Registration Dossier
Registration Dossier
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EC number: 435-190-8 | CAS number: 246871-16-9
Endpoint summary
Administrative data
Description of key information
LD50 (rat, oral, female/male) is greater than 2000 mg/kg bw.
LD50 (rat, dermal,male/female) is greater than 2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral toxicity test and dermal toxicity test of the test substance were performed under GLP test condition according to the OECD guideline. The inhalation toxicity test is waived according to COLUMN 2 of REACH ANNEX VIII.
The acute oral toxicity test was performed according to OECD guideline No. 423 and Directive 96/54/EEC, B.1 under GLP compliance. Two groups, each using three male or three female HanIbm: WIST (SPF) rats, were treated with FAT 41'029/A at 2000 mg/kg by oral gavage. No death occurred during the study. No clinical signs were observed during the observation period. Two male animals (nos. 4 and 6) showed a marginal loss of body weight (-5 %) between test day 8 and 15. The body weight of the other animals was within the range commonly recorded for animals of this strain and age. No macroscopic findings were observed at necropsy. Thus, the LD50 of FAT 41'029/A after single oral administration to rats of both sexes, observed over a period of 14 days, is greater than 2000 mg/kg body weight.
The acute dermal toxicity study of FAT41'029/A was performed according to OECD guideline No. 402 and Directive 92/69/EEC, B.3 under GLP compliance. A group of five male and five female HanIbm: WIST (SPF) rats was treated with FAT 41'029/A at 2000 mg/kg by dermal application. No deaths occurred during the study. A light orange discoloration of the treated skin sites was observed in all animals after removal of the semi-occlusive dressing only. The body weight of the animals was within the range commonly recorded for animals of this strain and age. No macroscopic findings were observed at necropsy. Thus, the LD50 of FAT 41'029/A after single dermal administration to rats of both sexes, observed over a period of 14 days is, greater than 2000 mg/kg body weight.
Justification for classification or non-classification
Based on the LD50 (oral, rat) and LD50 (rat, dermal), both of them were greater than 2000 mg/kg bw. Thus, the test article is not classified in accordance with CLP (Regulation EC No. 1272/2008) or DSD (Directive 67/548/EEC) for oral and dermal acute toxicity. Data on acute inhalative toxicity are not available. Classification for STOT SE (specific target organ toxicity, single exposure) is also not required, as no systemic effects were seen in the acute studies.
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