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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

1. - Acute (one single dose) study oral (gavage), rat m/f, (EPA FIFRA, Subdivision F, §81-1 (1984) = EEC B.1 (1992): LD50 > 5000 mg/kg bodyweight. 
2. - Acute (single 4 hour exposure) study inhalation, rat m/f, EPA FIFRA, Subdivision F, §81-3 (1984) = EEC B.2 (1992): LC50 > 4.62 mg/l (technical limit)
3. - Acute (one single application) study dermal, rabbit m/f, EPA FIFRA, Subdivision F, §81-2 (1984) = EEC B.3 (1992): LD50 > 2000 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Acute toxicity, local tolerance

Fluometuron is of low acute toxicity irrespective of the route of exposure (oral, dermal or inhalation) with LD50/LC50 values in excess of the international regulatory limit dose (See Table below). At the highest oral limit dose all animals initially showed lethargy and hunched posture recovery was complete within the first day, thereafter there were no clinical signs of reaction to treatment. No evidence of systemic toxicity or skin irritation was seen after a single dermal exposure of rats to 2000 mg/kg. Acute inhalation exposure caused non-specific signs typical of exposure to a high concentration of dust particles and method of restraint (wet fur and decreased respiratory rate). After exposure, hunched posture, decreased respiratory rate, lethargy and pilo-erection were recorded. All animals appeared normal two days after treatment and for the rest of the study period, no deaths were recorded.

Table 7.2 : Summary of acute toxicity of fluometuron

Parameter

Species

Result

Reference

Acute oral (LD50)

Rat

> 5000 mg/kg

Jones, 1989a

Percutaneous (LD50)

Rabbit

> 2000 mg/kg

Jones, 1989b

Acute inhalation (LC50)

Rat

> 4.62 mg/l

Jones, 1989c

Justification for classification or non-classification

In accordance with regulation 1272/2008, Annex I, 3.1, classification for acute toxicity is not required.

Within all tests LD50 values requiring classification were not reached. For inhalation concentration of Fluometuron was technically limited to 4.62 mg/L. As no deaths from inhalation up to the limit and also for oral administration at 5000 mg/kg bodyweight were observed, no deaths in the range between 4.62 and 5 mg/L are expected.