Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 December 1987 to 11 january 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 16 CFR Part 1500
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Charles River Breeding laboratories, Inc, Wilmington, MA- Age at study initiation: Young adult-Weight at study initiation: 224 to 316g- Fasting period before study: Overnight before day of dosing- Housing: Individually in wire mesh bottom cages- Diet (e.g. ad libitum): NIH Open Formula 07 (Zeigler Brothers) ad libitum- Water (e.g. ad libitum): tap water ad libitum- Acclimation period: Minimum of 5 daysENVIRONMENTAL CONDITIONSConformed to standards established in "Guide for the care and use of Laboratory animals" DHEW Publication No (NIH) 85-23.IN-LIFE DATES: From: 28 December 1987 To: 11 January 1988

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE- Concentration in vehicle: None, dosed as suppliedMAXIMUM DOSE VOLUME APPLIED: Not reported
Doses:
5000 mg/kg
No. of animals per sex per dose:
5/sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 Days- Frequency of observations and weighing: Three times on day of dosing, daily thereafter.- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight,
Statistics:
Not applicable

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No premature deaths were recorded. All animals survived to study termination (Day 15).
Clinical signs:
Decreased acitivity, diarrhea and apparent urinary incontinence were noted following dose administration. Three female rats exhibited hair loss on the hind legs. This finding started on days 5, 9 and 12, respectively, and continued to the end of the study for all three animals.
Body weight:
The test article administration did not cause an adverse effect upon mean body weight in either sex.
Gross pathology:
No gross lesions were noted in the five male and five female rats examined grossly at study termination.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material gave an LD50 value greater than 5000 mg/kg in the rat.
Executive summary:

Test Guidance

US EPA 16 CFR Part 1600.

Method

The test substance was administered by gavage to each of five male and five female Sprague-Dawley rats at a dose level of 5000 mg/kg body weight. The animals were observed for pharmacotoxic signs and mortality for 15 days.

Results

All animals survived the 15 day post-adminstration period.

Conclusion

The test material gave an LD50 value greater than 5000 mg/kg in the rat.