Registration Dossier

Administrative data

Description of key information

In both an acute oral and acute dermal toxiciy study the LD50 was established to exceed 2000 mg/kg bw. The studies were performed according to OECD/EC guidelines and GLP principles.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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

Additional information

Acute oral toxicity

FAT 40854/A TE was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg bw according to OECD 423. No mortality occurred. Hunched posture was noted in all animals on day 1. All animals showed red faeces on day 1 or 2. No effect on body weight was noted and no abnormalities were seen at macroscopy. The oral LD50 of FAT 40854/A TE in Wistar rats was established to exceed 2000 mg/kg bw.

Acute dermal toxicity

FAT 40854/A TE was administered to Wistar rats (5/sex) by a single dermal application at 2000 mg/kg bw for 24 hours according to OECD 402. No mortality occurred. Chromodacryorrhoea or scales on the snout was noted in three and one animal, respectively, on day 1. Redness, scales and/or scabs in the treated skin area of all animals was seen during the observation period. No effect on body weight was noted. No abnormalities were found at macroscopy.

The dermal LD50 of FAT 40854/A TE was established to exceed 2000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
Only reliable study available performed according to guideline.

Justification for selection of acute toxicity – dermal endpoint
Only reliable study available performed according to guideline.

Justification for classification or non-classification

Based on these results, FAT 40854/A TE does not have to be classified and has no obligatory labelling requirement for acute oral and dermal 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