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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:
05 December 1991 to 19 December 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report: T-5452
- Substance type: Clear liquid
- Physical state: Clear liquid

Test animals

Species:
rat
Strain:
other: Hsd: Sprague Dawley SD
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Sprague Dawley, Madison, WI, USA
- Age at study initiation: Approximately 8 to 12 weeks old
- Weight at study initiation: 202-286g
- Fasting period before study: 17-20 hours before test material administration
- Housing: Housed by sex in groups of five and identified by animal number and corresponsding ear tag.
- Diet (e.g. ad libitum): Rodent Chow # 5001, Purnia Mills, Inc. ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C); 21.1-22.8
- Humidity (%): 36-43
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: 05 December 1991 To: 19 December 1991

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.98 mL/kg body weight
Doses:
A single dose of 5.0 g/kg body weight was administered by oral gavage.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 2.5, and 4 hours after dosing, then daily thereafter for the remainder of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy

Results and discussion

Preliminary study:
None
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: A single dose of 5000 mg/kg (5.0 g/kg) was administered by oral gavage.
Mortality:
No mortality was observed in the study.
Clinical signs:
All animals appeared normal throughout the study with the exception of two male animals which exhibited soft stool on the day of treatment.
Body weight:
All animals exhibited body weight gain throughout the study.
Gross pathology:
There were no visible lesions in any of the animals.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The oral LD50 for the test article is considered to be >5000 mg/kg body weight.
Executive summary:

The acute oral toxicity of the test article was evaluated in male and female Hsd: Sprague Dawley SD rats when administered as a single oral gavage dose at a level of 5.0 g/kg of body weight (2.98 mL/kg body weight dose volume). Clinical observations and mortality checks were conducted at approximately 1, 2.5, and 4 hours after test material administration. Additional clinical observations and twice daily mortality checks (a.m. and p.m.) were conducted daily thereafter for 14 days. Body weights were determined before test material administration (Day 0), at Day 7, and at termination of the experimental phase (Day 14). At termination of the experimental phase, all animals were euthanized, subjected to gross necropsy examination. All animals appeared normal throughout the study with the exception of two male animals which exhibited soft stool on the day of treatment. All animals exhibited body weight gain throughout the study. The estimated oral LD50 for male and females was determined to be greater that 5000 mg/kg body weight.