Registration Dossier
Registration Dossier
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EC number: 253-057-0 | CAS number: 36483-57-5
Endpoint summary
Administrative data
Description of key information
14 day repeated dose Oral toxicity test
NOAEL= 1000 mg/kg bw/day (females); 300 mg/kg bw/day (males)
30 day feeding study with FR-1360:
NOAEL= 300 mg/kg bw/day (females); 30 mg/kg bw/day (males)
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 30 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
14 day Oral toxicity test: It is concluded that daily oral gavage administration of Trinol to CD rats at
doses up to 1000 mg/kg/day in females and 300 mg/kg/day in males was well tolerated and
these doses are considered to be the no-observed-adverse-effect-level (NOAEL). However,
doses of 1000 mg/kg/day in males necessitated premature sacrifice of these animals on Day 4
and was considered to exceed the maximum tolerated dose.
30 day dietary feeding study with FR-1360: Ingestion of up to 30 mg/kg/day of FR-1360 in the diet of rats for 30 days did not cause changes in the toxicological parameters evaluated (NOAEL = 30 mg/kg/day). At levels of 100 and 300 mg/kg/day, histologic changes in kidney and urinary bladder were noted in male rats. No changes were noted in any of the female rats in this study.
Justification for classification or non-classification
Based on the information gained, the test substance Tribromoneopentyl glycol does not need to be classified for repeated dose toxicity according to Directive 67/548/EEC or Regulation (EC) No 1272/2008.
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