Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Principles of method if other than guideline:
A group of male white rats was treated with a single dose of 5000 mg/kg b.w test substance, diluted with DMSO and administered by oral intubation.
GLP compliance:
no
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
DMSO
Details on oral exposure:
VEHICLE
-Amount of vehicle: 1.5 ml/100 g b.w.
Doses:
5000 mg/kg
No. of animals per sex per dose:
n.a.
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
The LD50 (rat, oral) was found to be > 5000 mg/kg b.w.
Executive summary:

The oral acute toxicity study was performed according to an internal method: a group of male white rats was treated with a single dose of 5000 mg/kg b.w. test substance, diluted with DMSO and administered by oral intubation.

The acute oral LD50 of the substance in rats was found to be more than 5000 mg/kg b.w..