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Administrative data

Description of key information

In both an acute oral and an acute dermal toxicity 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
Dose descriptor:
LD50
Quality of whole database:
The study has a Klimisch criterium 1.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Quality of whole database:
The study has Klimisch criterium 1.

Additional information

Acute oral toxicity

FAT 41043/A TE was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg body weight according to OECD 423.

No mortality occurred. Hunched posture and/or uncoordinated movements were noted among all animals on Day 1. Red faeces and/or red staining of the back was shown by all animals between Days 1 and 8. The mean body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals.

The oral LD50 value of FAT 41043/A TE in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

Acute dermal toxicity

FAT 41043/A TE was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight for 24 hours according to OECD 402.

Lethargy, piloerection, hunched posture, chromodacryorrhoea and/or ptosis were shown by all animals on Days 1 and/or 2. Red staining was noted on the treated skin-area of all animals between Days 2 and 15. The changes noted in body weight gain in males and females were within the normal range. Dark red discoloration of the liver was noted in the female that was found dead. No further abnormalities were found at macroscopic post mortem examination of the surviving animals.

The dermal LD50 value of FAT 41043/A TE in Wistar rats was established to exceed 2000 mg/kg body weight.


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 41043/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 (2007),

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