Registration Dossier

Administrative data

Description of key information

A 28-day oral toxicity study performed according to OECD/EC guideline and GLP principles is available.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Study duration:
subacute
Species:
rat
Quality of whole database:
The study has a Klimisch criterium 1.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

28-d oral toxicity

Wistar rats (5/sex/dose) were treated with FAT 41043/A TE for 28 consecutive days by daily oral gavage at a dose level of 0, 100, 300 or 1000 mg/kg bw.

No toxicologically significant changes were noted in any of the parameters investigated in this study (i.e. clinical signs, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination).

From the results presented in this report a NOAEL for FAT 41043/A TE of at least 1000 mg/kg bw was established.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
only reliable study available performed according to guideline

Justification for classification or non-classification