Registration Dossier

Administrative data

Description of key information

Acute Oral toxicity study to rats
Acute dermal toxicity study to rats

Key value for chemical safety assessment

Acute toxicity: via oral route

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

Acute toxicity: via dermal route

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

Additional information

Acute oral toxicity in rats: Mortality was observed in 1 out of 3 female rats in two separate observations following oral administration of FR-513 at 2000 mg/kg. Lethargy, restless behavior, hunched posture, ventro-lateral recumbency, flat gait, uncoordinated movements, labored respiration, piloerection, salivation, ptosis, squeaking, and/or hypothermia were noted among animals between days 1 and 3. No abnormalities were found and body weight gain was considered to be normal. The oral LD50 of the test material is judged to be greater than 2000 mg/kg in female rats.

Acute dermal toxicity to rats : No mortality observed. Lethargy, flat posture, hunched posture, piloerection, ptosis, red urine, chromodacryorrhoea and/or shallow respiration were noted among the animals. The animals had recovered from the symptoms by day 5. General or maculate erythema, necrosis, scales, scars and/or scabs were seen in the treated skin-area of the animals during the observation period. No abnormalities occurred and body weight gain was considered to be normal. The dermal LD50 value FR-513 in Wistar rats was established to exceed 2000 mg/kg body weight.

Acute inhalation toxicity: FR-513 is not expected to be available through the inhalation route, since the substance is a solid, in a flakes form (not powder), with a very low estimated vapour pressure.

 

Justification for classification or non-classification

Based on the high LD50 values for the oral and dermal exposure, together with the unlikelyhood for inhalation exposure of the substance, FR-513 does not need to be classified for acute toxicity under the EEC criteria for classification and labelling requirements for Dangerous Substances and Preparations (67/548/EEC) and the CLP Regulation (EC No 1272/2008).