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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline with acceptable restrictions (mostly due to reduced reporting in times before GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report Date:
1963

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Vinylpyrrolidon roh (crude)
- Physical state: liquid

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Heigl
- Weight at study initiation: males 136-215 g; females 128-186 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2% (200 mm3/kg bw) or 20% (800-1600 mm3/kg bw)


MAXIMUM DOSE VOLUME APPLIED: 2.15 mL (10 mL/kg bw)
Doses:
200, 800, 1000, 1250 and 1600 mm3/kg bw, corresponding to ca. 209, 834, 1043, 1304 and 1669 mg/kg bw; calculated with a density of 1.043 g/mL)
No. of animals per sex per dose:
5 (exception 200mm3/kg bw had total 5 animals of both sexes)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Weighing was only at the beginning of the study for dose calculation. Observation of clinical signs was several times on the day of administration and once daily afterwards with the exception of weekends and on holidays.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 043 mg/kg bw
Remarks on result:
other: original data: LD50 = 1.0 mL/kg bw; calculated with a density of 1.043 g/mL
Mortality:
200 mm3/kg bw: 0/5 animals died
800 mm3/kg bw: 0/10 animals died
1000 mm3/kg bw: 5/10 animals died within 7 days (3/10 within 48 hrs)
1250 mm3/kg bw: 8/10 animals died within 7 days (5/10 within 48 hrs)
1600 mm3/kg bw: 8/10 animals died within 7 days (7/10 within 48 hrs)
Clinical signs:
Staggering gait, partially draged hindlimbs, slight apathy, abdominal position, ruffled fur, crusted eyelids; all signs were reversible within at least 3 days
Body weight:
not measured
Gross pathology:
Animals that died: livers spotted bright, lobules marked; spleen and kidneys brightened; stomach with lamellar bleedings
Sacrificed animals: nothing abnormal found

Applicant's summary and conclusion