifiable as either a skin or an eye irritant according to Directive 67/548 EEC or Regulation (EC) 1272/2008 (CLP).