Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Study duration:
subacute
Species:
rat
Quality of whole database:
The study has a Klimisch 1.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Rats (5/sex/dose) were treated with 0, 100, 300 or 1000 mg/kg bw/d of FAT 40854/A TE by gavage according to OECD 421. Based on no effects observed on the parameters measured (mortality, clinical signs, body weight, food consumption, macroscopic examination, organ weights, microscopic examination, mating, fertility and conception indices, precoital time, number of corpora lutea and implantation sites, gestation index and duration of gestation) the NOAEL for parental toxicity and reproduction toxicity was established to be 1000 mg/kg bw/d.


Short description of key information:
In an OECD 421 study in rat the oral NOAEL for reproductive toxicity was found to be 1000 mg/kg bw/d based on no adverse effects observed.

Justification for selection of Effect on fertility via oral route:
Only reliable study available, performed according to OECD guideline and GLP principles.

Effects on developmental toxicity

Description of key information
In an oral OECD 421 study in rat the NOAEL for parental and developmental toxicity was found to be 1000 mg/kg bw/d based on no adverse effects observed.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Study duration:
subacute
Species:
rat
Quality of whole database:
The study has a Klimisch 1.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Rats (5/sex/dose) were treated with 0, 100, 300 or 1000 mg/kg bw/d of FAT 40854/A TE by gavage according to OECD 421. Based on no effects observed on the parameters measured (mortality, clinical signs, body weight, food consumption, macroscopic examination, organ weights, microscopic examination for parents and mortality, clinical signs, early postnatal development, body weight and macroscopy of pups) the NOAEL for parental toxicity and reproduction toxicity was established to be 1000 mg/kg bw/d.


Justification for selection of Effect on developmental toxicity: via oral route:
Only reliable study available performed according to OECD guideline and GLP principles.

Justification for classification or non-classification

Based on the results available, FAT 40854/A TE does not have to be classified for reproduction 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.