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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Test material

Constituent 1
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system 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:
other: 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
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.