N-(N6-trifluoroacetyl-L-lysyl)-L-proline

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-01-31 to 1990-04-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

1984

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(N6-trifluoroacetyl-L-lysyl)-L-proline

EC Number:

402-920-1

EC Name:

N-(N6-trifluoroacetyl-L-lysyl)-L-proline

Cas Number:

103300-89-6

Molecular formula:

C13H20F3N3O4

IUPAC Name:

(2S)-1-[(2R)-2-amino-6-(2,2,2-trifluoroacetamido)hexanoyl]pyrrolidine-2-carboxylic acid

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

other: Bor: WISW (SPFCpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Males 8 weeks Females 8 weeks
- Weight at study initiation: Males 154 - 212 g Females 127 - 131 g
- Fasting period before study: 16 h before treatment
- Housing: individually, Macrolon cages, type II, Bedding: Animal bedding chips, supplied by Jelu-Werk, J. Ehrler, Industriemehle, D-7092 Rosenberg/Württ.
- Diet (e.g. ad libitum): Standard diet ad libitum ssniff R, "Special diet for rats", supplied by ssniff Spezialfutter GmbH, D-4770 Soest
- Water (e.g. ad libitum): Water was provided ad libitum in drinking water quality from the Stadtwerke Bielefeld (Municipal Works), using an automatic drinking water system with drinking nipples.
- Acclimation period: The animals were kept at least 5 days under test conditions before administration of the test substance. Veterinary supervision of the animals was done before start of study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 -22.5
- Humidity (%): 40 - 65 (for a short period 25 - 30)
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 237 mg/mL
- Amount of vehicle (if gavage): 21.5 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 21.5 mL/kg

Doses:

5110 mg/kg b.w.

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The body weights were recorded at the beginning and also 7 and 14 days after administration. The animals were continuously observed for the first 4 to 6 hours after administration and then once daily. The nature of the toxicity as well as the onset, the intensity, and the duration of the signs were recorded. Mortality was checked twice daily (a.m. and p.m.), on Saturdays, Sundays, and on national holidays only once.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: Mortality

Statistics:

The LD 50 values were above a dose of 5110 mg/kg in male and female rats, thus no further statistics were performed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 110 mg/kg bw

Based on:

test mat.

Mortality:

No Mortality occurred

Clinical signs:

other: Signs of toxicity were not observed

Gross pathology:

At necropsy of the animals no abnormalities were detected.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a study conducted according to OECD guideline 401 (1987) the LD 50 values were above a dose of 5110 mg/kg in male and female rats. Thus, the test item does not need to be classified according Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) with respect to acute oral toxicity.