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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:
1980-04-15
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well-documented, scientifically acceptable study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Principles of method if other than guideline:
according to BASF-internal standard
GLP compliance:
no
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:
The animals were offered a standard animal laboratory diet. Fasting period 15 - 20 h before administration.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
Application form: emulsion
Concentrations used: 1.36, 2, 2.94, 4.3 and 5.22 % (G/V)
Application volume: 5 mL/kg bw
Doses:
68.1, 100, 147, 215 and 261 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
111 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Slope factor 1.38
Sex:
male
Dose descriptor:
LD50
Effect level:
121 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Slope factor 1.36
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 110 mg/kg bw
Based on:
test mat.
Remarks on result:
other: derived by interpolation
Mortality:
Male animals: 68.1 mg/kg bw: no deaths after 14 days; 100 mg/kg bw: 2/5 after 7 days; 147 mg/kg bw: 3/5 after 7 days; 215 mg/kg bw: 5/5 after 7 days; 261 mg/kg bw: 1/5 after 1 day, 4/5 after 7 days, 5/5 after 14 days
Female animals: 68.1 and 100 mg/kg bw: 1/5 after 14 days; 147 mg/kg bw: 3/5 after 7 days, 5/5 after 14 days; 215 mg/kg bw: 1/5 after 2 days, 5/5 after 7 days; 261 mg/kg bw: 5/5 after 7 days
Clinical signs:
Dyspnea, gasping, apathy, abnormal position, staggering, atony, trembling, spastic gait, ruffled fur, alopecia, exsiccosis, poor general state
Body weight:
Mean body weight male animals: 188 g at study start, 224 g after 13 days
Mean body weight female animals: 170 g at study start, 200 g after 13 days
Gross pathology:
Animals that died: heart: acute dilatation (right); acute congestive hyperemia; kidneys: papillae yellow-grey (papilla necrosis); urinary bladder: isolated bloody content
Sacrificed animals: white strips in the papilla, isolated papilla yellow (papilla necrosis)

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category III
Remarks:
Migrated information
Conclusions:
The acute oral LD50 of the test substance in olive oil was determined to be 111 mg/kg bw in male and female rats.
Executive summary:

The test substance was administered orally by gavage to male and female rats in olive oil. Doses of 68.1, 100, 147, 215 and 261 mg/kg bw were applied. Death and several clinical signs were observed. The acute oral LD50 was determined to be 111 mg/kg bw in male and female rats.