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Description of key information

acute oral toxicity: LD50 cut-off >2500 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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
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
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The study is GLP compliant and is of high quality (Klimisch score=1)

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

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.


Justification for selection of acute toxicity – oral endpoint
only one study available

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) for acute oral toxicity is not warranted.

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