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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)
28 day repeated dose Oral toxicity test
NOAEL=500mg/kg bw/day (males/females)
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
500 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.

28 days oral toxicity followed by 2 weeks recovery period: Oral gavage administration of FR-513 to Sprague-Dawley rats at doses of 30, 150 or 500 mg/kg/day for four weeks was well-tolerated and did not cause any adverse change. A test-article related response was evident in the liver (predominantly at ≥150 mg/kg/day) as indicated by increased organ weight and a correlative microscopic finding of slight minimal centrilobular hypertrophy. Some changes in blood chemistry (low sodium and high potassium concentrations in males at 500 mg/kg/day) or urine composition/output (increased urinary volume and total protein and glucose output in males at 500 mg/kg/day) occurred and a slight increase in kidney weight was evident in both sexes (predominantly at ≥150 mg/kg/day). None of these changes was considered adverse in nature, however, and the majority showed full or at least partial recovery. Consequently, the no-observed-adverse-effect level (NOAEL) was considered to be 500 mg/kg/day of FR-513.

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.