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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labeling and/or risk assessment
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970

Materials and methods

Principles of method if other than guideline:
Acute oral toxicity test with rat
GLP compliance:
no
Test type:
other:

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: not reported

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Adult Rats: weight at study initiation: 130-175 g; Age at study initiation: not reported
- Neonatal Rats: weight at study initiation: 6 - 9 g; Age at study initiation: not more than 24 hours old


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: suspended in 5% gum acacia solution (with and without tracer dye)
Details on oral exposure:
DOSAGE PREPARATION: Adult rats: The compound was ground in a mortar, suspended in 5% gum acacia solution and administered orally; Neonatal rats: The compound was suspended in 5% gum acacia solution containing a tracer dye and administered orally with a 20 gauge needle.

Doses:
highest dose tested 4000 mg/kg
No. of animals per sex per dose:
10 per dose level
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 5 days
- Frequency of observations and weighing: daily

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
none reported

Any other information on results incl. tables

No mortality at highest dose tested (4000 mg/kg).

Applicant's summary and conclusion

Conclusions:
This study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability).
LD50 > 4000 mg/kg
Executive summary:

The adult and neonatal rat oral LD50 of the test substance was determined to be greater than 4000 mg/kg/body weight.