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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16.02.2001 - 10.04.2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline and GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 1996
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Italy S.r.l., 33049 San Pietro al Natisone
- Age at study initiation: 5 to 6 weeks
- Weight at study initiation: 120 to 150 grams
- Fasting period before study: overnight fast prior to dosing
- Housing: polycarbonate cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 40-70 %
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
25, 200, 2000 mg/kg bw
No. of animals per sex per dose:
3 males (2000 and 200 mg/kg bw)
3 males and females (25 mg/kg bw)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Body weight: at allocation to the study (day -1), prior the dosing (day 1) and on day 8 and 15
- Clinical signs: 1,2 and 4 hours after dosing and daily thereafter for a total of 14 days

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 25 - < 200 mg/kg bw
Based on:
test mat.
Mortality:
25 mg/kg bw: no death
200 mg/kg bw: 2/3 males within 1 hour after dosing
2000 mg/kg bw: 3/3 males within 1 hour after dosing
Clinical signs:
25 mg/kg bw : no clinical signs were observed
200 mg/kg bw: 2/3 males showed convulsions and pronation approximately 5 minutes after dosing
2000 mg/kg bw: 3/3 males showed convulsions appproximately 1 minute after dosing
Body weight:
no outstanding changes in body weight
Gross pathology:
Abnormal content (yellow or pale mucoid or creamy material) in the stomach and in the jejunum of the early decedent male animals.
Skin/fur staining around the perioral/perinasal region in early decedent male animals.

Applicant's summary and conclusion