L-Leucine, 4-fluoro-N-[(1S)-2,2,2-trifluoro-1-[4'-(methylsulfonyl)[1,1'-biphenyl]-4-yl]ethyl]-, compd. with N-cyclohexylcyclohexanamine (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 05 to October 21, 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted according to OECD and in accordance with GLP. The study material is well characterized

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

N-cyclohexylcyclohexanaminium (2S)-4-fluoro-4-methyl-2-{[(1S)-2,2,2-trifluoro-1-{4'-methanesulfonyl-[1,1'-biphenyl]-4-yl}ethyl]amino}pentanoate

EC Number:

700-778-8

Cas Number:

1064076-86-3

Molecular formula:

C21H23F4NO4S.C12H23N

IUPAC Name:

N-cyclohexylcyclohexanaminium (2S)-4-fluoro-4-methyl-2-{[(1S)-2,2,2-trifluoro-1-{4'-methanesulfonyl-[1,1'-biphenyl]-4-yl}ethyl]amino}pentanoate

Test animals

Species:

rat

Strain:

other: Outbred Albino Rats (Rattus norvegicus)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan, Indianapolis, IN, USA
- Age at study initiation: at least 49 days old
- Weight at study initiation: 200.3 - 219.0 grams. The weight variation did not exceed ±20% of the mean weight.
- Fasting period before study: overnight
- Housing: Single housing, polycarbonate cages with hardwood chip bedding
- Diet: TEK 7012 Rodent Diet from Harlan Teklad, ad libitum.
- Water: tap water, ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68°± 5°
- Humidity (%): 30-70 %
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light):12 hour light/dark cycle, full spectrum fluorescent lights

Administration / exposure

Route of administration:

other: Intragastric intubation by ball tip gavaging needle and syringe

Vehicle:

cotton seed oil

Details on oral exposure:

Dose volume: 2.0 - 2.2 ml

Doses:

dose level: 2000 mg/kg

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

A single dose was administerd to each of the 6 female animals.
After dosing, the animals were returned to their cages and supplied with feed and water ad libitum.

Careful clinical observations were made at least twice on the day of dosing.
The animals were observed daily for at least 14 days for clinical manifestations.
Animals weighed on day 0 prior to dosing and on days 7 and 14.
At the end of the observation period the animals were sacrificed by carbon dioxide inhalation.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animal was found dead for the duration of the study.

Clinical signs:

other: No clinical manifestations of toxicity was observed in any of the animals for the duration of the in-life phase.

Gross pathology:

No unusual findings were found during necropsy in all the dosed animals.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Using OECD 423, the Acute Toxic Class Method, the test substance as defined under the Globally Harmonized System for the classification of chemicals falls under Catdefregory 5 or unclassified.