Registration Dossier

Diss Factsheets

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
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

Constituent 1
Chemical structure
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:
no findings
Body weight:
Body weight and body weight development of male and female rats were not affected by treatment.
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.