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Acute Toxicity: oral

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
December 17, 2001
Deviations:
no
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

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.