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 guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: polyethylene glycol
Doses:
2000 mg/kg
No. of animals per sex per dose:
6
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
other: LD50 cut-off
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
discriminating dose
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths
Clinical signs:
No clinical signs
Body weight:
no effects on weight gain
Gross pathology:
no findings
Other findings:
none

Any other information on results incl. tables

Dose (mg/kg bw) Toxicological results  Onset and duration of signs  Onset of mortality
(1st) 2000 0 / 0/ 3 --- --- 
(2nd) 2000 0 / 0/ 3 --- --- 

Toxicological results:

number of dead animals / number of animals with signs after treatment / number of animals treated

Applicant's summary and conclusion

Executive summary:

The LD50 cut-off value is > 5000 mg/kg bw based on the result of a study performed according to OECD TG 423. The test dose of 2000 mg/kg was tolerated without any findings.