Alanine, N-(1-oxobutyl)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

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-butyrylalanine

EC Number:

611-909-2

Cas Number:

59875-04-6

Molecular formula:

C7 H13 N O3

IUPAC Name:

N-butyrylalanine

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Strain: Hsd Cpb:WU (SPF)
- Age at study initiation: 8-12 weeks
- Mean weight at study initiation: 235 g (males) or 172 g (females)
- Housing: in groups of 3 animals
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): approx. 55 +/- 5
- Air changes (per hr): approx. 15-20
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

demineralized

Details on oral exposure:

- Application volume: 10 mL/kg bw

- Rationale for the selection of the starting dose:
The doses were chosen according to the flow charts of Annex 2 of OECD guideline 423 (1996) with a starting dose of 2000 mg/kg bw.

Doses:

2000 mg/kg (males and females)

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once daily (clinical signs, mortality) or once weekly (weight gain)
- Necropsy of survivors performed: yes

Statistics:

none

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

other: LD50 cut-off

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Mortality:

The dose of 2000 mg/kg bw was tolerated well by males and female rats without mortality or clinical signs. Body weight development was not affected and no gross pathological findings became obvious at sacrifice.

Clinical signs:

other: no findings

Gross pathology:

no findings

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information

Executive summary:

The acute oral toxicity of Butanoylalanin in male and female Wistar rats was tested according to OECD TG 423 (1996). The dose of 2000 mg/kg bw was tolerated well by the animals without mortality or clinical signs. Body weight development was not affected by treatment and no gross pathological findings became obvious at sacrifice. Thus, the LD 50 cut-off was determined with > 2500 mg/kg bw.