Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983

Materials and methods

Principles of method if other than guideline:
Method: other: similar to OECD 401 and OPPTS 870.110
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: as prescribed by 1.1 - 1.4

Test animals

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

Administration / exposure

Doses:
50, 100, 150, 250, 500 and 5000 mg/kg bw
No. of animals per sex per dose:
60

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
193.6 mg/kg bw

Any other information on results incl. tables

RS-Freetext:
Clinical Observations:  Gross signs and symptoms of toxicity
exhibited by all rats dosed at 50 and 100 mg/kg bw included only slight  depression on Day 1.  Clinical signs
observed in male and female animals after treatment with 150
mg/kg bw included rough coat, depression, slight depression,
salivation, soft feces, urine stains, red stains on the nose
and/or eyes, ataxia, convulsions, phonation, tremors,
prostration, and labored respiration on Day 1.  Female
animals continued to demonstrate rough coat, slight
depression, and urine stains through Day 2.  All female and
male animals died within 4 hours of treatment with 250, 500,
5000 mg/kg bw with the exception of one male animal that
completely recovered by Day 5.  All surviving rats appeared
normal by termination, and all but one gained or maintained
the same weight.  All the rats that died lost weight (range
1-7g) except one which maintained the same weight.

Gross Pathology:
There were no gross pathological findings noted in rats
surviving to termination. Findings among the rats that were
found dead included dark red lungs, compound-like material
in the stomach and/or intestines, and reddish fluid in the
intestines.

Sex: LD50 (mg/kg bw) (95% Confidence Limits)

Male: 206.4 mg/kg bw (149.0 to 285.9)

Female: 181.7 mg/kg bw (132.6 to 248.9)

Combined: 193.6 mg/kg bw (154.2 to 243.2)

Applicant's summary and conclusion

Conclusions:
CL-Freetext:
Oral LD50 is 193.6 mg/kg bw.