Registration Dossier

Administrative data

Description of key information

- Oral: LD50: > 2000 mg/kg bw for the rat (OECD TG 423); study Giannini (2008) /  Acute toxicity: oral
- Dermal: LD50: > 2000 mg/Kg bw for the rat (EU method B3); Giannini (2009) / Acute dermal toxicity in rats
- Inhalation: no data available

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

oral:

In the study "Giannini (2008) / Acute toxicity: oral" two groups, each of three female HanRcc:WIST (SPF) rats, were treated with FAT 40841/A TE by oral gavage administration at a dosage of 2000 mg/kg body weight according to OECD TG 423.

All animals survived until the end of the study period. In three animals blue feces were observed on test day 2. Otherwise, no clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy.

The median lethal dose of FAT 40841/A TE after single oral administration to female rats, observed over a period of 14 days is: LD50 (female rat): greater than 2000 mg/kg body weight.

dermal:

In the study "Giannini (2009) / Acute dermal toxicity in rats" the acute dermal toxicity of FAT 40481/A TE was tested in a GLP study in accordance with EU Method B.3. A single dose of 2000 mg/kg bodyweight of the test substance dissolved in water was applied topically to the backs of five male and five female adult HanRcc WIST(SPF) rats. The application site was kept under semiocclusive dressing for 24 hours. After removal of the dressing the skin was washed with lukewarm water. Animals were observed during a period of 14 days after removal of the dressing. No deaths occurred during the study. No clinical signs were observed. Due to a persisting blue staining of the skin a reliable assessment of potential skin irritating effects was not possible during the first study days. At later time points when the staining had vanished no reddening of the skin was seen. No gross findings were recorded during necropsy at the termination of the study at day 15. In conclusion, no adverse effects in rats were seen after the application of a single dermal dose of FAT 40481/A TE at a dose level of 2000 mg/kg bodyweight.

- inhalation:

no data available

Justification for classification or non-classification

- oral:

Based on the assessment presented above, stating the absence of measurable acute oral toxicity, FAT 40841/A TE does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) as implementation of UN-GHS in the EU.

- dermal:

Based on the assessment presented above, stating the absence of measurable acute dermal toxicity, FAT 40841/A TE does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) as implementation of UN-GHS in the EU.

- inhalation:

As no data on acute inhalation toxicity is available for FAT 40841/A TE a classification is not possible according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) as implementation of UN-GHS in the EU.