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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: study report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1958
Report Date:
1958

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
BASF test: In principle, the methods described in OECD Guideline 401 were used.
5-10 rats per dose were treated by gavage with preparations of the test substance in 10 % traganth. Group-wise documentation of clinical signs was performed over the 7-day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. The clinical signs and findings were reported in summary form.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Aqueous traganth emulsion
Doses:
2.040, 3.160 and 5.010 ml/kg bw (corresponding to 1840, 2840 and 4510 mg/kg bw) Calculation of concentrations (mg/kg bw) based on density of the test substance (0.90 g/ml).
No. of animals per sex per dose:
5-10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 3 150 mg/kg bw
Mortality:
One, 2 and 8 animals died in the dose groups of 1832, 2838 and 4500 mg/kg bw, respectively.
Clinical signs:
1832 mg/kg bw: only piloerection on the day after substance administration
2838 mg/kg bw: piloerection, staggering gait, one rat had diarrhea
4500 mg/kg bw: piloerection, labored breathing, abdominal position, crawling gait.
Gross pathology:
1832 mg/kg bw: mottled lung surface, thymus haemorrhagic, spleen congested
2838 and 4500 mg/kg bw: hyperemia of medulla renalis was observed.
Other findings:
- Histopathology: low grade of fatty degeneration was observed in liver of one animal in 2838 mg/kg bw dose group.

Any other information on results incl. tables

Dose (mg/kg bw)

No. of animals

Mortality

1 h

24 h

48 h

7 days

1832

5

0/5

1/5

1/5

1/5

2838

5

0/5

2/5

2/5

2/5

4500

10

0/10

4/10

8/10

8/10

Original value reported: LD50 = 3.5 ml/kg bw (corresponding to ca. 3150 mg/kg bw)

Applicant's summary and conclusion