Registration Dossier

Administrative data

Description of key information

No studies are available for testosterone and information is based on read across to a similar substance, androstenedione. Based on read across to androstenedione, the oral LD50 for testosterone is considered to be >500<1000 mg/kg in male rats and >500 mg/kg in female rats. The dermal LD50 is >2000 mg/kg in male and female rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
500 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

 

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

Based on read across to androstenedione, the oral LD50 for testosterone is considered to be >500<1000 mg/kg in male rats and >500 mg/kg in female rats. The dermal LD50 is >2000 mg/kg in male and female rats.

Justification for selection of acute toxicity – oral endpoint

Lowest acute toxicity value.  LD50 for testosterone, by read-across, is between 500-1000 mg/kg-bw.

Justification for selection of acute toxicity – dermal endpoint

Effect level is greater than the limit dose, 2000mg/kg-bw.

Justification for classification or non-classification

Based on read across to androstenedione and according to the Directive 67/548 EEC, testosterone is classified: Xn, R22 - Harmful if swallowed and as Category 4 according to Regulation (EC) 1272/2008 (CLP).