Orthosulfamuron

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 23 to July 17, 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

December 17, 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

August 1998

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

IR5878
Batch number: G 009/02
Purity: 98.56 ± 0.19 %

Test animals

Species:

mouse

Strain:

other: HanIbm: NMRI (SPF)

Sex:

female

Details on test animals or test system and environmental conditions:

Test animals:
Species and Strain: Female HanIbm: NMRI (SPF) mice
Age: 8 weeks
Body weight: 23.5 ÷ 27.6 g
Housing: 1 to 2 animals per Makrolon type-3 cage with wire mesh tops and standard softwood bedding.
Feed: pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet ad libitum. Community tap water from Füllinsdorf ad libitum.

Environmental conditions:
Temperature and humidity measured during the study were 22 ± 3°C and 30 ÷ 70%, respectively.
Light: 12 hours fluorescent light and 12 hours dark (music during the light period).

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: PEG

Details on oral exposure:

IR5878 was diluted in vehicle (PEG 300) at a concentration of 0.5 g/mL and administered to three female HanIbm: NMRI (SPF) mice, by oral gavage at the dose level of 5000 mg/kg bw.

Doses:

concentration of 0.5 g/mL
dose volume of 10 mL/kg

No. of animals per sex per dose:

3 females

Control animals:

not specified

Details on study design:

The test material was diluted in vehicle (PEG 300) at a concentration of 0.5 g/mL and administered to three female HanIbm: NMRI (SPF) mice fasted for 3 to 4 hours, by oral gavage at the dose level of 5000 mg/kg bw; the test substance preparation was applied at a dose volume of 10 mL/kg.
The animals were examined for mortality, clinical signs and body weight from day 1 to day 14. On day 15 mice were killed by i.p. overdosage of pentobarbitone and examined macroscopically.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities were observed in this test.

Clinical signs:

No clinical signs were observed during the course of the study.

Body weight:

One animal showed body weight loss (3.6%) from day 8 to the end of the observation period. Body weight of the other animals was not affected.

Gross pathology:

At gross necroscopy no macroscopic findings were recorded.

Applicant's summary and conclusion

Conclusions:

The oral LD50 of IR5878 in female mice was greater than 5000 mg/kg bw.

Executive summary:

IR5878 was diluted in vehicle (PEG 300) at a concentration of 0.5 g/mL and administered to three female HanIbm: NMRI (SPF) mice, by oral gavage at the dose level of 5000 mg/kg bw.

The oral LD₅₀of IR5878 in female mice was greater than 5000 mg/kg bw.