Registration Dossier

Diss Factsheets

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:
2002

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
4-chloro-6-(2-chlorophenoxy)-5-fluoropyrimidine
Cas Number:
213265-81-7
Molecular formula:
C10H5Cl2FN2O
IUPAC Name:
4-chloro-6-(2-chlorophenoxy)-5-fluoropyrimidine

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: demineralized water with 2 % Cremophor EL
Doses:
200 and 2000 mg/kg body weight (bw)
No. of animals per sex per dose:
3 male rats; 3 female rats
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 300 - < 500 mg/kg bw

Any other information on results incl. tables

A dose of 200 mg/kg body weight was tolerated by male and female rats without mortalities. Decreased motility and increased salivation were observed in females of this dose group, and in one male motility was decreased.

At 2000 mg/kg motility was increased, gait uncoordinated, breathing labored, salivation increased, and piloerection, lateral position, temporary convulsions and temporary clonical cramps were observed. In one female red discolored salivation occurred. All females of this group died up to 5 hours after administration.

The body weight and the body weight development of males and females were not affected by the treatment.

The gross pathology investigations performed at the end of the post-treatment observation period did not afford 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