Methanone, (2-chloro-5-iodophenyl)(4-fluorophenyl)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 Jul 2007 - 16 Oct 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

exception: The test article was characterized for composition and purity. However, it was not done under GMP/GLP. It was not characterized for stability.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

GLP compliance:

yes

Remarks:

exception: The test article was characterized for composition and purity. However, it was not done under GMP/GLP. It was not characterized for stability.

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(2-chloro-5-iodophenyl)(4-fluorophenyl)methanone

EC Number:

619-596-4

Cas Number:

915095-86-2

Molecular formula:

C13 H7 Cl F I O

IUPAC Name:

(2-chloro-5-iodophenyl)(4-fluorophenyl)methanone

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST animals
Male and female. Females assigned to the test
were nulliparous and non-pregnant. Rats were obtained from Harlan UK.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5% hydroxyethylcellulose (HEC) in deionized water

Details on oral exposure:

Each animal was dosed by oral intubation using a stainless-steel ball tipped gavage needle attached to a disposable syringe.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 male and 3 female

Control animals:

no

Details on study design:

All animals were observed at the beginning and the end of the working day for signs of ill health or overt toxicity.

Results and discussion

Preliminary study:

In the study fasted rats were given the test article as a single dose by oral
gavage at a dose level of 2000 mg/kg.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed in the animals at 2000 mg/kg.

Clinical signs:

other: No clinical signs were observed in the animals at 2000 mg/kg.

Gross pathology:

No visible lesions were observed in any of the animals at 2000 mg/kg at terminal necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: not classified acc. CLP

Conclusions:

The test article, BI 10773 Fluorid, was considered to have no significant acute toxic risk in respect
of its acute oral toxicity and did not meet the criteria for classification according to the
Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

Executive summary:

A. Title Acute Oral Toxicity Study of IN 00078280 in the Rat - Acute Toxic Class Method

B. Objective This study was designed to assess the toxicity of IN 00078280 following a single oral dose to the rat. The results of the study are believed to be of value in predicting the likely toxicity in man by the oral route.

C. Methods One group of three female Wistar rats were orally administered IN 00078280 via oral gavage at 2000 mg/kg. Due to the lack of mortality observed in the females at 2000 mg/kg, an additional group of three males was administered the test article at 2000 mg/kg. Mortality checks were made once daily. Clinical observations were recorded at approximately 0.5, 1 and 4 hours post dose (±15 minutes), and daily thereafter through Day 15. Body weights were recorded on Day 1 (fasted) and on Days 8 and 15. A gross necropsy was performed on all animals on Day 15.

D. Results No mortality was observed in any of the animals at 2000 mg/kg. No clinical signs were observed in the animals at 2000 mg/kg. All animals gained weight throughout the study. Necropsy revealed no visible lesions in any of the animals at 2000 mg/kg at terminal necropsy.

E. Conclusion According to the Globally Harmonized Classification System, IN 00078280 administered orally at dose levels of 2000 mg/kg in male and female rats was considered to be a Category 5 test substance with an LD50 ∞ (unclassified).