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 to EU / OECD guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007

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 material form:
solid: crystalline

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: tap water with the aid of 2% Cremophor EL
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
3 per dose
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 body weight died during the observation period. No deaths or moribound animals occured in the 300 mg/kg bw group.
Clinical signs:
2000 mg/kg bw : decreased motility, uncoordinated gait, labored breathing, piloerection, abdominal position, temporary creeping gait, closed eyelids, bloodcrusted snout, lateral position and bloody eyes.

A dose of 300 mg/kg body weight was tolerated by female rats without clinical signs.
Body weight:
A dose of 300 mg/kg body weight was tolerated by female rats without effects on body weight.
Gross pathology:
The gross pathology investigations revealed: liver dark-red; stomach hemorrhagic and indurate; kidneys dark-red.
A dose of 300 mg/kg body weight was tolerated by female rats without pathological findings.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to OECD guideline 423 the LD50 cut-off of the test item is 500 mg/kg bw. (Category 4 of the Globally Harmonized Classification System).