Registration Dossier

Diss Factsheets

Administrative data

acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: T003474 is an intermediate in the synthesis of abiraterone acetate. T003474 is the last step before the API. Both compounds have a silimar structure. Therefore, read-across from the API abiraterone acetate is performed.
Reason / purpose for cross-reference:
reference to other study

Data source

Reference Type:
other company data

Materials and methods

Results and discussion

Applicant's summary and conclusion

LD50: > 400 mg/kg, rat;
LD50: 800 mg/kg, mouse;
Executive summary:

A single oral-dose gastric irritation study in MF1 mice using abiraterone acetate at a dose of 800 mg/kg (2400 mg/m²) showed no evidence of toxicity. There were animal deaths in both control (4/10) and study treatment (2/10) groups. These were considered to be related to the dosing procedure since necropsy revealed esophageal injury during dosing and infiltration of dosing material into the pleural cavity. In the surviving animals, there were no treatmentrelated effects in the GI tract, in the viscera or in the general condition of the animals. A single-dose oral toxicity study of abiraterone acetate was conducted in male rats at a dose level of 400 mg/kg (2400 mg/m²). No mortality or treatment-related adverse effects were seen during the 14-day observation period. In one animal, red staining around one eye was noted on Day 5. Body weight was not affected by abiraterone acetate treatment. Some variations in hematology and clinical chemistry were observed but were within the normal ranges for this species and were attributed to normal biological variation. No gross findings were noted at necropsy. The no-observed-adverse-effect level (NOAEL) for acute toxicity was established at 400 mg/kg (2400 mg/m²) in male rats.