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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:
1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Toxic Substance Control Act (TSCA), 40 CFR, Part 798, Subpart A, General Toxicity Testing, Acute Oral Toxicity, 798.1175, July 1989
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): APD-1, 3
- Lot/batch No.: 227-124
- Analytical purity: No data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: USP sterile water for injection
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 5000 mg of the test substance was suspended in 10 mL USP sterile water for injection

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were determined prior to dosing and on the day of death or prior to terminal sacrifice. The frequency of observations is not reported.
- Necropsy of survivors performed: Yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 4/10 animals died within 24 hours after dosing
Mortality:
Four rats (4/10) died within 24 hours following administration of 5000 mg/kg bw.
Clinical signs:
Abnormal clinical signs were observed in all (10/10) animals; including piloerection and lethargy. The four animals that died showed abnormal signs at gross necropsy including discoloration of the kidneys, liver, spleen and small intestine and signs of hemorrhaging in the stomach. The local effects in the stomach were most likely caused by the alkaline pH of the test substance.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified