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 study according EU/OECD guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Doses:
300 and 2000 mg/kg body weight (bw)
No. of animals per sex per dose:
3 female rats
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals dosed with 2000 mg/kg bw died during the observation period.
Clinical signs:
Clonical cramps, tremor, labored breathing, lateral position and gasping.
Body weight:
No effects on body weight gain in the 300 mg/kg bw dose group.
Gross pathology:
The necropsy did not reveal any treatment-related findings.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

LD50 oral: >300 mg/kg bw- equivalent to Category 4 of the GHS (>300-2000) and

LD50 cut off 500 mg/kg bw according to OECD Test Guideline 423.