Registration Dossier

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:
other: GLP study according EU/OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: demineralized water with Cremophor EL 2% (V/V).
Doses:
male: 10, 100, 500, 1000, 3000, 4000, 4500, 5000 mg/kg bw
female: 500, 1000, 3000, 3150, 3500, 4000, 5000 mg/kg bw
No. of animals per sex per dose:
5 animal per sex and dose
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
3 574 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
4 378 mg/kg bw

Any other information on results incl. tables

For the male rats, an approximate LD50 of 4378 mg/kg b.w. was determined, and for the females an LD50 of 3574 (3169 - 4033) mg/kg b.w. The main signs of intoxication were generally conspicuous and were as follows: apathy, rough coats, reduced motility, tachypnea and labored breathing, staggering and/or spastic gait, salivation (occasionally red), narrowed palpebral slits, periodic twitching, loss of weight, emaciation, spasms, prostration, pallor, digging behavior, splayed rear legs, red nasal discharge, red-encrusted snouts, increased urine discharge, increase water intake, damp anus, light-colored and soft feces, vocalization on touching (F), red-encrusted front paws (F) and yellow-colored bedding at urination sites. These signs occurred shortly after administration and lasted among the males until max. day 11 and among the females until max. day 18 of the study. A dose of 10 mg/kg b.w. was tolerated by the males and a dose of 500 mg/kg b.w. by the females without signs occurring.

Applicant's summary and conclusion

Conclusions:
The test article was of low toxicity following acute oral administration to male and female rats.