Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Based on the PC data and the data reported in the EPA memorandum the below mentioned values were taken for DNEL calculation.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential
Absorption rate - oral (%):
100
Absorption rate - dermal (%):
5
Absorption rate - inhalation (%):
100

Additional information

There are no studies in the open literature.

Relevant PC data:

Pysical state: solid (no information on particle size distribution; granulometry)

Vapour pressure: <1.2 x 10E-6 hPa (at 25oC)

Partition coefficient: LogP(o/w): 4.6

Water solubility: 0.11 mg/l

Not intended to be a surfactant

In an EPA Memorandum some information on toxicokinetic studies is given. (Memorandum dated March 2, 2000; subject: Lactofen – Toxicology Evaluation; from Elizabeth Mendez;PC code: 12888.)

A dermal penetration study in rats indicated 1-4% dermal absorption at the 4 and 10 hr. time points. Absorption of 4.6% was reported in a dermal penetration study in monkeys. Metabolism and pharmacokinetic was investigated in rats after oral dosing. Seventy two hours after administration >/= 97% of the radiolabel was recovered in the excreta (urine and feces). Urinary excretion comprised 39 – 56% of the dose while the fecal output totaled ca. 43 – 67% of the dose. While the parent compound, lactofen, was the major metabolite in the feces, the major metabolite in urine was acifluorfen which accounted for >90% of the radioactivity recovered in this fraction. The maximum percentage of administered radioactivity that accounted in a tissue sample was 0.55 – 0.75% in the liver.

Overall, based on the PC data and the data reported in the EPA memorandum the following values were taken for DNEL calculation. Absorption oral: 100%; dermal : 5% and inhalation 100% (worst case)