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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: GLP, non-guideline, limitations in design and/or reporting

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 99,6 %

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Kingston, NY
- Age at study initiation: 8 weeks
- Weight at study initiation: 106-124 g


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 71-75
- Humidity (%): 51-52
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg b.w.
Doses:
0, 90, 722, 1445, 2890 mg/kg b.w.
No. of animals per sex per dose:
4
Control animals:
yes
Details on study design:
Animals were observed several times during the first 24 hours after dosing and once each workday thereafter for the duration of the test
(a total of 14 calendar days). Body weights were collected on the day of dosing and 1, 2, 3, 7, and 14 days after dosing.
All animals were necropsied . Animals which died after administration of the test article were necropsied promptly . All animals surviving the scheduled observation period were euthanetized and necropsied 14 days after test article administration.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
2 043 mg/kg bw
Based on:
test mat.
95% CL:
1 445 - 2 890
Mortality:
Dose (mg/kg b.w.):
90 mg/kg b.w.: 0/4
722 mg/kg b.w.: 0/4
1445 mg/kg b.w.: 0/4
2890 mg/kg b.w.: 4/4
Clinical signs:
weakness (90, 722, 1445 mg/kg b.w.)
prostration (2890 mg/kg b.w.)
Body weight:
All animals which survived the scheduled observation period gained weight. 14 of the 16 animals showed a minor decrease during the first 24 hours after dosing, but all surviving animals gained weight between 24 and 48 hours after dosing, and by 7 days, all had regained and exceeded their
original weights. All animals gained weight between 7 and 14 days after dosing.
Gross pathology:
90, 722 and 1445 mg/kg b.w. dose groups: no treatment-related changes were observed. No tissue was collected for microscopic examination.
2890 mg/kg b.w.: the cause of death for rats dying after exposure to the test material was not determined. Treatment-related changes consisted of compuond present in the duodenum(1/4), jejunum (3/4), ileum (3/4), cecum (4/4), colon (4/4) and fecal discoloration (1/4) and wetness (1/4) of the inguinal hair.

Applicant's summary and conclusion