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 with the NOAEL exceeding 1000 mg/kg bw/d based on no adverse effects observed.

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 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

Wistar rats (5/sex/dose) were treated with FAT 40854/A TE for 28 consecutive days by daily oral gavage at a dose of 0, 100, 300 or 1000 mg/kg bw/d according to OECD 407. 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). The NOAEL of FAT 40854/A TE was established to exceed 1000 mg/kg bw/d.


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

Justification for classification or non-classification

Based on the results available, FAT 40854/A TE does not have to be classified for repeated dose toxicity according to

the:

-Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011),

-Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.