Registration Dossier
Registration Dossier
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EC number: 691-746-1 | CAS number: 220380-44-9
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 3 females, 3 males
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 4 000 mg/kg bw
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- LD50 rat: greater than 4000 mg/kg body weight
- Executive summary:
LD50 rat: greater than 4000 mg/kg body weight
Reference
Two groups, each using three female or three male Hanlbm: WIST (SPF) rats, were treated with FAT 93'464/A at 4000 mg/kg by oral gavage. The test article was suspended in vehicle (polyethylene glycol PEG 300) at a concentration of 0.4 g/ml and administered at a volume of 10 ml/kg. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2-15. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically. No death occurred during the study. In all females, violet urine and dark feces were observed until test day 3. In all males, these findings were evident until test day 2. In one male, respiratory sounds were noted on test day 2. All clinical signs were reversible after 4 days. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 4 000 mg/kg bw
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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