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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Value:
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
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).