Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 January 1991 to 08 February 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:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):T-5333
- Substance type: Clear colorless liquid
- Storage condition of test material: Stored at room temperature

Test animals

Species:
rat
Strain:
other: Albino, Crl:CDBR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Inc., Portage MI
- Age at study initiation: Young adult
- Weight at study initiation: 208 to 240 g
- Fasting period before study: 17 to 20 hours before exposure
- Housing: Group cages by sex
- Diet (e.g. ad libitum): Rodent Chos #5001, Purina Mills, Inc. ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 14.4-25.6
- Humidity (%): 23-45
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 25 January 1991 To:08 February 1991

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5.0 g/kg bw
No. of animals per sex per dose:
5 male and 5 female
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs and mortality checks were conducted at 1, 2.5, and 4 hours after test article administration. The animals were observed dialy thereafter for 14 days for clinicals signs and twice a day (morning and afternoon) for mortality. Body weights were determined before test article administration (day 0), at day 7, and at Day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,gross necroscopy.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: fixed dose used
Effect level:
ca. 5 other: g/kg bw
Remarks on result:
other: All animals appeared clinically normal throughout the study after administration of 5.0 g/kg bw of the test article.
Mortality:
No mortality occured
Clinical signs:
No abnormal observations recorded
Body weight:
Body weight and weight gains were normal for test animals
Gross pathology:
No visible lesions in any test animals

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
All animals appeared clinically normal throughout the study. No legions were visible following gross necroscopy of all test animals. The test article is considered practically nontoxic by oral exposure at the dose administered (5.0 g/kg bw).
Executive summary:

An acute oral toxicity study was conducted according to OECD guideline 420. 5 male and 5 female acclimated albino rats were selected and maintained during the study in the same manner. Each test animal was administered an individual dose of the undiluted test article based upon its fasted body weight and administered by gavage. The test material was administered at a dose of 5.0 g/kg of body weight. Clinical signs and mortality checks were conducted at 1, 2.5, and 4 hours after test material administration. The animals were observed daily thereafter for 14 days for clinical signs and twice a day (morning and afternoon) for mortality. body weights were determined before test material administration (Day 0), at Day 7, and at termination of the experimental phase (Day 14). All animals appeared clinically normal throughout the study after administration of the test article. Gross necropsy of all animals revealed no visible lesions or abnormalities. All animals exhibited normal weight gain throughout the study. The estimated oral LD50 for males and females was determined to be greater than 5.0 g/kg. The test article is considered practically nontoxic by oral exposure at the does administered (5.0 g/kg bw).