Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Crl:CD (SD)
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
Dose volume: 10 mL/kg, the actual dosing volume was adjusted based on the individual body weight before dosing.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Female: 2000 mg/kg bw; Number of animals: 6; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
No clinical signs of systemic toxicity were noted.

Orange faeces and urine was noted among all animals on day 2,
which was considered to be related to staining properties of
the formulation (orange colour).
Gross pathology:
Effects on organs:
No gross lesion was found in all animals.

Any other information on results incl. tables

Gross Necropsy
  Animal ID.       Results    
1120150023 No gross lesion was observed
1120150014
1120150022
1120150007
1120150006
1120150016

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
Based on the data obtained from this study, the test article of Everzol SB44 would be assigned to GHS Category 5/unclassified and the harmonized
LD50 cut-off value is above 2000 mg/kg body weight.