Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
6 February 1986 to 20 February 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Groups of 5 male and 5 female young adult Sprague Dawley rats.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
The test article was dissolved in 1% carboxy methylcellulose and a volume of 50 ml/kg was administered.
Doses:
0, 100, 500, 1000, 2500, or 5000 mg/kg CGA154281
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
The animals were observed for 14 days and deaths, clinical signs and body weights were recorded.
Statistics:
Not reported.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: based on 20% mortality in males (only) at 5000 mg/kg
Mortality:
One male dosed with 5000 mg/kg died on day 4.
Clinical signs:
Signs of systemic toxicity were observed at dose levels > 500 mg/kg and included hypoactivity, perineal staining, soft feces, and squinting. At dose levels > 2500 mg/kg, chromodacryorrhea, staining around the mouth and few feces were noted additionally. All surviving rats recovered within 5 days.
Body weight:
Body weight development was comparable between all groups, except of top dose animals (5000 mg/kg), for which a slightly decreased body weight gain was recorded during week 1.
Gross pathology:
At necropsy, no treatment-related findings were observed.

Any other information on results incl. tables

There were no clinical findings at 100 mg/kg. Clinical signs of toxicity were apparent at doses of 500 mg/kg or greater. At the high dose 5000 mg/kg one of five males died (20% mortality). There were no other deaths.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study, the LD50 was determined to be greater than 5000 mg/kg.
Executive summary:

Single oral doses of 100, 500, 1000, 2500 or 5000 mg/kg of benoxacor (CGA154281) were administered by gavage to groups of 5 male and 5 female rats. There were no clinical signs at 100 mg/kg. Signs of toxicity were apparent at doses of 500 mg/kg or greater. One of five males died at the 5000 mg/kg dose level. There were no other mortalities. The median lethal dose was greater than 5000 mg/kg in both sexes. Benoxacor was considered to be of low toxicity when given as a single oral dose to rats.